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  • FDA commissioner touts real-time trial monitoring to cut drug development dead time
    The Food and Drug Administration announced a new approach that will let regulators view clinical trial endpoints as they happen, using cloud‑based data streams. The move targets the long delays th…
    STAT · 4mo agoRegulatoryPositive↗ source
  • Supreme Court to hear arguments on generic fish‑oil pill case, industry watches
    The U.S. Supreme Court is set to hear arguments this week on a case involving a prescription‑strength pill derived from fish oil. The dispute centers on whether the product qualifies as a generic…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
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  • Supreme Court to Hear Arguments on “Skinny Labeling” Case Impacting Generic Drug Access
    The U.S. Supreme Court scheduled oral arguments for Wednesday on a case concerning “skinny labeling,” a practice used by generic drug makers. Skinny labeling involves seeking approval to market a…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • BeOne Medicines licenses trispecific antibody targeting PD-1, CTLA-4 and VEGF from Chinese biotech
    BeOne Medicines, formerly known as BeiGene, announced a licensing agreement with a Chinese biotechnology firm to obtain rights to an experimental trispecific antibody. The antibody is engineered t…
    Endpoints · 4mo agoDealPositive↗ source
  • Coultreon secures $125M Series A to advance oral immune drug into Phase 2 trials
    Coultreon Biopharma announced a $125 million Series A financing round to fund development of an oral drug it licensed from Galapagos. The round was led by Sofinnova Investments and included nine i…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Coultreon Biopharma secures $125M to advance SIK inhibitor for autoimmune diseases
    Coultreon Biopharma announced a $125 million financing round on April 28, 2026, backed by major biotech investors from the United States and Europe. The capital will be used to develop a new appro…
    Endpoints · 4mo agoDealPositive↗ source
  • Boehringer's obesity injection shows 17% weight loss after 18 months, comparable to Wegovy but below Zepbound
    Boehringer Ingelheim, together with Zealand, released data from a late‑stage study of its experimental obesity injection. The trial followed patients for roughly a year and a half. Participants on…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • AI-driven admin tech continues to dominate health-tech funding landscape
    The article notes that administrative technology remains the leading segment within health‑tech investment. Startups that apply artificial intelligence to automate routine tasks such as patient fol…
    Endpoints · 4mo agoPositive↗ source
  • STAT+: Boehringer’s obesity drug shows 16.6% weight loss; more data needed
    Eli Lilly's deal with Profluent, Erasca's RAS-targeting cancer pill, and more biotech news today
    STAT · 4mo agoDealNeutral↗ source
  • Eli Lilly announces second partnership this year to advance recombinase-based gene editing
    Eli Lilly has entered a second partnership this year aimed at developing recombinase-based gene‑editing technologies. The collaboration follows earlier efforts to explore enzymes that can precisely…
    Endpoints · 4mo agoDealPositive↗ source
  • GOP Medicaid work requirements face data gap as states not required to report implementation
    The 2025 tax cut law added work requirements to Medicaid, prompting a sharp partisan split. Democrats warn the new rules will create red tape and lead to loss of coverage, while Republicans argue t…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Health system CEOs face Congress on affordability, hearing shifts blame to opposing party's policies
    The House Ways and Means Committee held a hearing to examine the drivers of rising health‑care costs, calling CEOs of several large health systems to testify. CEOs from HCA Healthcare, CommonSpiri…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Experts warn brain-health initiatives overlook mental illness
    The authors – a professor at Oxford and Yale, the dean of Mount Sinai’s medical school, and a former U.S. congressman – argue that the surge in funding for neuroscience is being directed mainly tow…
    STAT · 4mo agoNegative↗ source
  • Former NIAID adviser David Morens indicted for hiding emails and falsifying records
    David Morens, a former senior adviser at the National Institute of Allergy and Infectious Diseases, was indicted on Tuesday for allegedly concealing emails and providing false responses to Freedom…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Rocket Pharmaceuticals sells pediatric disease priority review voucher for $180 million; Oruka eyes $500 million offering
    Rocket Pharmaceuticals, a New Jersey gene-therapy company, sold its priority review voucher for a rare pediatric disease to an undisclosed buyer for $180 million. The voucher was earned after the…
    Endpoints · 4mo agoDealNeutral↗ source
  • Google’s clinical director discusses AI challenges in health care in STAT Health Tech newsletter
    STAT Health Tech newsletter featured an interview with Google’s clinical director, focusing on the practical challenges of deploying artificial intelligence in health care settings. The discussion…
    STAT · 4mo agoNeutral↗ source
  • Devoted Health reports first revenue decline in 2025 amid Medicare Advantage turbulence
    Devoted Health, a startup offering Medicare Advantage plans, saw its revenue and membership drop in 2025, marking the first decline since it began offering plans seven years ago. The downturn refl…
    Endpoints · 4mo agoNegative↗ source
  • New hepatitis B vaccine guidance prompts analysis of public trust and policy impacts
    The Morning Rounds newsletter examines how the latest recommendations for a hepatitis B vaccine could affect public health outcomes. It highlights recent surveys that show varying levels of confid…
    STAT · 4mo agoNeutral↗ source
  • EPA proposes first rule to flag microplastics and pharmaceuticals in drinking water, alongside $144 million ARPA-H study program
    The Environmental Protection Agency announced a proposed rule that would formally label microplastics and pharmaceutical residues in drinking water as contaminants that merit federal study and trac…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Adaptyv Bio shares results from its latest AI-driven protein design contest
    Adaptyv Bio, a biotech firm focused on protein engineering, released the outcomes of its newest competition that tests how well artificial‑intelligence models can create novel proteins. The challe…
    Endpoints · 4mo agoNeutral↗ source
  • Google AI clinical director says chatbot can serve as bridge for mental health crises
    Google’s clinical director, Megan Jones Bell, told STAT that the company is working to make its Gemini chatbot a helpful resource for users experiencing mental health crises. She emphasized that th…
    STAT · 4mo agoPositive↗ source
  • STAT seeks reader input on adopting AP’s “healthcare” spelling
    The Associated Press Stylebook recently announced that the term "healthcare" should be written as a single word, updating its long-standing guidance. STAT, which has used the two-word form "health…
    STAT · 4mo agoNeutral↗ source
  • Intellia's single-dose CRISPR therapy cuts hereditary angioedema attacks in Phase 3 trial
    Intellia Therapeutics reported that its gene-editing candidate lonvo-z produced a dramatic reduction in swelling attacks for patients with hereditary angioedema in a Phase 3 study. The single-dose…
    STAT · 4mo agoPositive readoutPositive↗ source
  • Intellia’s CRISPR therapy cuts hereditary angioedema attacks by 87% in Phase 3 trial
    Intellia Therapeutics reported that its experimental CRISPR-based drug lonvo-z met the primary endpoint in a Phase 3 study for hereditary angioedema, a rare swelling disorder. The trial showed an…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
  • Intellia's in-body CRISPR therapy achieves first Phase 3 success
    Intellia announced that its experimental in vivo CRISPR gene‑editing therapy has completed a Phase 3 trial with positive results. This is the first instance of a CRISPR‑based treatment delivered d…
    Endpoints · 4mo agoPositive readoutPositive↗ source