Evaluate California Pharma & Biotech Innovation Outlook 2017Evaluate Ltd
Report Highlights Include
• The Top of the California Rankings in 2022
• Where California Companies are Investing in the Future – Pipeline and Approvals
• Where California Companies are Investing in the Future – Venture Financing and M&A
This document provides an overview of Merck and its recalled drug Vioxx. It discusses Merck's history, leadership, stakeholders, vision, relationship with the FDA, political contributions, use of the blockbuster drug model, direct-to-consumer advertising, Vioxx's rise to fame, emerging safety concerns, and ultimate recall from the market in 2004. The recall came after studies showed Vioxx significantly increased heart attack risks. Questions remain about whether further action should have been taken against those responsible for the deaths and damages caused to consumers by Vioxx.
Earlier this year, the Department of Health and Human Services proposed exempting 84 types of Class II devices from 510(k) requirements, which stemmed from the relaxed regulations for the COVID-19 public health emergency. After reviewing adverse event data from both before and after the relaxed pandemic regulations, the FDA began to examine its current market authorization process for medical devices...
FDA the Gold Standard for Medical Device SafetyEMMAIntl
A year-long investigation titled “Implant Files”, which was initiated by the ICIJ (International Consortium of Investigative Journalists) and involved 250 journalists from 36 countries, was released a few weeks ago...
Just like every other nation, Australia has also taken several measures to respond to the global pandemic. To help prevent shortages of medical equipment and personal protective equipment, the Australian regulating authority- Therapeutic Goods Administration (TGA) has announced several exemptions and expedited paths to ensure an adequate supply of medical products...
The regulation of medical devices in AustraliaTGA Australia
The regulation of medical devices in Australia involves classifying devices based on their intended use and risk level. Higher risk devices undergo more rigorous assessment procedures to ensure they meet essential safety and performance principles before being approved for market. Ongoing monitoring is also conducted after devices enter the market to protect public health. The TGA regulates medical devices to confirm they are suitable for their intended purpose and that their benefits outweigh any risks when used correctly.
Evaluate California Pharma & Biotech Innovation Outlook 2017Evaluate Ltd
Report Highlights Include
• The Top of the California Rankings in 2022
• Where California Companies are Investing in the Future – Pipeline and Approvals
• Where California Companies are Investing in the Future – Venture Financing and M&A
This document provides an overview of Merck and its recalled drug Vioxx. It discusses Merck's history, leadership, stakeholders, vision, relationship with the FDA, political contributions, use of the blockbuster drug model, direct-to-consumer advertising, Vioxx's rise to fame, emerging safety concerns, and ultimate recall from the market in 2004. The recall came after studies showed Vioxx significantly increased heart attack risks. Questions remain about whether further action should have been taken against those responsible for the deaths and damages caused to consumers by Vioxx.
Earlier this year, the Department of Health and Human Services proposed exempting 84 types of Class II devices from 510(k) requirements, which stemmed from the relaxed regulations for the COVID-19 public health emergency. After reviewing adverse event data from both before and after the relaxed pandemic regulations, the FDA began to examine its current market authorization process for medical devices...
FDA the Gold Standard for Medical Device SafetyEMMAIntl
A year-long investigation titled “Implant Files”, which was initiated by the ICIJ (International Consortium of Investigative Journalists) and involved 250 journalists from 36 countries, was released a few weeks ago...
Just like every other nation, Australia has also taken several measures to respond to the global pandemic. To help prevent shortages of medical equipment and personal protective equipment, the Australian regulating authority- Therapeutic Goods Administration (TGA) has announced several exemptions and expedited paths to ensure an adequate supply of medical products...
The regulation of medical devices in AustraliaTGA Australia
The regulation of medical devices in Australia involves classifying devices based on their intended use and risk level. Higher risk devices undergo more rigorous assessment procedures to ensure they meet essential safety and performance principles before being approved for market. Ongoing monitoring is also conducted after devices enter the market to protect public health. The TGA regulates medical devices to confirm they are suitable for their intended purpose and that their benefits outweigh any risks when used correctly.
