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  • 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 · 1mo agoRegulatoryPositive↗ source
  • Lilly's obesity drug shows strong weight loss but fails to demonstrate cardiovascular benefit in heart disease trial
    Eli Lilly released Phase 3 results for its next‑generation obesity therapy retatrutide, showing it produces substantial weight loss in a trial of nearly 2,000 participants with severe obesity and e…
    STAT · 1mo agoNegative readoutNeutral↗ source
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  • 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 · 1mo agoDealNeutral↗ source
  • Eli Lilly's retatrutide shows strong weight loss but no clear heart risk reduction in Phase 3 trial
    Eli Lilly released new data from a Phase 3 trial of retatrutide, its next‑generation obesity drug. The study enrolled nearly 2,000 participants with severe obesity and existing heart disease, some…
    STAT · 1mo agoNegative readoutNegative↗ 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 · 1mo agoRegulatoryNeutral↗ source
  • EMA moves quickly to enforce clinical trial result reporting across Europe
    The European Medicines Agency announced new measures aimed at ensuring that results of clinical trials are posted publicly in line with legal obligations. The steps follow an analysis that found f…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Sanofi's Lantus Solostar insulin pen faces supply challenges, patients struggle to find product
    Sanofi's Lantus Solostar pen, a long-acting insulin glargine product, has become hard to locate in pharmacies. The company says demand has risen due to broader market dynamics, and while the FDA h…
    STAT · 1mo agoNegative↗ source
  • Congress rushes health-care bills on price transparency and prior authorization before August recess
    Congress is trying to pass a bundle of health-care legislation in the final week before the House and Senate adjourn for the August recess. Lawmakers are focusing on measures that would increase p…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • FDA advisory panel to decide on compounding of synthetic peptides amid safety concerns
    The FDA advisory committee is meeting to consider whether compounding pharmacies should be allowed to manufacture seven specific synthetic peptides. Use of these peptides has grown in the United St…
    STAT · 1mo 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 · 1mo 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 · 1mo agoDealPositive↗ source
  • Senate health committee delays vote on Trump nominee for ASPR amid anti-vaccine controversy
    The Senate health committee postponed its vote on Sean Kaufman, the Trump administration’s pick to lead the Office of the Assistant Secretary for Preparedness and Response (ASPR). The delay came ju…
    STAT · 1mo agoRegulatoryNegative↗ 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 · 1mo 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 · 1mo agoRegulatoryNegative↗ source
  • HHS, FDA and partners to convene experts on clinical AI standards
    The White House, the Department of Health and Human Services, the FDA and the Office of the National Coordinator for Health Information Technology are bringing together experts to discuss how clini…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • FDA peptide panel faces clash as Ebola outbreak kills over 1,000 and vaccine options remain limited
    The FDA is holding a two‑day panel on peptide therapeutics, and observers anticipate heated debate among regulators and industry. The African CDC reports the fastest‑growing Ebola outbreak, with m…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Advocacy group Public Citizen petitions FDA to ban direct-to-consumer prescription drug ads
    Public Citizen has filed a petition with the U.S. Food and Drug Administration calling for a ban on direct-to-consumer advertising of prescription medicines. The group argues that such ads are des…
    STAT · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoPositive↗ source
  • FDA advisory panel to debate allowing compounding pharmacies to produce unapproved peptides
    FDA advisers will convene on Thursday and Friday to discuss a proposal that would let compounding pharmacies manufacture seven synthetic peptides that are currently classified as unsafe for compoun…
    STAT · 1mo agoRegulatoryNegative↗ 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 · 1mo 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 · 1mo 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 · 1mo agoRegulatoryNeutral↗ source
  • Podcast explores father's quest for ultra‑rare disease therapy, telehealth GLP‑1 prescribing probe and fugitive posing as biotech exec
    The latest episode of STAT’s "The Readout Loud" podcast examines three distinct stories that intersect with the biotech world. Hosts Allison DeAngelis and Elaine Chen sit down with colleagues Jason…
    STAT · 1mo agoNeutral↗ source