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476 stories matching this filter · ← front page

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  • Roche signs $2.5 billion deal with Hanmi for experimental obesity drug targeting muscle loss
    Roche's Genentech unit has agreed to acquire global rights (outside South Korea) to Hanmi's clinical-stage urocortin-2 analog, HM17321, as part of a deal valued up to $2.5 billion. The agreement i…
    Fierce Biotech · 21d agoDealPositive↗ source
  • FDA places clinical hold on Regenxbio’s RGX-121 gene therapy after spine MRI findings, delaying refiling plans
    The U.S. Food and Drug Administration has issued a clinical hold on Regenxbio’s gene therapy candidate RGX-121 after routine MRI scans revealed asymptomatic changes in the spines of trial participa…
    Fierce Biotech · 21d agoRegulatoryNegative
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  • Massachusetts biotech sees record-first-half VC funding and IPO surge despite modest NIH funding dip
    The latest MassBio Industry Snapshot reports a strong start to 2026 for the state’s biotech sector, with venture capital inflows rising 25% year over year to $3.45 billion in the first half of the…
    Fierce Biotech · 20d agoPositive↗ source
  • Qiagen names Jonathan M. Pratt as new chief executive after nine-month search
    Qiagen announced that Jonathan M. Pratt will take over as chief executive, ending a nine‑month search for a successor. Pratt arrives from Filtration Group, where he served as president and CEO. He…
    Fierce Biotech · 21d agoNeutral↗ source
  • 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 · 21d 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 · 21d agoRegulatoryPositive↗ source
  • FDA clears Roche and Lilly Alzheimer’s blood tests, while Regenxbio gene therapy trial halted again
    The U.S. Food and Drug Administration announced it has granted clearance for blood-based diagnostic tests for Alzheimer’s disease developed by Roche and Eli Lilly. The clearances allow the compani…
    raps · 21d agoRegulatoryNeutral↗ source
  • FDA asks industry input on competency-based rules for generative AI medical devices
    The FDA announced it is soliciting comments on a proposed competency-based framework for overseeing medical devices that incorporate generative artificial intelligence. The agency says the approac…
    raps · 21d agoRegulatoryNeutral↗ source
  • FDA finalizes guidance on therapeutic equivalence evaluations for ANDAs
    The U.S. Food and Drug Administration has issued final guidance describing its approach to therapeutic equivalence (TE) evaluations and the assignment of TE codes for abbreviated new drug applicati…
    raps · 21d agoRegulatoryNeutral↗ source
  • Australian regulator TGA opens consultation on automated decision making for listed medicine variations
    The Therapeutic Goods Administration has launched a public consultation to gather input on proposed changes that would enable automated decision making for variation applications of listed medicine…
    raps · 21d agoRegulatoryNeutral↗ 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 · 21d agoNeutral↗ 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 · 24d 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 · 24d agoDealPositive↗ 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 · 25d 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 · 25d agoApprovalPositive↗ source
  • Trump nominates Heidi Overton as FDA Commissioner as agency releases CGT Q&A guidance
    The U.S. Food and Drug Administration issued final guidance that answers common questions about developing cellular and gene therapy products. The document aims to clarify regulatory expectations f…
    raps · 25d agoRegulatoryNeutral↗ 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 · 25d 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 · 25d 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 · 25d agoDealPositive↗ source
  • FDA approves Ultragenyx gene therapy for glycogen storage disorder; Overton faces confirmation hurdles
    The U.S. Food and Drug Administration has granted approval to Ultragenyx's gene therapy aimed at treating a glycogen storage disorder. This marks a regulatory milestone for the company and the rare…
    raps · 25d 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 · 25d 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 · 25d agoNeutral↗ source
  • Experts call for modernizing rare disease evidence models using FDA plausible mechanism framework
    A recent paper in The Journal of Clinical Investigation argues that the evidentiary approach for rare diseases needs updating. The authors suggest applying the FDA’s plausible mechanism framework,…
    raps · 25d 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 · 25d agoCRLNeutral↗ source
  • EMA launches consultation on draft framework to speed adoption of data standards
    EMA has opened a public consultation on a draft framework aimed at accelerating the implementation of data standards across the pharmaceutical sector. The agency says the new framework is intended…
    raps · 25d agoRegulatoryNeutral↗ source