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  • With no approved vaccine for Ebola outbreak, experts weigh testing a long shot
    With no approved vaccine for the fast-growing Ebola outbreak in the DRC, experts weigh testing one with unknown protection.
    STAT · 2mo ago↗ source
  • STAT+: Trump’s CMS to allow skimpier plans on ACA exchanges
    The new plans could leave patients on the hook for more of their health care costs.
    STAT · 2mo ago↗ source
  • Amgen stands by rare disease drug Tavneos amid Japan liver toxicity report
    The FDA wants it off the market. European regulators are investigating data-integrity concerns. And now, a pharma company selling the drug in Japan is warning doctors against writing new prescripti…
    Endpoints · 2mo ago↗ source
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  • FDA's unreleased Covid vaccine deaths report is published by lawmaker
    An analysis launched by former FDA leaders to look into claims of pediatric deaths related to Covid-19 vaccines was published by a Republican lawmaker, months after the agency's self-imposed deadli…
    Endpoints · 2mo ago↗ source
  • STAT+: Why the WakeMed – Atrium Health hospital merger matters
    Hospital execs worked in secret on the deal for two years.
    STAT · 2mo ago↗ source
  • STAT+: AstraZeneca picks up FDA approval for hypertension drug
    The China question, FDA leadership shakeups, and other biotech news from The Readout
    STAT · 2mo ago↗ source
  • U.S. bans entry from Ebola-affected countries as American patient is identified
    In response to an Ebola outbreak, the U.S. has banned entry for noncitizens who have been in the Democratic Republic of the Congo, Uganda, or South Sudan recently.
    STAT · 2mo ago↗ source
  • FDA approves AstraZeneca’s new kind of hypertension drug
    Baxfendy inhibits a blood-pressure-raising enzyme and, according to AstraZeneca executives, is poised to be a “big product” that should ultimately generate $5 billion or more in annual sales.
    BioPharma Dive · 2mo ago↗ source
  • Merck ADC, licensed from China, hits mark in first big global trial
    The endometrial cancer trial is the first of 17 late-stage studies Merck is running for a therapy that’s important to its ambitions of hitting $70 billion in annual sales next decade.
    BioPharma Dive · 2mo ago↗ source
  • Regeneron reaches $125M Parabilis deal for hard-to-catch drug targets
    As Regeneron’s cancer portfolio continues to suffer setbacks, the company is placing a bet in a different direction through a deal with Parabilis Medicines valued at as much as $2.2 billion. Parabi…
    Endpoints · 2mo ago↗ source
  • Design Therapeutics' Friedreich's ataxia data; Vincentage's obesity results from China
    Plus, news about Enhertu and Tecentriq. 💪 Design Therapeutics shares Phase 1/2 data in Friedreich's ataxia: The California biotech’s DT-216P2 given at 1 mg/kg led to an average 6.4-point improveme…
    Endpoints · 2mo ago↗ source
  • Høeg fired in latest FDA shakeup; 20 people die after taking Amgen drug
    The agency has once again shuffled the leadership for two top drug review offices. Elsewhere, Parabilis partnered with Regeneron and an obesity pill is headed toward an approval in China.
    BioPharma Dive · 2mo ago↗ source
  • Merck's ADC sac-TMT gets its first global Phase 3 win ahead of schedule
    An experimental antibody-drug conjugate from Merck and China-based Kelun-Biotech succeeded in a global Phase 3 study for the first time, giving Merck a key pipeline victory as it approaches the pat…
    Endpoints · 2mo ago↗ source
  • STAT+: Supreme Court rejects challenge to Medicare drug price negotiation
    The rejection may make the pharma firms remaining lawsuits more difficult.
    STAT · 2mo ago↗ source
  • The Supreme Court won't take up drugmakers' IRA cases
    The Supreme Court says it won’t wade into the pharma industry’s yearslong legal battle over Medicare drug price negotiations. The justices declined to review multiple cases brought by AstraZeneca,…
    Endpoints · 2mo ago↗ source
  • STAT+: Pharmalittle: We’re reading about U.S. biotech’s China problem, a Regeneron flop, and much more
    The question of whether to partner with Chinese firms — or see them as rivals — is tearing biotech apart, pitting peers and partners against one another
    STAT · 2mo ago↗ source
  • Regeneron immunotherapy combo comes up short in melanoma trial
    A two-drug regimen of Regeneron’s fianlimab and Libtayo didn’t significantly outperform Keytruda in a late-stage study, a finding that surprised Wall Street analysts and wiped out billions in marke…
    BioPharma Dive · 2mo ago↗ source
  • Texas is opening up a detransition clinic
    Americans exposed to Ebola outbreak, Bill Cassidy's primary defeat, and more health news from Morning Rounds
    STAT · 2mo ago↗ source
  • Regeneron's Phase 3 skin cancer miss adds to mounting failures in LAG-3
    Regeneron Pharmaceuticals’ LAG-3 inhibitor called fianlimab has flunked a late-stage skin cancer trial, marking yet another blow for the drug class. The announcement follows a spate of recent clini…
    Endpoints · 2mo ago↗ source
  • FDA approves AstraZeneca’s baxdrostat for certain patients with hypertension
    One of the key products underpinning AstraZeneca’s goal of hitting $80 billion in revenue by 2030 has been approved by the FDA, the drugmaker said Monday. The blood ...
    Endpoints · 2mo ago↗ source
  • Unlocking more value from mature drug products through strategic outsourcing
    See how strategic outsourcing can maximize value and reduce costs for mature drug portfolios.
    BioPharma Dive · 2mo ago↗ source
  • Opinion: ‘Patient autonomy’ has nothing to do with childhood vaccine policies
    Opinion: Vaccine policy it is not a matter of autonomy at all, because infants do not decline vaccination — their parents do.
    STAT · 2mo ago↗ source
  • STAT+: The China question is tearing biotech apart
    China's ascent is forcing U.S. biotech companies and investors to pick a side: Is it an ally or an existential threat?
    STAT · 2mo ago↗ source
  • Opinion: How to restore credibility to the CDC’s vaccine advisory committee
    Jesse Goodman, former director of CBER and former FDA chief scientist, calls for five critical changes to restore trust in the Advisory Committee on Immunization Practices.
    STAT · 2mo ago↗ source
  • STAT+: U.K. advocacy groups threaten court action over a key provision in the pharma trade deal with the U.S.
    A pair of advocacy groups is threatening legal action unless the U.K. government revokes regulations at the heart of a new pharma trade agreement with the U.S.
    STAT · 2mo ago↗ source