Presentation on marketing of medical devices in Europe (24.01.2012)Christian Dekoninck
Presentation on the legal implications & compliance in the sales & marketing of medical devices in Europe given at the 3rd annual Medical Device Reimbursement Conference in Brussels (Q1 Productions, January 24th, 2012)
A Survey on Current Applications for Tracking COVID-19EMMAIntl
The document summarizes current applications for tracking COVID-19 around the world and discusses regulatory requirements for such applications. It outlines several prominent COVID-19 tracking tools used by countries like Australia, China, India, UK, Germany and USA. It also discusses the FDA regulatory process for medical devices and software-as-a-medical device (SaMD), including requirements for registration, clinical testing, labeling, quality management and reporting issues. The document emphasizes that COVID-19 tracking applications must comply with FDA regulations to be legally marketed in the US.
Merck developed the drug Vioxx to treat arthritis pain. It was approved by the FDA in 1999 but later studies showed it increased risks of heart attacks and strokes. Merck faced thousands of lawsuits and eventually paid $4.85 billion to settle claims after voluntarily withdrawing Vioxx from the market in 2004. The document discusses the history of Merck and development of Vioxx, clinical trials that showed safety issues, lawsuits against Merck, and recommendations for how the FDA could strengthen drug safety processes going forward to prevent similar situations.
Regulation of IVD medical devices - presentation at National Histotechnology ...TGA Australia
The document discusses regulations for in vitro diagnostic (IVD) medical devices in Australia. It provides an overview of the current regulatory framework, which implemented a new four-tier classification system in 2010 based on risk. All commercial IVDs and high-risk in-house IVDs must be included in the Australian Register of Therapeutic Goods. The document announces reforms planned for 2015 to simplify requirements for certain in-house IVDs and provides guidance for laboratories on identifying devices and complying with regulations by 2017 deadlines.
Medical Device Regulations Global Overview And Guiding PrinciplesJacobe2008
WHO Library Cataloguing-in-Publication Data
World Health Organization.
Medical device regulations : global overview and guiding principles.
1.Equipment and supplies – legislation 2.Equipment and supplies –
standards 3.Policy making 4.Risk management 5.Quality control I.Title.
ISBN 92 4 154618 2 (NLM Classification: WA 26)
Medical device classification following MDR 2017/745Monir EL AZZOUZI
MDR 2017/745 Medical Device Classification. What are the regulatory changes for the new Medical Device Regulation. What is new on the classification of the products. Annex VIII contains 22 rules with 4 new rules. Receive a free form to download and some infographic. This slidedeck is provided by Easy Medical Device. #medtech #medicaldevice #medicaldevices
On February 10, 2020, Clarivate Analytics released the "The 2020 Cortellis Drugs to Watch" annual report, predicting 11 new drugs that will be launched in 2020 and with sales expected to exceed $ 1 billion in 2024. Among these 11 drugs, 2 are anti-tumor drugs. Coincidentally, these 2 drugs are Antibody–Drug Conjugates (ADC).
This is a comprehensive report on medical devices interoperability in India
This report covers global developments in interoperability of medical devices
Kalorama Information Report - Global Market for Medical DevicesBruce Carlson
The global medical device market is expected to grow steadily between 2013 and 2018. In 2013, the market was valued at around $300 billion. Major challenges facing the industry include reimbursement reductions, new taxes, and regulatory changes. Device companies are responding by innovating new products, finding new markets, and acquiring competitors. The top 18 companies earn most of the global revenue, with Johnson & Johnson, GE Healthcare, and Medtronic as the largest players by market share.
Pv day frankfurt june 2015 zittartz presentationpharmasol
Medical Devices and Pharmaceutical products have long been separate worlds with distinct regulations.
Advances in technology continue to create new opportunities by merging devices with drugs or biologics to provide previously impossible benefits to patients. As these combination products involve components that are normally regulated under different types of regulatory authorities, they raise several challenges to traditional pharmaceutical companies, not previously exposed to Device regulations.
Compared to drug regulations, device regulations are more diverse depending on the classification of the device. But the safety of Medical Devices has recently become the focus of regulatory activities in Europe following the scandal about industrial silicone breast implants in France, leading to changes in regulations that follow pharmacovigilance principles.
In this presentation Dr Marc Zittartz, Chief Quality Officer at pharmasol, provides an overview on drug-device combinations, the recent regulatory developments, and how this affects the traditional pharmacovigilance activities of pharmaceutical companies.
This document provides an overview of Japan's healthcare system and medical device market. It summarizes that Japan has universal healthcare coverage for its 127 million citizens, with total healthcare expenditures of $278 billion in 2000. The medical device market in Japan was worth $18 billion in 2000, with the United States having a large trade surplus of $4 billion in medical device exports to Japan. The regulatory system for medical devices is administered by the Ministry of Health and requires government approval and licensing for devices to be sold in Japan.
