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  • Pharma leaders risk industry collapse by over-relying on Chinese drug sourcing, says analyst
    Olivia Kosloff, a senior fellow at the American Economic Liberties Project and co-chair of a Council on Foreign Relations working group, argues that U.S. pharma and biotech executives are jeopardiz…
    STAT · 4mo agoNegative↗ source
  • Eli Lilly suggests low-dose Zepbound and Foundayo could safely maintain weight loss at lower cost
    New trial data indicate that lowering the dose of Eli Lilly's obesity injection Zepbound may still provide effective weight‑loss maintenance while improving safety. The study also highlights Found…
    Endpoints · 3mo agoPositive readoutPositive↗ source
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  • Former FDA Commissioner Marty Makary resigns under pressure, critics call his tenure the weakest in 25 years
    Marty Makary stepped down as FDA commissioner on Tuesday after mounting pressure, ending a tenure that many observers described as the weakest in the agency’s recent history. Critics said he lacke…
    STAT · 4mo agoRegulatoryNegative↗ source
  • EU drafts Critical Medicines Act to increase local production and curb drug shortages
    The European Union has reached a provisional agreement known as the Critical Medicines Act, aimed at strengthening the supply of essential medicines across member states. The plan focuses on incre…
    STAT · 4mo agoRegulatoryPositive↗ source
  • EU Parliament and Council provisionally approve Critical Medicines Act to strengthen drug supply chains
    The European Parliament and the Council have provisionally voted to adopt the Critical Medicines Act, marking a key step toward its implementation. The legislation is designed to reinforce the EU’…
    Endpoints · 4mo agoRegulatoryPositive↗ source
  • FDA Commissioner Marty Makary resigns amid internal turmoil, top food regulator Kyle Diamantas to serve as acting chief
    Food and Drug Administration Commissioner Marty Makary is leaving his post after serving a little over a year, according to an administration source. His tenure was marked by staff departures and i…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Iran war disruptions ripple through pharma supply chain, raising raw material and shipping costs
    The ongoing conflict between Iran and its adversaries has entered its third month, and analysts are now seeing early signs that the fighting is affecting the pharmaceutical supply chain. Disruptio…
    Endpoints · 4mo agoNegative↗ source
  • Hims sales dip as telehealth rivals intensify; Bristol partners with Chinese firm, other biotech updates
    Hims reported lower sales this quarter, attributing the shortfall to growing competition from other telehealth providers. Bristol announced a new partnership with Chinese drugmaker Hengrui Pharma…
    STAT · 4mo agoNeutral↗ source
  • FDA grants breakthrough therapy designation to Emi-Le for advanced adenoid cystic carcinoma
    The U.S. Food and Drug Administration has granted breakthrough therapy designation to Emi-Le for patients with locally advanced, recurrent or metastatic adenoid cystic carcinoma (ACC). Phase 1 tri…
    onclive · 4mo agoCRLPositive↗ source
  • Phase 1 trial shows safety and early PSA responses for novel PSMA radioligand in mCRPC
    A Phase 1 study evaluated the long‑circulating PSMA therapeutic radioligand [177Lu]Lu‑D‑Dan‑Phe‑PSMA in patients with metastatic castration‑resistant prostate cancer. The trial enrolled several dos…
    onclive · 4mo agoPositive readoutPositive↗ source
  • Pfizer, Arvinas sell recently approved breast cancer drug to Rigel for $35 million
    Pfizer and its partner Arvinas have agreed to transfer the commercial rights of a breast cancer therapy to Rigel Pharmaceuticals. The drug had just received regulatory approval, marking a mileston…
    Endpoints · 4mo agoDealNegative↗ source
  • FDA warns of secondary cancers linked to tazemetostat in follicular lymphoma and epithelioid sarcoma
    The FDA issued an alert after the voluntary withdrawal of tazemetostat indications for follicular lymphoma and epithelioid sarcoma, emphasizing the drug's association with secondary primary maligna…
    onclive · 4mo agoRegulatoryNegative↗ source
  • Bayer signals cautious yet aggressive push into pharma acquisitions after five-year pause
