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  • Australia's TGA adopts 23 international scientific guidelines from EMA, ICH and FDA
    The Therapeutic Goods Administration (TGA) in Australia announced it has formally adopted 23 scientific guidelines. The guidelines come from the European Medicines Agency, the International Counci…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Legend Biotech CEO Ying Huang resigns, Carvykti head Max Gelman appointed interim chief
    Legend Biotech announced that its chief executive officer, Ying Huang, has stepped down after serving in the role since November 2020. Huang's resignation was reported on Friday, marking the end o…
    Endpoints · 3mo agoNeutral↗ source
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  • FDA schedules advisory committee meetings for rejected Replimune melanoma drug and Capricor DMD cell therapy
    The FDA announced that it will hold two advisory committee meetings this week to revisit investigational therapies that were previously turned down. One meeting will consider Capricor Therapeutics'…
    BioSpace · 3mo agoRegulatoryNeutral↗ source
  • Upcoming Q2 earnings from Moderna, AstraZeneca, GSK and others highlighted in weekly pharma preview
    The Endpoints Weekly newsletter signals a busy earnings week for major pharmaceutical companies, with Q2 results slated from Moderna, AstraZeneca, GSK, Bristol Myers Squibb and several others. It…
    Endpoints · 3mo agoEarningsNeutral↗ source
  • Biogen's Alzheimer's trial data ignites excitement and uncertainty over tau-targeting therapies
    Biogen recently shared results from a late-stage Alzheimer's trial that tested a therapy aimed at the tau protein, a key hallmark of the disease. The findings have sparked enthusiasm among researc…
    Endpoints · 3mo agoNeutral↗ source
  • Amgen submits new analysis to FDA to defend continued availability of Tavneos
    Amgen has provided the FDA with a fresh analysis concerning its rare-disease therapy Tavneos, aiming to address the agency’s concerns. The company says the independent reevaluation supports the dr…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Sanofi scraps most atopic dermatitis trials after amlitelimab fails to outperform standard care
    Sanofi announced it is halting all but one ongoing trial for amlitelimab, an OX40‑ligand antibody acquired through its $1.4 billion purchase of Kymab. The decision follows the Phase 3 COAST‑1 stud…
    BioSpace · 3mo agoNegative readoutNegative↗ source
  • Scribe Therapeutics raises $129 million in rare early-stage IPO to fund epigenetic heart disease therapy
    Scribe Therapeutics, founded by Jennifer Doudna, completed an IPO raising nearly $129 million, selling 8.58 million shares at $15 each. It is the first gene‑editing company to go public in more tha…
    BioSpace · 3mo agoDealPositive↗ source
  • Amgen seeks FDA hearing to keep rare kidney drug Tavneos amid safety concerns
    Amgen has asked the U.S. Food and Drug Administration for a hearing to argue against a proposed withdrawal of its rare‑disease drug Tavneos. The company submitted a data package containing real‑wo…
    BioSpace · 3mo agoRegulatoryNegative↗ source
  • EU regulators back Minoryx’s ALD therapy while rejecting Zevra’s rare-disease drug
    The EU Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Minoryx Therapeutics' drug for adrenoleukodystrophy, marking a significant regulatory step after previous c…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Summit Therapeutics faces under a year of cash runway as FDA decision on ivonescimab looms
    Summit Therapeutics reported that its cash and short-term investments total just over $690 million, which the company says is insufficient to fund operations for a full year. The biotech’s lead ca…
    BioSpace · 3mo agoRegulatoryNeutral↗ source
  • Roche drops Carmot’s acmopatide after Phase 2 success, shifts focus to enicepatide for weight loss and diabetes
    Roche announced it will stop developing acmopatide, an investigational obesity treatment acquired from Carmot Therapeutics. Acmopatide had met its primary endpoint in a Phase 2 trial in type 1 dia…
    BioSpace · 3mo agoNeutral↗ source
  • Scribe Therapeutics launches $129M IPO, kicking off second-half biotech listing spree