Roundup of This Year's AACC Meeting in AtlantaBruce Carlson
Major developments in point-of-care (POC) testing were highlighted at the 2015 American Association of Clinical Chemistry Annual Meeting:
1) Several companies announced new POC devices, including a low-cost, battery-powered molecular diagnostics platform from Cepheid and a smartphone-based chlamydia test.
2) Existing POC tests for influenza, diabetes, kidney disease, liver disease, and pregnancy from companies like Alere, DiaSys Diagnostics, and Abbott were demonstrated.
3) The large POC diagnostics market, estimated at $17 billion globally, was a focus for many exhibitors given the potential for rapid results at the point of care.
Orthopaedics Medical Device Market Analysys and Future TrendsMarco Berizzi
Presentation of orthopaedics medical device industry market analysis. The document gives an historical perspective of market size / competitive landscape of the above industry and focuses on business drivers underlying future evolution. At the end of the document, market size figures relative to 2007-2016 time interval are shown.
Republic of Korea Patient Monitoring Market Outlook to 2018 - Fetal Monitors,...ReportsnReports
This report from GlobalData analyzes the market for patient monitoring devices in South Korea from 2004-2018. It provides market size data on product categories like fetal monitors, multiparameter monitors, and blood pressure monitors. The 164-page report was published in October 2012 and costs $2,500 for a single-user license. It contains detailed market segmentation data, company shares, and profiles of key industry players to help companies develop strategies for entering or expanding in the South Korean patient monitoring device market.
The EU’s medical device regulation
Medical device manufacturers seeking market access
to the European Union (EU) will soon face major changes
in the EU’s decades-old regulatory framework. The EU’s
Medical Device Regulation (MDR) was officially published
on 5 May 2017 and came into force on 25 May 2017.
The MDR will replace the EU’s current Medical Device
Directive (93/42/EEC) and the EU’s Directive on active
implantable medical devices (90/385/EEC).
This editorial discusses regulatory issues with medical devices. It notes recalls of breast implants and hip implants that reflect failings in regulation. Medical device regulation in Europe and the US is described as having low evidentiary standards, often only requiring devices to be "substantially equivalent" to existing ones without clinical trials. This has led to unsafe devices being approved and problems going unnoticed. Stricter evidence requirements are needed prior to approval, especially for implantable devices, to better protect patients.
The document summarizes the Indian medical device market. It finds that the market was worth $5.1 billion in 2012 and is expected to reach $9.2 billion by 2016, growing at a 15.8% CAGR. Currently, 72% of medical devices sold in India are imported, with imports favored due to taxation policies. The market is dominated by multinational companies in high-tech segments, while domestic players cater to lower-tech areas. The top opportunities are in medical and diagnostic equipment, expected to reach $6 billion and grow over 17% by 2017. Key drivers of growth are increasing incomes, insurance coverage, and government support of healthcare. Barriers include low penetration, over-reliance on
In this presentation we want to outline the principles of medical device regulations and the 510(k) Premarket notification process for an efficient product approval with the FDA.
This issue of Pharma Uptoday provides news and updates in the pharmaceutical industry. Key items include:
1) Fareva buys a Merck API plant in France and plans to invest €25 million to upgrade it for handling highly potent compounds.
2) Strides completes its acquisition of Aspen's generic business in Australia for Rs 1,910 crore.
3) Aurobindo Pharma receives USFDA approval for its generic version of the hepatitis B drug Entecavir.
This document provides an overview of Bayer's global operations and sales figures by region for 2009. It also summarizes the sales and R&D expenditures of Bayer's main divisions: CropScience, MaterialScience, and HealthCare. HealthCare had the highest sales at 15.9 billion Euros in 2009 and is divided into Pharmaceuticals, Consumer Care, Medical Care, Animal Health, and Diagnostic Imaging. The document highlights some of Bayer's major pipeline drugs and diagnostic imaging technologies in development.
