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Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by quality problems at an ex-Catalent facility in Indiana. Novo Nordisk, meanwhile, has been tight-lipped about whether its own FDA applications have been affected.

U.K.-based pharmas will not face tariffs as long as Donald Trump is president, according to the agreement.

Following Novo Nordisk’s price cuts for its own GLP-1 medicines, Eli Lilly is offering discounts for the obesity drug purchased through LillyDirect. Both pharmas recently struck a deal with the White House for cheaper prices via the yet-to-be-launched TrumpRx.

Protego Biopharma is advancing a small-molecule drug that helps light chain proteins fold correctly, in turn addressing the underlying biological cause of AL amyloidosis.

The centerpiece of the deal is the in vivo editor TSRA-196, which in preclinical studies has shown robust editing at SERPINA1, the locus linked to alpha-1 antitrypsin deficiency.

The alleged deaths were detected by the FDA’s Vaccine Adverse Event Reporting System, reports from which “generally cannot be used to determine” causation or even contribution, according to the agency.

If approved, Ascendis’ TransCon CNP would become the second therapy for achondroplasia, challenging BioMarin’s Voxzogo.

As bispecifics, ADCs, protein degraders, and AI-designed mini-proteins move into the clinic, discovery teams face a new bottleneck: engineering and producing molecules whose complexity challenges conventional workflows.

As big pharmas including Takeda and Novo Nordisk flee the cell therapy space and smaller biotechs shutter their operations, these players are sticking around to take the modality as far as it can go.

The FDA’s docket in December includes decisions for two big biologic franchises: BMS’s Breyanzi and Amgen’s Uplizna.

Perfecting microbial manufacturing processes means taming its greatest asset: speed. This rapid process for creating biologics also means a race against time, where success hinges on conquering three key challenges: designing a robust microbial strain, optimizing fermentation for industrial scale, and ensuring consistent high-yield product yield.

This year has seen the approval of several first-in-class therapies for HAE, but in a fragmented space, experts question whether they will be enough to net their developers a significant share of the entrenched market.

Acceptance of TempraMed’s products by Meuhedet Health Services strengthens TempraMed’s B2B institutional commercialization strategy as the Company advances reimbursement initiatives and expands relationships with leading healthcare organizations globally Highlights Meuhedet Health Services, Israel’s third-largest Health Maintenance Organization (HMO), serving more than one million insured members, has accepted TempraMed’s flagship VIVI Cap™ and VIVI Epi™ products. TempraMed products are now accepted by two of Israel’s four national HMOs—Maccabi Healthcare Services and Meuhedet—providing institutional access to approximately four million insured lives. The Company is executing a global B2B institutional strategy focused on healthcare organizations, insurers, distributors and government healthcare systems.

· New research team expands capabilities at Boehringer’s U.S. R&D site in Ridgefield, Connecticut.