i-bytes Healthcare Industry

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I-Bytes
Healthcare
September Edition 2020
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Table of Contents
1. Financial, M & A Updates...................................................................................................................................1
2. Solution Updates..................................................................................................................................................5
3. Rewards and Recognition Updates..................................................................................................................64
4. Customer Services.............................................................................................................................................69
5. Partnership Ecosystem Updates......................................................................................................................73
6. Miscellaneous Updates.....................................................................................................................................86

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Financial, M & A
Updates Healthcare Industry

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Financial, M&A Updates
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Grifols (Spain) to acquire Alkahest to enhance discovery research and development to identify innovative
therapies for age-related diseases based upon an understanding of the human plasma proteome
Grifols, a leading global producer of plasma-derived medicines and a leader in the development
of innovative diagnostic solutions, announced it has entered into a transaction to acquire the
remaining equity of Alkahest, Inc. in exchange for a total price of $146 million, on a debt-free
basis. No additional financing will be required. The closing of the transaction is subject to the
approval by the relevant antitrust authorities and is expected to close in early 2021. The Silicon
Valley-based biotechnology company was founded upon research into the therapeutic use of
plasma proteins in combating diseases associated with aging as identified in the Stanford
University laboratory of Professor of Neurology at Stanford and co-founder and board member
of Alkahest. In addition to the clinical development of specific plasma fractions and protein
inhibitors, Alkahest is focused on developing a complete understanding of the human plasma
proteome. This unique proteomic platform of targets will help Grifols and Alkahest to unlock
new therapeutics and diagnostics, develop new plasma proteins, new indications for currently
licensed plasma proteins, biomarkers for diagnostics, recombinant proteins and antibodies as
well as small-molecule drugs. Understanding the plasma proteome is the key to Alkahest’s
comprehensive discovery and development platform delivering transformational therapeutics.
Alkahest, as a wholly owned subsidiary within the Grifols innovation office (GIANT), will focus
on proteins with biological impact that change with age. Thus far, more than 8,000 separate
proteins have been identified by Alkahest and using advanced techniques of molecular analysis
at the cellular level, an array of new products are expected to enter Grifols’ discovery and
development pipeline and bring new therapeutic medicines to market.
Executive Commentary
“We saw the promise of Alkahest’s understanding of aging when we made our first
investment and entered into a collaboration agreement with them five years ago,” said
Co-CEO of Grifols. “Now we see a wealth of plasma-derived and non-plasma therapeutic
candidates identified by Alkahest that can significantly support the unmet needs of many
diseases associated with aging.”
Description
1

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Labcorp (USA) Acquires Clinical Ambulatory Laboratory Business of Franciscan Missionaries of Our
Lady Health System
LabCorp, a leading global life sciences company that is focused on advancing health
and guiding patient care decisions, and Franciscan Missionaries of Our Lady Health
System (FMOLHS), announced that they entered into a comprehensive laboratory
services relationship that will expand services in Louisiana and Mississippi. LabCorp
has acquired FMOLHS’clinical ambulatory laboratory business and select assets and
will provide reference testing for all FMOLHS facilities and clinics. FMOLHS is one
of the largest health systems in Louisiana, with hospitals, clinics and physicians
located throughout Louisiana and in Mississippi. Almost half of Louisiana’s citizens
receive care at FMOLHS facilities. Headquartered in Baton Rouge, Louisiana,
FMOLHS serves patients through a network of hospitals, clinics, physicians, and
post-acute services, supported by integrated information systems.
“LabCorp is excited to expand our geographic presence and to provide
world-class laboratory services to clinicians and patients across Louisiana and in
Mississippi,” said, senior vice president for LabCorp Diagnostics’ Southeast
Division. “We deeply appreciate FMOLHS’ long-standing, 100-year history of
providing high-quality care to patients in the communities it serves, and we look
forward to building a deep and strong collaboration with FMOLHS, especially at
this time when laboratory testing is more important than ever.”
Description
2

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Sanofi (France) to commence tender offer for acquisition of Principia
Biopharma Inc.
Sanofi announced that it intends to commence a tender offer to acquire all of the outstanding shares of common stock of Principia Biopharma Inc.
for $100 per share in cash, without interest thereon and net of any applicable withholding taxes. The Offer is being made pursuant to the
Agreement and Plan of Merger, dated as of August 16, 2020, by and among Principia, Sanofi and Kortex Acquisition Corp., a Delaware
corporation and an indirect, wholly owned subsidiary of Sanofi (“Purchaser”). The Offer is scheduled to expire one minute past 11:59 p.m.,
Eastern Time, on Friday, September 25, 2020, unless the Offer is extended in accordance with the Merger Agreement and the applicable rules and
regulations of the U.S. Securities and Exchange Commission (the “SEC”). The consummation of the Offer is subject to customary closing
conditions, including the tender of at least a majority of the outstanding shares of Principia common stock, the expiration or termination of the
waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary conditions. Following the successful
completion of the Offer, Purchaser will merge with and into Principia pursuant to Section 251(h) of the General Corporation Law of the State of
Delaware, with Principia continuing as the surviving corporation and becoming an indirect, wholly-owned subsidiary of Sanofi (the “Merger”).
At the effective time of the Merger, the outstanding shares of common stock of Principia not tendered in the Offer will be converted into the right
to receive the same $100 per share in cash that they would have received had they tendered their shares in the Offer.
Description
3

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Takeda (Japan) Divests Select Non-Core Assets in Europe to Cheplapharm for Approximately
$562 million USD
Takeda Pharmaceutical Company Limited announced that it has entered into an
agreement to divest a portfolio of select non-core prescription pharmaceutical products
sold predominantly in Europe and Canada to Cheplapharm. Cheplapharm is a specialty
pharmaceutical company headquartered in Germany with a 25-year history of
successfully acquiring, integrating and growing pharmaceutical products. Takeda will
receive an upfront payment of approximately $562 million USD, subject to customary
legal and regulatory closing conditions. The portfolio to be divested to Cheplapharm is
comprised of non-core prescription pharmaceutical products in a variety of therapeutic
categories sold predominantly in Europe and Canada. This includes
Cardiovascular/Metabolic and Anti-Inflammatory products along with Calcium. The
portfolio generated FY 2019 net sales of approximately $260 million USD. While the
products included in the sale address key patient needs in these countries, they are
outside of Takeda’s five key business areas. With a more focused portfolio, the
divestiture further enables Takeda’s Europe & Canada Business Unit (EUCAN) to focus
on and drive strategic core growth areas. In April 2020, Takeda announced to divest
EUCAN’s non-core over the counter (OTC) products to Orifarm Group.
President, EUCAN, Takeda, said, “These divestments represent another important
milestone in our portfolio simplification and optimization strategy as we position
Takeda for continued success across our five key business areas: Gastroenterology
(GI), Rare Diseases, Plasma-Derived Therapies, Oncology and Neuroscience. We
are pleased to have found a partner in Cheplapharm who shares our commitment to
patient care and has the experience and resources to continue investing in these
important products well into the future for the benefit of patients.”
Description
4

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Solutions Updates
Healthcare Industry

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AbbVie (USA) Submits Regulatory Application to FDA for RINVOQ™ (upadacitinib)
for the Treatment of Adults with Active Ankylosing Spondylitis
5
Solution Description
AbbVie announced that it has submitted an application for a new indication to the U.S. Food and Drug Administration (FDA) for
RINVOQ™, a selective and reversible JAK inhibitor, for the treatment of adult patients with active ankylosing spondylitis. AbbVie also
submitted an application to the European Medicines Agency (EMA) for RINVOQ earlier this year for the treatment of adult patients with
active ankylosing spondylitis who have responded inadequately to conventional therapy. The applications to the FDA and EMA are
supported by data from SELECT-AXIS 1, a Phase 2/3 study in which RINVOQ demonstrated significant improvements in signs and
symptoms in patients with active ankylosing spondylitis.1 In this study, twice as many patients receiving RINVOQ (52 percent) met the
primary endpoint of Assessment of SpondyloArthritis International Society (ASAS) 40 response versus placebo (26 percent) at week 14
(p<0.001).1 The safety profile of RINVOQ in ankylosing spondylitis was consistent with previously reported studies across therapeutic
areas, including rheumatoid arthritis, atopic dermatitis and psoriatic arthritis, with no new significant safety risks detected. Ankylosing
spondylitis is a chronic, progressive, inflammatory musculoskeletal disease impacting more than five million people worldwide.5,6 The
range of symptoms pose significant physical, psychological and economic burden on individuals impacted by the disease.

