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  • J&J offers $5.5 billion settlement to resolve talc lawsuits
    Johnson & Johnson has put forward a settlement proposal of $5.5 billion to end the litigation over its talc products. The proposal follows more than a decade of legal battles and three unsuccessfu…
    Endpoints · 3d agoDealNeutral↗ source
  • FDA updates guidance for generic makers of top GLP-1 weight-loss drugs
    The FDA has released a revised draft guidance aimed at companies that want to develop generic versions of leading weight-loss medications. The update focuses on products such as Eli Lilly's Zepbou…
    Endpoints · 3d agoRegulatoryNeutral↗ source
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  • 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 · 3d 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 · 3d agoLayoffsNegative↗ source
  • Trump administration proposes four-year visa cap for foreign PhD students and postdocs, sparking science community concerns
    The Department of Homeland Security announced a new rule that limits the stay of international graduate students and postdoctoral researchers in the United States to four years on nonimmigrant visa…
    STAT · 3d agoRegulatoryNegative↗ 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 · 3d agoDealNeutral↗ 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 · 3d 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 · 3d 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 · 3d 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 · 3d 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 · 3d 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 · 3d 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 · 3d 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 · 3d agoRegulatoryNeutral↗ source
  • Apnimed eyes up to $160M IPO to prep for sleep apnea drug launch
    If the offering closes, Apnimed will join the 2026 IPO class that has already far surpassed last year’s total.
    BioSpace · 3d agoRegulatoryNeutral↗ source
  • Oak Hill takes SPAC track to Nasdaq with Roche asset in tow
    Oak Hill Bio is developing the antisense therapy rugonersen, which it licensed from Roche in 2025, for Angelman syndrome.
    BioSpace · 3d agoRegulatoryNeutral↗ source
  • After PCOS became PMOS, there’s hope for new awareness among Black and Latina women
    Growing awareness of a painful endocrine disorder now named PMOS is good news for women of color, who have high prevalence and low diagnosis.
    STAT · 3d agoRegulatoryNeutral↗ source
  • Opinion: STAT+: Dementia finally has a business model
    The big takeaway from the recent Alzheimer’s Association International Conference in London is an economic message: Dementia finally has a business model, writes Jason Karlawish.
    STAT · 3d agoRegulatoryNeutral↗ source
  • STAT+: From ‘lost cause’ to gold rush: Biotechs swarm to cure AATD
    Biotech companies are racing to cure alpha-1 antitrypsin deficiency, AATD, fueling patent disputes, startup defections, arbitration, and a U.S.-China rivalry.
    STAT · 3d agoRegulatoryNeutral↗ source
  • STAT+: CMS evaluates one year of health tech progress, announces eight new pledge categories
    One year after launching the CMS Health Tech Ecosystem, officials convened in D.C. to celebrate the Trump administration modernizing health technology.
    STAT · 3d agoRegulatoryNeutral↗ source
  • ADA faces member backlash and calls for CEO and CSO resignations after expert expulsions
    The American Diabetes Association’s 2026 Scientific Sessions in New Orleans ended with the expulsion of five diabetes experts, sparking a wave of criticism. More than 200 members signed an open le…
    STAT · 2d agoNegative↗ source
  • Webinar Explores AI-Driven Intelligence Engine for Optimizing Antibody, ADC and Peptide Candidates
    Drug discovery teams are grappling with an ever‑growing volume of data, and converting that data into actionable insight remains a key hurdle. In a recent BioSpace webinar, Patsnap’s Ben Coverdale…
    BioSpace · 3d agoNeutral↗ source
  • Anthony Fauci scheduled to testify before Senate Homeland Security Committee
    Anthony Fauci has been subpoenaed to appear before the Senate Homeland Security Committee for a new testimony. The hearing is scheduled for tomorrow and will focus on issues related to the federal…
    STAT · 3d agoRegulatoryNeutral↗ source
  • Senate Republicans, led by Rand Paul, compel Dr. Fauci to testify at hearing on COVID-19 response
    Senate Republicans, especially Rand Paul, have long criticized the government’s handling of the COVID-19 pandemic and are using a Senate hearing to question Dr. Anthony Fauci. Paul, who has accuse…
    STAT · 3d agoRegulatoryNeutral↗ source
  • Oak Hill Bio merges with RA Capital SPAC; InnoCare's TYK2 drug hits in Phase 3
    💵 Oak Hill Bio’s SPAC merger: The Angelman syndrome biotech will merge with RA Capital’s blank-check company, called Research Alliance Corporation III, and get about ...
    Endpoints · 3d agoNeutral↗ source