Industry’s reaction to the U.S. FDA’s draft guidance for remote regulatory assessments included a request for more clarity on when the agency would issue a post-assessment report, but the final guidance makes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

Abbott Laboratories grabbed attention in early June with its announcement of a partnership with Tandem Diabetes Care Inc. to develop a multianalyte sensor for people with diabetes that would measure ketones as well as glucose.

With a growing number of people wearing continuous glucose monitors and an ever-shrinking number of hospital-based nurses, bringing your own device or using personal CGMs to measure glucose levels during hospitalizations seems like a no-brainer.

A June 25 hearing in the U.S. House of Representatives highlighted some of the health care spending benefits of remote patient monitoring, but Medicare payment is seen as deficient – a problem that may be resolved by pending legislation.