News

GAITHERSBURG, Md., Nov. 11, 2024 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on Novavax’s Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The FDA has cleared the Company to begin enrolling the planned Phase 3 trial following the determination that Novavax satisfactorily addressed all clinical hold issues. Novavax will be working with the clinical trial investigators and other partners to resume trial activities as quickly as possible.

GAITHERSBURG, Md., Nov. 07, 2024 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced the successful completion of its End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) and agreement on the design of a Phase 3 registrational program for its product candidate, pemvidutide, in the treatment of obesity.

Novavax Inc. (NASDAQ: NVAX) has tapped AstraZeneca and Pfizer alum Åsa Manelius to oversee operations at the Swedish lab where it manufactures a key vaccine ingredient that’s expected to help drive the Gaithersburg company’s growth.

The company said this week it has named Manelius as its new managing director of the Novavax AB site in Uppsala, Sweden — where it makes Matrix-M, the adjuvant for its Covid-19 vaccine and other candidates it’s developing. She will assume the post in Feburary.

Manelius succeeds Magnus Savenhed, a nearly 20-year Novavax executive who held that position since 2018. He became CEO of Swedish biotech TdB Labs AB in September.

BETHESDA, Md. & WEST JEFFERSON, Ohio–(BUSINESS WIRE)–Vitrian, the leading end-to-end provider of investment capital and capacity building services for biomanufacturing, announced today that it closed a $50 million investment, with ability to scale to $65 million, into AmplifyBio’s Manufacturing Enablement Center (AMEC) in New Albany, Ohio as a first step of a larger commitment to support biomanufacturing in Central Ohio. AmplifyBio is a leading advanced therapy CRO and CDMO offering a full range of drug development and manufacturing services.

10 groundbreaking startups to pitch at Richmond’s Main Street Station on November 20, 2024

RICHMOND, Va., Nov. 4, 2024 /PRNewswire/ — Activation Capital, an innovation ecosystem development organization, is thrilled to announce the Frontier BioHealth Showcase, an event highlighting the achievements of 10 fast-growing life science startups that have completed the inaugural Frontier BioHealth program. Taking place on November 20 at Main Street Station in downtown Richmond, VA, the event kicks off with networking and beverages in the Head House at 4 pm, followed by the Showcase in the Concourse Room at 5 pm, where each startup will deliver a five-minute pitch to an audience of mentors, investors, and community leaders.

Germantown, Maryland, and Venlo, the Netherlands, Nov. 04, 2024 (GLOBE NEWSWIRE) — QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Meningitis/Encephalitis Panel for clinical use.

This marks the fourth QIAstat-Dx syndromic test to receive U.S. regulatory clearance in 2024.

Meningitis (inflammation of the membrane surrounding the brain and spinal cord) and encephalitis (inflammation within the brain) are medical emergencies that require immediate treatment. One in five cases of bacterial meningitis results in permanent complications, such as hearing loss, brain damage and seizures and without prompt treatment, about half of patients will die.[1]

Nov 3, 2024 LaunchPort is pleased to announce that Nanochon (https://www.nanochon.com/) has joined their City Garage/Baltimore Peninsula location as a LaunchPort Resident.

Nanochon’s mission is to develop a new approach to treat cartilage replacement and repair so that the hundreds of thousands of young, active patients with knee damage can return to their lifestyles without having to undergo costly and invasive short-term fixes. Founded in 2016, their technology is a minimally-invasive early intervention that could help avert the need for total knee replacement. Nanochon’s Chondrograft device is a sturdy medical advancement that is one part orthopedic load-bearing implant, one part tissue growth scaffold, and completely revolutionary. Their implant replaces lost or damaged cartilage and encourages new growth using innovative nanomaterial and 3-D printed designs. This technology has the potential to provide a more successful, faster, longer-lasting, and more affordable solution to joint disease and injury.

In this episode of BioTalk, Rich Bendis sits down with Rachel Rath, the Head of JLABS @ Washington, DC, to discuss her journey and insights on building a thriving ecosystem for life sciences innovation. Rachel shares her academic and professional background, from roles at PCORI and BARDA Blue Knight to leading JLABS @ Washington, DC. She offers an in-depth look at JLABS’ national and international footprint, and the significant partnerships with organizations like Children’s National, Virginia Tech, and BARDA that strengthen the innovation landscape across the mid-Atlantic.

Tune in as Rachel shares the current priorities at JLABS, highlighting the diversity of its tenant portfolio, which spans MedTech, Pharma, and Integrated Healthcare Solutions. She also discusses how JLABS companies benefit from the support and resources available through Johnson & Johnson, including access to valuable connections, mentorship, and funding opportunities via JJDC.

Listen now via your favorite podcasting platform:

Apple: https://apple.co/4fybjcO
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TuneIn: https://bit.ly/4ecryv7

The Indo US Bridging RARE Summit 2024 is set to be an unmissable event for those dedicated to advancing rare disease research and fostering global collaborations. Taking place from November 16-18, 2024, this second annual summit is hosted by the Indo US Organization for Rare Diseases (IndoUSrare) in partnership with AIIMS (All India Institute of Medical Sciences, New Delhi) and other key partners. The main venue is the Indian National Science Academy (INSA) Campus, New Delhi, with an opening gala at the outdoor AIIMS Swimming Pool Venue on the evening of November 16th. Virtual participation will be available, offering opportunities for online networking, exhibits, and posters.