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  • 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
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  • 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
  • Maryland board caps Ozempic price at $274 per month, aiming to save $5.8 million annually
    Maryland's Prescription Drug Affordability Board announced a price ceiling for Ozempic, a type 2 diabetes medication. The cap limits the cost of a 30‑day supply to $274, a figure based on Medicare…
    STAT · 5mo agoRegulatoryPositive↗ source
  • White House expands TrumpRx, adding 600 generics through Amazon, GoodRx and Cost Plus partnership
    The White House announced an expansion of its prescription drug discount platform, TrumpRx, adding more than 600 generic medicines to the site. The new catalog is supplied through partnerships wit…
    STAT · 5mo agoRegulatoryPositive↗ source
  • CMS moves to allow lower-premium, less comprehensive ACA exchange plans starting 2027
    The Centers for Medicare and Medicaid Services finalized a proposal that will let Affordable Care Act exchange plans offer more limited coverage and lower monthly premiums beginning in 2027. The r…
    STAT · 5mo agoRegulatoryNegative↗ source
  • Republican lawmaker releases FDA analysis of alleged pediatric Covid vaccine deaths
    A Republican congressman has made public an analysis that the FDA commissioned to examine claims of child deaths linked to Covid-19 vaccines. The study was initiated by former senior FDA officials…
    Endpoints · 5mo agoRegulatoryNeutral↗ source
  • WakeMed and Atrium Health finalize two-year secret merger, sparking local backlash and national attention
    Hospital executives from WakeMed and Atrium Health worked on a merger in secrecy for two years before announcing the deal. The combination brings together two major health systems in North Carolina…
    STAT · 5mo agoDealNeutral↗ source
  • U.S. imposes 30-day entry ban on travelers from Ebola-affected DRC, Uganda, South Sudan
    The CDC issued an order banning non-citizen travelers who have been in the Democratic Republic of the Congo, Uganda, or South Sudan within the past 21 days from entering the United States. The ban…
    STAT · 5mo agoRegulatoryNeutral↗ source
  • Regeneron signs up to $125 million deal with Parabilis to target difficult drug targets
    Regeneron announced a deal with Parabilis Medicines valued up to $2.2 billion, with an upfront payment of $125 million. The agreement aims to give Regeneron access to Parabilis’s platform that dis…
    Endpoints · 5mo agoDealNeutral↗ source
  • Supreme Court Declines to Hear Lawsuits Against Medicare Drug Price Negotiation Program
    The U.S. Supreme Court on Monday refused to hear challenges to the Medicare drug price negotiation program, delivering a setback to the pharmaceutical industry's legal effort. The Court declined t…
    STAT · 5mo agoRegulatoryNegative↗ source
  • US biotech faces internal split over reliance on Chinese-developed drug candidates
    Ed Silverman's Pharmalittle column notes that US biotech firms are wrestling with how to treat Chinese partners, with some seeing them as collaborators and others as competitors. The column highli…
    STAT · 5mo agoNegative↗ source
  • Regeneron's LAG-3 inhibitor fianlimab fails Phase 3 skin cancer trial
    Regeneron announced that its experimental LAG-3 inhibitor fianlimab did not meet its primary endpoint in a late-stage trial for a skin cancer indication. The Phase 3 study was designed to evaluate…
    Endpoints · 5mo agoNegative readoutNegative↗ source
  • Pharma firms turn to outsourcing to boost value of aging drug portfolios
    For many years pharma companies treated legacy brands as low-maintenance cash generators, focusing only on steady but declining revenue once patents expired. With the largest patent cliff in histo…
    BioPharma Dive · 5mo agoPositive↗ source
  • Experts debate testing Merck’s Ervebo vaccine for DRC Ebola outbreak amid lack of approved shot
    The Democratic Republic of the Congo confirmed a new Ebola outbreak at the end of May, making it the fourth largest on record. The virus is spreading in a conflict-affected region, complicating con…
    STAT · 5mo agoNegative↗ source
  • Design Therapeutics reports early Friedreich's ataxia trial shows 6.4-point improvement; Vincentage reports Chinese obesity data
    Design Therapeutics disclosed Phase 1/2 results for its Friedreich's ataxia candidate DT-216P2. The trial administered a 1 mg/kg dose and reported an average 6.4-point improvement on the study endp…
    Endpoints · 5mo agoPositive readoutPositive↗ source
  • Supreme Court declines to hear pharma challenges to Medicare drug price negotiations
    The U.S. Supreme Court has refused to review several lawsuits filed by drug makers contesting the Medicare drug price negotiation provisions of the Inflation Reduction Act. The cases, brought by co…
    Endpoints · 5mo agoRegulatoryNeutral↗ source
  • Trump administration cuts childhood vaccine schedule, citing personal autonomy
    The opinion argues that the concept of patient autonomy does not apply to childhood vaccination because infants cannot refuse shots; the decision rests with parents. In January, the Department of…
    STAT · 5mo agoRegulatoryNegative↗ source
  • Goodman urges five reforms to restore trust in CDC vaccine advisory committee
    Jesse Goodman, a former director of the FDA's Center for Biologics Evaluation and Research and former chief scientist, wrote an opinion piece calling for major changes to the CDC's Advisory Committ…
    STAT · 5mo agoRegulatoryNegative↗ source