Presentation on marketing of medical devices in Europe (24.01.2012)Christian Dekoninck
Presentation on the legal implications & compliance in the sales & marketing of medical devices in Europe given at the 3rd annual Medical Device Reimbursement Conference in Brussels (Q1 Productions, January 24th, 2012)
A Survey on Current Applications for Tracking COVID-19EMMAIntl
The document summarizes current applications for tracking COVID-19 around the world and discusses regulatory requirements for such applications. It outlines several prominent COVID-19 tracking tools used by countries like Australia, China, India, UK, Germany and USA. It also discusses the FDA regulatory process for medical devices and software-as-a-medical device (SaMD), including requirements for registration, clinical testing, labeling, quality management and reporting issues. The document emphasizes that COVID-19 tracking applications must comply with FDA regulations to be legally marketed in the US.
Merck developed the drug Vioxx to treat arthritis pain. It was approved by the FDA in 1999 but later studies showed it increased risks of heart attacks and strokes. Merck faced thousands of lawsuits and eventually paid $4.85 billion to settle claims after voluntarily withdrawing Vioxx from the market in 2004. The document discusses the history of Merck and development of Vioxx, clinical trials that showed safety issues, lawsuits against Merck, and recommendations for how the FDA could strengthen drug safety processes going forward to prevent similar situations.
Regulation of IVD medical devices - presentation at National Histotechnology ...TGA Australia
The document discusses regulations for in vitro diagnostic (IVD) medical devices in Australia. It provides an overview of the current regulatory framework, which implemented a new four-tier classification system in 2010 based on risk. All commercial IVDs and high-risk in-house IVDs must be included in the Australian Register of Therapeutic Goods. The document announces reforms planned for 2015 to simplify requirements for certain in-house IVDs and provides guidance for laboratories on identifying devices and complying with regulations by 2017 deadlines.
Medical Device Regulations Global Overview And Guiding PrinciplesJacobe2008
WHO Library Cataloguing-in-Publication Data
World Health Organization.
Medical device regulations : global overview and guiding principles.
1.Equipment and supplies – legislation 2.Equipment and supplies –
standards 3.Policy making 4.Risk management 5.Quality control I.Title.
ISBN 92 4 154618 2 (NLM Classification: WA 26)
Medical device classification following MDR 2017/745Monir EL AZZOUZI
MDR 2017/745 Medical Device Classification. What are the regulatory changes for the new Medical Device Regulation. What is new on the classification of the products. Annex VIII contains 22 rules with 4 new rules. Receive a free form to download and some infographic. This slidedeck is provided by Easy Medical Device. #medtech #medicaldevice #medicaldevices
On February 10, 2020, Clarivate Analytics released the "The 2020 Cortellis Drugs to Watch" annual report, predicting 11 new drugs that will be launched in 2020 and with sales expected to exceed $ 1 billion in 2024. Among these 11 drugs, 2 are anti-tumor drugs. Coincidentally, these 2 drugs are Antibody–Drug Conjugates (ADC).
This is a comprehensive report on medical devices interoperability in India
This report covers global developments in interoperability of medical devices
Kalorama Information Report - Global Market for Medical DevicesBruce Carlson
The global medical device market is expected to grow steadily between 2013 and 2018. In 2013, the market was valued at around $300 billion. Major challenges facing the industry include reimbursement reductions, new taxes, and regulatory changes. Device companies are responding by innovating new products, finding new markets, and acquiring competitors. The top 18 companies earn most of the global revenue, with Johnson & Johnson, GE Healthcare, and Medtronic as the largest players by market share.
Pv day frankfurt june 2015 zittartz presentationpharmasol
Medical Devices and Pharmaceutical products have long been separate worlds with distinct regulations.
Advances in technology continue to create new opportunities by merging devices with drugs or biologics to provide previously impossible benefits to patients. As these combination products involve components that are normally regulated under different types of regulatory authorities, they raise several challenges to traditional pharmaceutical companies, not previously exposed to Device regulations.
Compared to drug regulations, device regulations are more diverse depending on the classification of the device. But the safety of Medical Devices has recently become the focus of regulatory activities in Europe following the scandal about industrial silicone breast implants in France, leading to changes in regulations that follow pharmacovigilance principles.
In this presentation Dr Marc Zittartz, Chief Quality Officer at pharmasol, provides an overview on drug-device combinations, the recent regulatory developments, and how this affects the traditional pharmacovigilance activities of pharmaceutical companies.
This document provides an overview of Japan's healthcare system and medical device market. It summarizes that Japan has universal healthcare coverage for its 127 million citizens, with total healthcare expenditures of $278 billion in 2000. The medical device market in Japan was worth $18 billion in 2000, with the United States having a large trade surplus of $4 billion in medical device exports to Japan. The regulatory system for medical devices is administered by the Ministry of Health and requires government approval and licensing for devices to be sold in Japan.
