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  • 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
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  • 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
  • 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
  • Scribe Therapeutics raises $129 million in gene-editing IPO, debuting on Nasdaq
    Scribe Therapeutics completed an initial public offering that raised close to $129 million. The company sold 8.58 million shares at $15 each and will trade on Nasdaq under the ticker SCTX. The off…
    BioPharma Dive · 3mo agoDealPositive↗ 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
  • Baxter voluntarily recalls Cefazolin in Dextrose injection after cardboard particles found
    Baxter International announced a voluntary nationwide recall of Lot LD175708 of its Cefazolin in Dextrose Injection, a single-dose infusion bag. The recall follows a report that cardboard particle…
    fda recalls · 3mo agoCRLNegative↗ 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
  • Lidl US recalls Eridanous shortbread cookies over undeclared wheat, soy, milk, and egg allergens
    Lidl US announced a recall of its Eridanous Shortbread Cookies with Chocolate Truffle Coating & Apricot Filling, 11.6 oz boxes, after discovering that the packaging was in a foreign language and om…
    fda recalls · 3mo agoRegulatoryNegative↗ source
  • Eli Lilly to file FDA application for obesity drug retatrutide after Phase 3 trial results
    Eli Lilly announced that two additional Phase 3 trials of its experimental obesity medicine retatrutide met their primary goals, and the company plans to submit an FDA application for the drug next…
    BioPharma Dive · 3mo agoRegulatoryPositive↗ 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
  • 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
  • Most FDA-approved drugs meet postmarketing study requirements, and advisory panel backs two peptides for bulk compounding
    A recent analysis published in JAMA Network Open found that nearly nine out of ten drugs approved by the U.S. Food and Drug Administration have completed their postmarketing requirements or commitm…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Merck CEO warns Congress that restricting US-China biotech deals could cost America its biotech leadership
    Merck CEO Rob Davis told Congress and the Trump administration that limiting or cutting off US-China dealmaking would jeopardize US biotech leadership. He emphasized that collaboration with Chines…
    Endpoints · 3mo agoRegulatoryNegative↗ source
  • Scancell to merge into Neuphoria and seek $89 million equity as AstraZeneca's breast cancer drug gains EU approval
    Scancell announced it will merge into Neuphoria Therapeutics, taking over Neuphoria's Nasdaq listing ($NEUP) and planning to change the ticker to SCLT. The combined entity aims to raise up to $89 m…
    Endpoints · 3mo agoDealPositive↗ source
  • Biogen looks to Apellis acquisition to boost lagging Leqembi sales
    Biogen CEO Chris Viehbacher said the company's Alzheimer's drug Leqembi has underperformed since its 2023 launch. The drug, co-developed with Eisai, has struggled to meet sales expectations, promp…
    Endpoints · 3mo agoDealNeutral↗ source
  • Medicare proposal threatens funding for remote patient monitoring programs
    Medicare announced a proposal to sharply reduce reimbursement for remote patient monitoring services, reversing earlier policy support. The change would cut payments to firms that supply technolog…
    Endpoints · 3mo agoRegulatoryNegative↗ source
  • Roche stresses careful AI token use and pauses drug from Carmot acquisition
    Roche's CEO Thomas Schinecker said the company is adopting a thoughtful approach to how it employs AI tokens, emphasizing responsible use. He noted that AI tools have already helped increase the n…
    Endpoints · 3mo agoNeutral↗ source
  • Verdiva Bio appoints former Metsera CMO Steve Marso as it nears key obesity pill readouts
    Verdiva Bio, a developer of a long-acting oral obesity treatment, announced the appointment of Steve Marso as its chief medical officer. Marso joins from Metsera, a biotech that pursued similar GL…
    Endpoints · 3mo agoNeutral↗ source
  • Teladoc expands beyond single-visit model with new service launch
    Teladoc, a pioneer in virtual care, originally built its platform around brief, one-time doctor appointments that could be completed without an in-person visit. The company now says that this sing…
    Endpoints · 3mo agoPositive↗ source
  • J&J gets FDA clearance for general surgery robot; study finds 90% of approved drugs meet post-marketing commitments
    J&J received FDA authorization for a general‑surgery robot, a notable regulatory step for the company. The FDA is also being urged to ban direct‑to‑consumer drug advertisements, highlighting ongoi…
    raps · 3mo agoRegulatoryNeutral↗ source
  • EMA seeks input on draft revisions to biosimilar efficacy guidance
    The European Medicines Agency has issued a draft concept paper and is asking stakeholders for feedback on proposed revisions to its guideline for biosimilar efficacy studies. The changes are inten…
    raps · 3mo agoRegulatoryNeutral↗ source
  • FDA advisory panel votes to add two peptides, BPC-157 and KPV, to 503A bulk compounding list
    The FDA’s advisory committee voted 8-6, with one abstention, to recommend that two peptides be placed on the 503A Bulks List for bulk compounding. The recommendation covers BPC-157, proposed for ul…
    raps · 3mo agoRegulatoryNeutral↗ source