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Hitachi Constructs Japan’s First Platform for Integrated Management of Cell and Tracing Information throughout the
Value Chain for Regenerative Medicine Products through Collaborative Creation with Alfresa and Others
6
Hitachi, Ltd. has constructed a platform for the integrated management of cell and tracing information throughout the value chain, from cell collection, through production and
transport, to the administration of regenerative medicine products(1) through collaborative creation with Alfresa Corporation (“Alfresa”), pharmaceutical companies, medical
institutions, and others. Hitachi will start practical operation of the platform in 2021 following an operational test and Alfresa will be one of the first users of the platform. The platform
will individually identify and trace samples, throughout the processes of cell collection, transportation, and administration of regenerative medicine products that require strict quality
control and information traceability. It is the first common service infrastructure for regenerative medicine products in Japan that involves all stakeholders throughout the value chain
(medical institutions, pharmaceutical/logistics/manufacturing companies). The platform will eliminate the need for each company to maintain its own management system, reduce the
complication of management arising from differences between businesses’ systems, and enable unified data management. As a result, it drives prompt, safe and secure execution of
business. Hitachi will use this platform to support the healthcare and pharmaceutical industries as one of its Lumada solutions for accelerating digital innovation, explore potential
applications for specialty pharmaceuticals that require rigorous information management in the distribution and aim for overseas deployment. Moreover, Hitachi will contribute to
improving the social, environmental and economic value of its global customers in these industries and a better Quality of Life for everyone. Alfresa distributes products such as ethical
pharmaceuticals, medical devices/materials, and diagnostic reagents to medical institutions including hospitals, clinics, and dispensing pharmacies while fully controlling quality and
ensuring reliability and safety. The company owns 13 logistics/pharmaceutical centers and is one of the key operating companies of the Alfresa Group, which is Japan’s top wholesaler
of ethical pharmaceuticals. Making use of a substantial expertise and know-how that have been cultivated through the distribution of pharmaceutical products, Alfresa has established
a high-quality distribution system in a specialty pharmaceutical field requiring strict temperature control and the traceability of each product.

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Align Technology (USA) Extends Innovation With New Invisalign Stickables – Designed To Personalize Invisalign®
Clear Aligners
7
Align Technology, Inc. announced the launch of Invisalign® Stickables, innovative sticker accessories designed exclusively for use with the
patented SmartTrack® material in Invisalign clear aligners. Available in an array of designs, colors, shapes and themes, Invisalign Stickables are
a cool, engaging and fun way for patients to show their personal flair during Invisalign treatment. Starting with young patients, Invisalign
Stickables are initially available in 10 fun themes, including fantasy and gaming, shapes and colors, sports and activities, travel and transit, emojis
and faces, animals and nature, letters and numbers, party and holidays, foods and sweets, and basic shapes and images, with more options available
soon. The sticker and applicator are made from a water-resistant multi-layer plastic material and biocompatibility tested. Invisalign® Stickables
have been optimized to use with SmartTrack® Invisalign aligner material. Invisalign Stickables patent-pending accessories are available now in
the US and Canada and will be introduced in other countries in 2021. Invisalign providers can purchase Invisalign Stickables through the Webstore
in Invisalign Doctor Site.

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IntrinsiQ Specialty Solutions Launches UroChartEHR® Telehealth to Offer Urologists a
HIPAA-Compliant Virtual Visit Tool
8
IntrinsiQ Specialty Solutions, a part of AmerisourceBergen, announced the launch of UroChartEHR Telehealth, a new HIPAA-compliant, virtual visit tool
created in partnership with Backline by DrFirst. The solution allows urologists to quickly extend patient care beyond the traditional doctor’s office and
connect with each other and with patients from any location at any time. With UroChartEHR Telehealth, urology patients now have the added convenience
of seeking in-home care with quick and easy access to their virtual visit via a mobile phone, tablet, or computer – eliminating the need to download an app,
access a patient portal, or undergo a registration process. UroChartEHR Telehealth is offered as an extended feature of UroChartEHR. With UroChartEHR
Telehealth, practices, caregivers, and patients now have access to the following features:
• Video-Enabled Patient Care: Quick check-ins with simple-to-use video chats to help reduce no-shows, ensure adherence with medication protocols and
allow for remote patient diagnostics
• Comprehensive Communication Technology: Streamlined communication and documentation processes for virtual visits and secure texting and email to
initiate telehealth sessions with patients
• Integrated Patient Information: Fully integrated seamless data flow of patient demographic data allowing telehealth visits to get started quickly,
automatically updating visit notes each time the program is launched
• Reimbursement Support: Date and timestamp for video chatting that can be added to Common Procedural Technology (CPT) codes for a seamless
reimbursement process and simplified Medicare reimbursements and billing

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New Amgen (USA) Data To Be Presented At ESC Congress 2020 Highlighting Repatha®
(evolocumab) Efficacy In High-Risk Patient Populations
9
Amgen announced the presentation of 12 cardiovascular scientific research abstracts, including clinical trial and real-world evidence studies of Repatha®
(evolocumab), that add to the growing body of evidence demonstrating the efficacy and safety of Repatha and the importance of managing high-risk patients
in accordance with global treatment guidelines. The data will be presented at ESC Congress 2020 – The Digital Experience, organized by the European
Society of Cardiology, Aug. 29–Sept. 1. Notable abstracts include data from the first randomized controlled Phase 3 study of a PCSK9 inhibitor, Repatha, in
pediatric patients with heterozygous familial hypercholesterolemia (HeFH), which will be presented as a late-breaking abstract in an oral presentation. HeFH
is a genetic disorder that affects approximately 1 in 250 individuals globally and results in high levels of low-density lipoprotein cholesterol (LDL-C) at a
very young age despite treatment with statins and other cholesterol-lowering therapies.1,2 With HeFH, there is an accelerated development and increased
lifetime risk of atherosclerotic cardiovascular disease (ASCVD).3 Aseparate study across 18 European countries described how lipid-lowering therapy (LLT)
is used for primary and secondary prevention of ASCVD and assessed how current practice impacts LDL-C goals recommended by the ESC/EAS guidelines.
A third study across 10 European countries evaluated the reduction of LDL-C by the real-world use of Repatha in patients at very high-risk for a
cardiovascular event and simulated the associated 10-year cardiovascular risk and risk reduction relative to baseline.

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Amgen (USA) Announces Positive Data from Phase 3B Study Of Repatha® (Evolocumab) In Pediatric
Patients With Heterozygous Familial Hypercholesterolemia At ESC Congress 2020
10
Amgen announced positive data from the HAUSER-RCT Phase 3b study evaluating the safety and efficacy of Repatha® (evolocumab) in pediatric patients,
10-17 years of age, with heterozygous familial hypercholesterolemia (HeFH). The study showed that Repatha, in combination with statins and other
lipid-lowering therapies, significantly reduced low-density lipoprotein cholesterol (LDL-C) compared to placebo. These data are being presented during an
oral presentation at ESC 2020 – The Digital Experience, organized by the European Society of Cardiology, Aug. 29–Sept. 1 and simultaneously published in
The New England Journal of Medicine. HeFH is an inherited, genetic condition with a prevalence of one in 250 people worldwide.1 High levels of
low-density lipoprotein cholesterol (LDL-C) starting at birth accelerate the development of atherosclerotic cardiovascular disease, leading to an overall
increased risk of cardiovascular events, including heart attack and other vascular conditions, and decreasing the age at which such events occur.2 Children
with FH can be normal weight, have a good diet, exercise enough, and still have high LDL-C.2,3 The risk of heart disease in people with FH is about 20 times
greater versus the general population. Results from the randomized, double-blind 24-week study show that in pediatric patients with HeFH, monthly
treatment with Repatha reduced LDL-C by mean 38.3% from baseline compared to placebo, and absolute reduction in LDL-C was 68.6 mg/dL (mean
absolute reduction) meeting its primary endpoint and showing superiority of evolocumab administered on top of statins.

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Astellas Pharma Inc. (Japan): Science-Based Fitness Service, Fit-eNce®
11
Astellas Pharma Inc. announced that it will start accepting advance applications and taking reservations for its exercise support service Fit-eNce®1, which encourages
continous implementation of science-based exercise programs2. The service is planned to be offered in limited areas from September 1 through fitness clubs in Kanagawa
Prefecture. Exercise therapy is reported to be beneficial as a treatment for various diseases including type 2 diabetes. However, it is often difficult for physicians to offer
specific guidance on exercise therapy or to be aware of all of the exercises that a patient performs. Meanwhile, it is difficult for patients to know which exercise programs
are appropriate and to maintain the motivation to exercise, which brings challengeｓ in starting and continuing exercise. Fit-eNce® is a new exericse support service
designed to resolve these issues by helping patients to continuously implement science-based exercise programs under the guidance of physicians. With this service,
patients who have been referred to the service by a physician submit an application to enroll in the service through a dedicated smartphone app and receive physician
approval for use of the service. Patients then register with the affiliated fitness club to begin exercising. At the fitness club, trainers will suggest a lineup of exercises
tailored to the patient’s physical condition (age, muscular strength, physical strength, etc.) , on the basis of science-based exercise programs that combine aerobic exercise
with resistance exercise (repetitive exercises that exert resistance on target muscles) for the patient to perform. Patients will be able to share their exercise records with
their physician through the smartphone app, and physicians will be able to check their patients’ frequency of fitness club use, exercise history, and goal achievement on
a dedicated website. By using this website to check on their patients’ daily exercise status and enhancing communication, it allows the physicians to support patients in
contuining to exercise.

