News Archive

In a job market that’s become increasingly competitive and employer-driven, it’s imperative for both active and passive job candidates to do their homework. Understanding national biotech market trends and how those forces are impacting regional biohubs and the market at large could be a key differentiator between job seekers.

If you’re a job seeker in the BioHealth Capital Region (BHCR) or Greater Philadelphia, there are a host of valuable resources for job market research that can help target your search. The weekly BioBuzz Newsletter and Job Board, BioHealth Innovation’s newsletter, the Maryland Tech Council’s Biohub Maryland Pathways website, and Big4Bio are all just a few of the great sources of information and job opportunities.

Add to that LinkedIn and local in-person networking events, and there are many ways for job seekers to educate themselves on market conditions, specific job qualifications, and where one might fit within the overall talent market.

• FDA will consider an accelerated approval pathway for RGX-121; BLA filing expected in 2024
• Pivotal program is active and enrolling patients
• RGX-121 is a potential first-in-class, one-time gene therapy for the treatment of MPS II
• Internal cGMP manufacturing process expected to support BLA

ROCKVILLE, Md., Aug. 3, 2022 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced its intention to file a Biologics License Application (BLA) in 2024 using the FDA’s accelerated approval pathway for RGX-121 for the treatment of Mucopolysaccharidosis Type II (MPS II), also known as Hunter Syndrome. The Company also announced that a pivotal program for RGX-121 is active and enrolling patients. RGX-121 is an investigational, one-time AAV Therapeutic using the NAV AAV9 vector to deliver the gene that encodes the iduronate-2-sulfatase (I2S) enzyme.

“We are pleased to share that our recent discussions with the FDA support our plans to submit a BLA for RGX-121 in 2024 using the accelerated approval pathway, which was created to allow for expedited development of drugs that treat serious conditions and provide a meaningful advantage over available therapies based on a surrogate endpoint,” said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. “We believe RGX-121 for the treatment of Hunter Syndrome has demonstrated emerging positive impact on neurodevelopmental function, and we intend to advance this program as quickly as possible with the aim of providing a much-needed new treatment option for the MPS II community.”

Emergent BioSolutions, already flush with products against public health threats like anthrax attacks and opioid overdoses, is expanding its arsenal of medical countermeasures by scooping up global rights to smallpox newcomer Tembexa.

Emergent will furnish developer Chimerix with $225 million in upfront cash plus upward of $100 million in milestone payments for worldwide rights to the med, also known as brincidofovir. The drug last summer snagged FDA approval as the first antiviral cleared to treat smallpox regardless of a patient’s age.

GlaxoSmithKline (GSK) has signed an agreement to reserve, produce, and supply its influenza vaccine Adjupanrix to 12 European countries.

Under the terms of the deal, GSK has signed a contract with the European Commission’s (EC) Health Emergency Preparedness and Response Authority (HERA), for the reservation of future manufacture of 85 million doses of Adjupanrix (split virion, inactivated, adjuvanted).

ROCKVILLE, MARYLAND, August xx, 2022 – BioHealth Innovation Inc. (BHI) is pleased to welcome Kelly Murphy, M.S., as a new Life Sciences Business Strategist. In this role, Murphy will evaluate the commercial potential of clients’ emerging technologies and assist start-ups with their go-to-market strategies. Her work will also focus on helping biohealth companies to secure non-dilutive funding.

Murphy is a recent graduate of the Masters of Biotechnology Program at Northwestern University. During her time at Northwestern, she gained professional experience in government affairs, project management, and corporate strategy at two life sciences companies. Prior to earning her graduate degree, she received her BS from the University of Nevada, Reno in neuroscience and chemistry.  

The Fischell Institute is working with University of Maryland (UMD) I-Corps representatives to plan a Medical Device I-Corps program, targeting dates in November. I-Corps is a National Science Foundation (NSF) program designed to foster, grow, and nurture innovation ecosystems regionally and nationally. UMD is the lead institution of the NSF I-Corps Hub: Mid-Atlantic Region and a member of the larger National Innovation Network.

UMD’s Introduction to I-Corps Course is a short, intense, bootcamp-style cohort. Participants work closely with teammates, other teams, and with mentors and instructors to develop business models around their innovations. Courses are approximately two weeks in duration, with the cohort meeting three or four times during the two-week span.

Children’s National Innovation Day features the hospital’s life science and healthcare projects that are looking for strategic partnership, co-development, and licensing opportunities. The event will also showcase startup companies whose mission is aligned with our quest to bring novel pediatric products to patients and families.