Generic Drug Labeling Proposed Rule: The Generic Drug Industry PerspectiveMichael Swit
May 15, 2014 webinar sponsored by the Drug Information Association (DIA) on the November 2013 FDA proposed rule to require generic drug firms to amend their labels with new safety information even if the brand name label has not been changed with the same information.
Business and scientific updates presentation given by Dr. Wayne Danter at the Critical Outcome Technologies Inc. 2013 Annual and Special Meeting of Shareholders on December 5, 2013.
Generic Drug Labeling Proposed Rule: The Generic Drug Industry PerspectiveMichael Swit
May 15, 2014 webinar sponsored by the Drug Information Association (DIA) on the November 2013 FDA proposed rule to require generic drug firms to amend their labels with new safety information even if the brand name label has not been changed with the same information.
Business and scientific updates presentation given by Dr. Wayne Danter at the Critical Outcome Technologies Inc. 2013 Annual and Special Meeting of Shareholders on December 5, 2013.
For the most part, everyone in the medical device industry is familiar with the term “510(k)”, but not many people know that there are three different types of the premarket notification. The following are the different types of 510(k)’s a firm can submit: Traditional, special, and abbreviated. Each 510(k) is a premarket notification, which if cleared, grants the firm permission by the FDA to market the device; but each one has different benefits and processes that medical device firms can take advantage of...
American CryoStem Corporation (CRYO) a leading strategic developer, marketer and global licensor of patented adipose tissue-based cellular technologies for the Regenerative and Personalized Medicine industries, today released Summary corporate and financial highlight information regarding the Company’s year ending September 30, 2016.
Kiromic BioPharma, Inc. is a target discovery and gene-editing company utilizing artificial intelligence and its proprietary neural network platform with a therapeutic focus on immuno-oncology.
Hancock, MD, Oct. 17, 2016 - PetLife Pharmaceuticals, Inc. (OTC QB: PTLF) (the "Company"), a developer of a new generation of high potency veterinary cancer medications and Nutraceuticals for pets, has completed the corporate website overhaul as FDA/CVM submission and testing nears.
Lantern Pharma is a clinical stage biotechnology company focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic date to streamline the drug development process and to identify patients who will benefit from their targeted oncology therapies. Their portfolio of therapies consists of compounds that others have tried, but failed, to develop into an approved commercialized drug. Additionally, they develop new compounds with the assistance of their A.I. platform (RADR) and biomarker driven approach. The Company is currently developing four therapeutic programs.
What the Government Shutdown Means to the Med Device Industry?EMMAIntl
On December 22nd, 2018, the Federal Government went into a partial shutdown. Forty one percent of the FDA staff has been furloughed, which means that out of 17,397 FDA staff members, only 10,344 members have been retained for work. The number of furloughed employees may increase as the shutdown progresses...
Critical Outcome Technologies Inc. streamlines drug discovery - dramatically reducing the time and cost to bring new drugs to market. The Company is listed on the TSX Venture Exchange (ticker symbol: COT).
Lantern Pharma is a clinical stage biotechnology company focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic date to streamline the drug development process and to identify patients who will benefit from their targeted oncology therapies. Their portfolio of therapies consists of compounds that others have tried, but failed, to develop into an approved commercialized drug. Additionally, they develop new compounds with the assistance of their A.I. platform (RADR) and biomarker driven approach. The Company is currently developing four therapeutic programs.
G Medical Innovations Holdings Ltd is a mobile health (mHealth) and e-health company. It develops and markets clinical and consumer medical-grade health monitoring solutions and offers end-to-end support for e-health projects. The company offers a suite of both consumer and clinical grade products and platforms which are positioned to reduce inefficiencies in healthcare delivery, improve access, reduce costs, increase the quality of care, and make healthcare more personalized and precise.
For the most part, everyone in the medical device industry is familiar with the term “510(k)”, but not many people know that there are three different types of the premarket notification. The following are the different types of 510(k)’s a firm can submit: Traditional, special, and abbreviated. Each 510(k) is a premarket notification, which if cleared, grants the firm permission by the FDA to market the device; but each one has different benefits and processes that medical device firms can take advantage of...
American CryoStem Corporation (CRYO) a leading strategic developer, marketer and global licensor of patented adipose tissue-based cellular technologies for the Regenerative and Personalized Medicine industries, today released Summary corporate and financial highlight information regarding the Company’s year ending September 30, 2016.
Kiromic BioPharma, Inc. is a target discovery and gene-editing company utilizing artificial intelligence and its proprietary neural network platform with a therapeutic focus on immuno-oncology.