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AstraZeneca’s (UK) Imfinzi approved in the EU for the treatment of extensive-stage small cell
lung cancer
12
AstraZeneca’s Imfinzi has been approved in the European Union for the 1st-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC)
in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin. SCLC is a highly aggressive, fast-growing form of lung cancer
that typically recurs and progresses rapidly despite initial response to chemotherapy. The approval by the European Commission was based on positive results
from the Phase III CASPIAN trial showing Imfinzi plus chemotherapy demonstrated a statistically significant and clinically meaningful overall survival (OS)
benefit for the 1st-line treatment of patients with ES-SCLC. It follows the recommendation for approval by the Committee for Medicinal Products for Human
Use of the European Medicines Agency in July 2020. The CASPIAN trial met the primary endpoint of OS for Imfinzi plus chemotherapy in June 2019,
reducing the risk of death by 27% versus chemotherapy alone (based on a hazard ratio [HR] of 0.73; 95% confidence interval [CI] 0.59-0.91; p=0.0047), with
median OS of 13.0 months versus 10.3 months for chemotherapy alone. These results were published in The Lancet in 2019.3 Results also showed an
increased confirmed objective response rate for Imfinzi plus chemotherapy (68% versus 58% for chemotherapy alone) and that Imfinzi added to
chemotherapy delayed the time for disease symptoms to worsen.

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Statement on AstraZeneca (UK) Oxford SARS-CoV-2 vaccine, AZD1222, COVID-19 vaccine
trials temporary pause
13
As part of the ongoing randomised, controlled clinical trials of the AstraZeneca Oxford coronavirus vaccine, AZD1222, a standard review process has been
triggered, leading to the voluntary pause of vaccination across all trials to allow an independent committee to review the safety data of a single event of an
unexplained illness that occurred in the UK Phase III trial. This is a routine action which has to happen whenever there is a potentially unexplained illness in
one of the trials, while it is investigated, ensuring we maintain the integrity of the trials. In large clinical trials, illnesses will happen by chance and must be
independently reviewed. AstraZeneca is working to expedite the review of the single event to minimise any potential impact on the trial timeline. We are
committed to the safety of our participants and the highest standards of conduct in our trials. AZD1222 was co-invented by the University of Oxford and its
spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that
causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is
produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body. AstraZeneca (LSE/STO/NYSE: AZN) is a global,
science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the
treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK,
AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

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Baxter (USA) Announces U.S. FDA De Novo Authorization for Theranova Dialyzers Enabling
HDx Therapy
14
Baxter International Inc., a global innovator in renal care, announced the U.S. Food and Drug Administration (FDA) has granted the De Novo application for
Theranova, the company’s novel dialysis membrane. Theranova was designed to deliver expanded hemodialysis (HDx) therapy, which filters a wider range
of molecules from the blood than traditional hemodialysis (HD) filters, like high-flux membranes, by targeting effective removal of conventional (500 Da to
25 kDa) and large middle molecules (25 kDa to 45 kDa) 3,4,5. These middle molecules may be associated with inflammation and cardiovascular disease in
patients with kidney failure. By granting a De Novo application, the FDA is establishing a new class of dialyzer technology with unique performance
standards. The FDA utilizes the De Novo pathway for low and moderate risk medical devices that have no existing predicate in the United States; such
designations are rare in the dialysis space. In fact, less than 1% of devices granted marketing authorization under De Novo have been for the care of patients
with kidney failure since the pathway’s inception in 1997. HDx is performed the same way as conventional HD, with only a change of the dialyzer membrane
required. Once in the machine, the Theranova dialyzer’s innovative Medium Cut-Off® membrane combines high permeability and selectivity for uremic
toxins (up to 45 kDa), while retaining essential proteins and maintaining albumin levels during treatment. This unique cut-off and high retention onset profile
expands clearance, allowing for filtration closer to that of the natural kidney.

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BioMarin (USA) Announces The Lancet Publishes Detailed Vosoritide Phase 3 Data Demonstrating Statistically
Significant Increase in Annualized Growth Velocity (AGV) Over 52 Weeks in Children with Achondroplasia
15
BioMarin Pharmaceutical Inc. announced that The Lancet has published online results from a randomized, double-blind, phase 3, placebo-controlled,
multicenter trial for vosoritide, an investigational analog of C-type Natriuretic Peptide (CNP), in children aged 5 to 18 years with achondroplasia.
Achondroplasia is the most common form of disproportionate short stature in humans. The data demonstrated that daily subcutaneous administration of
vosoritide to children with achondroplasia resulted in significantly increased growth velocity and height Z scores over baseline after one year of treatment as
compared to those who received placebo with similar adverse effect profiles. The primary endpoint was change from baseline in AGV at 52 weeks in
participants administered daily subcutaneous injections of vosoritide, at a dose of 15.0 µg/kg/day, compared with placebo. The findings demonstrated that
the adjusted mean difference in AGV between children in the vosoritide group and placebo group was 1.57cm per year in favor of vosoritide (95% CI: 1.22
- 1.93, p value <0·0001), a substantial proportion of the approximately 2 cm/yr AGV deficit relative to average-stature children. The results of subgroup
analyses for change from baseline in AGV were consistent with the overall mean difference between treatment groups in favor of vosoritide, with all 95%
CIs overlapping.

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Boston Scientific (USA): CMS Grants Additional Reimbursement For The Eluvia™ Drug-Eluting Vascular
Stent System
16
Boston Scientific announced that the U.S. Centers for Medicare and Medicaid Services (CMS) granted a New Technology Add-on Payment (NTAP) for the
Eluvia™ Drug-Eluting Vascular Stent System as part of the 2021 Inpatient Prospective Payment System (IPPS). The NTAP designation, awarded to new
medical devices determined to substantially improve the diagnosis or treatment of Medicare beneficiaries, will be effective on October 1, 2020 and will
provide eligible hospitals with incremental reimbursement for the Eluvia stent system for up to three years. The Medicare criteria for an NTAP designation
is based on newness of the device, cost and a substantial clinical improvement. The Eluvia stent system was developed for the treatment of peripheral artery
disease (PAD) – the narrowing of the arteries of the legs due to plaque buildup – which affects approximately 8.5 million people in the United States and
more than 200 million people worldwide.[i],[ii] Left untreated, PAD restricts blood flow to the legs and feet and patients often experience pain, swelling and
a diminished quality of life. The Eluvia stent re-opens the blocked artery and restores blood flow, while also utilizing a drug-polymer combination to offer a
sustained, low-dose release of drug to prevent tissue regrowth within the stented artery. The NTAP designation will support access to the Eluvia stent for
Medicare beneficiaries in the hospital inpatient setting, making it possible for eligible hospitals to receive NTAP payment in addition to the standard
Medicare Severity Diagnosis Related Group (MS-DRG) payment.

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Boston Scientific (USA) Launches Vercise Genus™ DBS System In Europe
17
Boston Scientific Corporation announced it has received CE Mark and initiated a limited market release of the fourth generation Vercise Genus™ Deep Brain
Stimulation (DBS) System in Europe. Featuring full-body MRI conditional1 and Bluetooth capabilities across the portfolio, the Vercise Genus System is indicated
to treat the symptoms of Parkinson's disease (PD), essential tremor, and dystonia by delivering precisely targeted electrical stimulation in the brain designed to
provide optimal symptom relief. Vercise Genus adds features for patients, including a low-profile two-in-one extension with the option of abdominal placement.
New clinician software optimizes programming with integrated visualization using patient imaging via the company's exclusive relationship with Brainlab. More
than 10 million people worldwide are living with PD – a progressive, neurodegenerative disorder which causes stiffness, slowness and tremors due to the decrease
of dopamine in the brain.2 Dystonia is the third most common movement disorder after essential tremor and PD, affecting more than half a million men, women,
and children across Europe. In Europe, the Vercise Genus DBS System is indicated for use in unilateral or bilateral stimulation of the subthalamic nucleus or
internal globus pallidus for treatment of levodopa-responsive PD which is not adequately controlled with medication and for treatment of intractable primary and
secondary Dystonia, for persons 7 years of age and older. Thalamic stimulation using the Vercise Genus DBS System is indicated for the suppression of tremor not
adequately controlled by medications in patients diagnosed with essential tremor or PD.

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Bristol Myers Squibb (USA) Provides Update on Phase 3 IDHENTIFY Trial in Patients with Relapsed or
Refractory Acute Myeloid Leukemia
18
Bristol Myers Squibb announced that the Phase 3 IDHENTIFY study evaluating IDHIFA®(enasidenib) plus best supportive care (BSC) versus conventional care
regimens, which include best supportive care (BSC) only, azacitidine plus BSC, low-dose cytarabine plus BSC or intermediate-dose cytarabine plus BSC, did not
meet the primary endpoint of overall survival (OS) in patients with relapsed or refractory acute myeloid leukemia (R/R AML) with an isocitrate dehydrogenase-2
(IDH2) mutation. The safety profile of IDHIFA was consistent with previously reported findings. The company will complete a full evaluation of the IDHENTIFY
data and work with investigators to present detailed results at a future medical meeting. In August 2017, Bristol Myers Squibb received full approval in the U.S.
for IDHIFA for the treatment of adult patients with R/R AML with an IDH2 mutation as detected by a U.S. Food and Drug Administration (FDA)-approved test.
IDHIFA is the first and only FDA-approved therapy for patients with R/R AML and positive for an IDH2 mutation, which represents up to 19 percent of AML
patients. IDHIFA is also approved in Australia and Canada.

