Industry’s reaction to the U.S. FDA’s draft guidance for remote regulatory assessments included a request for more clarity on when the agency would issue a post-assessment report, but the final guidance makes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.

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.

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.

Industry’s reaction to the U.S. FDA’s draft guidance for remote regulatory assessments included a request for more clarity on when the agency would issue a post-assessment report, but the final guidance makes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.

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.

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.

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.

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.

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.

Xlear Inc., of Salt Lake City filed a petition in U.S. district court that could terminate the Federal Trade Commission’s practice of demanding substantiation of health care claims.