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  • Trump reportedly plans to dismiss FDA Commissioner Marty Makary
    Multiple media outlets report that President Donald Trump is considering removing FDA Commissioner Marty Makary from his post. The reports say the decision has not been finalized and could still be…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • WSJ reports Trump plans to fire FDA Commissioner Marty Makary, decision not yet final
    The Wall Street Journal reported that President Donald Trump is considering removing FDA Commissioner Marty Makary from his post. The report said the administration has not yet made a final decisi…
    Endpoints · 4mo agoRegulatoryNegative↗ source
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  • Daiichi Sankyo writes off $950 million after abandoning ADC manufacturing plan
    Daiichi Sankyo announced it will abandon its planned antibody-drug conjugate (ADC) manufacturing facility. The company said the decision follows a serious over-estimate of third-party demand for AD…
    Endpoints · 4mo agoEarningsNegative↗ source
  • FDA pushes Leqembi subcutaneous decision to Aug. 24; Artiva secures $300M and Pharvaris sets pricing
    The U.S. Food and Drug Administration has postponed its review of the subcutaneous formulation of Leqembi. The original target date earlier this month has been moved to August 24, as Biogen and Eis…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Pierre Fabre aligns with FDA on resubmission of Ebvallo cell therapy
    Pierre Fabre Laboratories announced that it has reached an agreement with the U.S. Food and Drug Administration on a new path for its cell therapy Ebvallo, which had been rejected twice. The FDA w…
    BioPharma Dive · 4mo agoRegulatoryNeutral↗ source
  • Odyssey Therapeutics raises $279 million in IPO, begins Nasdaq trading
    Odyssey Therapeutics, a biotech focused on autoimmune diseases, announced that its initial public offering generated $279 million. The company sold about 15.5 million shares and priced the IPO at…
    Endpoints · 4mo agoDealPositive↗ 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 · 4mo agoDealNeutral↗ source
  • Top young AI researchers avoid careers at large pharmaceutical companies
    Mazdak Abulnaga, a 33‑year‑old postdoctoral fellow at MIT and Harvard Medical School, is highlighted as the type of employee pharmaceutical companies hope to attract this year. Despite the demand,…
    Endpoints · 4mo agoNegative↗ source
  • Natalie Holles appointed CEO after Third Harmonic shutdown; Mark Alles steps down at ADC Biotech
    Natalie Holles quickly found a new role after the decision to wind down operations at Third Harmonic. She has taken over as chief executive, succeeding Elisabet de los Pinos. At the same time, Mar…
    Endpoints · 4mo agoNeutral↗ source
  • Capricor sues Nippon Shinyaku over pricing dispute for Duchenne cell therapy candidate
    Capricor Therapeutics announced it has filed a lawsuit against its Japanese partner Nippon Shinyaku. The suit alleges a flaw in the pricing terms of the distribution and commercialization agreemen…
    Endpoints · 4mo agoNegative↗ source
  • Sarepta's Elevidys sales beat forecasts but dip again, prompting stock slide and shift to RNA pipeline
    Sarepta Therapeutics reported that its gene therapy Elevidys generated net product revenue that exceeded Wall Street estimates for the first quarter. However, sales continued to decline compared wi…
    BioPharma Dive · 4mo agoEarningsNegative↗ source
  • Astellas reports promising early results for stem cell eye therapy ASP7317 in age-related disease
    Astellas announced data from an early-stage trial of ASP7317, a stem cell-derived therapy aimed at an age-related eye condition. The study showed encouraging signs of efficacy and safety in most p…
    Endpoints · 4mo agoPositive readoutPositive↗ 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo ago↗ source
  • Entrada stock falls on Duchenne data; Wegovy expands access
    Plus, news about BioCryst, GSK and Roche. 🙃 Entrada’s Duchenne drug disappoints: The biotech reported initial data in six patients who received the low dose of its exon 44 skipping drug ...
    Endpoints · 4mo ago↗ source
  • Roche to acquire digital pathology firm PathAI in deal potentially worth over $1B
    Roche plans to offer PathAI’s tools as part of an effort to improve cancer diagnosis and tailored treatment.
    BioPharma Dive · 4mo ago↗ source
  • Amgen adds $300M to Puerto Rico budget; Novartis to exit oral drug factory in Germany
    Plus, news about FDA's one-day inspections and BioMADE: 🇵🇷 Amgen pours another $300M into Puerto Rico: The funds will be used to bolster its biologics production in Juncos, which was established ...
    Endpoints · 4mo ago↗ source
  • Atara, Pierre Fabre's cell therapy to get another shot at FDA approval
    There's new life for a twice-rejected T cell therapy from Atara Biotherapeutics and Pierre Fabre Pharmaceuticals. US regulators are willing to reconsider using a Phase 3 study as the basis for an a…
    Endpoints · 4mo ago↗ source
  • Pennsylvania sues AI chatbot company for posing as a licensed doctor
    The state of Pennsylvania has sued Character.AI, a startup that lets users chat with different AI-generated personas, for illegally presenting a chatbot as a licensed doctor in the state. This is t…
    Endpoints · 4mo ago↗ source
  • Angelini fortifies neurology portfolio with $4.1B buyout of Catalyst
    Angelini Pharma is spending $4.1 billion to buy Catalyst Pharmaceuticals and its trio of FDA-approved treatments for rare neurological diseases. The buyout will add three medicines to Angelini’s po…
    Endpoints · 4mo ago↗ source
  • Amgen, AbbVie say IRA negotiations impacted Q1 sales
    At least two drugmakers say they’re feeling the impact of the Inflation Reduction Act, after the first drug prices negotiated under the law took effect in January. Amgen and AbbVie reported in thei…
    Endpoints · 4mo ago↗ source