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U.S. Food and Drug Administration Approves Onureg® (azacitidine tablets), a New Oral Therapy, as
Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia
19
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has approved Onureg® for the continued treatment of adult patients with acute myeloid
leukemia (AML) who achieved first complete remission (CR) or CR with incomplete blood count recovery (CRi) following intensive induction chemotherapy and who are not
able to complete intensive curative therapy.1 AML is one of the most common acute leukemias in adults. The approval is based on results from the pivotal Phase 3 QUAZAR®
AML-001 study in which treatment with Onureg resulted in a statistically significant and clinically meaningful improvement in overall survival (OS), the study’s primary
endpoint, of nearly 10 months compared to placebo. Median OS from time of randomization was greater than two years (24.7 months; 95% Confidence Interval [CI]: 18.7 to
30.5) among patients who received Onureg compared to 14.8 months (95% CI: 11.7 to 17.6) among patients receiving placebo (Hazard Ratio [HR]: 0.69, 95% CI: 0.55 to 0.86;
p=0.0009). Onureg was continued until disease progression or unacceptable toxicity. Onureg has warnings and precautions for risks of substitution with other azacitidine
products, myelosuppression, increased early mortality in patients with myelodysplastic syndromes (MDS) and embryo-fetal toxicity. Due to substantial differences in the
pharmacokinetic parameters, Onureg should not be substituted for intravenous or subcutaneous azacitidine as it may result in a fatal adverse reaction. New or worsening Grade
3 or 4 neutropenia and thrombocytopenia occurred in 49% and 22% of patients who received Onureg, respectively. Febrile neutropenia occurred in 12% of patients. Complete
blood counts should be monitored, dosing should be modified as recommended and standard supportive care should be provided if myelosuppression occurs. Enrollment was
discontinued early in the study AZA-MDS-003 due to a higher incidence of early fatal and/or serious adverse reactions in the Onureg arm compared with the placebo arm.
Treatment of MDS with Onureg is not recommended outside of controlled trials. Onureg can cause fetal harm when administered to a pregnant woman.

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Celltrion (South Korea) receives Korean MFDS approval to initiate Phase I trial of COVID-19 antiviral
antibody treatment candidate, CT-P59, in patients
20
Celltrion Group announced that the Korean Ministry of Food and Drug Safety (MFDS) has approved the company’s Investigational New Drug (IND) application
for a Phase I clinical trial of CT-P59, a COVID-19 antiviral antibody treatment candidate. Celltrion has initiated enrolment of patients with mild symptoms of
SARS-CoV-2 infection and the clinical trial is set to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of CT-P59. Celltrion
anticipates global pivotal study results from the Phase II and III trials in patients with mild symptoms, the Phase III trial in patients with moderate-to-severe
COVID-19, and the prevention clinical trial, by the end of the year. Celltrion plans to enrol people that are in close contact with COVID-19 patients and those with
no symptoms as part of a prevention clinical trial to evaluate whether CT-P59 can elicit a neutralising antibody response to prevent the virus from infecting human
cells. In July, Celltrion initiated a Phase I trial of CT-P59 in the UK following the approval of the clinical trial authorisation (CTA) application from the UK
Medicines and Healthcare products Regulatory Agency (MHRA). Celltrion has also completed an infusion and initial safety assessment for the Phase I study in
healthy volunteers in Korea and the study is set for completion by Q3 this year as originally planned.

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Daiichi Sankyo (Japan) Announces Results of Phase 3 Clinical Trial for Anticoagulant Edoxaban
(ELDERCARE-AF Study)
21
Daiichi Sankyo Company Limited announced that the primary endpoint has been achieved in the Japan phase 3 clinical trial for the anticoagulant, edoxaban, in
elderly patients with non-valvular atrial fibrillation and high bleeding risk. The results of the study will be presented at the virtual European Society of Cardiology
(ESC) Congress 2020, and have already been published online in the New England Journal of Medicine. The study was a double-blind placebo-controlled study
to evaluate the efficacy (prevention of stroke and systemic embolism) and safety (bleeding events, etc.) of edoxaban administered orally at 15 mg once daily in 984
non-valvular atrial fibrillation patients of 80 years and above with a high bleeding risk and who are ineligible for other available anticoagulation therapies. In the
study, the primary endpoint of annual incidence of stroke and systemic embolism was 2.3% in the edoxaban arm and 6.7% in the placebo arm, demonstrating the
superiority of edoxaban for the primary efficacy outcome. The annual incidence of major bleeding, which was a safety evaluation endpoint, was 3.3% in the
edoxaban arm vs. 1.8% in the placebo arm, showing a numerically higher rate in the edoxaban arm. However, there was no difference between the treatment arms
in fatal bleeding or intracranial bleeding, either of which would be considered to be clinically significant.

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Daiichi Sankyo (Japan) Submits Supplemental Application in Japan for Approval of Partial Changes in
Usage or Dosage for Anticoagulant Edoxaban
22
Daiichi Sankyo Company Limited announced that it submitted an supplemental application in Japan for an expanded approved usage or dosage for the
anticoagulant, edoxaban(edoxaban tosilate hydrate), for elderly patients with non-valvular atrial fibrillation and high bleeding risk. This application is based
on results from the Japanese phase 3 clinical trial (ELDERCARE-AF Study) in 984 non-valvular atrial fibrillation patients of 80 years and above with a high
bleeding risk and who are ineligible for other available anticoagulation therapies. Daiichi Sankyo expects to contribute to the treatment of elderly patients
with non-valvular atrial fibrillation by providing the new treatment option.

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Eisai (Japan) To Take Over Manufacturing And Marketing Approval For Equfina® 50mg Tablets
(Safinamide Mesilate) In Japan From Meiji Seika Pharma
23
Eisai Co., Ltd. announced that it will take over by transfer the manufacturing and marketing approval of Parkinson’s disease treatment Equfina® 50mg TABLETS in Japan from
Meiji Seika Pharma Co., Ltd., effective September 23, 2020. In Japan, Meiji conducted clinical studies of Equfina and obtained its manufacturing and marketing approval in
September 2019. Eisai has exclusively sold Equfina in Japan as a distributor. Based on the license agreement signed between Eisai and Meiji, Eisai will take over by transfer
the manufacturing and marketing approval of Equfina from Meiji. Eisai, as the manufacturer and distributor of Equfina in Japan, will continue to provide information on the
proper usage of Equfina. Equfina, developed by Meiji in Japan, is a once-daily oral treatment for Parkinson’s disease. It is a selective and reversible monoamine oxidase B
(MAO-B) inhibitor that helps to maintain the density of endogenous dopamine and exogenous dopamine from levodopa-containing drugs in the brain. In addition, Equfina
blocks voltage-dependent sodium ion channels and inhibits glutamate release (non-dopaminergic mechanism). In the clinical studies conducted in Japan for Parkinson's disease
patients under treatment with a drug containing levodopa, the extension of levodopa’s duration of effect (“on” time) of one hour or more and improvement of motor functions
were shown. Improvement effect on the wearing off phenomenon is expected. Following the completion of the transfer, Eisai will continue to deliver Equfina, a new option for
Parkinson’s disease treatment in Japan to patients, thereby increasing the amount of time that they can freely engage in activities on their own initiative. Eisai will further
contribute to improving the QOL of patients and enabling their families to create a vibrant daily life.

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New England Journal of Medicine Publishes Phase 1/2 Data for Retevmo™ in Advanced
RET-Driven Lung and Thyroid Cancers
24
Eli Lilly and Company announced that the New England Journal of Medicine (NEJM) published Phase 1/2 study results of the registrational trial for Retevmo™, the first and
only therapy specifically indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC),
and the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic
therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is
appropriate). Retevmo was approved under the FDA's Accelerated Approval regulations based on the LIBRETTO-001 Phase 1/2 trial's endpoints of overall response rate (ORR)
and duration of response (DoR). Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. NEJM
published separate articles focusing on efficacy and safety data in the RET fusion-positive NSCLC and RET-altered thyroid patient cohorts independently, with data
demonstrating durable objective responses across both patient populations. The U.S. Food and Drug Administration (FDA) approval of Retevmo in May 2020 was based on
results from LIBRETTO-001. The study enrolled both treatment-naive patients and heavily pretreated patients with a variety of advanced solid tumors including RET
fusion-positive NSCLC, RET-mutant MTC, RET fusion-positive thyroid cancer, and certain other advanced solid tumors with RET alterations. The major efficacy outcomes in
LIBRETTO-001 were ORR and DoR.

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Jardiance® reduced the combined relative risk of cardiovascular death and hospitalization for heart failure by
25% in adults with and without diabetes who had heart failure with reduced ejection fraction
25
Full results from the EMPEROR-Reduced phase III trial in adults with heart failure with reduced ejection fraction, with and without diabetes, showed that
Jardiance® (empagliflozin) was associated with a significant 25% relative risk reduction in the primary endpoint of time to cardiovascular death or hospitalization
due to heart failure. The trial evaluated the effect of adding Jardiance (10 mg) versus placebo to standard of care. The results will be presented today at the ESC
Congress 2020, the annual meeting of the European Society of Cardiology, and published in The New England Journal of Medicine, Boehringer Ingelheim and Eli
Lilly and Company announced. The findings from the primary endpoint were consistent in subgroups with and without type 2 diabetes. Key secondary endpoint
analyses from the trial demonstrated that Jardiance reduced the relative risk of first and recurrent hospitalization for heart failure by 30%. Additionally, the rate of
decline in eGFR, a measure of kidney function decline, was slower with Jardiance than with placebo. In an exploratory analysis, the absolute risk reduction
observed in the primary endpoint of EMPEROR-Reduced corresponded to a number needed to treat of 19 patients over 16 months to prevent one cardiovascular
death or hospitalization for heart failure. An additional exploratory analysis showed that Jardiance decreased the relative risk of a composite kidney endpoint*,
including end stage kidney disease and a profound loss of kidney function, by 50%.

