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994 stories matching this filter · ← front page

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  • European regulators greenlight Fractyl Health's clinical test of GLP-1 gene therapy
    Drug developers are racing to make gene therapies that could replace chronic GLP-1 injections and pills with a one-and-done treatment. Now, a company based just outside of Boston is poised to becom…
    Endpoints · 2mo ago↗ source
  • CSL sinks to nine-year low on revenue warning, $5B write-down
    CSL's stock hit its lowest price since early 2017 on Monday after it lowered its full-year revenue guidance by about 4% and said it would have to take a new $5 billion impairment charge. The ...
    Endpoints · 2mo ago↗ source
  • Precision in motion: Decoding the critical operations behind the logistics of next-generation cell and gene therapies
    The future of medicine is here. See how specialized logistics are saving lives with next-gen cell and gene therapies.
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BioPharma Dive · 2mo ago
↗ source
  • The capacity crunch in biopharma is a location problem
    Cell and gene therapies aren’t limited by ideas—they’re limited by where they’re built. See how “ready-now” locations change the math on scaling.
    BioPharma Dive · 2mo ago↗ source
  • Biotech’s new company model; The super poop behind a startup launch; and more
    Welcome back to another edition of Endpoints Weekly! Earnings season is in full swing, but we had plenty of original reporting and exclusives you won’t find anywhere else this week. Chief among the…
    Endpoints · 2mo ago↗ source
  • Trump plans to fire Makary from FDA role, according to reports
    FDA Commissioner Marty Makary is expected to be fired from his role, according to multiple media reports. The plans haven’t been finalized and could still change, said the Wall Street Journal ...
    Endpoints · 2mo ago↗ source
  • FDA Commissioner Makary to be fired, WSJ reports
    President Donald Trump is planning to fire FDA Commissioner Marty Makary, the Wall Street Journal reported on Friday. The plans haven't been finalized and could still change, the Journal said. Repr…
    Endpoints · 2mo ago↗ source
  • Daiichi Sankyo posts 'extraordinary loss' of nearly $1B
    Daiichi Sankyo is scrapping plans to build antibody-drug conjugate manufacturing capacity and recorded an "extraordinary loss" of 149.4 billion Japanese yen ($950 million) after overpromising deman…
    Endpoints · 2mo ago↗ source
  • Lilly to invest extra $4.5B across Indiana manufacturing
    The Indianapolis-based company expanded its spend to ensure it can meet growing demand for its weight-loss drugs.
    BioPharma Dive · 2mo ago↗ source
  • FDA delays Leqembi decision; Artiva raises $300M; Pharvaris prices offering
    🗓️ FDA delays subcutaneous Leqembi decision: Originally slated for later this month, the decision date now falls on August 24, Biogen and Eisai said. The agency asked for more information from ...
    Endpoints · 2mo ago↗ source
  • FDA to reevaluate spurned cell therapy; Under-the-skin Leqembi review extended
    Pierre Fabre claims to now be “aligned” with U.S. regulators on the path forward for a twice-rejected treatment. Elsewhere, Argenx swapped CEOs and Blackstone made a $250 million biotech investment.
    BioPharma Dive · 2mo ago↗ source
  • Lilly, Gilead lead pharma’s M&A boom
    Deal volume in 2026 is substantially outpacing last year, and activity is being driven by interest in cancer and autoimmune disease drugs.
    BioPharma Dive · 2mo ago↗ source
  • 'Pharma, not really’: Top young AI talent shuns careers at big drugmakers
    RIO DE JANEIRO — Mazdak Abulnaga should be the poster child for the type of employee pharma companies want to hire this year. Abulnaga, a 33-year-old postdoctoral fellow at MIT and Harvard Medical…
    Endpoints · 2mo ago↗ source
  • Natalie Holles' next move after Third Harmonic shutdown; Mark Alles passes the torch at ADC biotech
    → It didn’t take long for Natalie Holles to rebound after the decision to wind down operations at her previous company. She has replaced Elisabet de los Pinos as CEO of ...
    Endpoints · 2mo ago↗ source
  • Capricor sues Nippon Shinyaku over Duchenne drug 'pricing flaw' and launch prep
    Capricor Therapeutics said Thursday it has filed a lawsuit against Nippon Shinyaku over a distribution and commercialization agreement for deramiocel, a cell therapy candidate for Duchenne muscular…
    Endpoints · 2mo ago↗ source
  • Odyssey raises more than $300M as biotech goes public
    Odyssey Therapeutics pulled together $279 million from its initial public offering, the autoimmune disease drug developer said Thursday night. Odyssey began trading on the Nasdaq on Friday. The bio…
    Endpoints · 2mo ago↗ source
  • Odyssey, on second try, snags $279M in an IPO
    After withdrawing its initial filing last year, the immune drugmaker rebounded and added to a recent run of sizable new biotech stock offerings — while boosting its haul even higher through a concu…
    BioPharma Dive · 2mo ago↗ source
  • Astellas touts data from early test of stem cell-derived eye therapy
    Astellas reported promising results with its stem cell-derived therapy in an age-related eye disease, though data in a handful of high-dose patients in the early-stage study raised questions. The e…
    Endpoints · 2mo ago↗ source
  • Sarepta tumbles as its gene therapy sales decline further
    Even though Elevidys beat Wall Street expectations, analysts expect investor focus to shift toward Sarepta's early-stage RNA drugs.
    BioPharma Dive · 2mo ago↗ source
  • Amazon adds Ozempic pill to same-day prescription drug kiosks
    The Ozempic pill is coming to Amazon Pharmacy’s prescription drug kiosks. It’s an expansion for the kiosks, which operate like vending machines and have been stocking oral Wegovy since February. Am…
    Endpoints · 2mo ago↗ source
  • EnGene's shares crash on updated pivotal bladder cancer data
    EnGene’s latest Phase 2 results on an experimental treatment for certain bladder cancer patients alarmed investors and raised concerns around the therapy’s future prospects. The Canadian biotech's…
    Endpoints · 2mo ago↗ source
  • Are health insurers out of the woods after a tough 2025?
    Last year, health insurer after health insurer slashed or withdrew their profit outlooks after being sucker-punched by high medical costs. This year is shaping up ...
    Endpoints · 2mo ago↗ source
  • Blackstone puts $250M into Anagram to tackle cystic fibrosis complication
    Blackstone Life Sciences, fresh off one of the largest private investment funds in industry history, is putting $250 million to work on a little-known biotech seeking to drastically reduce the numb…
    Endpoints · 2mo ago↗ source
  • Angelini to buy Catalyst in $4B play for rare neuro drugs
    The acquisition hands the Italian pharma a group of medicines approved to treat various CNS disorders and gives it wider market access in the U.S.
    BioPharma Dive · 2mo ago↗ source
  • Entrada shares dive as Duchenne results disappoint
    While the company claimed a victory, analysts said data from a Phase 1/2 study fell short of expectations. Entrada shares subsequently tumbled more than 50%.
    BioPharma Dive · 2mo ago↗ source