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  • Relay Therapeutics' zovegalisib meets efficacy endpoint in Phase 2 vascular anomalies trial
    Relay Therapeutics reported that its PI3Kα inhibitor zovegalisib achieved the predefined efficacy threshold in a Phase 2 study of a rare genetic vascular anomaly. The data readout exceeded Wall Str…
    Endpoints · 5mo agoPositive readoutPositive↗ source
  • BioMarin's Phase 3 trial of ENPP1 enzyme therapy fails to show benefit
    BioMarin reported that its late-stage study of an enzyme replacement therapy for ENPP1 deficiency did not meet its primary efficacy endpoints. The trial, which enrolled patients lacking the ENPP1 e…
    Endpoints · 5mo agoNegative readoutNegative↗ source
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  • Over 1 in 8 U.S. Pregnant Women Report Alcohol Use, Raising Fetal Health Concerns
    More than one in eight pregnant adults in the United States reported drinking in the past month, according to STAT's analysis of 2024 government data, making alcohol use more common than gestationa…
    STAT · 5mo agoNegative↗ source
  • UK adopts tobacco-free generation law, mirroring Massachusetts policy
    The United Kingdom has passed a tobacco‑free generation law that bars retailers from selling cigarettes, vapes or nicotine pouches to anyone born on or after Jan. 1, 2009. Existing customers may co…
    STAT · 5mo agoRegulatoryPositive↗ source
  • Heart transplant patient warns of 'ghost approval' gap that leaves life-saving drugs out of reach
    A heart transplant recipient and patient advocate describes how the medication everolimus (Zortress) is essential to prevent organ rejection, not an optional treatment. The author coins the term "…
    STAT · 5mo agoNegative↗ source
  • Trump-era foreign aid cuts likely hampered Ebola detection and response in Congo
    The United States reduced funding for programs that help prevent and control infectious diseases in the Democratic Republic of Congo during the final months before a fast-moving Ebola outbreak, acc…
    STAT · 5mo agoRegulatoryNegative↗ source
  • Out-of-network spine surgery bills soar to $34,000 under No Surprises Act arbitration
    A new analysis shows that the median price for a lumbar laminectomy, a common spine surgery, is about $1,400 when performed by in-network providers. When the same procedure is done by out-of-netwo…
    STAT · 5mo agoRegulatoryNegative↗ source
  • Wave Life Sciences reports early-stage data showing monthly dosing possible for RNA editing therapy in AATD
    Wave Life Sciences announced an updated cut of data from its early-stage study of an RNA editing treatment aimed at alpha‑1 antitrypsin deficiency (AATD). The new data suggest the genetic therapy…
    Endpoints · 5mo agoPositive readoutPositive↗ source
  • Nourish secures $100M funding, valuation climbs to $1.75B
    Nourish, a New York-based telehealth platform that connects patients with nutritionists, announced a fresh financing round. The round raised $100 million and lifted the company's valuation to abou…
    Endpoints · 5mo agoDealPositive↗ source
  • Paragon Therapeutics moves migraine-focused Mentari Therapeutics public via reverse merger
    Paragon Therapeutics, a hub-and-spoke biotech company, is taking its migraine drug subsidiary Mentari Therapeutics public through a reverse merger. The approach follows Paragon's prior use of reve…
    Endpoints · 5mo agoDealNeutral↗ source
  • TrumpRx expands catalog with over 600 additional generic drugs
    The White House announced that the TrumpRx direct‑to‑consumer platform has added a large batch of new generic medicines. The expansion brings the total number of generics available on the site to w…
    Endpoints · 5mo agoPositive↗ source
  • Study finds many Canadian medical societies lack robust conflict-of-interest policies
    A new analysis of 68 Canadian medical societies shows that just under half have comprehensive conflict-of-interest policies. The researchers identified that 35 societies, or about 52%, do not addre…
    STAT · 5mo agoNegative↗ source
  • TrumpRx expands generic drug lineup through partnership with Mark Cuban, Amazon Pharmacy and GoodRx
