News

• If approved by the FDA, NARCAN Nasal Spray will be the first 4 mg naloxone nasal spray switched from prescription status to over-the-counter use

GAITHERSBURG, Md., Feb. 15, 2023 (GLOBE NEWSWIRE) —  Today, Emergent BioSolutions Inc. (NYSE:EBS) announced the U.S. Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee have unanimously voted in favor (a total of 19 votes) that the benefit-risk profile of NARCAN® (naloxone HCl) Nasal Spray is supportive of its use as a nonprescription opioid overdose reversal agent. Emergent presented an overview of its over-the-counter (OTC) development program, the medical need, Human Factors study data and seven years of post-marketing safety data. The FDA is not bound by the committees’ guidance but will take its advice into consideration.

The commitment and mission of growing the BioHealth Capital Region is being continued with new board member

ROCKVILLE, MARYLAND, February 14, 2023 – The Board of Directors of BioHealth Innovation, Inc. (BHI) unanimously approved the appointment of Dr. Michael Friedlander, Vice President for Health Sciences & Technology, Virginia Tech, to its Board of Directors. The BioHealth Innovation Board of Directors is a distinguished group of accomplished and respected leaders committed to the BioHealth Capital Region. Their wealth of experience and expertise provides invaluable guidance and support to BHI’s mission of translating market-relevant research into commercial success by connecting management, funding, and markets.

Modified agreement also includes the development of an updated vaccine in fall 2023

GAITHERSBURG, Md., Feb. 13, 2023 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced a modification to its existing agreement with the U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense, to deliver up to 1.5 million doses of the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373). This agreement will maintain the U.S. public’s access to Novavax’ vaccine and support the development of smaller dose vials, strain selection in line with U.S. Food and Drug Administration (FDA) recommendations, and a smooth transition to the commercial market.

By Sarah Ellinwood with contributions by Mark Nardone, Chris Frew, Sean Rae, Laura Frew, Jeff Caskey, and Heather Mudrick February 9, 2023

If you have lab experience and are looking to break out into industry or biotech, chances are you might be wondering what skills will make you competitive.

BioBuzz consulted with our colleagues, our expert recruiters at our sister company, Workforce Genetics, as well as perused scientist job listings to see what technical skills are in high demand.

Image: https://biobuzz.io

ATTN Awardees: #DYK that #NIAsbir has #Entrepreneurs-in-Residence? Our #EIRs, Diane Ignar, Ph.D., R.Ph., and John P. Reinhart, CPA, M.B.A., bring unique expertise and experience from the field. They provide innovator planning support, business development guidance, and more to #SBIR #STTR awardees. Learn more and connect with an #EIR today: bit.ly/3Ov55gH #NIAFunded

I want to share our team at NSF’s $60 M initiative focused on driving more research translation out of universities, with a specific focus on universities with high research output but lower levels of research translation.

Accelerating Research Translation (ART) Program will provide institutions of higher education with $6 M (over 4 years) to:

• Create the necessary capacity and infrastructure to increase the speed and scale at which they translate technologies from lab to market
• Flexible seed funds to support promising projects with clear translational potential (up to 50% of budget)
• Develop training opportunities — especially for graduate students and postdoctoral researchers — to become entrepreneurs and/or seek translational research-oriented careers in the public and private sectors

First informational webinar is on February 21, 2023. RSVP here: https://nsf.zoomgov.com/webinar/register/WN_N-mFOgtjSkijCuOI7orPvw

Full program announcement: https://beta.nsf.gov/news/new-60-million-nsf-program-aims-increase-speed

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Many parties are involved when a life sciences startup is raising capital. This program will explore strategic and tactical considerations of equity financing for life sciences companies from the legal, investor, and start up perspectives. The panel discussion will cover investor outreach, presentation materials and potential sources and types of equity capital.

The panelists will also explore how to raise equity at various stages of the company’s life cycle, and how navigate fundraising hurdles such as the due diligence process, costs and commonly negotiated terms.

HERNDON, VA. (PRWEB) FEBRUARY 08, 2023

Global life expectancy has more than doubled over the last two centuries, from less than 30 years to more than 72 years.(1) Despite the advances during the ‘golden age of medicine’ throughout the first half of the 20th century, for persons living with rare diseases, 26% still die before the age of five, and depending on the severity of the disease, 37% have a reduced life expectancy.(2) Pharmaceutical companies were historically loathe to research and develop life-saving drugs and treatments for rare diseases because it wasn’t profitable marketing drugs to such a small segment of the population. Rare disease patients became known as ‘orphans,’ having been abandoned by prescription drug manufacturers.(3) In 1983, the U.S. Congress passed the Orphan Drug Act to incentivize drug manufacturers to pursue the development of drug treatments for rare diseases. Dr. Harsha Rajasimha is the Founder and Executive Chairman of the Indo-US Organization for Rare Diseases (IndoUSrare), a not-for-profit organization that seeks to bridge the gap between the western and eastern hemispheres when it comes to orphan diseases. He notes, “It has been 40 years since this watershed moment in the research and development of treatments for rare diseases. While we celebrate our significant progress, we must continue to look toward the still foggy road ahead.”

2022 was an incredibly productive year for American scientists. Biopharmaceutical researchers conducted over 7,000 clinical programs, including more than 3,000 for cancer, 182 for cardiovascular diseases, 111 for Alzheimer’s, and 57 for Type II diabetes. Importantly, 77% of these therapeutics originated at small biotech companies working toward their first breakthrough.

The biggest controversy surrounding the Bayh-Dole Act — which allows academic institutions and private contractors to own and manage inventions they make with federal funds — is the false claim that the law allows the government to relicense patents on these inventions to ensure that prices of resulting products are “reasonable.” While this claim has been widely bandied about, it has been rejected by every administration that has considered it for the past 20 years because that’s not how the law works. Still, attempts to undermine Bayh-Dole in this way continue.