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REYVOW™ C-V Demonstrated Pain Freedom from Migraine Attacks At 60 Minutes and Up to 48 Hours in
New Phase 3 Study
26
Adults who took REYVOW™ C-V for their migraine attacks at doses of 100 mg or 200 mg had 3.8 and 4.6 times greater odds, respectively, of achieving pain
freedom at 2 hours compared to those taking placebo (co-primary endpoint), according to results from the recently completed Phase 3 study CENTURION.
Additionally, Eli Lilly and Company's REYVOW demonstrated superiority over placebo in all gated endpoints, including proportions of study participants who
after treating their first migraine attack reported pain freedom at 1 hour (200 mg dose), pain relief at 1 hour and 2 hours (both doses), sustained pain freedom at 24
hours (both doses) and 48 hours (200 mg dose), and no disability at 2 hours (both doses). These results are being presented virtually at the PAINWeek® 2020 Live
Virtual Conference, Sept. 11-13. The CENTURION study assessed REYVOW's efficacy and safety, including consistency of response, in the acute treatment of
migraine for adults, with or without aura, across four attacks. In the trial, 1,471 people with migraine were randomized and received at least one dose of either
REYVOW 200 mg (n=486), REYVOW 100 mg (n=485) or control treatment (placebo for some but not all attacks, n=500) per attack. Study participants treated a
migraine attack when their pain was at least of moderate severity and within 4 hours after pain onset. Co-primary efficacy endpoints included pain freedom at 2
hours for the first attack and pain freedom at 2 hours for 2 of 3 attacks. Secondary endpoints included pain freedom at 60 minutes, sustained pain freedom at 24
and 48 hours, and pain relief at 1 hour and 2 hours, among others. Patients entered results into an electronic diary at 30 minutes, 60 minutes, as well as 2, 4, 6, 24
and 48 hours after dosing. All of the study's treatment comparisons were prespecified and 18 endpoints were gated, meaning they were set before the study ended
and each comparison was reviewed separately in a specified order to verify the accuracy of the study results.

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Gilead’s (USA) Investigational Antiviral Veklury® (Remdesivir) Receives U.S. Food and Drug Administration
Emergency Use Authorization for the Treatment of Patients With Moderate COVID-19
27
Gilead Sciences, Inc. announced the U.S. Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) enabling use of the
investigational antiviral Veklury® (remdesivir) to treat all hospitalized patients with COVID-19, in addition to the previous authorization for patients hospitalized
with severe COVID-19. The expanded EUA is based on results from the Phase 3 SIMPLE trial evaluating Veklury in hospitalized patients with moderate
COVID-19 pneumonia, as well as results from the National Institute of Allergy and Infectious Diseases (NIAID) ACTT-1 trial in hospitalized patients with a range
of disease severity. Results from the Phase 3 SIMPLE study were published in the Journal of the American Medical Association (JAMA) on August 21, 2020 and
confirm top-line results previously announced on June 1, 2020. The primary endpoint evaluated patients at Day 11 on a 7-point ordinal scale and found patients
randomized to a 5-day course of Veklury plus standard of care were 65 percent more likely to have an improvement in clinical status compared with those
randomized to standard of care alone (OR, 1.65; 95% confidence interval, 1.09-2.48; p=0.017). For patients in the 10-day Veklury group, the improvement in
clinical status at Day 11 was not statistically different compared with the standard of care group (OR, 1.31; 95% confidence interval, 0.88-1.95; p=0.183). The data
published in JAMA demonstrate that Veklury was generally well-tolerated in both the 5-day and 10-day treatment groups. The most commonly reported adverse
events in the 5-day, 10-day, and standard of care groups, respectively, were nausea (10% vs 9% vs 3%), diarrhea (6% vs 5% vs 7%), hypokalemia (5% vs 7% vs
2%), and headache (5% vs 5% vs 3%). All-cause mortality at Day 28 was ≤ 2% in all treatment groups.

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Gilead’s (USA) Kite Submits Supplemental Biologics License Application to U.S. Food and Drug Administration
for Yescarta® in Relapsed or Refractory Indolent Non-Hodgkin Lymphomas
28
Kite, a Gilead Company announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA)
for Yescarta® (axicabtagene ciloleucel) for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma after two or more prior lines
of systemic therapy. Yescarta was previously granted Breakthrough Therapy Designation (BTD) by the FDA for these indications. If approved, Yescarta would
become the first chimeric antigen receptor (CAR) T cell therapy approved for the treatment of relapsed or refractory indolent non-Hodgkin lymphoma (NHL). The
sBLA submission is supported by data from the primary analysis of the Phase 2 ZUMA-5 trial, which is being submitted for presentation at an upcoming scientific
congress. Findings from an interim analysis of ZUMA-5 were recently presented during an oral session at the 2020 American Society of Clinical Oncology
(ASCO) Annual Meeting. Yescarta was the first CAR T cell therapy to be approved by the FDA for the treatment of adult patients with relapsed or refractory large
B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal
large B-cell lymphoma, and high grade B-cell lymphoma and DLBCL arising from FL. Yescarta is not indicated for the treatment of patients with primary central
nervous system lymphoma. The Yescarta U.S. Prescribing Information has a BOXED WARNING for the risks of cytokine release syndrome (CRS) and neurologic
toxicities, and Yescarta is approved with a risk evaluation and mitigation strategy (REMS) due to these risks; see below for Important Safety Information. Yescarta
has not been approved by any regulatory agency for the treatment of indolent non-Hodgkin lymphoma, including follicular lymphoma or marginal zone lymphoma.
Its safety and efficacy have not been established in these lymphomas.

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European Commission approves BLENREP (belantamab mafodotin) for the treatment of patients with relapsed
and refractory multiple myeloma
29
GlaxoSmithKline plc announced the European Commission has granted conditional marketing authorisation for BLENREP as monotherapy for the treatment of
multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one
immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. BLENREP is a
first-in-class humanised anti-BCMA (B-cell maturation antigen) treatment for these patients whose disease has progressed despite the current standard of care. The
approval is based on data from the pivotal DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study, including 13-month follow-up data.
These data demonstrated that treatment with single-agent BLENREP, administered as a 2.5 mg/kg dose every three weeks (Q3W), resulted in an overall response
rate of 32%. The median duration of response was 11 months and median overall survival was 13.7 months. The safety and tolerability profile were consistent with
previously reported data on BLENREP. The most commonly reported adverse events in the 2.5 mg/kg arm (greater than or equal to 20%) were
keratopathy/microcyst-like epithelial changes or MECs (71%), thrombocytopenia (38%), anaemia (27%), blurred vision events (25%), nausea (25%), pyrexia
(23%), increased aspartate aminotransferase (AST) (21%), infusion-related reactions (21%), and lymphopenia (20%).

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FDA approves Trelegy Ellipta as the first once-daily single inhaler triple therapy for the treatment of
both asthma and COPD in the US
30
GlaxoSmithKline plc and Innoviva, Inc. announced the US Food and Drug Administration (FDA) has approved a new indication for Trelegy Ellipta for
the treatment of asthma in patients aged 18 years and older adding to its current license for use in patients with chronic obstructive pulmonary disease
(COPD). Trelegy Ellipta is not indicated for relief of acute bronchospasm. The FDA-approved strength for both COPD and asthma is fluticasone furoate
/ umeclidinium / vilanterol 100/62.5/25mcg. There is an additional strength for asthma alone which is fluticasone furoate / umeclidinium / vilanterol
200/62.5/25mcg. The approval means Trelegy is the first single inhaler triple therapy approved for the maintenance treatment of both asthma and COPD
and is the only single inhaler triple therapy available for patients in a convenient once-daily inhalation in the US. Today’s announcement marks GSK’s
sixth major medicine approval in 2020 across areas of significant unmet medical need including cancer, HIV, respiratory and chronic kidney disease.
Trelegy’s approval for the maintenance treatment of asthma in patients aged 18 years and older introduces a new paradigm for managing the
approximately 30% of adult asthma patients who still experience symptoms despite being adherent to inhaled corticosteroids/ long-acting beta agonist
(ICS/LABA) combination therapy.

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Teledentistry Platform Helps Dental Practices Provide Safe Quality Care Amid COVID-19
31
Henry Schein is now offering TeleDent by MouthWatch, a teledentistry and patient engagement platform that incorporates live video conferencing,
patient messaging, and cloud collaboration to ensure a seamless integration into the dental practice. Available to customers through Henry Schein
Dental and Henry Schein One, TeleDent offers real-time, two-way video conferencing so practitioners can conduct emergency triages, consultations,
pre-visit screenings, post-op visits, and visual case presentations virtually. Using TeleDent, dentists can connect with patients through a desktop or
mobile devices, and their consultations can be recorded for integration into clinical care and patient records to help ensure effective and thorough virtual
dental care. The patient-facing messaging included in the TeleDent platform is designed so practitioners can communicate directly with patients, as well
as seamlessly collaborate and share diagnostic information with their dental team and specialists in a cloud-based portal. The dental team can also easily
transition patients to a specialist and see their task assignments within the TeleDent platform.

