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  • AstraZeneca and Ionis gene silencer Wainua fails trial after patients also took Pfizer heart drug
    At the ESC Congress in Munich, a high‑profile trial of the gene‑silencing therapy Wainua, developed by AstraZeneca and Ionis, was reported to have failed. The failure was linked to participants co…
    Endpoints · 15d agoNegative readoutNegative↗ source
  • FDA greenlights Takeda and Protagonist's rusfertide (Mimrylo) for polycythemia vera
    The U.S. Food and Drug Administration has granted approval to rusfertide, a therapy developed jointly by Takeda Pharmaceutical and Protagonist Therapeutics. The drug, to be marketed under the name…
    Endpoints · 14d agoApprovalPositive↗ source
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  • BioNTech and Genentech halt Phase 2 trial of personalized mRNA cancer vaccine
    BioNTech and its partner Genentech announced the termination of a Phase 2 study evaluating a personalized mRNA cancer vaccine. The decision was made shortly after the trial had entered its second s…
    Endpoints · 15d agoNegative↗ source
  • CRISPR Therapeutics to test highest dose of lipid‑lowering gene editing therapy after mixed durability data
    CRISPR Therapeutics presented early‑stage data at the European Society of Cardiology meeting showing that its lipid‑lowering gene editing candidate produced mixed durability results a year after pa…
    Endpoints · 15d agoNegative readoutNeutral↗ source
  • Roche commits over $1 billion to DualityBio for ADC development targeting TOP1 resistance
    Roche's Genentech unit announced a major investment in DualityBio to advance antibody-drug conjugate (ADC) technology. Under the agreement DualityBio will receive an upfront payment of $45 million…
    Endpoints · 15d agoDealPositive↗ source
  • Cytokinetics aims for broader Myqorzo approval next year after supportive trial data
    Cytokinetics reported new data on its cardiac therapy Myqorzo, presented at a European scientific meeting. The results reinforce the drug’s efficacy in a specific heart muscle disorder. The compan…
    Endpoints · 15d agoApprovalPositive↗ source
  • FDA alerts on possible Aspergillus contamination in Avid Medical IV start kits
    The FDA’s Center for Devices and Radiological Health has issued an Early Alert warning that certain IV start kits from Avid Medical may be contaminated with the fungus Aspergillus penicillioides, a…
    fda medwatch · 15d agoRegulatoryNegative↗ source
  • Boston Scientific recalls Imager II angiographic catheters over tip detachment risk
    FDA's CDRH issued an Early Alert about Boston Scientific's Imager II angiographic catheters due to a manufacturing problem that can cause the catheter tip to detach. The company sent a letter on A…
    fda medwatch · 15d agoRegulatoryNegative↗ source
  • Daiichi Sankyo to restructure its commercial organization, appointing Ken Keller as chief commercialization officer
    Daiichi Sankyo announced plans to overhaul its commercial operations, with a split of its commercialization activities slated for April 1, 2027. The company has appointed veteran executive Ken Kel…
    Endpoints · 15d agoNeutral↗ source
  • FDA approves Roivant's oral dermatomyositis drug Lisraya (brepocitinib)
    The U.S. Food and Drug Administration has granted approval to Roivant's drug brepocitinib, which will be sold under the brand name Lisraya. The decision marks the first major regulatory clearance f…
    Endpoints · 15d agoApprovalPositive↗ source
  • Gilead secures another FDA approval for HIV therapy, bolstering lenacapavir portfolio
    Gilead Sciences announced that the U.S. Food and Drug Administration has approved a new HIV treatment, adding to the company's growing portfolio of antiviral drugs. The approval extends the reach o…
    Endpoints · 15d agoApprovalPositive↗ source
  • Fifth Circuit Court rejects pharma industry's challenge to Medicare negotiation rules
    The Fifth Circuit Court of Appeals issued a ruling that ends the pharmaceutical industry's legal effort to overturn Medicare's negotiation framework. The court denied the industry's request, markin…
    Endpoints · 15d agoRegulatoryNegative↗ source
  • Eli Lilly stops disclosing Phase 1 pipeline, prompting mixed reactions
