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  • Blood centers poised to boost cell and gene therapy supply chains
    Blood centers have the donors, resources and community footprint that drug sponsors need to address supply chain bottlenecks for cell and gene therapies. Cell and gene therapies such as CAR‑T and…
    BioSpace · 1mo agoPositive↗ source
  • Legend Biotech appoints former Novartis executive as CEO while Vera pursues full approval for kidney drug
    Legend Biotech announced that Ingrid Zhang, a former Novartis executive, will take over as chief executive officer, replacing Ying Huang who stepped down in July. Vera reported that its recently l…
    STAT · 1mo agoNeutral↗ source
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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
  • 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
  • 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
  • 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
  • Summit and Akeso report ivonescimab extends lung cancer survival by eight months versus Keytruda in Phase 3 trial
    Summit Therapeutics and its partner Akeso said their experimental dual-target drug ivonescimab added about eight months of overall survival for patients with lung cancer compared with Merck's Keytr…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • AstraZeneca’s newly approved pill fails frontline breast cancer study
    Etcamah is the second oral “SERD” to recently fall short in first-line breast cancer, following a similar setback from Roche earlier this year.
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • FDA approves Scholar Rock's muscle-targeted SMA therapy Isembyld
    The Food and Drug Administration has approved a new medication for spinal muscular atrophy (SMA). The drug, apitegromab marketed as Isembyld, is the first muscle-targeted therapy for the disease.…
    BioPharma Dive · 1mo agoApprovalPositive↗ 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 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
  • 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
  • Cellectis abandons CAR-T programs, shifts focus to in vivo gene editing
    Cellectis announced it will discontinue its donor-derived CAR‑T programs and redirect its efforts toward in vivo gene‑editing medicines. The company said the commercial and clinical landscape for…
    BioPharma Dive · 1mo agoNegative↗ source
  • Definium's LSD candidate DT120 shows positive Phase 3 results, moving toward FDA submission
    Definium Therapeutics reported positive topline data from its Phase 3 Panorama trial of DT120, an oral LSD formulation for generalized anxiety disorder (GAD). The trial met its primary endpoint, s…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • GSK presents promising late-stage lung cancer data from two investigational drugs
    GSK highlighted late-stage results for two of its lung cancer candidates, reporting encouraging efficacy signals that could advance the programs toward regulatory review. The company shared the da…
    STAT · 1mo agoPositive readoutNeutral↗ source
  • Novo drops Nordisk from name, rebrands as Novo with new bull logo
    Novo Nordisk announced it will drop the "Nordisk" part of its name, rebranding simply as Novo and rotating the iconic Apis bull in its logo to signal a new direction. CEO Mike Maziar Doustdar said…
    BioSpace · 1mo agoNeutral↗ source
  • AstraZeneca's breast cancer drug camizestrant fails pivotal first-line trial
    AstraZeneca announced that its investigational breast cancer drug camizestrant did not meet primary endpoints in a pivotal Phase 3 trial evaluating it as a first-line treatment for advanced disease…
    STAT · 1mo agoNegative readoutNegative↗ source
  • Definium’s LSD therapy cuts anxiety scores in second late-stage trial
    Definium Therapeutics reported that its LSD-based drug DT120 reduced anxiety symptoms in a second late-stage study. In the 12-week trial, patients receiving a 100-microgram dose saw an average 9.8…
    STAT · 1mo agoPositive readoutPositive↗ source
  • Public backing fuels FDA hearing on psychedelic therapies and potential COMP360 approval
    The FDA is holding a hearing on Monday to discuss the future of psychedelic drug development, after a wave of public comments expressed strong support for further research. Analysts say the suppor…
    BioSpace · 1mo agoRegulatoryPositive↗ source