News Archive

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.

For as long as I can remember I have been preparing for college.

And not because I wanted to, but because I was “encouraged” (nagged) by my parents. It started in middle school. I had to get good grades so I could get into a good program at my high school, where I had to get good grades so I could get into a good college.

Howard County’s Economic Development Authority on Thursday unveiled its newest workspace, a prototyping lab devoted to 3D printing and rapid technology. 

The Innovation + Prototyping Lab, located at the Maryland Center for Entrepreneurship’s Columbia headquarters on Bendix Road, is an 1800-square-foot space stocked with four 3D printers, computers offering software tutorials and shelves of printed parts.