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  • Biotech earnings season kicks off as Agios reports Phase 2 setback for sickle-cell drug
    The second‑quarter earnings window has begun, and analysts are zeroing in on a handful of biotech companies with high‑profile catalysts. Smaller biotechs are increasingly opting to launch their pr…
    BioSpace · 3h agoNegative readoutNeutral↗ source
  • Visa time limits on foreign Ph.D. students and postdocs will harm U.S. science, experts warn
    A Trump administration plan to limit visas for graduate student and postdocs to four years is fueling concerns that the U.S. could lose out on foreign scientists
    STAT · 15h agoApprovalPositive↗ source
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  • FDA says Replimune’s melanoma data package is ‘not interpretable,’ setting up tough adcomm
    The FDA's rebuff of Replimune comes a day after the agency similarly called into question the Phase 3 trial for Capricor’s Duchenne muscular dystrophy cell therapy.
    BioSpace · 18h agoApprovalPositive↗ source
  • STAT+: Preliminary trial results suggest a path to a safer Alzheimer’s treatment
    ProMIS Neurosciences is trying to design a safer amyloid-clearing drug for Alzheimer's. Early results suggest it might be on to something.
    STAT · 22h agoApprovalPositive↗ source
  • GSK prepares for patent cliff with $2.5B cost-cutting plan
    The pharma hasn’t yet revealed what kind of job cuts might be involved in the plan, which will help it absorb the coming loss of patents important to its HIV drug franchise.
    BioPharma Dive · 16h agoLayoffsNegative↗ source
  • GSK shares rise as $2.5B cost-cutting plan unveiled
    As GSK records $2.4 billion in impairment charges for the second quarter, the U.K. pharma has announced a sweeping restructure designed to save about the same amount of money over the next few years.
    BioSpace · 17h agoLayoffsNegative↗ source
  • Boston Scientific unveils major restructuring, plots job cuts amid savings drive
    Medical device maker Boston Scientific has been a prolific dealmaker this year but is now taking a step back as it looks to make changes internally.
    Fierce Biotech · 1d agoLayoffsNegative↗ source
  • As pharma descends on China for deals, BIOSECURE Act raises intellectual property risk
    When signing a biotech licensing deal in China, experts say that pharma’s patent attorneys need to understand the geopolitical risk of the BIOSECURE Act.
    BioSpace · 1d agoDealNeutral↗ source
  • Industry urges FDA to clarify and broaden QSP guidance for first-in-human dose selection
    Industry stakeholders have asked the U.S. Food and Drug Administration for more detailed guidance on using quantitative systems pharmacology (QSP) to select first-in-human doses in phase-1 studies.…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA draft guidance seeks clearer, more flexible QSP dose selection for first-in-human trials
    Industry groups have asked the FDA for more clarity in a draft guidance that outlines how sponsors can use quantitative systems pharmacology (QSP) to select doses for first-in-human studies. The r…
    raps · 1d agoRegulatoryNeutral↗ source
  • Webinar: Building the Intelligence Engine for Drug Discovery R&D Teams
    Drug discovery teams have more data than ever, but turning that data into actionable insight remains a major challenge. In this candid conversation, Patsnap’s Ben Coverdale is joined by Mark Davies…
    BioSpace · 10h agoRegulatoryNeutral↗ source
  • Six key issues we’re watching at Fauci’s hearing
    Sen. Rand Paul is forcing Fauci to appear before his Senate panel.
    STAT · 12h agoRegulatoryNeutral↗ source
  • FDA reminds investors about the risks of advisory panels
    Two days, two similar briefing documents and two companies with diving share prices. The FDA this week laid out its concerns with clinical data from both Capricor Therapeutics and
    Endpoints · 12h agoRegulatoryNeutral↗ source
  • FDA offers updated guidance for generics of weight loss blockbusters
    The FDA revised its draft guidance for generic companies looking to develop copycats of some of the world's best-selling weight loss drugs, including Eli Lilly's Zepbound and Novo Nordisk's Ozempic…
    Endpoints · 13h agoRegulatoryNeutral↗ source
  • STAT+: Bracing for another Fauci hearing
    Plus: Democrats take on Trump over IVF, and Trump's White House releases a new science funding blueprint.
    STAT · 15h agoRegulatoryNeutral↗ source
  • FDA staff say Replimune's melanoma trial failed to prove RP1 works
    FDA staff threw cold water on Replimune’s advanced melanoma drug ahead of a critical meeting with agency advisors, writing that the pivotal study design failed to prove its drug actually works. The…
    Endpoints · 17h agoRegulatoryNeutral↗ source
  • The future of gray-market peptides
    Two days’ worth of debate among FDA advisory committee members and agency staff over whether compounding pharmacies should be able to make seven different peptides left me with some big ...
    Endpoints · 17h agoRegulatoryNeutral↗ source
  • STAT+: GSK lays out plans to cut costs, pursue more late-stage drug trials
    New GSK CEO Luke Miels outlined his strategy to help the company navigate a patent cliff and get on a path toward long-term growth.
    STAT · 17h agoRegulatoryNeutral↗ source
  • STAT+: FDA staff reiterate concerns about Replimune skin cancer treatment
    Regulators at the FDA have reiterated concerns that Replimmune does not have adequate data to support an approval of its investigational skin cancer treatment.
    STAT · 18h agoRegulatoryNeutral↗ source
  • STAT+: Pharmalittle: We’re reading about FDA views on a Duchenne drug, GSK cost savings, and more
    The FDA said a Capricor stem cell treatment for Duchenne muscular dystrophy did not meet a Phase 3 trial's objectives — contrary to company claims
    STAT · 18h agoRegulatoryNeutral↗ source
  • STAT+: Three questions with Whoop’s new CMO
    In this edition of STAT Health Tech: A chat with Whoop's new chief medical officer, an update on CMS health tech initiative, and more.
    STAT · 18h agoRegulatoryNeutral↗ source
  • Altimmune rises as GLP-1/glucagon drug curbs heavy drinking in mid-stage study
    Pemvidutide showed a “highly statistically significant” treatment effect in patients with alcohol use disorder. Altimmune is going up against Eli Lilly and newcomer Baseline Therapeutics, among oth…
    BioSpace · 19h agoRegulatoryNeutral↗ source
  • An eye drug biotech banks $118M and stocks its executive suite
    Claris Bio has appointed veteran CEO Stephen Brady to lead advanced development of what it hopes to be the first drug therapy for a blinding condition called limbal stem cell deficiency.
    BioPharma Dive · 20h agoRegulatoryNeutral↗ source
  • The FDA was all in on AI. Will that change?
    High-level turnover has introduced uncertainty about how quickly the FDA’s agency-wide AI strategy will move forward.
    BioPharma Dive · 20h agoRegulatoryNeutral↗ source
  • Anthony Fauci’s pandemic-era diary entries
    New data on American substance use, concerns of a global HIV resurgence, and more health news from Morning Rounds
    STAT · 20h agoRegulatoryNeutral↗ source