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  • Novartis CEO says Trump’s drug pricing plan creates a very difficult situation for makers and patients
    Novartis chief executive Vas Narasimhan warned that the United States drug‑pricing policy under President Trump presents a "very difficult situation" for both drugmakers and patients. He said the…
    STAT · 6mo agoRegulatoryNegative↗ source
  • BridgeBio's heart drug Attruby exceeds sales expectations, shifting investor outlook
    BridgeBio prepared to sell its heart drug Attruby on its own, prompting skepticism from investors and analysts who doubted the company could compete with larger rivals. The drug far outperformed f…
    BioPharma Dive · 6mo agoPositive↗ source
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  • AIDS advocacy group sues Trump administration over hidden Gilead HIV-prevention settlement
    The AIDS advocacy group PrEP4All filed a lawsuit against the Trump administration, alleging it failed to disclose a research and development agreement with Gilead Sciences. The agreement was part…
    STAT · 6mo agoRegulatoryNegative↗ source
  • FDA launches AI-driven pilot to review trial data in real time, aiming to speed clinical studies
    Washington officials said the Food and Drug Administration is starting a new program to speed clinical trials by reviewing data as it is generated. The first pilots will use real-time data from tr…
    STAT · 6mo agoRegulatoryPositive↗ source
  • 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 · 6mo agoRegulatoryPositive↗ source
  • 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 · 6mo agoRegulatoryNeutral↗ 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 · 6mo agoDealPositive↗ 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 · 6mo agoDealNeutral↗ 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo agoRegulatoryNegative↗ 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 · 6mo agoNeutral↗ 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 · 6mo 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 · 6mo agoRegulatoryNeutral↗ 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo agoPositive readoutPositive↗ source
  • Intellia's single-dose CRISPR therapy slashes hereditary angioedema attacks by 87% in Phase 3 trial
    Intellia Therapeutics reported that its CRISPR-based gene editing drug lonvo-z achieved a dramatic reduction in swelling attacks for patients with hereditary angioedema (HAE) in a Phase 3 study. T…
    STAT · 6mo agoPositive readoutPositive↗ source
  • Veradermics reports positive Phase 3 results for oral baldness pill
    Veradermics said its experimental oral formulation of minoxidil met the primary goal of its Phase 3 trial, showing significantly more new hair growth over six months compared with placebo. The dru…
    BioPharma Dive · 6mo agoPositive readoutPositive↗ source
  • New U.S. hepatitis B vaccine policy targeting only at-risk newborns could raise infant infections and costs, studies warn
    A new U.S. recommendation limits the birth‑dose hepatitis B vaccine to infants who are judged to be at risk of neonatal infection, rather than offering it universally to all newborns. One study co…
    STAT · 6mo agoRegulatoryNegative↗ source
  • Oruka’s experimental psoriasis drug achieves near-complete skin clearance in Phase 2 trial
    Oruka Therapeutics reported that its experimental IL-23 inhibitor ORKA-001 cleared the skin of 40 of 63 patients (about 63%) in a Phase 2 study, achieving a PASI 100 response at 16 weeks. A further…
    BioPharma Dive · 6mo agoPositive readoutPositive↗ source
  • Eli Lilly to acquire Ajax Therapeutics for up to $2.3 billion to develop improved JAK inhibitor
    Eli Lilly announced Monday it will purchase Ajax Therapeutics, a biotech based in New York and Cambridge, Massachusetts, in a deal valued at up to $2.3 billion. The transaction includes cash up fr…
    BioPharma Dive · 6mo agoDealPositive↗ source
  • Oruka's yearly injectable shows 63% complete clearance in mid-stage psoriasis trial
    Oruka Therapeutics reported results from a Phase 2 trial of its long-acting injectable, ORKA-001, in patients with plaque psoriasis. In the study, 63% of participants achieved complete skin cleara…
    STAT · 6mo agoPositive readoutPositive↗ source