    Eli Lilly announced that it will no longer publicly share details of its Phase 1 drug candidates. The policy shift comes as the company’s GLP-1 product continues to generate the highest sales among…
    Endpoints · 16d agoNeutral↗ source
  • CMS GLP-1 pilot shows early uptake and health benefits for seniors, signaling broader weight-loss drug access
    CMS launched a federal pilot program to expand access to GLP-1 weight-loss medications for seniors. After about two months, early data show that enrollment is rising and participants report improv…
    Endpoints · 15d agoRegulatoryPositive↗ source
  • Moderna to raise $2 billion via convertible senior notes to fund oncology expansion and reduce debt
    Moderna announced it will issue $2 billion of convertible senior notes. The company says the financing will give it flexibility to invest in its growing oncology portfolio and to repay existing deb…
    Endpoints · 16d agoDealNeutral↗ source
  • Lonza appoints Samanta Cimitan as chief commercial officer as WuXi Biologics posts revenue surge
    Lonza said it will create a new chief commercial officer position and has selected Samanta Cimitan, the current chief executive of Celonic, to take the role on Jan. 1 next year. Cimitan will be re…
    Endpoints · 16d agoPositive↗ source
  • Medtronic and Given Imaging issue early alert for Bravo CF esophageal pH capsule delivery devices due to attachment failures
    The FDA's Center for Devices and Radiological Health issued an Early Alert about a potential high‑risk issue with Medtronic’s Bravo CF esophageal pH monitoring capsule delivery devices. The proble…
    fda medwatch · 16d agoRegulatoryNegative↗ source
  • Akeso CEO says biliary tract cancer data could be a breakthrough
    Akeso’s chief executive Michelle Xia told ChinaPharma that the company’s PD-1xVEGF bispecific antibody, ivonescimab, is generating strong interest after early biliary tract cancer results. She not…
    Endpoints · 16d agoPositive↗ source
  • Metriport secures $26 million Series A to streamline doctor access to patient data
    Metriport, a health-tech startup focused on simplifying how physicians obtain patient information, announced a $26 million Series A financing. The round was led by Matrix, with participation from…
    Endpoints · 16d agoDealPositive↗ source
  • AVID Medical issues correction for convenience kits containing recalled Medline Namic Star Off-Handle manifolds
    AVID Medical has sent a letter to customers directing a correction of certain convenience kits that include manifolds affected by the Medline Namic Angiographic Star Off-Handle manifold recall. Th…
    fda medwatch · 16d agoCRLNegative↗ source
  • Generate:Biomedicines shares early Phase 1 respiratory data after ERS poster leak
    Generate:Biomedicines presented Phase 1 data for its respiratory disease candidate at the European Respiratory Society annual meeting. The presentation came after the conference posters were releas…
    Endpoints · 16d agoNeutral↗ source
  • Venture investor Redesign Health shifts from studio model to firm amid AI-driven startup boom
    AI is allowing founders to launch companies faster, challenging traditional venture studios that create ideas internally. Redesign Health, known for its studio approach, is changing its strategy,…
    Endpoints · 16d agoNeutral↗ source
  • FDA approves Revolution Medicines' daraxonrasib for second-line pancreatic cancer
    The U.S. Food and Drug Administration announced approval of Revolution Medicines' drug daraxonrasib for patients with pancreatic cancer who have already received prior therapy. The approval marks…
    Endpoints · 17d agoApprovalPositive↗ source
  • Biohaven secures up to $795 million partnership with SK Biopharma for global epilepsy drug rights
    Biohaven announced a commercial partnership for its late-stage epilepsy program. South Korea-based SK Biopharma has agreed to pay up to $795 million for worldwide rights to the company's Kv7 ion ch…
    Endpoints · 17d agoDealPositive↗ source
  • MassBio CEO warns 2025 may be biotech's toughest year amid China and NIH challenges
    Massachusetts is widely regarded as the epicenter of biotech because of its world‑class research institutions and vibrant startup ecosystem. MassBio CEO Kendalle Burlin O’Connell said 2025 will pr…
    Endpoints · 16d agoNegative↗ source