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1,403 stories matching this filter · ← front page

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  • TME Pharma narrows licensing talks for brain-cancer drug NOX-A12, eyes $1 billion market
    TME Pharma, a German biotech, says it has narrowed potential partners for its experimental glioblastoma therapy NOX-A12, a CCL2 inhibitor, to two firms and entered a final evaluation phase. The co…
    Fierce Biotech · 2mo agoDealNeutral↗ source
  • Spruce Biosciences advances toward Q4 FDA filing for ultra-rare Sanfilippo B therapy
    Spruce Biosciences reported progress toward filing its enzyme replacement therapy, tralesinidase alfa (TA-ERT), for Sanfilippo syndrome type B, an ultra-rare lysosomal disorder. The company said t…
    Fierce Biotech · 2mo agoRegulatoryPositive↗ source
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  • Pharma marketers urged to adopt share-of-answer strategy as AI use surges among physicians
    Pharma marketers are planning for 2027 as artificial intelligence reshapes how clinicians seek clinical answers. The rise of AI tools means that traditional metrics like share of voice and broad om…
    BioPharma Dive · 2mo agoNeutral↗ source
  • Cellares to cut 100 jobs after losing contract with unnamed large pharma customer
    Cellares, a cell therapy manufacturing startup based in South San Francisco, announced it will lay off about 100 employees. The cuts follow the termination of a contract by an unnamed large pharma…
    BioPharma Dive · 2mo agoLayoffsNegative↗ source
  • Texas lawmaker warns Chinese biotech firms gaining early-stage advantage over U.S. industry
    Rep. Nathaniel Moran, a Republican from Texas and member of the House Select Committee on China, told Fierce that the United States is overlooking how Chinese biotech companies are outpacing Americ…
    Fierce Biotech · 2mo agoNeutral↗ source
  • Lilly leads GLP-1 weight-loss market while Novo Nordisk’s Wegovy exceeds expectations but falls short of forecasts
    Eli Lilly and Novo Nordisk are intensifying their battle for dominance in the multibillion‑dollar GLP‑1 weight‑loss market, with each company promoting its own set of injectable therapies and pipel…
    BioPharma Dive · 2mo agoEarningsNeutral↗ source
  • Takeda wins FDA nod for orexin drug oveporexton, first treatment for narcolepsy type 1 and potential broader uses
    Takeda received FDA approval for oveporexton (brand Orzeyful), an orexin receptor agonist, marking the first approved therapy that targets the orexin system for narcolepsy type 1. The drug mimics…
    Fierce Biotech · 2mo agoApprovalPositive↗ source
  • Ambros Therapeutics merges with Werewolf, raises $150M to fund phase 3 trial of rare disease drug
    Ambros Therapeutics announced an all‑stock reverse merger with Werewolf Therapeutics, accompanied by a $150 million private placement. The transaction will see the combined company operate under th…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Activist Kaos Capital pushes governance overhaul at Capricor ahead of FDA Duchenne decision
    Activist investor Kaos Capital has sent a letter to Capricor Therapeutics shareholders demanding a “governance reset.” The firm asks for a meeting to nominate two independent directors, create an M…
    BioPharma Dive · 2mo agoNegative↗ source
  • Moderna’s melanoma vaccine trial success sparks $45 billion market value surge
    Moderna’s shares jumped more than 170% after the company announced that its experimental melanoma vaccine, intismeran, met its primary goals in a Phase 3 trial. The surge added roughly $45 billion…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Moderna's cancer vaccine boost lifts stock, sparks talk of Keytruda-like reach
    Moderna’s shares surged 177% after a phase 3 topline win for its Merck‑partnered cancer vaccine, intismeran autogene, was disclosed. The data, released on Wednesday, added roughly $45 billion to Mo…
    Fierce Biotech · 2mo agoPositive readoutPositive↗ source
  • FDA clears Vitestro's Aletta, first robotic blood draw device for U.S. clinics
    The U.S. Food and Drug Administration has granted clearance to Vitestro's Aletta, making it the first standalone robotic system approved to draw blood without direct human handling. Aletta can per…
    Fierce Biotech · 2mo agoApprovalPositive↗ source
