News

LONDON, Nov. 12, 2024 /PRNewswire/ — Ascend Advanced Therapies (Ascend), a gene-to-GMP development partner, has partnered with EW Healthcare Partners to expand the footprint and capabilities of the company in the US and to continue investing further in infrastructure. Advanced BioScience Laboratories (ABL), a biotherapy, oncolytic and viral vector contract development, and manufacturing organization (CDMO) located in Rockville, MD, a portfolio company of EW Healthcare Partners, will become part of Ascend. EW will also make a significant capital investment in Ascend to support continued growth of the company.

The Accelerate Investor Conference spurs the region’s innovation and startup ecosystem engagement to a new level and showcases the Virginia, Maryland, and metropolitan Washington, D.C., region as a destination for business development, venture investment, and job creation.

Each year the event grows in size and stature. This year Mason Enterprise, which plans the event, reports there were 480 registered attendees, 19 speakers, 48 company pitches, 72 investors judged and participated, and 14 student teams that pitched. 

The competition targeted entrepreneurs with early to mid-seed stage, high-growth businesses with the potential to have an immediate and positive impact on our local economy, as well as student concepts with longer-term business viability. After days of networking, engagement, and education, the winners were selected.

The 11th Annual BioHealth Capital Region Week has been rescheduled to take place from September 23rd through 25th, 2025, at USP in Rockville, Maryland. Mark your calendars for this premier gathering of industry leaders, innovators, investors, and experts shaping the future of the biohealth industry.

Building on the tremendous success of our 10th Annual Week, the 2025 event will continue to feature hallmark events like the Forum, Crab Trap Competition and the Investment Conference, offering invaluable networking and presentation opportunities for both emerging companies and seasoned investors.

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]