Hancock, MD, Oct. 17, 2016 - PetLife Pharmaceuticals, Inc. (OTC QB: PTLF) (the "Company"), a developer of a new generation of high potency veterinary cancer medications and Nutraceuticals for pets, has completed the corporate website overhaul as FDA/CVM submission and testing nears.
Lantern Pharma is a clinical stage biotechnology company focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic date to streamline the drug development process and to identify patients who will benefit from their targeted oncology therapies. Their portfolio of therapies consists of compounds that others have tried, but failed, to develop into an approved commercialized drug. Additionally, they develop new compounds with the assistance of their A.I. platform (RADR) and biomarker driven approach. The Company is currently developing four therapeutic programs.
What the Government Shutdown Means to the Med Device Industry?EMMAIntl
On December 22nd, 2018, the Federal Government went into a partial shutdown. Forty one percent of the FDA staff has been furloughed, which means that out of 17,397 FDA staff members, only 10,344 members have been retained for work. The number of furloughed employees may increase as the shutdown progresses...
Critical Outcome Technologies Inc. streamlines drug discovery - dramatically reducing the time and cost to bring new drugs to market. The Company is listed on the TSX Venture Exchange (ticker symbol: COT).
Lantern Pharma is a clinical stage biotechnology company focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic date to streamline the drug development process and to identify patients who will benefit from their targeted oncology therapies. Their portfolio of therapies consists of compounds that others have tried, but failed, to develop into an approved commercialized drug. Additionally, they develop new compounds with the assistance of their A.I. platform (RADR) and biomarker driven approach. The Company is currently developing four therapeutic programs.
G Medical Innovations Holdings Ltd is a mobile health (mHealth) and e-health company. It develops and markets clinical and consumer medical-grade health monitoring solutions and offers end-to-end support for e-health projects. The company offers a suite of both consumer and clinical grade products and platforms which are positioned to reduce inefficiencies in healthcare delivery, improve access, reduce costs, increase the quality of care, and make healthcare more personalized and precise.
Breaching a Web Application - Common Issues and Mitigating Stepsjasonjfrank
It seems like every day that another company's logo is plastered across the media and they have lost thousands, if not millions of customer records. This kind of data loss is damaging to a company's reputation and their customers have little control of their private information. Attackers often want this data for financial gain or to embarrass that company. There are several methods a malicious attacker will use to gain access to this data. Injection-based attacks leverage an application's lack of input validation to extract information and allow for unauthorized data access. In addition, the platform on which the application resides can be leveraged to gain unauthorized admin access and ultimately, data access. Both scenarios will be discussed and demonstrated in this talk. Finally, mitigating steps will be discussed at every level of the attack. The approach will be a defense in depth model that will proactively protect a web application. While there is no silver bullet against a determined attacker, these mitigations will make their lives more difficult.
TCP & UDP Streaming Comparison and a Study on DCCP & SCTP ProtocolsPeter SHIN
As a graduate student work, I have compared the performance between TCP and UDP media streaming with empirical results. Also, I have researched on different attempts on UDP to be more reliable, but why its progress has not been as fast as possible
Go Hack Yourself - 10 Pen Test Tactics for Blue Teamersjasonjfrank
This presentation, given at BSidesPittsburgh 2015, discusses free tools and techniques penetration testers use that can be translated to network defenders for immediate impact and value.
Lantern Pharma is a clinical stage biotechnology company focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic date to streamline the drug development process and to identify patients who will benefit from their targeted oncology therapies. Their portfolio of therapies consists of compounds that others have tried, but failed, to develop into an approved commercialized drug. Additionally, they develop new compounds with the assistance of their A.I. platform (RADR) and biomarker driven approach. The Company is currently developing four therapeutic programs.
Lantern Pharma is a clinical stage biotechnology company focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic date to streamline the drug development process and to identify patients who will benefit from their targeted oncology therapies. Their portfolio of therapies consists of compounds that others have tried, but failed, to develop into an approved commercialized drug. Additionally, they develop new compounds with the assistance of their A.I. platform (RADR) and biomarker driven approach. The Company is currently developing four therapeutic programs.
Prescient Therapeutics (PTX:ASX) is an ASX-listed biotechnology company focused on improving outcomes for cancer patients by developing personal medicines, using CAR-T and targeted therapy approaches.
Universal CAR-T therapies like OmniCAR have the potential to take personalised cancer treatment to the next level, by combining the cancer-killing capabilities of a T-cell with the control and pharmacology of a drug.
Dr. Patrick Soon-Shiong Presents at the 37th Annual J.P. Morgan Healthcare Co...
