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  • 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…
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Endpoints · 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
  • 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
  • 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
  • Makary resigns; Biogen reports Alzheimer’s data; and more
    Welcome back to Endpoints Weekly. The biggest news this week was Marty Makary’s resignation from his role as FDA Commissioner. The announcement came days after reports emerged that President Donald…
    Endpoints · 2mo ago↗ source
  • CDER chief Høeg fired from FDA as other top roles turn over
    The leader of the FDA's drug division, Tracy Beth Høeg, is expected to depart, as part of a broad shakeup at the top of the agency after the exit of now-former Commissioner Marty Makary, according ...
    Endpoints · 2mo ago↗ source
  • Biopharma M&A maintains strength even as large deals wane
    Biopharma's deals landscape could hardly be better, as large companies take a multi-pronged approach to withstand an avalanche of major patent expiries. But there’s one notable missing piece: megad…
    Endpoints · 2mo ago↗ source
  • Amgen expands crackdown on what it says is misuse of 340B program
    Amgen is expanding its claims data requirements for pharmacies dispensing its drugs under the 340B federal drug discount program. The company said the new policy addresses what it claims is fraud a…
    Endpoints · 2mo ago↗ source
  • FDA hold puts Aardvark Prader-Willi drug in limbo
    The company plans to unblind the late-stage study that was halted due to safety concerns, which could lead to an overhaul of its entire development program.
    BioPharma Dive · 2mo ago↗ source
  • Supreme Court preserves access to abortion pill by mail
    The ruling maintains access to the drug while litigation continues. Mifepristone can still be prescribed at pharmacies or by mail without requiring in-person visits.
    BioPharma Dive · 2mo ago↗ source
  • Biotech leaders campaign for Pazdur; Takeda to lay off 4,500 workers
    Hundreds of executives and investors are pushing for Rick Pazdur to be the next FDA commissioner. Elsewhere, Takeda detailed its latest restructuring and Alumis is discarding a once-highly touted i…
    BioPharma Dive · 2mo ago↗ source
  • Candel reports prostate cancer drug's long-term data ahead of FDA filing
    Candel Therapeutics produced long-term follow-up data that may bolster the case for its prostate cancer drug that's heading to the FDA for marketing approval later this year. The company followed u…
    Endpoints · 2mo ago↗ source
  • Post-Hoc Live: Makary's out at FDA and what comes next
    Marty Makary resigned as FDA commissioner on Tuesday after a turbulent tenure at the head of the agency. Makary was scheduled to sit down with senior reporter Max Bayer this week at ...
    Endpoints · 2mo ago↗ source
  • Aardvark's next move after clinical hold; Alumis' verdict on Acelyrin asset
    Plus, news about Tenaya’s TN-401 and Taiho’s Inqovi. 📉 Aardvark to unblind rare disease trial following clinical hold: The FDA has placed a full clinical hold on the company's candidate for ...
    Endpoints · 2mo ago↗ source
  • India’s pharma industry is going global. But can it catch up to China?
    A record Sun Pharma acquisition signals global ambitions. But infrastructure, capital and policy gaps could stand in the way of India becoming an R&D powerhouse.
    BioPharma Dive · 2mo ago↗ source
  • M&A isn’t just for big pharma. Mid-size companies are stepping up deal hunts
    In what is shaping up to be one of the most active years for biopharma M&A on record, a different-looking set of buyers is going shopping. Mid-cap American drugmakers, family-owned pharma groups, f…
    Endpoints · 2mo ago↗ source
  • Andrea Pfeifer ends 23-year reign at AC Immune; Acadia's top R&D exec announces retirement
    AC Immune will be searching for a new CEO for the first time, as the company announced this week that Andrea Pfeifer plans to retire after 23 years at the helm. ...
    Endpoints · 2mo ago↗ source
  • #ASGCT26: A Zillow-like marketplace for abandoned gene therapies goes live
    BOSTON — Two nonprofit organizations have devised a plan to help abandoned cell and gene therapies find a new home. On Thursday, the American Society of Gene & Cell Therapy (ASGCT) and the Orphan T…
    Endpoints · 2mo ago↗ source
  • Supreme Court preserves mail access for abortion pill
    The Supreme Court will continue to allow the abortion pill mifepristone to be distributed by mail, at least for now. The Thursday ruling maintains mifepristone's current safety protocols while liti…
    Endpoints · 2mo ago↗ source
  • #ASGCT26: Encoded's gene therapy reduced seizures in Dravet syndrome
    A gene therapy designed by Encoded Therapeutics reduced seizures by 76% in children with Dravet syndrome, a severe neurodevelopmental disorder. The remarkable reduction was observed only in three p…
    Endpoints · 2mo ago↗ source
  • #ASGCT26 dispatch: In vivo CAR-T is everywhere
    BOSTON — Greetings from Boston, where I’ve been on the ground covering the American Society of Gene & Cell Therapy’s annual meeting all week. It’s a crucial moment for the field. Genetic medicine d…
    Endpoints · 2mo ago↗ source