The U.S. FDA finalized the latest edition of its premarket cybersecurity guidance, but the agency is of the view that any device with software is subject to the terms of the guidance even though the statute would seem to exempt device software that lacks connectivity.
Weighing in on the marketing exclusivity provided by the Orphan Drug Act, the U.S. Court of Appeals for the District of Columbia Circuit said the FDA didn’t act beyond its statutory authority when it approved Avadel CNS Pharmaceuticals plc’s narcolepsy drug, Lumryz, for marketing during the exclusivity period granted to Jazz Pharmaceuticals plc’s Xywav, even though both drugs contained the same active ingredient, sodium oxybate, and were approved for the same disease or condition.
Solid phase III efficacy results for Moderna Inc.’s seasonal influenza vaccine, mRNA-1010, may lead the company to resubmit a BLA for a flu/COVID-19 combo shot it has been developing. The top-line data showed Moderna’s flu vaccine produced a superior relative efficacy that was 26.6% higher than a comparator standard-dose seasonal influenza vaccine in people ages 50 and older.
Abbvie Inc. is shelling out up to $2.1 billion to acquire CAR T player Capstan Therapeutics Inc., gaining rights to a phase I-stage program targeting CD19 as well as an in vivo cell engineering platform. The announcement comes on the heels of recently published data detailing Capstan’s delivery approach using targeted lipid nanoparticles (tLNPs) and marks Abbvie’s latest foray into the CAR T space.
Inmune Bio Inc. claimed a phase II win with TNF inhibitor Xpro (pegipanermin) in early Alzheimer’s disease (AD), though the study missed its primary and secondary endpoints, leading shares of the firm (NASDAQ:INMB) to close at $2.16, down $3.18, or almost 60%.
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. “We’re very excited that this round is able to get us positioned for a successful series A once we meet some internal confidential milestones,” Edward Raskin, CEO of Abvance, told BioWorld.
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.
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.
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