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  • STAT+: Pharmalittle: We’re reading about a GSK deal for a drug from China, job losses in the U.S., and more
    GSK has continued its drive to bulk up its pipeline, taking global rights to a multiple myeloma treatment developed in China
    STAT · 1mo agoDealNeutral↗ source
  • GSK to cut 650 jobs as it shuts German vaccine plant and consolidates production in Canada
    GSK announced it will close its vaccine manufacturing facility in Dresden, Germany, resulting in about 650 layoffs. The decision follows a review and aligns with a $2.5 billion cost‑saving program…
    BioSpace · 1mo agoLayoffsNegative↗ source
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  • NIH now allows businesses to apply for its research funding
    The National Institutes of Health announced that companies are eligible to submit grant applications, expanding the pool of potential research partners. This change aims to foster collaboration bet…
    STAT · 1mo agoRegulatoryPositive↗ source
  • GSK signs new agreement with China's Chimagen for trispecific T-cell engager targeting blood cancers
    GSK, the UK‑based pharmaceutical company, has entered into a fresh licensing agreement with Chinese biotech Chimagen Biosciences. The partnership focuses on a trispecific T‑cell engager designed fo…
    Endpoints · 1mo agoDealPositive↗ source
  • Experts urge FDA to require credentials for psychedelic therapy providers
    At a recent public hearing, mental health experts called on the FDA to adopt safety measures as it pushes to speed up psychedelic therapy development. The experts specifically recommended that pro…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Sionna Therapeutics to lay off 46% of staff after cystic fibrosis trial setback
    Sionna Therapeutics announced it will cut 46% of its workforce following an unexpected failure in its cystic fibrosis trial. The company, which employed about 59 people, said roughly 27 employees…
    Endpoints · 1mo agoLayoffsNegative↗ source
  • Rare disease reform, CMC risk, reshoring US trials top of mind ahead of PDUFA VIII meeting
    The FDA gathers Wednesday to hear what industry stakeholders and the public want included in the latest iteration of the Prescription Drug User Fee Act that sets the agency’s priorities for fiscal…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • HHS nominee Chris Klomp faces questioning from Sen. Elizabeth Warren on voluntary drug‑pricing contracts
    Deputy Secretary of Health and Human Services nominee Chris Klomp testified before the Senate Finance Committee on September 15, 2026. The hearing was described as relatively mild overall. During…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Rocket Pharmaceuticals aligns with FDA on Danon therapy as Novo exits Ascendis and Lilly announces new deal
    Rocket Pharmaceuticals said it has reached alignment with the U.S. FDA regarding its commercial-stage program for Danon disease, indicating the agency and the company are on the same page about the…
    Endpoints · 1mo agoNeutral↗ source
  • Omada Health posts first profitable quarter and prepares CEO succession
    Omada Health, a digital health company, completed its IPO a little over a year ago and has now posted its first profitable quarter, achieved in the spring. The profitability marks a milestone for…
    Endpoints · 1mo agoEarningsPositive↗ source
  • Kairon Health raises $5M to turn patient data into actionable to‑do lists for value‑based care practices
    Kairon Health, a health‑tech startup, offers a platform that aggregates patient information from claims, electronic health records and pharmacy data and converts it into actionable to‑do lists for…
    Endpoints · 1mo agoDealPositive↗ source
  • States urged to apply tobacco-settlement lessons to Meta’s $18 billion payout
    Susan Morrisey, former head of Colorado’s tobacco‑control coalition, reflects on how the 1998 tobacco settlement was debated and allocated among competing interests in the state. She recalls that…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • RFK Jr. to keynote Children’s Health Defense event as hospitals criticize GOP rural health fund
    Robert F. Kennedy Jr. is slated to deliver the keynote address at a Children’s Health Defense gathering, marking a return to the anti-vaccine activism that defined his recent public profile. Hospi…
    STAT · 1mo agoNeutral↗ source
  • AstraZeneca’s Etcamah fails Phase 3 trial, dashing hopes for $2.9 billion breast cancer market
    AstraZeneca’s oral selective estrogen receptor degrader Etcamah was evaluated in the Phase 3 SERENA-4 trial as a first-line option for patients with ER-positive, HER2-negative advanced breast cance…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • FDA approves Moderna’s mRNA flu vaccine as company reports positive Phase 3 cancer vaccine results
    The FDA has granted approval to Moderna’s mRNA‑based flu vaccine, marking a notable rebound for the technology after the Trump administration cut $500 million in funding for mRNA programs a year ea…
    BioSpace · 1mo agoApprovalPositive↗ source
  • AAM warns that price pressures threaten sustainability of US generics and biosimilars market
    The Association for Accessible Medicines (AAM) issued its annual report warning that the economics of off‑patent drugs have deteriorated, putting the sustainability of the generic and biosimilar ma…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Scholar Rock receives FDA approval for Isembyld, first muscle-targeted SMA therapy
    Scholar Rock announced that its monoclonal antibody apitegromab, branded Isembyld, has been cleared by the FDA for treatment of spinal muscular atrophy (SMA). The approval follows a previous rejec…
    BioSpace · 1mo agoApprovalPositive↗ source
  • BioNTech's CTLA-4 antibody gotistobart shows 8.5-month survival boost in previously treated lung cancer patients
    BioNTech reported new data on its CTLA-4 targeting antibody gotistobart in lung cancer. The study focused on patients whose disease had progressed after prior therapy. Those receiving gotistobart…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • BioNTech's anti-CTLA-4 drug shows survival advantage in advanced squamous lung cancer at WCLC
    BioNTech, together with partner OncoC4, presented new overall survival data at the World Conference on Lung Cancer in South Korea, joining other companies such as Summit Therapeutics, GSK and Roche…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Scholar Rock receives FDA approval for apitegromab (Isembyld) to treat spinal muscular atrophy
    Scholar Rock announced FDA approval for its injectable drug apitegromab, marketed as Isembyld, for treating spinal muscular atrophy, a rare muscle-wasting condition. The approval follows earlier s…
    Endpoints · 1mo agoApprovalPositive↗ source
  • Judge blocks Trump administration's plan to cap visas for grad students and postdocs
    A federal judge issued a preliminary injunction on Monday, stopping the Trump administration's plan to limit the length of visas used by graduate students and postdoctoral researchers. The Departm…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Abbott to pay $385 million to settle claims over 2022 baby-formula plant shutdown
    Abbott Laboratories agreed to a $385 million settlement related to the 2022 shutdown of its Sturgis, Michigan baby-formula plant, the largest in the United States. The plant’s problems triggered a…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • FDA seeks external input on rare disease trial criteria and endpoint selection
    The FDA announced it will seek additional external feedback as it reviews how to evaluate efficacy and safety data for rare disease therapies. The agency noted the difficulty of setting appropriat…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • GSK reports 94% response rate for Jideytro in ROS1-positive lung cancer at World Conference
    GSK is moving a newly acquired lung-cancer drug, Jideytro, toward FDA review after presenting data at the World Conference on Lung Cancer. The conference data showed a 94% response rate when Jidey…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Sanofi-backed Electra Therapeutics targets $297 million IPO as Enhertu shows Phase 3 lung cancer success
    Electra Therapeutics, a biotech company supported by Sanofi, announced plans to raise roughly $297 million through an initial public offering. The firm hopes to launch the offering shortly after La…
    Endpoints · 1mo agoDealPositive↗ source