    Scribe Therapeutics, a nine-year-old biotech co-founded by CRISPR pioneer Jennifer Doudna, announced its initial public offering. The company priced the IPO at about $128.7 million, raising roughl…
    Endpoints · 3mo agoDealPositive↗ source
  • FDA advisory panel recommends adding peptides BPC-157 and KPV to bulk compounding list
    An FDA advisory committee voted 8-6, with one abstention, to recommend that two experimental peptides – BPC-157 for ulcerative colitis and KPV for wound and inflammatory conditions – be placed on t…
    raps · 3mo agoRegulatoryNeutral↗ source
  • FDA advisory panel adds six peptides to compounding bulk drug list, rejects one
    The FDA’s advisory committee concluded a two-day meeting on Friday, reviewing seven peptide drug substances for inclusion on the agency’s bulk-drug compounding list. Committee members voted to add…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Ipsen's Bylvay fails Phase 3 trial in children with biliary atresia
    Ipsen announced that its experimental therapy Bylvay did not meet its primary endpoint in a Phase 3 trial targeting biliary atresia in infants. Biliary atresia is a rare pediatric liver disorder i…
    Endpoints · 3mo agoNegative readoutNegative↗ source
  • Lilly’s $3.8B psychedelics bet won’t open the M&A floodgates
    Eli Lilly’s $3.8 billion play for AtaiBeckley has fueled speculation that Big Pharma is ready to embrace psychedelics. But while the acquisition does validate the drug class, analysts say it is unl…
    BioSpace · 3mo agoDealNeutral↗ source
  • Sanofi halts development of Kymab-derived OX40L antibody for atopic dermatitis
    Sanofi announced that it will no longer pursue the OX40L antibody program it was developing with Kymab for the treatment of atopic dermatitis. The drug was being positioned as a potential follow‑on…
    Endpoints · 3mo agoNegative↗ source
  • Novo Nordisk seeks court order to halt Lilly GLP-1 ads as Merck announces HIV PrEP partnership
    Novo Nordisk asked a New Jersey federal court to temporarily block Eli Lilly's GLP-1 advertisements, claiming the ads are misleading. Merck disclosed that it has entered into a partnership focused…
    Endpoints · 3mo agoDealNeutral↗ source
  • Michael Ehlers leaves Ascidian Therapeutics to head R&D at Formation Bio; Black Diamond co-founder passes away at 67
    Michael Ehlers has stepped down as chief executive of Ascidian Therapeutics, the exon‑editing company he co‑founded, to take on the role of head of research and development at Formation Bio, an AI‑…
    Endpoints · 3mo agoNeutral↗ source
  • Eli Lilly to seek FDA approval for retatrutide in early 2027 after Phase 3 trials show over 20% weight loss
    Eli Lilly said its next‑generation obesity drug retatrutide produced substantial weight loss in two late‑stage Phase 3 studies. The data were presented from the TRIUMPH‑2 and TRIUMPH‑3 trials, whic…
    BioSpace · 3mo agoPositive readoutPositive↗ source
  • Eli Lilly to seek approval next year for retatrutide after strong Phase 3 obesity results
    Eli Lilly announced that its experimental obesity drug retatrutide will be submitted to regulators for approval early next year. The decision follows recent Phase 3 trial data that showed the drug…
    Endpoints · 3mo agoApprovalPositive↗ source
  • GSK receives FDA approval for ROS1 inhibitor Jideytro, marking its first lung cancer drug
    GSK's FDA approval of Jideytro, a ROS1 inhibitor for advanced non-small cell lung cancer patients with ROS1 gene fusions who have already received ROS1-directed therapy, was announced on Wednesday.…
    BioSpace · 3mo agoApprovalPositive↗ source
  • FDA advisory panel backs broader use of wellness peptide BPC-157 despite internal concerns
    The FDA advisory committee voted Thursday to recommend loosening restrictions on BPC-157, a peptide popular among health and wellness enthusiasts for muscle repair, injury healing, metabolism suppo…
    Endpoints · 3mo agoRegulatoryPositive↗ source
  • Repligen to acquire BioLife Solutions for $1.5 billion as BeOne announces $300 million US expansion
    Repligen announced it will acquire cell‑processing services provider BioLife Solutions in a transaction valued at roughly $1.5 billion. The deal adds BioLife’s platform to Repligen’s portfolio of b…
    Endpoints · 3mo agoDealNeutral↗ source