Drug development, clinical trials and industry dynamics. What changes timelines, risk and competitive positioning.
Page 4 of 30
Sep 30, 2026The new data, presented at EASD in Milan and published in The Lancet, cover 1,152 adults with obesity and Type 2 diabetes. They deepen the commercial contrast between Lilly’s next-generation triple-G candidate and its existing GIP/GLP-1 franchise by pairing very high weight loss with a more modest glycemic profile.
Mazumdar said the leadership change reflects Bicara’s next phase rather than a break from the company, with her moving into a strategic advisor role and becoming vice chair of the board. The timing ties directly to the company’s push to develop ficerafusp alfa as a first-line treatment for advanced head and neck cancer and to prepare for a potential launch path.
Sep 30, 2026The company said it evaluated the resources needed for its current priorities and decided to right-size across all departments. With zelicapavir facing a key infant Phase 2b readout next year and EDP-978 expected to post Phase 1 topline data before the end of the year, the cuts appear tied to capital discipline ahead of catalyst-heavy execution.
Sep 29, 2026uniQure reported that AMT-130 was associated with a 44% slowing of disease progression on cUHDRS at month 48 in 12 patients, down from the 75% slowing it had linked to the therapy at month 36. The result missed statistical significance, but total functional capacity showed a 61% slowing at month 48, close to the 60% result reported at month 36 and notable because TFC is the primary endpoint of the company’s confirmatory trial.
Sep 29, 2026Novo is licensing HRS-1596 from Hengrui Pharma in a deal that could reach $2.6 billion including milestone payments, plus royalties according to BioSpace. The candidate has been cleared in China for a Phase 1 study and is aimed at obesity, type 2 diabetes and other metabolic diseases. The move adds to Novo’s recent push for longer-acting and oral incretin options as it tries to rebuild confidence in its pipeline.
Sep 29, 2026The phase 3 portion of Azure-1 randomized patients to two brelovitug regimens or delayed treatment for 24 weeks, and both active arms beat control on a composite endpoint combining virologic response and ALT normalization. For Mirum, the readout supports the $620 million Bluejay Therapeutics buyout it struck late last year and starts to define how it may try to differentiate against Gilead and Vir.
Sep 29, 2026Atebrioz is a once-daily pill that inhibits the activin receptor-like kinase 2 protein and was approved based on Phase 2 PROGRESS data showing large reductions in new lesion volume and total lesion volume versus placebo at 24 weeks. The approval quickly expands competition in FOP, where Ipsen and Regeneron had already reached the market with therapies that work in different ways.
Sep 28, 2026The agreement gives Merck exclusive global rights to develop, manufacture and commercialize SPR2015, an oral molecular glue designed to inhibit KRAS G12D (ON). For SciBrunch, the transaction is a first publicly announced partnership and a large validation event for a company founded in late 2024.
Sep 28, 2026The approval puts a Parkinson’s drug from AbbVie’s $8.7 billion Cerevel takeover on the market after the deal’s highest-profile schizophrenia program failed in mid-stage testing. It also gives AbbVie an entry into what Chief Commercial Officer Jeffrey Stewart has described as a $5 billion market opportunity.
Sep 28, 2026Ultragenyx’s past month brought approvals for Fayuvi in Sanfilippo syndrome type A and Genglycos in glycogen storage disease type Ia, each with a priority review voucher attached. But the company is also reassessing its cost structure after apazunersen failed in Phase 3 in Angelman syndrome and after another recent late-stage setback with setrusumab.
Sep 28, 2026Immunology remains one of biopharma’s biggest commercial arenas even as aging franchises face patent and exclusivity pressure. BioSpace’s review highlights how companies from Johnson & Johnson and Merck to argenx, Kymera and Nurix are positioning around targets such as FcRn and STAT6 to capture the next phase of growth.
Sep 26, 2026As pandemic urgency fades, biomanufacturing groups are trying to preserve the speed and flexibility built during COVID without leaving expensive capacity idle. The emerging model is less about one-off emergency mobilization and more about turning platform technologies, transferable processes and regional production networks into services that can support routine biologics and vaccines as well as future outbreaks.
Machine learning, predictive models and computational biology: how AI is changing discovery workflows and probability of success.
Gene therapy, CRISPR, synthetic biology and emerging platforms. Separating what is real from what is hype, and what actually translates.
Where capital is flowing and why the tape moves, across funding rounds, M&A, IPOs and market analysis.
Digital health, diagnostics and medical devices, and the signals that matter for adoption, reimbursement and outcomes.
FDA actions, approvals, policy shifts and compliance: how the rules change timelines and probability.