Ocata Therapeutics Announces Pricing of $30 Million Offering of Common Stock and Warrants
1. Ocata Therapeutics Announces Pricing of $30 Million
Offering of Common Stock and Warrants
MARLBOROUGH, Mass.--(BUSINESS WIRE)--Ocata Therapeutics, Inc. (NASDAQ:OCAT), a clinical
stage biotechnology
company focused on the development and commercialization of Regenerative
Ophthalmology(TM), today announced the pricing of an underwritten offering
of 5,500,000 shares of its common stock together with accompanying
warrants to purchase an aggregate of 2,750,000 shares of common stock.
The combined offering price of each share of common stock and
accompanying warrant was $5.50. The gross proceeds to Ocata Therapeutics
from this offering are expected to be $30.25 million, before deducting
underwriting discounts and commissions and other estimated offering
expenses payable by Ocata Therapeutics. The warrants will be exercisable
at $7.48 per share, will be exercisable beginning on December 22, 2015
and will expire on December 22, 2020. The shares of common stock and
warrants are immediately separable and will be issued separately. Ocata
Therapeutics has granted the underwriters a 30-day option to purchase up
to an additional 825,000 shares of common stock and/or warrants to
purchase 412,500 shares of common stock to cover over-allotments, if
any. Ocata Therapeutics intends to use the net proceeds from the sale of
the offered securities to fund its clinical activities, including the
commencement of its Phase 2 AMD and pivotal SMD clinical trials, the
advancement of its pre-clinical studies in other ocular indications and
other programs, and for general corporate purposes, which may include,
but are not limited to, working capital, potential business development
activities, ongoing research and development activities, funding
2. regulatory approval application processes, and capital expenditures.
All of the shares and accompanying warrants in the offering are to be
sold by Ocata Therapeutics. The offering is expected to close on or
about June 22, 2015, subject to the satisfaction of customary closing
conditions. Additional details regarding the offering will be included
in a Form 8-K filed by Ocata Therapeutics with the Securities and
Exchange Commission.
Jefferies LLC and Cowen and Company, LLC are acting as joint bookrunners
for the offering. Raymond James Associates, Inc. is acting as
co-manager for the offering.
The securities described above are being offered pursuant to a shelf
registration statement (File No. 333-199311), which was declared
effective by the United States Securities and Exchange Commission
("SEC") on November 14, 2014. A final prospectus supplement relating to
the offering will be filed with the SEC and will be available on the
SEC's web site at www.sec.gov.
When available, copies of the final prospectus supplement and
accompanying prospectus may be obtained by contacting Jefferies LLC, 520
Madison Avenue, 12th Floor, New York, NY 10022, Attention:
Prospectus Department, or by email to prospectus_department@jefferies.com;
or Cowen and Company, LLC, c/o Broadridge Financial Services, Attention:
Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, by
telephone at (631) 274-2806, or by fax at (631) 254-7140.
3. This press release shall not constitute an
offer to sell or the
solicitation Stock report of an offer to buy
these securities, nor shall there be any
sale of these securities in any jurisdiction in
which such offer,
solicitation or sale would be unlawful prior to
the registration or
qualification under the securities laws of any
such jurisdiction.
About Ocata Therapeutics, Inc.
Ocata Therapeutics, Inc. is a biotechnology company focused on the
development and commercialization of novel therapies based on terminally
differentiated cells.
Forward-Looking Information is Subject to Risk and Uncertainty
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to Ocata Therapeutics'
expectations regarding the completion of the offering. Actual results or
developments may differ materially from those projected or implied in
these forward-looking statements. Factors that may cause such a
difference include, without limitation, risks and uncertainties related
to market and other conditions, the satisfaction of customary closing
conditions related to Stock report the offering and the impact of general economic,
industry or political conditions in the United States or
internationally. There can be no assurance that Ocata Therapeutics will
be able to complete the offering on the anticipated terms, or at all.
Additional risks and uncertainties relating to Ocata Therapeutics and
4. its business can be found in Ocata Therapeutics' periodic reports,
including its Annual Report on Form 10-K for the fiscal year ended
December 31, 2014 and its Quarterly Report on Form 10-Q for the fiscal
quarter ended March 31, 2015. You should not place undue reliance on
these forward-looking statements, which apply only as of the date of
this press release. Forward-looking statements are based on the beliefs,
opinions, and expectations of Ocata's management at the time they are
made, and Ocata Therapeutics does not assume any obligation to update
its forward-looking statements if those beliefs, opinions, expectations,
or other circumstances should change.