BioSpace

The FDA outlined a path for one application to cover multiple variants of a gene therapy. Meanwhile, the Centers for Medicare & Medicaid Services revealed plans to expand the Cell and Gene Therapy Access Model to increase patient access to these products. hubs.li/Q04CCgC70

GSK’s three-year restructuring plan is hitting its home country, though CEO Luke Miels said the expected U.K. cuts will have a “limited impact.” hubs.li/Q04CCc_D0

With pressure on GSK’s vaccine business, analysts predict the U.K. pharma will face challenges as it prepares for the loss of exclusivity on a key product. hubs.li/Q04CCcfV0

Eli Lilly’s next-gen weight loss drug retatrutide soundly beat Novo’s approved medicine Ozempic in weight loss and blood sugar reduction, padding the case for a regulatory application that’s expected in the first quarter of 2027. hubs.li/Q04CzKKs0

Astellas Pharma could secure the exclusive global rights to Audax Biosciences’ DAX-044, an antibody-cytokine fusion therapy that activates the immune system in the vicinity of the tumor. hubs.li/Q04CzmMs0

Growth portfolio products like Leqembi and Spinraza helped drive Biogen to $2.8 billion in revenue for the third quarter. hubs.li/Q04Czhbl0

Updated Today - BioSpace's IPO dashboard helps the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026. hubs.li/Q04CzcmL0

A clearly superior clinical profile, reasonable pricing and easy access has helped a handful of recently approved therapies achieve impressive launches. hubs.li/Q04Czb_z0

The largest pharmas have a collective $188 billion in firepower to spend on M&A transactions, with all but one signaling a desire to execute, according to a new analysis from Leerink Partners. hubs.li/Q04CzbMF0

Three former employees of large pharmas, including Novo and Sanofi, share how they were let go. They appreciated severance and outplacement resources but criticized a lack of public transparency, a mishandled notification and puzzling outsourcing. hubs.li/Q04Czbz30

Drug developers increasingly have the option of seeking regulatory approval and commercializing a medicine themselves, rather than accepting an early exit offer. Doing so requires a worldwide strategy. hubs.li/Q04Cz9-k0

Merck’s Moderna-partnered personalized cancer vaccine data leaked ahead of ESMO, while its ADC sac-TMT impressed in endometrial cancer; BMS reported an MS patient death in an early zola-cel trial; and pharma dealmaking is set to surpass last year’s tally. hubs.li/Q04Czb860

Kaye/Bassman’s Michael Pietrack explores the guilt and grief executives feel when their direct reports are downsized and provides a strategy that helps both the leader and the people who need new jobs. hubs.li/Q04Cz9hM0

Artiva Biotherapeutics, which had been evaluating cell therapy AlloNK for the treatment of rheumatoid arthritis and other autoimmune diseases, is exploring strategic options that could include dissolution and liquidation. hubs.li/Q04CtcJW0

Teva Pharmaceuticals is closing its manufacturing facility in Fairfield, New Jersey, and laying off 61 employees. The cuts will be effective Feb. 1, 2027, according to a Worker Adjustment and Retraining Notification (WARN) Act notice. hubs.li/Q04CsW650

In Phase 1, Incyte’s KRAS G12D inhibitor plus standard-of-care chemotherapy yielded an 89% confirmed objective response rate in patients with a type of pancreatic ductal adenocarcinoma, prompting analyst comparisons with Revolution Medicines’ zoldonrasib. hubs.li/Q04CsThV0

The corporate investor arms of Eli Lilly, Sanofi and Pfizer have participated in billions worth of venture capital rounds, but GV is the industry’s biggest spender. hubs.li/Q04Cspdw0

Novartis remains “very happy” with its $12 billion acquisition of Avidity Biosciences, despite a Phase 3 disappointment for the antibody-oligonucleotide conjugate del-desiran. hubs.li/Q04CsnPL0

Since 2025, U.S. biopharma firms have raised $37.2B—68% of the total global VC funding in the industry—with startups in the San Francisco Bay Area & Boston leading the way. hubs.li/Q04CrG1j0

Sac-TMT significantly extended overall and progression-free survival for patients with advanced or recurrent endometrial cancer by 6.9 months over chemotherapy in Phase 3—becoming the first TROP2-directed ADC to do so in this setting, Merck told BioSpace. hubs.li/Q04CjSsC0