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.
The increased use of GLP-1 receptor agonists has led on to an increase in reports of acute pancreatitis in people taking these weight loss drugs in the U.K. That has prompted the launch of a pharmacogenomics project to investigate if there are any genetic links underlying the occurrence of this adverse event.
Innovent Biologics Inc. announced June 27 that it gained National Medical Products Administration’s (NMPA) approval of mazdutide as a new weight loss therapy for obese or overweight patients in China. Mazdutide is a dual glucagon/glucagon-like peptide-1 (GCG/GLP-1) receptor agonist originally discovered by Eli Lilly and Co., of Indianapolis.
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%.
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