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#辉瑞

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Oct 14Wed
  1. nature.com62

    Talazoparib plus enzalutamide in high-volume metastatic hormone-naive prostate cancer: a randomized phase 2 trial

    Adding the PARP inhibitor talazoparib to enzalutamide improved prostate-specific antigen response in patients with high-volume metastatic hormone-sensitive prostate cancer in the randomized phase 2 ZZ-FIRST trial. Spatial transcriptomic analysis of paired biopsies showed that androgen receptor inhibition suppresses homologous recombination repair-related programs, and this suppression correlated with proliferation arrest rather than functional HRR deficiency.

    Why it matters: Links AR inhibition to HRR program suppression, giving a mechanistic basis for combining PARP inhibition with androgen receptor inhibitors.

  2. biospace.com48

    Alnylam bulls and bears fight it out after business-shaking guidance cut

    Alnylam cut full-year guidance by about $200 million after second-quarter sales of the TTR silencer Amvuttra in transthyretin-mediated amyloidosis fell short, and its stock has dropped from near $500 to around $250. Analysts at Guggenheim question whether the ATTR-CM opportunity is smaller than expected or whether stabilizers from Pfizer and BridgeBio are becoming preferred, while TD Cowen reiterated a $482 target and BMO argues the cut reflects second-line patient exhaustion. Alnylam is running Phase 3 trials of nucresiran in ATTR-CM and ATTR-PN, and a Phase 3 cardiovascular outcomes trial of zilebesiran in hypertension.

Oct 13Tue
  1. biospace.com56

    Pfizer pens $500M+ deal with Enodia to destroy disease-causing proteins

    Pfizer has signed a deal with Paris-based Enodia Therapeutics worth up to $500 million, covering an upfront payment plus research, development and sales milestones, with tiered royalties on net sales. Enodia will screen, optimize and develop small-molecule inhibitors of the Sec61 membrane protein complex, while Pfizer handles clinical studies, manufacturing, regulatory and commercial work. Target indications are not yet specified. Pfizer's venture arm had co-led Enodia's €20.7 million ($25 million) seed round in January.

    Why it matters: Pfizer commits over $500 million to a Sec61-targeting platform less than a year after the biotech's launch.

Oct 9Fri
  1. biorxiv.org51

    Single-nucleus multi-omics reveals reversible molecular signatures in skeletal muscle of patients with heart failure with preserved ejection fraction

    Single-nucleus multiome profiling of 140 skeletal muscle biopsies from 95 individuals (25 healthy controls, 70 HFpEF patients) maps molecular signatures of skeletal muscle remodeling in HFpEF, including type 1 fiber and pericyte depletion and type 2x fiber enrichment. Paired biopsies from 45 HFpEF patients before and after a supervised diet and exercise intervention show the chromatin accessibility and transcriptional changes were partially reversible. HFpEF-linked chromatin was enriched for heart failure and cardiometabolic GWAS signals.

Oct 8Thu
  1. biospace.com40

    Q3 layoffs down YOY, with 90% fewer biopharma employees affected

    BioSpace tallies show biopharma layoffs fell sharply year over year in Q3, with a 56% drop in companies making or projecting cuts and a 90% plunge in affected employees; the 27 companies and 2,568 people affected are the lowest quarterly figures since tracking began in 2024. Eight Big Pharma companies accounted for cuts of 1,845 employees in the quarter, including Bristol Myers Squibb letting go of 265 people in Princeton, New Jersey, GSK closing a German vaccine site with about 650 job losses, and Novartis, whose 2026 disclosures total at least 922 people. Novo CEO Mike Maziar Doustdar said overall headcount has dropped by 13,000 over the past year, including 9,000 layoffs under a restructuring announced in September 2025 targeting around $1.25 billion in annualized savings.

  2. fda.gov80

    FDA approves tucatinib with trastuzumab and pertuzumab for the maintenance treatment of HER2-positive breast cancer

    The FDA approved tucatinib (Tukysa, Seagen, a Pfizer subsidiary) with trastuzumab and pertuzumab on October 7, 2026, for maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer after induction therapy. In the 654-patient HER2CLIMB-05 trial, median progression-free survival was 24.9 months with tucatinib 300 mg twice daily versus 16.3 months with placebo (HR 0.64, p<0.0001). The label carries a boxed warning for hepatotoxicity; overall survival data were immature.

    Why it matters: FDA approval extends tucatinib to first-line maintenance, with PFS results from a randomized phase 3 trial.

