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Manufacturing powerhouse Emergent BioSolutions unveiled its seventh COVID-19 CDMO tie-up Monday, this time to help crank out Humanigen’s late-stage antibody hopeful lenzilumab.

Emergent will hustle along fill-finish work on lenzilumab at its Camden plant in Baltimore, boosting supplies ahead of a possible emergency nod early this year. Humanigen’s monoclonal antibody, designed to treat and prevent the immune hyper-response known as cytokine storm, is currently in a phase 3 trial in hospitalized patients, and the company says it expects to file for an emergency use authorization in 2021’s first quarter.

Image: Emergent recently completed a new filling line at its Camden plant in Baltimore, pictured above. (Emergent BioSolutions) (Emergent Biosolutions )

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This interview is part of a series of conversations with the people working at Mimetas. The 'I' in Mimetas focuses on the personal side of the scientists that drive our world. Today we have a chat with Jos Joore, CEO and co-founder of Mimetas.

What small things in life make you happy?

That's an interesting one. I would say it's, in particular, the small things that make me happy. Being out in nature, taking a run, being with family. People need a firm, happy basis to cope with challenges like setting up and running a company. That basis is made up of all the small things in life that are, in fact, the most important.

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What does #USPVerified mean? It means that you can trust that what's on the label is what's in the bottle. The USP Verified Mark has appeared on more than 880 million bottle labels, making quality visible so you can choose dietary supplements with confidence. Learn more about USP Verified products at quality-supplements.org #NoDoubtAboutIt

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EY Americas IPO Leader Rachel Gerring joins Yahoo Finance Live to discuss the U.S. IPO market, navigating through recessionary fears, inflation, supply chain woes, volatility, and the outlook for IPOs.

Video Transcript BRIAN SOZZI: Companies are pumping the brakes on public debuts with the number of IPOs in the US plunging by 75% in the first half of this year compared to last year according to new data from EY. Joining us now to break down the latest in the IPO space is EY Americas IPO leader Rachel Gerring. Rachel, good to see you here this morning. Have we reached a bottom yet?

Image: From Video

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WASHINGTON – Today, U.S. Secretary of Commerce Gina Raimondo announced grant awards to 32 industry-led workforce training partnerships across the country as part of the $500 million Good Jobs Challenge funded by President Biden’s American Rescue Plan. The Good Jobs Challenge is administered by the Commerce Department’s Economic Development Administration and will enable communities across the country to invest in innovative approaches to workforce development that will secure job opportunities for more than 50,000 Americans.

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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.

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• 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."

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The National Institutes of Health (NIH) Applicant Assistance Program (AAP) is designed to assist small businesses who have never received NIH SBIR/STTR funding in preparing and submitting a Small Business Innovation Research or Small Business Technology Transfer (SBIR/STTR) application.

The goal of this program is to increase participation in the SBIR program by socially/economically disadvantaged small businesses, women-owned small businesses, and small businesses located in under-represented states.

The AAP application portal will be opening on August 5th, 2022 and information about the program is available at the NIH Application Assistance Program website. For more information about the AAP, be sure to attend the AAP Informational Webinar on August 5th at 3:00 PM ET and the Q&A Office Hours on September 15th at 2:00 PM ET. All applications must be submitted no later than September 22nd, 2022 at 5:00 PM ET.

Please note that this service is NOT available to support preparation of a Fast-Track or Phase II application. Companies who have a current SBIR/STTR application under review with the same scope of work are not eligible for AAP support.

Click here for more information.

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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).

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You are invited to our exclusive Biotech & Beer networking event at The Black Sheep Restaurant on August 16th from 4:30-6:30pm, where we will bring together our Northern Virginia life science community from academia, industry, and healthcare.

Learn about new resources available in Virginia to grow your research and development capabilities. Also, come hear about the latest in the life sciences by exchanging in conversation with with old and new friends!

Register to attend for free at: https://members.vabio.org/events/biotech-and-beer–nova/register

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