    TrumpRx said it is adding a range of generic medicines to its portfolio after striking a deal that includes Mark Cuban, Amazon Pharmacy and GoodRx. The agreement is expected to broaden the company…
    STAT · 5mo agoDealNeutral↗ source
  • Dexcom CEO discusses future applications of continuous glucose monitors and provides updates on WiSeR and Epic market share
    Dexcom's chief executive spoke about potential new uses for the company's continuous glucose monitoring technology, suggesting that the device could play a broader role in health management beyond…
    STAT · 5mo agoNeutral↗ source
  • Former Stanford President Marc Tessier-Lavigne Addresses Allegations in New Book
    Former Stanford President Marc Tessier-Lavigne, now chief executive of AI drug‑discovery startup Xaira, spoke publicly for the first time at the STAT Breakthrough Summit West in San Francisco. Dur…
    STAT · 5mo agoNeutral↗ source
  • U.S. imposes 30‑day travel ban on travelers from DRC, Uganda, South Sudan amid Ebola outbreak
    The CDC announced a new order that bars anyone who has been in the Democratic Republic of the Congo, Uganda, or South Sudan within the past 21 days from entering the United States. The restriction…
    STAT · 5mo agoRegulatoryNeutral↗ source
  • Health Tech team hosts consumer health discussions at FT US Pharma and Biotech Summit
    On Thursday, the Health Tech team led a series of conversations at the Financial Times’ US Pharma and Biotech Summit, an event organized in collaboration with Endpoints News. The sessions focused…
    Endpoints · 5mo agoNeutral↗ source
  • FDA approves AstraZeneca’s novel hypertension pill Baxfendy
    The U.S. Food and Drug Administration has cleared AstraZeneca’s new hypertension medication, Baxfendy, marking the first approval of a drug that works by inhibiting a blood‑pressure‑raising enzyme.…
    BioPharma Dive · 5mo agoApprovalPositive↗ source
  • Merck's China-sourced ADC shows survival benefit in Phase 3 endometrial cancer trial
    Merck & Co., in partnership with Chinese biotech Kelun-Biotech, reported that its experimental antibody-drug conjugate sacituzumab tirumotecan (Sac-TMT) met its primary endpoint in a global Phase 3…
    BioPharma Dive · 5mo agoPositive readoutPositive↗ source
  • FDA approves AstraZeneca’s baxdrostat for select hypertension patients
    AstraZeneca announced that the U.S. Food and Drug Administration has granted approval for its blood‑pressure pill baxdrostat, targeting a specific group of patients with hypertension. The approval…
    Endpoints · 5mo agoApprovalPositive↗ source
  • Amgen defends Tavneos as FDA, European regulators and Japanese doctors raise safety concerns
    Amgen said it continues to support its rare-disease therapy Tavneos despite recent safety alerts. The U.S. FDA has indicated it wants the drug removed from the market after a report of 20 deaths l…
    Endpoints · 5mo agoRegulatoryNegative↗ source
  • FDA leadership overhaul follows firing of acting CDER director; 20 deaths linked to Amgen’s Tavneos in Japan
    The FDA announced another leadership change, removing acting directors of its two main drug review centers. Tracy Beth Høeg, acting head of the Center for Drug Evaluation and Research (CDER), poste…
    BioPharma Dive · 5mo agoRegulatoryNegative↗ source
  • China's rapid drug development fuels split among U.S. biotech firms
    Damian Garde spoke with more than a dozen investors, entrepreneurs and industry leaders about how China's growing role is reshaping U.S. biotech strategy. American companies have poured roughly $6…
    STAT · 5mo agoNeutral↗ source
  • AstraZeneca receives FDA approval for new hypertension medication
    AstraZeneca announced that the U.S. Food and Drug Administration has approved its hypertension drug, marking a regulatory milestone for the company. The approval adds to AstraZeneca's cardiovascul…
    STAT · 5mo agoApprovalPositive↗ source
  • Merck and Kelun-Biotech's ADC sac-TMT secures first global Phase 3 win ahead of schedule
    Merck and China-based Kelun-Biotech reported that their experimental antibody-drug conjugate sac-TMT achieved a positive outcome in a global Phase 3 study, marking the first such success for the ca…
    Endpoints · 5mo agoPositive readoutPositive↗ source