Roundup of This Year's AACC Meeting in AtlantaBruce Carlson
Major developments in point-of-care (POC) testing were highlighted at the 2015 American Association of Clinical Chemistry Annual Meeting:
1) Several companies announced new POC devices, including a low-cost, battery-powered molecular diagnostics platform from Cepheid and a smartphone-based chlamydia test.
2) Existing POC tests for influenza, diabetes, kidney disease, liver disease, and pregnancy from companies like Alere, DiaSys Diagnostics, and Abbott were demonstrated.
3) The large POC diagnostics market, estimated at $17 billion globally, was a focus for many exhibitors given the potential for rapid results at the point of care.
Orthopaedics Medical Device Market Analysys and Future TrendsMarco Berizzi
Presentation of orthopaedics medical device industry market analysis. The document gives an historical perspective of market size / competitive landscape of the above industry and focuses on business drivers underlying future evolution. At the end of the document, market size figures relative to 2007-2016 time interval are shown.
Republic of Korea Patient Monitoring Market Outlook to 2018 - Fetal Monitors,...ReportsnReports
This report from GlobalData analyzes the market for patient monitoring devices in South Korea from 2004-2018. It provides market size data on product categories like fetal monitors, multiparameter monitors, and blood pressure monitors. The 164-page report was published in October 2012 and costs $2,500 for a single-user license. It contains detailed market segmentation data, company shares, and profiles of key industry players to help companies develop strategies for entering or expanding in the South Korean patient monitoring device market.
The EU’s medical device regulation
Medical device manufacturers seeking market access
to the European Union (EU) will soon face major changes
in the EU’s decades-old regulatory framework. The EU’s
Medical Device Regulation (MDR) was officially published
on 5 May 2017 and came into force on 25 May 2017.
The MDR will replace the EU’s current Medical Device
Directive (93/42/EEC) and the EU’s Directive on active
implantable medical devices (90/385/EEC).
This editorial discusses regulatory issues with medical devices. It notes recalls of breast implants and hip implants that reflect failings in regulation. Medical device regulation in Europe and the US is described as having low evidentiary standards, often only requiring devices to be "substantially equivalent" to existing ones without clinical trials. This has led to unsafe devices being approved and problems going unnoticed. Stricter evidence requirements are needed prior to approval, especially for implantable devices, to better protect patients.
The document summarizes the Indian medical device market. It finds that the market was worth $5.1 billion in 2012 and is expected to reach $9.2 billion by 2016, growing at a 15.8% CAGR. Currently, 72% of medical devices sold in India are imported, with imports favored due to taxation policies. The market is dominated by multinational companies in high-tech segments, while domestic players cater to lower-tech areas. The top opportunities are in medical and diagnostic equipment, expected to reach $6 billion and grow over 17% by 2017. Key drivers of growth are increasing incomes, insurance coverage, and government support of healthcare. Barriers include low penetration, over-reliance on
In this presentation we want to outline the principles of medical device regulations and the 510(k) Premarket notification process for an efficient product approval with the FDA.
This issue of Pharma Uptoday provides news and updates in the pharmaceutical industry. Key items include:
1) Fareva buys a Merck API plant in France and plans to invest €25 million to upgrade it for handling highly potent compounds.
2) Strides completes its acquisition of Aspen's generic business in Australia for Rs 1,910 crore.
3) Aurobindo Pharma receives USFDA approval for its generic version of the hepatitis B drug Entecavir.
This document provides an overview of Bayer's global operations and sales figures by region for 2009. It also summarizes the sales and R&D expenditures of Bayer's main divisions: CropScience, MaterialScience, and HealthCare. HealthCare had the highest sales at 15.9 billion Euros in 2009 and is divided into Pharmaceuticals, Consumer Care, Medical Care, Animal Health, and Diagnostic Imaging. The document highlights some of Bayer's major pipeline drugs and diagnostic imaging technologies in development.
Advanced Medical Isotope Corporation is developing a brachytherapy device called RadioGel for cancer treatment in humans and animals. It plans to generate near-term revenue from veterinary clinics and international licensing while pursuing FDA approval. RadioGel consists of yttrium-90 phosphate particles delivered via a hydrogel vehicle that solidifies in the body. It has the potential to treat multiple cancer types more effectively than existing therapies.
