Pfizer Inc. upped its original $7.3 billion September offer to buy Metsera Inc., but the obesity specialist maintained that a now-improved unsolicited bid by semaglutide developer Novo Nordisk A/S is superior.
The U.S. FDA once again has a leadership gap at the top of its drug center, which already has been ravaged this year by massive terminations, resignations and retirements of senior leaders. George Tidmarsh, a biopharma industry veteran who’s helmed CDER for a little more than three months, resigned effective immediately Nov. 2 after being placed on administrative leave two days earlier amid a Department of Health and Human Services probe.
Vera Therapeutics Inc.’s atacicept gained still more airtime at the Cantor Fitgerald health care conference held Sept. 4, and some on Wall Street believe the appetite for the BAFF and APRIL dual inhibitor could bode well for others in the same mechanistic space.
The activin E mechanism of action in obesity is having something of an early stage heyday with such players as Wave Life Sciences Ltd. and Ibio Inc. talking up data that have perked the ears of Wall Street.
Pfizer Inc. is threatening legal action at an attempt by Novo Nordisk A/S to scupper its acquisition of Metsera Inc., with an unsolicited $9 billion offer for the anti-obesity specialist. That trumps Pfizer’s agreed bid made in September, which valued New York-based Metsera at $7.3 billion.
Only two days after Bridgebio Pharma Inc. impressed investors with data from BBP-418 in limb-girdle muscular dystrophy type 2I/R9, the company was back at it again, this time reporting positive top-line results from its global phase III study of encaleret in autosomal dominant hypocalcemia type 1, a genetic form of hypoparathyroidism.
Hanmi Pharmaceutical Co. Ltd. announced Oct. 27 that its glucagon-like peptide-1 receptor agonist, efpeglenatide (HM-11260C), met the co-primary endpoints in a phase III study of obese adults without diabetes.
Adocia SA is looking to further apply its Biochaperone formulation technology to metabolic disorders, Olivier Soula, Adocia co-founder and CEO told BioWorld, the firmhaving recently gained positive top-line phase III results of Tonghua Dongbao Pharmaceutical Co. Ltd.’s THDB-0206 injection (Biochaperone Lispro) in diabetes patients in China.
Stem cells are a promising therapeutic modality to fight aging and age-related disease, speakers at the Bio-Plus Interphex Korea 2025 said. Progress in cell-based longevity medicine is being made, they added, although safety, ethical and regulatory issues are ongoing challenges.
The U.S. FDA named the first nine recipients of the recently unveiled commissioner’s national priority voucher (CNPV) program aimed at addressing unmet public health needs by shortening regulatory review times to as little as one to two months. For one of those firms, Disc Medicine Inc., which submitted an NDA for bitopertin for rare genetic disorder erythropoietic protoporphyria in September, that could mean a potential approval before the end of 2025.
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