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CERENOVUS Launches New Suite of Technologies to Advance Stroke Treatment
32
CERENOVUS, part of Johnson & Johnson Medical Devices Companies* announced that it has launched CERENOVUS Stroke Solutions™, which includes a
suite of three devices designed to aid physicians in clot removal procedures. The announcement was made during the virtual European Society of Minimally
Invasive Neurological Therapy (ESMINT). Strokes are the second leading cause of death globally, and account for an estimated 140,000 deaths in the United States
each year.[i],[ii] Over half of stroke survivors become chronically disabled placing an estimated $34 billion economic burden on healthcare systems each year in
the United States. CERENOVUS Stroke Solutions™ were designed with compatibility in mind to help physicians perform mechanical thrombectomy procedures.
The suite of technologies includes:
• CEREBASE™ DA Guide Sheath, a long guide sheath, designed with more trackability and support to allow physicians to navigate challenging anatomy and
secure Distal Access for Geometric Anchoring.
• CERENOVUS Large Bore Catheter is designed for atraumatic vessel wall interaction to balance trackability with more durability and compatibility. Featuring
excellent distal kink resistance in a thin wall design, it allows rapid navigation to the middle cerebral artery based on anatomically optimized design.
• EMBOTRAP® III Revascularization Device, the latest generation stent retriever, is designed to engage a wide range of clot types, improve procedural confidence
and provide more tailored options to achieve the First Pass Effect (FPE). FPE is an independent predictor of good functional outcome and has resulted in faster
patient recovery times, which may translate to lower healthcare costs.

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Farxiga demonstrated unprecedented reduction in the risk of kidney failure and cardiovascular or
renal death in patients with chronic kidney disease in the Phase III DAPA-CKD trial
33
Farxiga is the first medicine to significantly prolong survival in a renal outcomes trial in patients with chronic kidney disease with and without type-2 diabetes.
Detailed results from the ground-breaking Phase III DAPA-CKD trial showed that AstraZeneca’s Farxiga (dapagliflozin) on top of standard of care reduced the
composite measure of worsening of renal function or risk of cardiovascular (CV) or renal death by 39% compared to placebo (p<0.0001) in patients with chronic
kidney disease (CKD) Stages 2-4 and elevated urinary albumin excretion. The results were consistent in patients both with and without type-2 diabetes (T2D).
CKD is a serious, progressive condition defined by decreased kidney function affecting nearly 700 million people worldwide,1,2 many of them still
undiagnosed,3,4 and the most common causes are diabetes, hypertension and glomerulonephritis. The primary composite endpoint was ≥50% sustained decline in
estimated glomerular filtration rate (eGFR), onset of end-stage kidney disease (ESKD) and CV or renal death. The absolute risk reduction (ARR) was 5.3% over
the median time in study of 2.4 years. The trial also met all secondary endpoints, including significantly reducing death from any cause by 31% (ARR = 2.1%,
p=0.0035) compared to placebo. The safety and tolerability of Farxiga were consistent with the well-established safety profile of the medicine. In the trial, patients
treated with Farxiga experienced fewer serious adverse events compared to placebo (29.5% versus 33.9%, respectively). Diabetic ketoacidosis was not reported in
the Farxiga group versus in two patients in the placebo group.

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Development of COVID-19 vaccine AZD1222 expands into US Phase III clinical trial across all adult
age groups
34
AZD1222 development expanded into a Phase III clinical trial in the US to assess its safety, efficacy and immunogenicity. The US trial, called D8110C00001, is
funded by the Biomedical Advanced Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response (ASPR) at the
U.S. Department of Health and Human Services (HHS) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes
of Health, and led by AstraZeneca. The NIAID-supported COVID-19 Prevention Network (CoVPN) will participate in the trial. Trial centres across the US are
recruiting up to 30,000 adults aged 18 years or over from diverse racial, ethnic and geographic groups who are healthy or have stable underlying medical
conditions, including those living with HIV, and who are at increased risk of infection from the SARS-CoV-2 virus. Centres outside the US are included based on
predicted transmission rates of the virus and sites in Peru and Chile are planned to initiate recruitment shortly. Participants are being randomised to receive two
doses of either AZD1222 or a saline control, four weeks apart, with twice as many participants receiving the potential vaccine than the saline control. The trial is
assessing efficacy and safety of the vaccine in all participants, and local and systemic reactions and immune responses will be assessed in 3,000 participants.
Clinical development of AZD1222 is progressing globally with late-stage clinical trials ongoing in the UK, Brazil and South Africa and trials are planned to start
in Japan and Russia. These trials, together with the US Phase III clinical trial will enrol up to 50,000 participants globally. Results from the late-stage trials are
anticipated later this year, depending on the rate of infection within the clinical trial communities.

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AstraZeneca (UK): Farxiga Phase III DAPA-CKD trial paradigm-shifting data to be presented at ESC 2020
35
AstraZeneca will present the highly anticipated detailed results from the ground-breaking Phase III DAPA-CKD trial of Farxiga in chronic kidney disease (CKD)
at ESC Congress 2020 – The Digital Experience. These results are among 20 abstracts being presented by AstraZeneca at ESC between 29 August to 1 September
2020 showcasing the breadth of its cardiovascular (CV), renal and metabolic portfolio. In July 2020, the Company announced that the DAPA-CKD trial met all
primary and secondary endpoints in patients with CKD. High-level results showed a statistically significant and clinically meaningful effect with Farxiga on the
trial’s primary endpoint of a composite of worsening of renal function or risk of death in CKD patients with and without type-2 diabetes (T2D). The results also
make Farxiga the first medicine to significantly reduce the risk of death from any cause in this patient population compared to placebo. DAPA-CKD is yet another
landmark trial from AstraZeneca’s global DapaCare clinical programme, which is dedicated to exploring the potential of Farxiga to protect against CV and renal
disease. The programme first shared results from the DECLARE-TIMI 58 trial, the largest CV outcomes trial conducted for an SGLT2 inhibitor to date, showing
that Farxiga achieved a statistically significant reduction in the composite endpoint of hospitalisation for heart failure (hHF) or CV death versus placebo.3 The
Phase III DAPA-HF trial results followed DECLARE, showing that Farxiga was the first SGLT2 inhibitor to improve outcomes in patients with heart failure with
reduced ejection fraction (HFrEF) with and without T2D.

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Medtronic (Ireland) Cryoablation Superior to Drug Therapy for Symptomatic Paroxysmal Atrial Fibrillation
36
Medtronic plc, the global leader in medical technology, announced clinical trial results demonstrating superiority of the Arctic Front™ Advance Cardiac
Cryoballoon and Freezor® MAX Cardiac CryoAblation Catheter for the first-line treatment (prior to drug therapy) of recurrent symptomatic paroxysmal atrial
fibrillation (PAF) compared to antiarrhythmic drug (AAD) treatment. Primary results of the randomized STOP AF First trial were presented as a late breaking
clinical trial at the European Society of Cardiology (ESC) Congress 2020 Digital Experience. Additionally, 12-month outcomes from the Cryo-FIRST trial showed
a significant improvement in atrial fibrillation-related quality of life with the use of the Medtronic cryoablation system compared to anti-arrhythmic drug therapy
in patients who had not previously received antiarrhythmic drugs to treat their symptomatic PAF. Atrial fibrillation (AF) is a progressive condition that impacts
more than 33 million people worldwide.1 Without early intervention, progression of the condition is associated with a higher rate of cardiovascular admissions,2
heart failure hospitalization,3 and mortality,4 along with a reduced quality of life.5 Antiarrhythmic drug therapy is currently the standard first-line treatment for
patients with AF; however, AF recurs in approximately 50% of patients treated with AADs within a year of therapy onset. In addition, AAD therapy frequently
causes side effects that can lead many patients to discontinue treatment.6 Cryoablation uses cold energy (freezing) delivered through an inflatable balloon to create
scar tissue to interrupt unwanted electrical pathways in the heart.

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Medtronic (Ireland) Announces FDAApproval for Minimed™ 770G Insulin Pump System with
Smartphone Connectivity for People with Type 1 Diabetes
37
Medtronic plc the global leader in medical technology, announced it has received U.S. Food and Drug Administration (FDA) approval of its MiniMed™ 770G
hybrid closed loop system. This newest insulin pump system offers the company’s most advanced SmartGuard™ technology, as featured in the MiniMed™ 670G
system, with the added benefits of smartphone connectivity and an expanded age indication to children as young as 2. This latest system by Medtronic expands the
benefits of hybrid closed loop therapy to younger children living with type 1 diabetes and makes it easier to access and share real-time CGM and pump data. The
system will enable caregivers and care partners to see user data remotely on their smartphones, with proactive in-app notices sent when sugar levels are out of
range. The data can also be shared automatically with clinicians and educators to help facilitate more effective telehealth visits and product trainings. This
connectivity also gives Medtronic the ability to provide upgrades to future technology via software updates which can further enhance security and device features.
The growing body of clinical evidence on hybrid closed loop therapy demonstrates both the safety of the technology and improved clinical outcomes across adults,
adolescents and younger children. A clinical study of the MiniMed 670G system conducted in children two to six years of age showed an improvement in outcomes
comparable to those observed in older adolescents and adults, and supported the submission of the MiniMed 770G system. In the study, A1C and Time in Range
from 151 children were assessed alongside outcomes from 124 adolescents and adults over two weeks in Manual Mode and three months in SmartGuard Auto
Mode (hybrid closed loop algorithm)1. There were no episodes of severe hypoglycemia or diabetic ketoacidosis, and no serious device-related adverse events while
in SmartGuard Auto Mode.

