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  • 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 · 14d 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 · 14d agoApprovalPositive↗ source
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  • Vaccine claims dominate federal autism advisory committee meeting, sidelining research funding plan
    At a recent meeting of the federal autism advisory committee, members spent most of the time discussing vaccines as a possible trigger for autism. The discussion eclipsed the committee’s intended…
    STAT · 14d agoNegative↗ source
  • FDA sends warning to Alar over misleading claims about investigational depression drug
    The U.S. Food and Drug Administration’s Office of Prescription Drug Promotion sent an untitled warning letter to Alar Pharmaceuticals. The agency says Alar’s promotional materials for ALA-3000, an…
    raps · 14d agoRegulatoryNegative↗ source
  • FDA considers two new executive posts and approves first-of-its-kind early drug and ketone‑glucose wearable
    The Health and Human Services department is reportedly evaluating the creation of two additional senior positions within the FDA, a step that could increase agency oversight. In recent approvals,…
    raps · 14d agoRegulatoryNeutral↗ source
  • Juul receives FDA clearance for new e-cigarette with optional age-verification feature
    Juul Labs announced that the U.S. Food and Drug Administration has granted the company permission to market an updated version of its flagship vaping device. The new model, called Juul2, includes…
    STAT · 13d agoRegulatoryNeutral↗ source
  • FDA approves Roivant's new dermatomyositis therapy
    The FDA has granted approval to a therapy developed by Roivant for the treatment of dermatomyositis, a rare autoimmune condition that causes muscle inflammation and skin rash. The decision adds a…
    STAT · 14d agoApprovalPositive↗ source
  • Former CDC leaders resign, warn of lingering political interference and call for stronger public health safeguards
    Three former CDC officials-Debra Houry, Daniel Jernigan, and Demetre Daskalakis-announced they resigned from the agency last year. Their careers included senior roles in disease control, emerging i…
    STAT · 14d 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 · 14d agoNeutral↗ source
  • Federal autism advisory panel reaffirms discredited theories amid vaccine controversy
    At a recent meeting of the federal autism advisory committee, members again promoted theories linking vaccines to autism that have been repeatedly disproven by scientific studies. The discussion c…
    STAT · 14d agoNegative↗ source
  • Teva named stalking horse bidder to acquire BioXcel's neuroscience assets for $57.5 million
    BioXcel Therapeutics, a Connecticut biotech focused on neuroscience, filed for Chapter 11 bankruptcy after running out of cash to fund operations through August. In the filing, the company selecte…
    Fierce Biotech · 14d agoDealNeutral↗ source
  • Medicare’s G2211 billing code for relationship-based primary care falls short of expectations
    The Medicare G2211 billing code, added in 2024, lets doctors add $16 to each visit when they provide comprehensive, relationship‑based primary care. It was meant to reward the broader set of servic…
    STAT · 14d agoRegulatoryNegative↗ source
  • Legal scrutiny of Lindsay Clancy case may deter psychiatrists from treating mothers with mental illness
    Psychiatrists and reproductive specialists warn that the high-profile Lindsay Clancy criminal case could have unintended effects on care for mothers with mental illness. The authors acknowledge th…
    STAT · 13d agoNegative↗ source
  • Erasca appoints Charles Fuchs, former Tubulis CMO, as president of research and development
    STAT+ columnist Ed Silverman highlighted a recent personnel change in the pharmaceutical sector. The regular "comings and goings" feature tracks hires, promotions, and departures across the industr…
    STAT · 14d 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 · 14d agoApprovalPositive↗ source
  • Moderna raises $2 billion after Phase 3 success of its algorithm-driven personalized cancer vaccine with Merck
    Moderna announced a $2 billion convertible debt financing, a move that follows the Phase 3 success of its personalized cancer vaccine developed with Merck. The vaccine relies on software that scan…
    STAT · 15d agoPositive readoutPositive↗ source
  • FDA approves Revolution Medicines' first genetic-targeted therapy for advanced pancreatic cancer
    The U.S. Food and Drug Administration has granted approval for a new treatment developed by Revolution Medicines aimed at patients with advanced pancreatic cancer. The therapy is designed to extend…
    STAT · 15d agoApprovalPositive↗ source
  • Moderna and Merck report late-stage success for personalized mRNA cancer vaccine
    Moderna and Merck announced that their personalized cancer vaccine achieved its primary goals in a late-stage clinical trial, sparking enthusiasm across the biotech community. The experimental the…
    STAT · 15d agoPositive readoutPositive↗ 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 · 14d agoApprovalPositive↗ source
  • Hospitals Mobilize to Challenge $1 Trillion Medicaid Funding Cuts
    Hospital leaders are reacting to a law that will cut nearly $1 trillion in Medicaid funding over the next ten years, prompting a rapid re‑evaluation of their financial models. Lobbyists and execut…
    STAT · 15d agoRegulatoryNegative↗ source
  • CEPI pledges up to $16.5M to advance Egyptian biotech's Ebola vaccine candidate
    CEPI has committed up to $16.5 million to help bring Minapharm’s Bundibugyo Ebola vaccine candidate into clinical testing. The funding will support preclinical work and an early-stage human trial…
    Fierce Biotech · 15d agoDealPositive↗ 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 · 14d 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 · 15d agoNeutral↗ source
  • Senator Cassidy's report blames FDA for lax oversight of abortion pill manufacturers
    Senator Bill Cassidy released a report accusing the Food and Drug Administration of failing to tighten restrictions on the abortion pill mifepristone and of lacking transparency in its oversight.…
    STAT · 15d agoRegulatoryNegative↗ source
  • Alnylam’s heart drug outlook dimmed as rival eplontersen fails at ESC Congress
    The European Society of Cardiology Congress in Munich is a focal point for Alnylam Pharmaceuticals as it seeks clarity on the future of its two ATTR-CM programs. Data presented by AstraZeneca and…
    STAT · 15d agoNegative readoutNegative↗ source