News Archive

Before April 16, 2014, NIH permitted one resubmission (A1) of an unfunded application (see NOT-OD-09-016).  The extension on the NIH grant number could follow the pattern (A0, A1).  A first-time submission is informally referred to as an A0, and the first resubmission is known as an A1.  Any virtual A2s would be flagged by the NIH Center for Scientific Review.

For all application due dates after April 16, 2014, following an unsuccessful resubmission (A1) application, applicants may submit the same idea as a new (A0) application for the next appropriate new application due date (see NOT-OD-14-082).

Resubmissions (A1) must be submitted within 37 months of the new (A0) application (see NOT-OD-10-140).  For more details on the Resubmission Policy, visit the Resubmissions webpage and the Guide Notice, NOT-OD-14-074.

GlaxoSmithKline plc today announces a major 3-part inter-conditional transaction with Novartis AG involving its Consumer Healthcare, Vaccines and Oncology businesses (the “Transaction”). In summary:

• GSK and Novartis will create a new world-leading Consumer Healthcare business with 2013 pro forma revenues of £6.5 billion. GSK will have majority control with an equity interest of 63.5%
• GSK will acquire Novartis’ global Vaccines business (excluding influenza vaccines) for an initial cash consideration of $5.25 billion with subsequent potential milestone payments of up to $1.8 billion and ongoing royalties
• GSK will divest its marketed Oncology portfolio, related R&D activities and rights to its AKT inhibitor and also grant of commercialisation partner rights for future oncology products to Novartis for an aggregate cash consideration of $16 billion (of which up to $1.5 billion depends on the results of the COMBI-d trial)
• GSK shareholders to receive £4 billion capital return funded by net cash transaction proceeds and expected to be delivered via a B share scheme
• Transaction expected to be accretive to core EPS from first year, reflecting execution of intended B share scheme, and thereafter with growing contribution from 2017 as projected cost savings and new growth opportunities are delivered
• Transaction is expected to complete during the first half of 2015 subject to approvals

Emergent BioSolutions Inc.  today announced that it has initiated manufacturing of BioThrax® (Anthrax Vaccine Adsorbed) consistency lots in Building 55, following review by the U.S. Food and Drug Administration (FDA) of the Manufacturing and Non-Clinical Study Protocols submitted by the company supporting the Building 55 comparability program. The goal of the comparability program is to generate data that will show BioThrax manufactured at large scale in Building 55 is comparable to the BioThrax currently manufactured in the approved facility, Building 12. BioThrax is the only FDA-licensed vaccine for the prevention of anthrax disease.

“Emergent is pleased to have reached an agreement with FDA that now enables the final steps towards securing approval of Building 55 for large scale manufacturing of BioThrax. This progress could not have been achieved without the successful collaboration between the company, FDA, and BARDA,” said Adam Havey, executive vice president and president, biodefense division at Emergent BioSolutions. “This multi-year effort to expand our manufacturing capability is intended to address the U.S. Government’s stated need for this critical medical countermeasure in the Strategic National Stockpile. We look forward to our continued partnership with the government to bring this program to completion.”

Herndon-based APX Labs has raised $10 million from New Enterprise Associates to bring its software platform for Google Glass and other wearables to manufacturing, health care and other enterprise customers.

The Series A investment from NEA embodies the prediction that the near-future of smart glasses lies in the enterprise, whether that be the sort of  heads-up displays offered by Google Glass or more substantial  augmented reality overlays provided by ( noticeably less sleek) devices like the Epson Moverio. APX, through its flagship product Skylight, provides both the user interface and the back-end software that could, for example, give assembly line workers data on an individual part as it crossed they field of view.

The impact of federal budget cuts compounded by the challenges of securing funding for biotechnology companies has led to a growing trend of drug development. Scientists are turning to crowdfunding for biotechnology as a way to scrape up money.

A concept for a nonprofit crowdfunding website for medical research hatched at Lehigh Valley StartUp Weekend last fall is moving ahead.

Healthbox, which helps medical startups grow through accelerators in the U.S. and U.K., is expanding its business through a $7 million fundraising.

Healthbox CEO Nina Nashif Healthbox Healthbox and groups like Rock Health and Blueprint Health help entrepreneurs launch businesses in hot markets like health information technology and digital health. Medical software and information services startups raised $297 million in the first quarter, a 130% jump from Q1 of 2013, according to Dow Jones VentureSource.

Funding in the wider category of digital health topped $1.9 billion last year, up 39% from 2012, according to Rock Health.

Two Big Pharma companies with strong ties to the Philadelphia region are the subject of the latest mega-merger rumor in the drug manufacturing industry.

Pfizer Inc. has expressed an interest in acquiring AstraZeneca for $101 billion, according to a  report in London’s Sunday Times. The two companies declined commenting on the report.

April 30, 2014

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Emergent BioSolutions Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BioThrax® (Anthrax Vaccine Adsorbed) for post-exposure prophylaxis (PEP) of anthrax disease resulting from suspected or confirmed exposure to Bacillus anthracis. Orphan status is given to drugs and biologics that are being developed to treat rare medical conditions, specifically those affecting fewer than 200,000 persons in the U.S. This designation provides incentives to the BioThrax PEP Program, including the waiver of the Biologics License Application (BLA) supplemental regulatory filing fee and marketing exclusivity of up to seven years.

“Emergent is pleased with FDA’s Orphan Drug Designation of BioThrax for post-exposure prophylaxis,” said Adam Havey, executive vice president and president, biodefense division at Emergent BioSolutions. “This designation will help streamline discussions around regulatory requirements at our pre-BLA meeting with FDA next month. We look forward to discussing our supplemental application for the expanded indication of post-exposure prophylaxis and the role of BioThrax in the treatment of inhalation anthrax.”

Three Johns Hopkins University School of Medicine researchers have been awarded two-year grants for their work on potential treatments for diabetes, Novo Nordisk announced this month. Of the 110 initial submissions to the new Novo Nordisk Diabetes and Obesity Biologics Science Forum Program, only four projects were funded, three of which are led by Johns Hopkins researchers. They are Jonathan Powell, M.D., Ph.D.; G. William Wong, Ph.D.; and Elias Zambidis, M.D., Ph.D.