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Medtronic (Ireland) Receives Breakthrough Device Designation from FDA, Begins Early Feasibility Study for
Investigational Intrepid™ Transcatheter Valve System for the Treatment of Tricuspid Valve Regurgitation
38
Medtronic plc, a global leader in structural heart therapies, announced U.S. Food and Drug Administration (FDA) approval of an early feasibility study (EFS) of
the Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) system in patients with severe, symptomatic tricuspid regurgitation, a disease in which the
diseased, damaged or malfunctioning tricuspid valve allows blood to flow back into the heart's upper right chamber causing eventual heart failure or death. The
study begins on the heels of a recent Breakthrough Device Designation issued by the FDA for the Intrepid TTVR System. The Intrepid TTVR system is an
investigational device worldwide. Representing a large, unmet clinical need, tricuspid regurgitation affects more than 2 million patients in the United States. It is
a highly undertreated disease due to the morbidity and mortality associated with surgical intervention. Medtronic recently received Breakthrough Device
Designation by the FDA for the Intrepid TTVR system. The FDA Breakthrough Device Program is intended to help patients receive more timely access to certain
technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. The
Intrepid transcatheter valve is the same valve being evaluated for the treatment of symptomatic mitral valve regurgitation in the transfemoral mitral early feasibility
study. The device is implanted using a transfemoral delivery catheter, which assists physicians in delivering and placing the valve through a catheter inserted in the
femoral vein.

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Merck’s (USA) Gefapixant (45 mg Twice Daily) Significantly Decreased Cough Frequency Compared to
Placebo at Week 12 and 24 in Patients with Refractory or Unexplained Chronic Cough
39
Merck, known as MSD outside the United States and Canada, has announced the results from two pivotal Phase 3 trials (COUGH-1 and COUGH-2)
evaluating the efficacy and safety of gefapixant (MK-7264), an investigational, orally administered, selective P2X3 receptor antagonist, for the potential
treatment of refractory or unexplained chronic cough. COUGH-1 and COUGH-2 are the first companion Phase 3 trials ever conducted in patients with
refractory chronic cough, a cough that persists despite appropriate treatment of underlying conditions, or unexplained chronic cough, a cough where the
underlying cause cannot be identified despite a thorough evaluation. In these studies, adult patients treated with gefapixant 45 mg twice daily demonstrated
a statistically significant reduction in 24-hour cough frequency (measured objectively, as coughs per hour, using 24-hour sound recordings) versus placebo
at 12 weeks (COUGH-1) (18.45% reduction relative to placebo, 95% CI [-32.92, -0.86; p=0.041]) and 24 weeks (COUGH-2) (14.64% reduction relative to
placebo, 95% CI [-26.07, -1.43; p=0.031]). The gefapixant 15 mg twice daily treatment arms did not meet the primary efficacy endpoint in either Phase 3
study. These results were presented at the virtual European Respiratory Society (ERS) International Congress 2020 (abstract #3800). Merck plans to share
data from COUGH-1 and COUGH-2 with regulatory authorities worldwide.

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Beyond “99.9%” claims: Novozymes (Denmark) launches probiotic solution in cleaning
40
Novozymes announced the introduction of Microvia probiotics for cleaning products. The microbial technology provides superior and continuous
deep cleaning on hard surfaces over conventional chemistry alone – and enables consumers to avoid overuse of harsh cleaning and disinfection
agents in their own homes. As many begin to question the longer-term health effects of chemical cleaning and disinfection products, not least
during the current COVID-19 pandemic, consumer interest in safer, more effective, and greener probiotic cleaner products is growing. Novozymes
has been researching the use of probiotics in household cleaning for many years. As well as scientific studies into the effectiveness and safety of
probiotic cleaning solutions, it has carried out extensive research into consumer perceptions of innovative, but naturally derived formulas that
leverage probiotic technology.

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Regeneron Pharmaceuticals, Inc. (USA): Late-Breaking Libtayo® (Cemiplimab) Pivotal Data In Advanced
Non-Small Cell Lung Cancer And Basal Cell Carcinoma To Be Presented At Esmo
41
Regeneron Pharmaceuticals, Inc. and Sanofi today announced the presentation of new, positive data for the PD-1 inhibitor Libtayo® (cemiplimab)
at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 from September 19-21. Among the accepted abstracts are two
late-breaking oral presentations on the investigational use of Libtayo monotherapy in first-line advanced non-small cell lung cancer (NSCLC) and
locally advanced basal cell carcinoma (BCC) previously treated with a hedgehog inhibitor. Additional presentations will include patient-reported
quality-of-life and real-world patient data for Libtayo in advanced cutaneous squamous cell carcinoma (CSCC).
Late-breaking oral presentations include:
• EMPOWER-Lung 1: Phase 3 first line cemiplimab monotherapy vs platinum-doublet chemotherapy in advanced NSCLC with programmed cell
death ligand-1 (PD-L1) ≥50% (Abstract 1158, LBA52; Ahmet Sezer, M.D.; Proffered Paper Presentation)
• Primary analysis of Phase 2 results for cemiplimab in patients with locally advanced BCC who progress on or are intolerant to hedgehog
inhibitors (HHIs) (Abstract 3933, LBA47; Alexander Stratigos, M.D.; Mini-oral Presentation)

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Regeneron Pharmaceuticals, Inc. (USA): Dupixent® (Dupilumab) Long-Term Data Show Sustained Improvement In Lung
Function And Reduction In Severe Exacerbations In Adults And Adolescents With Moderate-To-Severe Asthma
42
Regeneron Pharmaceuticals, Inc. and Sanofi announced new results from a Dupixent® (dupilumab) Phase 3 open-label extension trial that showed the safety and efficacy
profile observed in previous Dupixent trials was maintained for up to three years in adults and adolescents with moderate-to-severe asthma. Data from the trial will be
presented during a live session at the virtual 2020 European Respiratory Society (ERS) International Congress. The analyses to be presented at ERS included more than
2,200 patients who previously participated in Dupixent asthma trials, including three pivotal trials that lasted between 24 and 52 weeks. Patients entered the extension
trial after finishing active treatment or placebo in the initial trials and were treated for up to an additional two years, providing up to three years of treatment data in total.
The safety analyses included patients from all three pivotal asthma trials, and the efficacy and biomarker analyses included patients who were not dependent on oral
corticosteroids (OCS) from the pivotal Phase 2b and Phase 3 QUEST trials. Additional long-term efficacy data in OCS-dependent patients will be presented at a later
congress. Results showed:
Efficacy:
• Lung function: Patients continued to experience improvement in lung function by 13-22% at 96 weeks, as measured by the average change in forced expiratory volume
over one second (FEV1) compared to baseline for the initial asthma trials.
• Asthma attacks: Patients maintained a low rate of severe asthma attacks (unadjusted annualized severe exacerbation rate) with an average of 0.31-0.35 events per year.
In the year prior to commencing Dupixent trials, the rate of severe asthma attacks was 2.09-2.17 events per year.
• Type 2 inflammation: Improvements in lung function and asthma attacks were greater in those with elevated baseline blood eosinophils or fractional exhaled nitric oxide
(FeNO), which are markers of type 2 inflammation. In these long-term results, patients showed reductions in blood eosinophils (23-35%) and in blood IgE for patients
from the pivotal Phase 2b trial (82%) compared to baseline for the initial asthma trials.

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Roche (Switzerland) announces FDA approval of FoundationOne Liquid CDx, a comprehensive
pan-tumour liquid biopsy test
43
Roche announced that the U.S. Food and Drug Administration (FDA) has approved FoundationOne®Liquid CDx, Foundation Medicine’s comprehensive pan-tumour
liquid biopsy test for patients with solid tumours. FoundationOne Liquid CDx is a comprehensive genomic profiling (CGP) test that analyses more than 300
cancer-related genes and multiple genomic signatures to optimise patient care. Cancer is a disease of the genome, driven by genetic mutations within a tumour’s DNA.
CGP is used to identify these unique mutations to determine how a tumour behaves and grows, and these insights can help physicians to determine a personalised
treatment plan for each individual patient based on the specific mutations identified. As well as approving FoundationOne Liquid CDx as a CGP test for patients with
any solid tumour, the FDA approved the test for use as a companion diagnostic to identify patients who may benefit from treatment with certain prostate and lung cancer
therapies, including Rubraca® (rucaparib), a poly (ADP-ribose) polymerase (PARP) inhibitor for treatment in patients with BRCA 1/2-mutant metastatic
castration-resistant prostate cancer, and three first-line tyrosine kinase (TKI) inhibitors for the treatment of patients with non-small cell lung cancer. By incorporating
multiple genes, including several companion diagnostic biomarkers, the test can help save time versus sequential biomarker testing. FoundationOne Liquid CDx analyses
circulating cell-free DNA from a patient’s blood sample and uses massively parallel sequencing to detect the four main classes of genomic alterations. The test is
FDA-approved to report short variants in 311 genes including rearrangements and copy number losses in BRCA1 and BRCA2 genes. The results are delivered in an
integrated report that identifies alterations matched to FDA-approved therapies. The report also delivers information about genomic signatures, including microsatellite
instability and blood tumour mutational burden, as well as single gene alterations, including all NTRK fusions, to help inform the use of other therapies including
immunotherapies, and provides relevant clinical trial information.