Advanced Medical Isotope Corporation is developing a brachytherapy device called RadioGel for cancer treatment in humans and animals. The company plans to generate near-term revenue from veterinary clinics and international licensing while pursuing FDA approval for human use. RadioGel consists of yttrium-90 phosphate particles delivered via a hydrogel that solidifies inside the body. The company expects to begin sales to veterinary clinics in early 2018 and obtain international licensing deals. It is working with national labs and universities to optimize the device and treatment techniques.
Weekly News Wrap-up on Health Care Industry (Europe, North America, Asia/Pacific) showing the latest development of most striking fundamental economic and financial news
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
To recap the previous month's pharma highlights to Pharma Uptoday followers, Monthly magazine Volume 17 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
483 Observations
EU Non Compliance Report
- INTEGRA LIFE SCIENCES CORP, United States
- JINAN JINDA PHARMACEUTICAL CHEMISTRY CO., LTD., China
- WUXI JIDA PHARMACEUTICAL CO., LTD, China
- PARABOLIC DRUGS LIMITED, India
Warning Letters
- Mahendra Chemicals, India
Regulations of the Month
- Sec. 211.25 Personnel qualifications
- Sec. 211.28 Personnel responsibilities
Antisense Therapeutics is a biotech company developing antisense drugs to treat diseases. It has two drugs that showed positive results in Phase 2 clinical trials. ATL1103 for acromegaly was partnered with Strongbridge Biopharma who will fund further development and commercialization in exchange for milestone payments up to $124 million plus royalties. ATL1102 showed positive results for multiple sclerosis in a Phase 2 trial. The company is working to establish an early access program for ATL1102 in Europe to potentially generate near-term revenue while seeking a partner for a Phase 2b trial. Antisense Therapeutics believes its antisense technology platform has potential applications for cancer and diabetic complications as
HealthBIO 2020_Tero Piispanen_Turku Science ParkBusiness Turku
- 12 new biotech companies were created in Finland between June 2019 and October 2020, the smallest number in years, due to the COVID-19 pandemic.
- Total Finnish health tech export was €2.4 billion in 2019, with China as the largest export market thanks to strong demand for diagnostic equipment.
- Several Finnish biotech companies had successful clinical trials, funding rounds, partnerships and FDA/EMA approvals in areas such as oncology, neurology, rare diseases and COVID-19 vaccines.
This document provides an overview of Bayer HealthCare as of March 2011. It discusses the company's structure, key financial data, business areas, research and development activities, and goals for strengthening its position in pharmaceuticals, consumer health, and emerging markets. Bayer HealthCare aims to be a leading diversified healthcare company through innovation, building strong brands, and expanding in high-growth areas.
The FDA regulates food, drugs, medical devices, cosmetics, and other products. It was established in 1930 as part of the US Department of Health and Human Services. The FDA's headquarters is in Maryland and it has many field offices across the US and internationally. Its goals are to ensure consumer safety, increase access to medical products, and improve product quality and manufacturing processes. It regulates a wide range of products from food to drugs to medical devices and ensures they are safe before reaching consumers.
Finnish biotech year 2016 saw several new startups created and funding rounds completed. Highlights included Faron Pharmaceuticals completing an IPO and funding round, Labmaster raising funds for diagnostic technology, and Aurealis Pharma completing a funding round for chronic inflammation and cancer treatments. The Finnish health technology industry saw growing exports, with the medical equipment sector being the largest. Challenges remain in increasing venture financing amounts in Finland compared to other European countries.
Gino Martini, EIPG President
Presentation at Malta Qualified Persons Association-European Industrial Pharmacists Group-University of Malta joint seminar “The Successes And Challenges Of Today’s Pharmaceutical Industry”, Malta 2008.
This issue of Pharma Uptoday provides news and updates from the pharmaceutical regulatory world. Key highlights include:
- The MHRA says it provided free expert advice to AstraZeneca on building a new UK manufacturing plant, and this help is available to all drugmakers.
- Common deficiencies cited in MHRA inspections relate to manufacturers' quality systems.
- An API plant of Dr. Reddy's in India received a US FDA Form 483 with nine observations primarily related to procedural compliance issues.
- Various regulatory agencies like Health Canada, TGA, and the Indian government announce new guidances, regulations, and plans to improve clinical trial quality standards.
