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BioWorld - Thursday, July 3, 2025
Home » Topics » North America » U.S.

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Illustration of TAVR device

NICE still wary of TAVR in moderate and low risk patients

June 27, 2025
By Mark McCarty
The U.K. National Health Service may or may not deploy transcatheter aortic valve replacement devices as widely as in the U.S., but the National Institute for Health and Care Excellence officially staked out the position the data are not yet compelling for anyone other than high risk patients.
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Laptop displaying FDA logo

FDA waffles on post-assessment reports in final guidance for RRAs

June 27, 2025
By Mark McCarty
Industry’s reaction to the U.S. FDA’s draft guidance for remote regulatory assessments included a request for more clarity on when the agency would issue a post-assessment report, but the final guidance makes clear the FDA sees no compelling reason to issue such a report in every instance.
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CAR T cell attacking cancer cells

China’s NMPA accepts Carsgen’s NDA for Claudin18.2-targeted CAR T

June 27, 2025
By Tamra Sami
No Comments
China’s National Medical Products Administration (NMPA) has accepted for review Carsgen Therapeutics Holdings Ltd.’s NDA for satricabtagene autoleucel (satri-cel, CT-041), an autologous CAR T candidate targeting Claudin18.2 for treating Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. Just one day earlier, Carsgen announced that it had submitted the satri-cel NDA to the NMPA.
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!insulet dexcom CGM
ADA 2025

Pump manufacturers: Patches are the fix for low AID uptake

June 26, 2025
By Annette Boyle
The rapid adoption of the Omnipod 5 answered a question automated insulin delivery system manufacturers posed for years: with clear health benefits and payer coverage, why has pump adoption been so slow? Insulet Corp.’s Omnipod 5’s rapid rise to dominance demonstrated unequivocally that people with diabetes want a stick-and-forget device. The American Diabetes Association’s 85th Scientific Sessions in Chicago on June 20-23 made just as clear that pump makers received the message with several companies outlining plans to introduce a patch system in the next two years.
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Laptop displaying FDA logo

FDA waffles on post-assessment reports in final guidance for RRAs

June 26, 2025
By Mark McCarty
Industry’s reaction to the U.S. FDA’s draft guidance for remote regulatory assessments included a request for more clarity on when the agency would issue a post-assessment report, but the final guidance makes clear the FDA sees no compelling reason to issue such a report in every instance.
Read More
Hand holding money plant
Newco news

Abvance Therapeutics secures seed funding to limit glucose lows

June 26, 2025
By Brian Orelli
No Comments
Abvance Therapeutics Inc. secured an undisclosed amount of capital in a seed round led by Zubi Capital to support development of an insulin and glucagon combination product that the company has been in the process of developing for approximately 18 months.
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Limb exam

Edgewise FDA try goes sideways as sevasemten Becker hope lives on

June 26, 2025
By Randy Osborne
No Comments
Edgewise Therapeutics Inc. CEO Kevin Koch speculated that “perhaps a different environment at the FDA” from four months ago led to reviewers’ caution on sevasemten, his firm’s fast skeletal myelin inhibitor for Becker muscular dystrophy and Duchenne muscular dystrophies.
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Liver illustration

Altimmune’s phase IIb in MASH hits and misses, stock halves

June 26, 2025
By Lee Landenberger
No Comments
Top-line results from Altimmune Inc.’s phase IIb Impact study of pemvidutide in treating metabolic dysfunction-associated steatohepatitis showed the peptide-based GLP-1/glucagon dual receptor agonist hit one primary endpoint while not hitting statistical significance in another.
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Enflonsia

ACIP delivers good news for Merck, makes unprecedented precedent

June 26, 2025
By Mari Serebrov
No Comments
Despite the controversies swirling around the June meeting of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP), the reconstituted committee delivered good news to Merck & Co. Inc. when it voted 5-2 June 26 to recommend that infants younger than 8 months who are not protected by maternal vaccination get one dose of a monoclonal as they head into their first respiratory syncytial virus season.
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Deal handshake with coin, chart background

After axing 95% workforce, Vor bets $4B+ on Remegen’s telitacicept

June 26, 2025
By Marian (YoonJee) Chu
No Comments
Just a month after laying off 147 employees and announcing plans to mull “strategic alternatives,” Vor Biopharma Inc. reported raising $175 million in private placement in public equity financing and inking a new $4.23 billion license deal for Yantai Rongchang Biotechnologies (Remegen) Co. Ltd.’s telitacicept, a dual-target fusion protein drug approved in China for three autoimmune indications. The news was disclosed after U.S. market hours June 25. Vor’s shares (NASDAQ:VOR) gained 34 cents, or 60.5%, to close June 26 at 89 cents. The company’s shares had risen for eight consecutive trading days since June 17.
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