Oct 6Tue
  1. biospace.com46

    Compliance concerns hinder rollout of AI in drug manufacturing: Survey

    Fewer than 10% of drugmakers are scaling AI in clinical or commercial manufacturing, according to a CRB survey of more than 400 R&D and manufacturing professionals for its 2026 Horizons report. Use is concentrated in nonregulated areas such as administrative workflows (56%) and drug discovery (45%), with accuracy and quality concerns and insufficient validation standards cited as the main barriers. CRB found that 31% of respondents plan to use AI in regulated manufacturing within three years, and another 31% are considering it without a formal plan.

    Why it matters: Shows regulatory and validation concerns are blocking AI adoption in drug manufacturing, with an FDA warning letter already issued.

Oct 5Mon
  1. nature.com75

    COPD trial wins spur broad respiratory hopes

    AstraZeneca's tozorakimab, an IL-33-targeted antibody, reduced COPD exacerbations by up to 30% in current and former smokers in two trials, with an FDA decision expected in the first quarter of 2027. Unlike dupilumab and mepolizumab, it worked across patients with all blood eosinophil counts, addressing non-eosinophilic COPD. The success, after mixed results for other IL-33 agents like itepekimab, is reviving industry interest in IL-33 and alarmin targets across respiratory disease.

    Why it matters: First IL-33 win in COPD works regardless of eosinophil count, reshaping the inflammatory biologic landscape.

Oct 2Fri
  1. biocentury.com40

    China biopharma still faces a long road to globalization

    Franck Le Deu of KerZheng Ventures argues that Chinese biopharma companies are unlikely to become conventional global competitors by 2030, despite strong science, because the U.S. dominates the profit pool, taking about 53% of world prescription-medicine sales in 2025 and 74% of sales of medicines launched in 2020-24. He weighs Pfizer's Innovent Biologics collaboration worth up to $10.5 billion and China's Five-Year Plan targets, including first-in-class drugs reaching a quarter of the global total and five products exceeding $1 billion in sales by 2030, against barriers like CFIUS and geopolitics. He suggests few will succeed in the Western model, and alternative paths such as affordable innovation outside the U.S. market may define globalization instead.

Oct 1Thu
  1. medrxiv.org46

    Axitinib in Progressive Metastatic Pheochromocytoma and Paraganglioma: Results of a Phase II Study

    Single-agent axitinib produced confirmed partial responses in 35.3% of 17 treated patients with progressive metastatic or unresectable pheochromocytoma and paraganglioma, with median progression-free survival of 7.9 months and median overall survival of 29 months. Hypertension occurred in 79% of patients but was managed with antihypertensive therapy and dose modification, and no patient stopped treatment for toxicity. The phase II trial's efficacy compares favorably with sunitinib in this rare disease.

    Why it matters: First prospective single-arm data on selective VEGFR inhibition with axitinib in a rare cancer with few systemic options.

Aug 30Sun
  1. NEJM Evid63

    Durability of RSV Prefusion F Vaccine Protection across Two RSV Seasons.

    A single dose of the RSVpreF vaccine remained associated with fewer RSV-related RTD hospitalizations among adults 60 years or older in a second RSV season, with an incidence of 0.11 versus 0.25 events per 1000 person-years and vaccine effectiveness of 56.2% (95% CI, -12.4% to 84.8%), down from 83.3% in season one. Across both seasons of the 130,991-participant intention-to-treat analysis, vaccine effectiveness was 70.6% (95% CI, 39.1%-87.0%). The results extend RSVpreF protection beyond one season while indicating waning estimates.

    Why it matters: First randomized data on how well one RSVpreF dose protects older adults through a second RSV season.

Aug 28Fri
  1. fiercepharma.com73

    Priovant pushes ex-Pfizer asset across FDA finish line in rare skin and muscle disease

    The FDA has approved Priovant Therapeutics' brepocitinib, to be marketed as Lisraya, a once-daily pill for adults with dermatomyositis, making it the first targeted therapy approved in the disease. The approval rests on the phase 3 Valor trial of 241 patients, where the high dose achieved a mean Total Improvement Score of 46.5 versus 31.2 for placebo, with 55% of treated patients reaching moderate or better improvement with minimal or no steroid use versus 30% on placebo. The Roivant-backed company, formed in 2022 with a Pfizer deal, is also testing the dual TYK2/JAK1 inhibitor in phase 3 noninfectious uveitis and cutaneous sarcoidosis.

    Why it matters: First FDA approval of a targeted therapy for dermatomyositis, for a company's debut drug with further late-stage indications underway.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org