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  • 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
  • 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
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  • 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
  • Angelini to acquire Catalyst Pharmaceuticals for $4.1 billion, adding rare CNS drug portfolio
    Angelini Pharma announced it will purchase Catalyst Pharmaceuticals in a cash transaction valued at about $4.1 billion. The agreement pays $31.50 per Catalyst share, representing a 21% premium to…
    BioPharma Dive · 4mo agoDealPositive↗ 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
  • EnGene shares tumble 80% after Phase 2 bladder cancer data raise safety concerns
    EnGene, a Canadian biotech firm, released updated Phase 2 results for its experimental therapy aimed at a specific group of bladder cancer patients. The company said the new data fell short of expe…
    Endpoints · 4mo agoNegative readoutNegative↗ source
  • Entrada Therapeutics shares plunge after Duchenne trial shows modest dystrophin increase
    Entrada Therapeutics reported early data from a Phase 1/2 study of its RNA‑based therapy ENTR‑601‑44 for Duchenne muscular dystrophy, noting favorable safety and tolerability. The trial showed a d…
    BioPharma Dive · 4mo agoNegative readoutNegative↗ source
  • Blackstone invests $250 million in Anagram to address cystic fibrosis complication
    Blackstone Life Sciences announced a $250 million investment in Anagram, a biotech focused on cystic fibrosis complications. The funding is part of one of the largest private investment funds in t…
    Endpoints · 4mo agoDealPositive↗ source
  • Entrada's Duchenne drug shows disappointing early data, shares tumble
    Entrada disclosed initial results from a low‑dose version of its exon‑44 skipping therapy for Duchenne muscular dystrophy. The data, collected from six patients, failed to meet the company’s expect…
    Endpoints · 4mo agoNegative readoutNegative↗ source
  • Amgen invests $300 million in Puerto Rico biologics plant as Novartis plans to close German oral drug factory
    Amgen announced an additional $300 million investment in Puerto Rico to expand its biologics manufacturing capacity in Juncos, building on earlier commitments. The funding will be used to upgrade…
    Endpoints · 4mo agoDealNeutral↗ source
  • Atara and Pierre Fabre's T-cell therapy gets new chance for FDA approval after twice rejected
    Atara Biotherapeutics and Pierre Fabre Pharmaceuticals have received notice from the U.S. FDA that it will reconsider a previously rejected T-cell therapy. The therapy, which had been turned down…
    Endpoints · 4mo agoRegulatoryPositive↗ 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
  • 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 agoDealNeutral↗ source
  • Health insurers grapple with profit cuts after a costly 2025, outlook for 2026 remains uncertain
    In 2025, a wave of health insurers reduced or withdrew their profit forecasts after being hit by rising medical expenses. The cost pressures stemmed from higher drug prices, increased utilization…
    Endpoints · 4mo agoNegative↗ source
  • Amazon Pharmacy adds Ozempic pill to its same-day prescription kiosks
    Amazon Pharmacy announced that its same-day prescription kiosks will now dispense the Ozempic tablet, expanding the range of drugs available through the vending-style machines. The kiosks, which h…
    Endpoints · 4mo agoNeutral↗ source
  • Pennsylvania files lawsuit against Character.AI for presenting chatbot as licensed physician
    The Commonwealth of Pennsylvania has filed a lawsuit against Character.AI, a startup that offers users the ability to converse with AI-generated personas. The suit alleges that the company illegall…
    Endpoints · 4mo agoRegulatoryNegative↗ 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
  • Lilly plans new $4.5B manufacturing investment in Indiana
    Eli Lilly is committing to its roots, allocating $4.5 billion for new manufacturing investments across Indiana as drugmakers pledge more US projects. The world’s largest pharma company, headquarter…
    Endpoints · 4mo ago↗ source