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Roche (Switzerland) receives FDA approval for first HIV-1/HIV-2 Qualitative Test on the cobas
6800/8800 Systems in the fight against HIV/AIDS
44
Roche announced U.S. Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800
Systems in the U.S. The test provides healthcare professionals with a single result to confirm HIV diagnosis and differentiate HIV-1 and HIV-2, an important distinction
needed to identify appropriate treatment options. Studies show that 50% of new HIV infections may be transmitted during the acute period, between three days and three
weeks from the time of infection1. Current serology-based testing methods rely on the ability to detect an antibody or antigen response. As a result, they can fail to
identify an infection if the person is tested prior to having a detectable antibody or antigen response, which can take several weeks to generate. The higher sensitivity of
PCR technology, which is used with the cobas HIV-1/HIV-2 Qualitative Test, can reduce this time-to-detection period by one week or more. This significant reduction
in time to detection is critical to improve personalised healthcare while curbing further disease transmission. cobas HIV-1/HIV-2 Qualitative for use on the cobas
6800/8800 Systems is an in vitro nucleic acid amplification test for the qualitative detection and differentiation of human immunodeficiency virus type 1 (HIV-1) and
type 2 (HIV-2) RNA in human serum and plasma.

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Roche (Switzerland) to launch SARS-CoV-2 Rapid Antigen Test in countries accepting CE mark,
allowing fast triage decisions at point of care
45
Roche announced that it will launch a SARS-CoV-2 Rapid Antigen Test, in late September, for markets accepting the CE Mark. Roche also intends to file for Emergency
Use Authorisation (EUA) to the U.S. Food and Drug Administration (FDA). The SARS-CoV-2 Rapid Antigen Test is for use in point of care settings for both
symptomatic and asymptomatic people. This can help healthcare professionals identify a SARS-CoV-2 infection in people suspected to carry the virus with results
typically ready in 15 minutes.1 In addition, it serves as a valuable initial screening test for individuals that have been exposed to SARS-CoV-2 infected patients or a high
risk environment.The test has a sensitivity of 96.52% and a specificity of 99.68%, based on 426 samples from two independent study centers.* At launch, there will be
40 million SARS-CoV-2 Rapid Tests available, per month. This capacity will increase more than two-fold at the end of this year to help with testing demands of
healthcare systems globally. The launch is a partnership with SD Biosensor Inc., with whom Roche has a global distribution agreement and had also launched a Rapid
Antibody Test in July. The test is the tenth addition to the comprehensive Roche diagnostic portfolio to help healthcare systems combat COVID-19 through testing in the
laboratory and at the point of care. Currently, this portfolio includes molecular, serology and digital solutions which help diagnose and manage COVID-19 during the
initial stages of infection, during the recovery phase, as well as following the resolution of infection. The SARS-CoV-2 Rapid Antigen Test is performed by healthcare
professionals in a number of different settings close to the patient. This is highly beneficial where timely decisions are needed or laboratory testing is inaccessible. The
test will help to quickly identify people who are infected and allows better patient management as well as more effective use of healthcare resources.

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Roche (Switzerland) receives FDA Emergency Use Authorization for the cobas SARS-CoV-2 &
Influenza A/B Test for use on the cobas 6800/8800 Systems
46
Roche announced that the cobas® SARS-CoV-2 & Influenza A/B Test for use on the cobas® 6800/8800 Systems has received Emergency Use
Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This test is intended for the simultaneous qualitative detection and
differentiation of SARS-CoV-2, Influenza A and Influenza B in patients suspected by their healthcare provider of having respiratory viral infection
consistent with COVID-19. Additionally, it is available in markets accepting the CE mark. Roche’s widely-available, fully-automated cobas 6800/8800
Systems, which are used to perform the SARS-CoV-2 & Influenza A/B Test, offer the fastest time to results with the highest throughput and the longest
walk-away time available among automated molecular platforms. The systems provide up to 96 results in about 3 hours and 384 results for the cobas
6800 System and 1,056 results for the cobas 8800 System in an 8-hour shift. Roche is committed to delivering as many tests as possible within the limits
of supply. The test is another key addition to the comprehensive Roche diagnostic portfolio to help healthcare providers combat COVID-19 and make
informed decisions for optimised patient care. Currently, this portfolio includes molecular, serology and digital solutions, which help during the initial
stages of infection, during the recovery phase, as well as following the resolution of infection.

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Roche (Switzerland) announces FDA approval of Gavreto (pralsetinib) for the treatment of
adults with metastatic RET fusion-positive non-small cell lung cancer
47
Roche announced that the United States (US) Food and Drug Administration (FDA) has approved Gavreto™ (pralsetinib) for the treatment of adults with
metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. This indication was
approved under the FDA’s Accelerated Approval programme, based on data from the phase I/II ARROW study. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in a confirmatory trial. Gavreto is a once-daily, oral precision therapy designed to selectively target
RET alterations, including fusions and mutations. It is jointly commercialised by Genentech, a wholly owned member of the Roche Group, and Blueprint
Medicines in the US and will be commercialised by Roche outside of the US, excluding Greater China*.RET-activating fusions and mutations are key disease
drivers in many cancer types, including NSCLC and medullary thyroid cancer (MTC), and treatment options that selectively target these genetic alterations are
limited. In NSCLC, RET fusions represent approximately 1-2% of patients.1 Biomarker testing for these fusions is the most effective way to identify people who
are eligible for treatment with Gavreto. The approval is based on the results from the phase I/II ARROW study, in which Gavreto produced durable clinical
responses in people with RET fusion-positive NSCLC with or without prior therapy, and regardless of RET fusion partner or central nervous system involvement.2
Gavreto demonstrated an overall response rate (ORR) of 57% (95% CI: 46%, 68%) and complete response (CR) rate of 5.7% in the 87 people with NSCLC
previously treated with platinum-based chemotherapy, and the median duration of response (DoR) was not reached (95% CI: 15.2 months, not reached).2 In the
27 people with treatment-naïve NSCLC, the ORR was 70% (95% CI: 50%, 86%), with an 11% CR rate.2 The most common adverse reactions (≥25%) were
fatigue, constipation, musculoskeletal pain and increased blood pressure (hypertension).

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Roche (Switzerland) receives FDA clearance for BK virus quantitative test on cobas 6800/8800
Systems to support better care for transplant patients
48
Roche announced U.S. Food and Drug Administration (FDA) 510k clearance for the cobas® BKV Test on the cobas® 6800 and 8800 Systems. The test was
previously granted FDA Breakthrough Device designation demonstrating the improved treatment or diagnosis of life-threatening diseases or conditions for
transplant patients. The test provides standardised, high-quality results that can help healthcare professionals better assess the risk of complications caused by the
BK virus in transplant patients and identify effective treatment options. BK virus (BKV) is a member of the polyomavirus family that can cause severe
transplant-associated complications. Infection can occur without symptoms and happen early in life. After primary infection, the virus can remain inactive, only to
possibly reactivate in immunocompromised individuals such as transplant recipients. The cobas BKV Test is a polymerase chain reaction (PCR) viral load test that
runs on the fully automated and widely available cobas® 6800 and cobas® 8800 Systems. Along with the previously approved cobas® EBV and CMV Tests, the
cobas BKV Test has been calibrated to the World Health Organization (WHO) International Standard. This means that test results are reported in international units,
making it possible for laboratories anywhere in the U.S. to obtain comparable results when measuring levels of BKV DNA.

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Roche (Switzerland) expands its multiple sclerosis portfolio with investigational BTK inhibitor
fenebrutinib and initiates novel clinical trials for OCREVUS (ocrelizumab)
49
Roche announced the initiation of an innovative Phase III clinical trial programme for its investigational medicine fenebrutinib in multiple sclerosis (MS),
along with a higher-dose Phase III clinical trial programme for OCREVUS® (ocrelizumab) and a distinct OCREVUS trial specifically to support
African-American and Hispanic- and Latinx-American patients with MS. Overviews of clinical trials and scientific rationale will be presented at
MSVirtual2020, the 8th Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and the European
Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from 11-13 September 2020. Roche is initiating a Phase III clinical trial
programme for fenebrutinib, an investigational oral Bruton’s tyrosine kinase (BTK) inhibitor in relapsing MS (RMS) and primary progressive MS (PPMS).
Increasing evidence suggests that B cells and myeloid lineage cells contribute to disease progression in MS. Fenebrutinib is a dual inhibitor of both B-cell
and myeloid lineage-cell activation, which may conceivably offer a novel approach to suppress disease activity and slow disease progression by targeting
both acute and chronic inflammatory aspects of MS, which will be studied in the Phase III clinical trial programme. Pre-clinical data have shown
fenebrutinib is highly selective and acts as a non-covalent agent with a slow release rate from its target.

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