  • Ultragenyx secures FDA approval for Glenglycos, first gene therapy for GSD Ia
    Ultragenyx announced FDA approval of Glenglycos, a one-time gene therapy for glycogen storage disease type Ia, a rare genetic disorder. The therapy delivers a functional gene to the liver to resto…
    BioPharma Dive · 2mo agoApprovalPositive↗ source
  • Medigen partners with Charles River to advance multivalent enterovirus vaccine globally
    Charles River Laboratories and Taiwan's Medigen Vaccine Biologics announced a collaboration to prepare Medigen’s multivalent enterovirus vaccine for worldwide use. The partnership will focus on ch…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Chai Discovery partners with Bristol Myers Squibb to use AI for antibody discovery
    Chai Discovery, an AI-driven drug discovery company, announced a collaboration with Bristol Myers Squibb to apply its artificial-intelligence models to therapeutic antibody research. The partnershi…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Eli Lilly partners with Amplitude Therapeutics to develop trans-amplifying RNA vaccines for infectious diseases
    Eli Lilly announced a collaboration with Boston-based Amplitude Therapeutics, a company that emerged from Lilly’s Gateway Labs incubator. The partnership will focus on developing trans-amplifying…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Regeneron wins FDA approval for Pasatru, targeting rare bone disease FOP
    The U.S. Food and Drug Administration has approved Regeneron Pharmaceuticals' drug Pasatru for the treatment of fibrodysplasia ossificans progressiva (FOP), a very rare condition in which muscle an…
    BioPharma Dive · 2mo agoApprovalPositive↗ source
  • Neumora Therapeutics appoints Joshua Pinto as CEO and Doron Sagman as CMO ahead of IND filing
    Neumora Therapeutics announced leadership changes, naming Joshua Pinto, Ph.D., as its new chief executive officer. Pinto, who joined Neumora in 2021 as chief financial officer and most recently se…
    Fierce Biotech · 2mo agoNeutral↗ source
  • Pheast Therapeutics sticks with open R&D despite competitor Antengene moving ahead with anti‑CD24 trials
    Pheast Therapeutics, a Redwood City biotech founded in 2021, builds on Irv Weissman’s 2019 Nature paper that highlighted the CD24 protein as a promising "don’t eat me" target for cancer immunothera…
    Fierce Biotech · 2mo agoNeutral↗ source
  • Boehringer Ingelheim pauses phase 1 trial of BI 3031185 in Japan to investigate safety event
    Boehringer Ingelheim has placed a phase 1 study of its investigational oral small‑molecule candidate BI 3031185 on voluntary hold after a safety event was reported. The trial, which began in early…
    Fierce Biotech · 2mo agoCRLNeutral↗ source
  • Moderna-Merck mRNA cancer vaccine shows landmark interim success in melanoma trial
    An interim analysis of a Phase 3 trial of an individualized mRNA cancer vaccine from Moderna and Merck showed the treatment met its primary goals. The vaccine, given together with Merck's immunothe…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Trump administration eyes Heidi Overton as next FDA commissioner
    President Donald Trump is reported to be preparing a nomination for Heidi Overton to become the next commissioner of the Food and Drug Administration, according to multiple news outlets. Overton i…
    BioPharma Dive · 2mo agoRegulatoryNeutral↗ source
  • Trump nominates White House aide Heidi Overton as FDA commissioner
    President Donald Trump announced his intent to nominate Heidi Overton, M.D., Ph.D., a current White House aide, to lead the Food and Drug Administration. Overton earned her medical degree from the…
    Fierce Biotech · 2mo agoRegulatoryNeutral↗ source
  • Tolerance Bio secures up to $260 M for thymus‑targeting fusion protein, moves into Phase 2 trials
    Tolerance Bio, a Philadelphia biotech founded in October 2024, has signed a licensing agreement to acquire rights to NeoImmuneTech’s long‑acting IL‑7 fusion protein, efineptakin alfa, for up to $26…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Merck partners with Sarah Cannon to accelerate community oncology trials
    Merck & Co. has entered a collaboration with the Sarah Cannon Research Institute to expand patient access to oncology trials at community sites across the United States. The partnership will use S…
    Fierce Biotech · 2mo agoDealPositive↗ source