Streptomirus (Streptovancin) is a new treatment for necrotizing fasciitis (NF) developed by Catalent Pharmaceutical Inc. Non-clinical studies in mice and dogs showed Streptomirus was safer, faster-acting, and more effective than current NF treatments. Clinical trials confirmed Streptomirus' efficacy and safety profile. Catalent is seeking FDA approval to market Streptomirus globally as an orphan drug for NF, an unmet medical need with high mortality. If approved, Streptomirus would provide a more effective treatment option for NF patients.
The document provides a history of Good Manufacturing Practices (GMP) regulations from the early 1900s to present day. Key events that prompted increased regulation include children dying from contaminated diphtheria antitoxin in 1902 and Upton Sinclair's The Jungle exposing unsanitary meat packing practices in 1905. Major milestones included the 1906 Pure Food and Drug Act, regulations in the 1960s in response to thalidomide birth defects, and revisions in the 1970s-2000s to address issues with medical devices, drug quality controls, and electronic record keeping. GMP guidelines are now internationally harmonized through organizations like the International Conference on Harmonization.
5 companies in the wound healing market to watch for in 2019Avi Surana
The global wound healing market is projected to reach USD 42,069 million by 2024 growing at a CAGR of 6.2%, according to ResearchAndMarkets.com. North America is the largest market for wound care, with U.S alone taking a lion’s share of 38.5% in 2017 while Asia-Pacific is the fastest growing market.
We take a look at some of the companies that are developing novel technologies to address the unmet and growing needs of the wound care market.
Top 10 Free Accounting and Bookkeeping Apps for Small BusinessesYourLegal Accounting
Maintaining a proper record of your money is important for any business whether it is small or large. It helps you stay one step ahead in the financial race and be aware of your earnings and any tax obligations.
However, managing finances without an entire accounting staff can be challenging for small businesses.
Accounting apps can help with that! They resemble your private money manager.
They organize all of your transactions automatically as soon as you link them to your corporate bank account. Additionally, they are compatible with your phone, allowing you to monitor your finances from anywhere. Cool, right?
Thus, we’ll be looking at several fantastic accounting apps in this blog that will help you develop your business and save time.
IMPACT Silver is a pure silver zinc producer with over $260 million in revenue since 2008 and a large 100% owned 210km Mexico land package - 2024 catalysts includes new 14% grade zinc Plomosas mine and 20,000m of fully funded exploration drilling.
Discover timeless style with the 2022 Vintage Roman Numerals Men's Ring. Crafted from premium stainless steel, this 6mm wide ring embodies elegance and durability. Perfect as a gift, it seamlessly blends classic Roman numeral detailing with modern sophistication, making it an ideal accessory for any occasion.
https://rb.gy/usj1a2
𝐔𝐧𝐯𝐞𝐢𝐥 𝐭𝐡𝐞 𝐅𝐮𝐭𝐮𝐫𝐞 𝐨𝐟 𝐄𝐧𝐞𝐫𝐠𝐲 𝐄𝐟𝐟𝐢𝐜𝐢𝐞𝐧𝐜𝐲 𝐰𝐢𝐭𝐡 𝐍𝐄𝐖𝐍𝐓𝐈𝐃𝐄’𝐬 𝐋𝐚𝐭𝐞𝐬𝐭 𝐎𝐟𝐟𝐞𝐫𝐢𝐧𝐠𝐬
Explore the details in our newly released product manual, which showcases NEWNTIDE's advanced heat pump technologies. Delve into our energy-efficient and eco-friendly solutions tailored for diverse global markets.
The Steadfast and Reliable Bull: Taurus Zodiac Signmy Pandit
Explore the steadfast and reliable nature of the Taurus Zodiac Sign. Discover the personality traits, key dates, and horoscope insights that define the determined and practical Taurus, and learn how their grounded nature makes them the anchor of the zodiac.
Unveiling the Dynamic Personalities, Key Dates, and Horoscope Insights: Gemin...my Pandit
Explore the fascinating world of the Gemini Zodiac Sign. Discover the unique personality traits, key dates, and horoscope insights of Gemini individuals. Learn how their sociable, communicative nature and boundless curiosity make them the dynamic explorers of the zodiac. Dive into the duality of the Gemini sign and understand their intellectual and adventurous spirit.
