News Archive

Emergent BioSolutions Inc. today announced successful completion of the last licensure-enabling study in its BioThrax® (Anthrax Vaccine Adsorbed) Post-Exposure Prophylaxis (PEP) program. This clinical study, also known as the non-interference study, was designed to evaluate the pharmacokinetic profile of the antimicrobial ciprofloxacin when administered prior to and following the administration of a three-dose series of BioThrax. It was also designed to evaluate the immune response to BioThrax when administered with or without ciprofloxacin. The primary endpoints were the ratio of the maximum concentration (Cmax) and area under the curve (AUC) for ciprofloxacin and the secondary endpoint was the ratio of the geometric mean titer of the antibody response to BioThrax two weeks following the last dose. The study met the prospectively defined success criteria for both the primary and secondary endpoints. Data from this study show no interaction between ciprofloxacin and BioThrax.

Emergent has submitted the final clinical study report to the Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Food and Drug Administration (FDA). Results from this study will be used to support a supplemental Biologics License Application (sBLA) seeking licensure of a PEP indication for BioThrax to be used in combination with antibiotics in people with suspected or confirmed exposure to anthrax spores. BioThrax is currently licensed for a pre-exposure prophylaxis indication only.

Qiagen NV, the Dutch diagnostics technology company that bought  Gaithersburg-based Digene for $1.6 billion in 2007, is preparing to clear out of Digene’s old offices and move staff to an expanded Germantown headquarters.

The move has  been in the works for years, but Qiagen can finally push forward following recent FDA clearance of its 270,000-square-foot Germantown site for manufacturing the company’s human papillomavirus (HPV) test. That HPV test, developed by Digene, was the impetus for the 2007 acquisition.

The University of Maryland announced today that the 2014 University of Maryland Corporate Connector of the Year Award recipient will be Dr. Michael Pecht and the UMD Center for Advanced Life Cycle Engineering (CALCE).  The UMD Corporate Connect Council annually recognizes a University of Maryland researcher, staff or unit that has achieved significant engagement with the private sector in corporate research, philanthropy, or student support.

Pecht will receive his award as part of the University’s Celebration of Innovation and Partnerships on Tuesday, April 29, 2014 at University House in College Park, Maryland. Pecht’s engagement with the private sector has played a large role in making UMD CALCE, headquartered at the College Park campus, the world’s largest manufacturing consortium in electronic parts reliability engineering, accelerated testing, and supply chain management. Over 150 corporations, federal labs, universities and leading international research centers are members. 

The Maryland Technology Development Corporation (TEDCO) announced today that nine finalists have been selected in the organization’s fourth annual ICE Awards. The awards program, which recognizes Innovation, Corporate Excellence and Entrepreneurship, will reward outstanding businesses and individuals from TEDCO’s diverse portfolio of more than 300 seed and early-stage companies. Winners will be announced on Thursday, May 15 from 8:30 am – 11:30 am during the awards ceremony at the Sheraton Columbia Town Center Hotel in Columbia, Md.  

“TEDCO’s portfolio companies encompass an incredibly diverse range of industries, technologies and innovations,” said Rob Rosenbaum, president and executive director of TEDCO. “We are pleased to announce this year’s ICE Awards finalists and congratulate them on their continued success in some of the fastest-growing and most competitive fields out there. Most importantly, we look forward to continuing to support leading Maryland innovators.”

On Friday, March 28th, a contingent of Johns Hopkins University Depart­ment of Biomedical Engineering (JHU BME) undergraduate students and faculty visited the University of Maryland campus in College Park, Md. to participate in the second annual JHU–UMD Under­graduate Research Day with undergraduates from the University of Maryland’s Fischell Department of Bio­engineering (UMD BioE).

This event is organized by the two universities’ student Biomedical Engineering Society (BMES) chapters — under the leadership of chapter presidents Anvesh Annadanam (JHU BME), and Luke Peterken (UMD BioE).

Now that the Maryland General Assembly has adjourned for the year, it is time to take a quick review of significant accomplishments. Amid the hotly-contested debate on honoring soft shell crabs, kudos to the legislature for passing two little-noticed initiatives to create jobs and spur local economic development by leveraging the state’s huge academic, federal and private research sectors.

The first initiative, the “E-nnovate” bill, creates a $100 million matching fund to recruit the world’s best scholars to Maryland in areas as diverse as cyber security, biotechnology, STEM education, autonomous systems, language science and food safety. The fund will require these scholars to work with other Maryland universities, federal labs or with innovative startup companies, ensuring integration of research into economic development.

The University of Maryland, College Park, has announced a new master’s degree program that will focus on technology entrepreneurship — and, appropriately, it will be offered online.

The program will be part of the university’s Maryland Technology Enterprise Institute (Mtech), and enrollees will have access to the institute’s Technology Advancement and Venture Accelerator programs in addition to their online curriculum.

Governor Deval Patrick announced Thursday a plan to keep highly-skilled international students in Massachusetts post-graduation. Under his proposed Global Entrepreneur in Residence program, however, the “highly-skilled” appear to have one trait in common: technical talent. And now is not the time to be focusing solely on science, technology, engineering and math.

Patrick’s proposed legislation exploits a loophole in federal immigration law, and could bolster the number of H-1B visas the state is allotted. Students eligible for a nonimmigrant visa but unable to obtain it due to a federal cap will be designated an “entrepreneur in residence” if they have plans to start or grow a business locally.

As early as February, analysts were saying that it would be a good year for healthcare IT companies looking for venture capital.

Communications and consulting firm Mercom Capital echoed that today with results from its first-quarter investment analysis which found that healthcare IT companies raised more VC money last quarter than in any quarter before.

The most extensive collaboration between the patient social network and a drug company to-date is likely to be just the first of its kind.

PatientsLikeMe, the largest online network for patients, has established its first broad partnership with a drug company. Genentech, the South San Francisco biotechnology company bought by Roche in 2009, now has access to PatientsLikeMe’s full database for five years.