    Bayer's CEO Bill Anderson told investors on the first-quarter earnings call that the company is ready to re-enter the pharmaceutical merger-and-acquisition market after a five-year hiatus. He emph…
    Endpoints · 4mo agoDealPositive↗ source
  • Knit Health secures $11.6M seed round to develop doctor-like AI for healthcare operations
    Knit Health, a startup spun out of UC Berkeley, announced it has closed a seed financing round of $11.6 million. The round was co‑led by Uncork Capital, providing the capital the company plans to…
    Endpoints · 4mo agoDealPositive↗ source
  • Immunotherapy trials like PODIUM-303 are reshaping treatment for squamous cell anal cancer, says Dr Parikh
    Dr Aparna R. Parikh, an oncologist at Massachusetts General Hospital and Harvard professor, highlighted the growing feasibility of immunotherapy studies in squamous cell anal carcinoma (SCAC). She…
    onclive · 4mo agoPositive↗ source
  • Capsida Biotherapeutics still unable to determine cause of child death in brain-targeted gene therapy trial
    Capsida Biotherapeutics reported that it still has no explanation for the death of a child who participated in its CAP-002 gene therapy trial last September. The trial was intended to test a new c…
    STAT · 4mo agoNegative readoutNegative↗ source
  • Alcohol Remains U.S. Deadliest Drug, Killing 178,000 Annually, Study Finds
    STAT’s investigative series "The Deadliest Drug" catalogues the United States' failure to address excessive alcohol use as a leading cause of disease, injury and death. Even as overall drinking ra…
    STAT · 4mo agoNegative↗ source
  • Pharma firms spend $130M lobbying on TrumpRx plan, while Novo Nordisk reports 27.7% weight loss in high‑dose Wegovy trial
    Seventeen pharmaceutical companies that back the White House’s TrumpRx prescription‑drug pricing program collectively spent more than $130 million on federal lobbying in 2025. That represents a ro…
    STAT · 4mo agoNeutral↗ source
  • Honesty and Humor Offer Hope in Breast Cancer Survivorship, Says Dr Nunnery and Survivor Annie Bond
    The Breast Cancer Briefing podcast, hosted by Dr Sara Nunnery of Tennessee Oncology, featured a conversation with Annie Bond, a breast cancer survivor and patient advocate. Bond, who was first dia…
    onclive · 3mo agoPositive↗ source
  • FDA Commissioner Marty Makary steps down after weeks of uncertainty
    Marty Makary, the commissioner of the U.S. Food and Drug Administration, announced his resignation on Tuesday. The decision came after his employment status was uncertain for several days, accordi…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Hims reports $33 million loss after shifting focus to GLP-1 market
    Hims said its latest earnings were hit by a $33 million charge tied to a strategic shift toward GLP-1 treatments. The charge stems from costs of redirecting product development and marketing resou…
    STAT · 4mo agoEarningsNegative↗ source
  • Fox Chase Cancer Center and Labcorp launch study of ultra-sensitive blood test for early-stage lung cancer recurrence
    Fox Chase Cancer Center and Labcorp announced a new clinical trial to evaluate a tumor-informed, whole-genome sequencing ctDNA minimal residual disease (MRD) assay for early-stage non-small cell lu…
    onclive · 4mo agoPositive↗ source
  • FDA reopens comment period for BHT and launches post-market chemical safety program
    The U.S. Food and Drug Administration announced two actions as part of its ongoing food chemical safety agenda. The agency will reopen the comment period for the Request for Information on butylat…
    fda press · 4mo agoRegulatoryNeutral↗ source
  • Experts highlight unmet needs and emerging role of antibody drug conjugates in endometrial cancer
    Experts note that significant unmet needs persist in endometrial cancer even as antibody drug conjugates (ADCs) begin to expand treatment options. They suggest ADCs could address gaps in recurrent…
    onclive · 4mo agoNeutral↗ source
  • Experts discuss emerging therapies shaping the future of relapsed and refractory multiple myeloma
    In a recent opinion segment, Dr. Ajay Nooka and Dr. Noopur Raje explore how new treatments and ongoing trials are influencing the landscape for patients with relapsed and refractory multiple myelom…
    onclive · 4mo agoNeutral↗ source