NIMA2024 | De toegevoegde waarde van DEI en ESG in campagnes | Nathalie Lam |...BBPMedia1
Nathalie zal delen hoe DEI en ESG een fundamentele rol kunnen spelen in je merkstrategie en je de juiste aansluiting kan creëren met je doelgroep. Door middel van voorbeelden en simpele handvatten toont ze hoe dit in jouw organisatie toegepast kan worden.
SATTA MATKA SATTA FAST RESULT KALYAN TOP MATKA RESULT KALYAN SATTA MATKA FAST RESULT MILAN RATAN RAJDHANI MAIN BAZAR MATKA FAST TIPS RESULT MATKA CHART JODI CHART PANEL CHART FREE FIX GAME SATTAMATKA ! MATKA MOBI SATTA 143 spboss.in TOP NO1 RESULT FULL RATE MATKA ONLINE GAME PLAY BY APP SPBOSS
The Most Inspiring Entrepreneurs to Follow in 2024.pdfthesiliconleaders
In a world where the potential of youth innovation remains vastly untouched, there emerges a guiding light in the form of Norm Goldstein, the Founder and CEO of EduNetwork Partners. His dedication to this cause has earned him recognition as a Congressional Leadership Award recipient.
Digital Marketing with a Focus on Sustainabilitysssourabhsharma
Digital Marketing best practices including influencer marketing, content creators, and omnichannel marketing for Sustainable Brands at the Sustainable Cosmetics Summit 2024 in New York
Zodiac Signs and Food Preferences_ What Your Sign Says About Your Tastemy Pandit
Know what your zodiac sign says about your taste in food! Explore how the 12 zodiac signs influence your culinary preferences with insights from MyPandit. Dive into astrology and flavors!
Industrial Tech SW: Category Renewal and CreationChristian Dahlen
Every industrial revolution has created a new set of categories and a new set of players.
Multiple new technologies have emerged, but Samsara and C3.ai are only two companies which have gone public so far.
Manufacturing startups constitute the largest pipeline share of unicorns and IPO candidates in the SF Bay Area, and software startups dominate in Germany.
Anny Serafina Love - Letter of Recommendation by Kellen Harkins, MS.AnnySerafinaLove
This letter, written by Kellen Harkins, Course Director at Full Sail University, commends Anny Love's exemplary performance in the Video Sharing Platforms class. It highlights her dedication, willingness to challenge herself, and exceptional skills in production, editing, and marketing across various video platforms like YouTube, TikTok, and Instagram.
2. 2
Pharmaceutical Project Manager
Analyzes investments,
Review market data, and
Comes up with new promotions for
new drugs and devices
Industry Updates
Merck KGaA pays $230M for fourVertex cancer programs.
OrchardTherapeutics announces a manufacturing alliance with PharmaCell.
Ivantis bags $25M for glaucoma-treating microstent.
Singulex enters into collaboration with Qiagen to develop companion
diagnostics.
Amid insulin market scrutiny, Novo faces class action alleging 'collusive price
fixing'.
Eli Lilly's Alimta escapes early generics—and sales hit—with patent win over
Teva.
Daiichi axes 170-person Indian R&D site.
3. 3
Pharmaceutical Project Manager
Analyzes investments,
Review market data, and
Comes up with new promotions for
new drugs and devices
FDA extends review period for Baricitinib, an investigational rheumatoid
arthritis treatment.
Surprise Keytruda-chemo FDA filing puts Merck ahead in I-O combo race.
Medicrea announces 510(k) submission for FDA clearance of proprietary
3D-printed titanium spinal interbody devices.
Ionis to get its heart drug volanesorsen in front of the FDA as soon as
possible.
CureVac's lead mRNA drug is down but not out, says CEO, after its lead
drug failed a phase 2b trial in prostate cancer.
FDA accepts BLA for Mylan and Biocon proposed biosimilarTrastuzumab.
Treatments Under Development
4. 4
Pharmaceutical Project Manager
Analyzes investments,
Review market data, and
Comes up with new promotions for
new drugs and devices
Regulatory News
FDA approves Egalet’s Arymo ER for severe pain.
Novo Nordisk announced that the European Commission has granted
marketing authorisation for Fiasp (fast acting insulin aspart) for the
treatment of diabetes in adults.The authorisation covers all 28 EU
member states.
FDA grants Genentech’s cancer immunotherapyTecentriq priority review
in additional type of advanced bladder cancer.
Aurobindo receives FDA nod for manufacture and market Levetiracetam.
OptiScan earns CE mark for automated bedside glucose, lactate
monitoring system.