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  • FDA updates guidance for generic makers of top GLP-1 weight-loss drugs
    The FDA has released a revised draft guidance aimed at companies that want to develop generic versions of leading weight-loss medications. The update focuses on products such as Eli Lilly's Zepbou…
    Endpoints · 3d agoRegulatoryNeutral↗ source
  • FDA finds Capricor's Duchenne stem cell therapy failed to meet Phase 3 goals, contradicting company claims
    The U.S. Food and Drug Administration announced that the stem cell treatment from Capricor Therapeutics did not achieve the primary objectives in its Phase 3 trial for Duchenne muscular dystrophy.…
    STAT · 3d agoRegulatoryNegative↗ source
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  • FDA finds Replimune's melanoma data package uninterpretable, foreshadows tough advisory committee review
    The FDA has deemed the single-arm mid-stage study submitted by Replimune for its oncolytic immunotherapy RP1 as not interpretable, raising concerns ahead of an upcoming advisory committee meeting.…
    BioSpace · 3d agoRegulatoryNegative↗ source
  • Eli Lilly climbs to top of Norstella’s Pipeline-to-Patient Productivity Index, beating 24 peers
    Eli Lilly has risen to the top of Norstella’s inaugural Pipeline-to-Patient Productivity Index, a new benchmark that rates large global biopharma firms on research productivity, market access and c…
    Fierce Biotech · 3d agoPositive↗ source
  • Apnimed targets up to $160 million IPO to fund sleep‑apnea drug AD109
    Apnimed, a sleep‑specialist biotech, announced plans for an initial public offering that could raise up to $160 million in gross proceeds. The company will sell 10 million shares at $14‑$16 each,…
    BioSpace · 3d agoDealPositive↗ source
  • Altimmune’s pemvidutide cuts heavy drinking days in phase 2 AUD trial
    Altimmune announced that its experimental dual GLP-1/glucagon receptor agonist pemvidutide reduced heavy drinking in a phase‑2 study of alcohol use disorder. In the 24‑week Reclaim trial, particip…
    Fierce Biotech · 3d agoPositive readoutPositive↗ source
  • Oak Hill Bio to merge with RA Capital SPAC as InnoCare’s TYK2 candidate reports positive Phase 3 results
    Oak Hill Bio, a biotech focused on Angelman syndrome, announced it will combine with RA Capital’s special purpose acquisition company, Research Alliance Corporation III. The transaction will give O…
    Endpoints · 3d agoDealPositive↗ source
  • FDA staff say Replimune's melanoma trial fails to demonstrate efficacy
    FDA staff reviewing Replimune's pivotal melanoma study concluded that the trial design did not provide sufficient evidence that the RP1 therapy works. The assessment was issued ahead of a schedule…
    Endpoints · 3d agoRegulatoryNegative↗ source
  • GSK launches $2.5 billion restructuring plan to fund late-stage pipeline and offset upcoming HIV drug patent loss
    GSK reported $2.4 billion in impairment charges for the second quarter and unveiled a three‑year restructuring designed to save roughly $2.5 billion. The company says the savings will be redirecte…
    BioSpace · 3d agoPositive↗ source
  • GSK CEO outlines £1.9bn cost-saving drive and aims to launch 20 Phase 3 trials by year-end
    GSK chief executive Luke Miels presented a three‑year plan to make the company more agile and generate significant cost efficiencies. The strategy targets £1.9 billion in annual savings by 2029, wi…
    STAT · 3d agoPositive↗ source
  • Alnylam shares tumble 30% even as biotech sector rallies
    Alnylam's stock fell about 30% on July 28, 2026, even though the broader biotech market is experiencing a resurgence. The market rebound follows years of a bearish environment, with increased merg…
    Endpoints · 3d agoNegative↗ source
  • FDA staff raise concerns over Replimune's skin cancer drug data
    FDA staff have reiterated concerns that Replimune's investigational skin cancer therapy lacks sufficient data for approval. The agency highlighted the single-arm trial, in which patients previousl…
    STAT · 3d agoRegulatoryNegative↗ source
  • Mirae secures $5.4 million to convert patient chatbot messages into clinical data
    Mirae, a health‑tech startup, announced it has closed a financing round that brought in $5.4 million. The capital will be used to develop its chatbot platform that encourages patients to describe…
    Endpoints · 3d agoDealPositive↗ source
  • Altimmune's pemvidutide cuts heavy drinking days in Phase 2 trial
    Altimmune reported that its experimental GLP-1/GIP injection pemvidutide achieved its primary and key secondary goals in a Phase 2 study of alcohol use disorder. The double-blind trial enrolled 10…
    BioSpace · 3d agoPositive readoutPositive↗ source
  • Claris Bio secures $118 million to launch pivotal eye-drop trials next year
    Claris Bio announced a financing round that raised $118 million to move its investigational eye‑drop therapy forward. The capital will fund two pivotal Phase 3 studies slated to start next year, f…
    Endpoints · 3d agoDealPositive↗ source
  • GSK launches three-year cost-cutting plan as new CEO targets R&D efficiency
    GSK announced a three-year restructuring program designed to cut costs and sharpen focus on its advanced assets. The plan was presented by CEO Luke Miels, who has been in the role for just over si…
    Endpoints · 3d agoNeutral↗ source
  • Oak Hill Bio to go public via SPAC merger, securing $175 million for Angelman syndrome program
    Oak Hill Bio announced it will become a publicly traded company through a merger with the special purpose acquisition company Research Alliance Corporation III. The transaction will provide $75 mi…
    BioSpace · 3d agoDealPositive↗ source
  • Altimmune's GLP-1/glucagon shot reduces drinking in Phase 2 alcohol use disorder trial
    Altimmune announced results from its mid‑stage Phase 2 RECLAIM trial evaluating pemvidutide, a GLP‑1/glucagon dual agonist, in patients with moderate‑to‑severe alcohol use disorder. The trial comp…
    Endpoints · 3d agoPositive readoutPositive↗ source
  • ProMIS Neurosciences early trial shows low brain bleeding and no swelling, hinting at safer Alzheimer’s drug
    ProMIS Neurosciences reported interim safety data from a early‑stage trial of its amyloid‑targeting therapy for Alzheimer’s disease. The analysis pooled data from participants receiving the investi…
    STAT · 4d agoPositive readoutPositive↗ source
  • GSK launches three-year £1.9bn savings plan to boost late-stage R&D and relocate research HQ
    GSK announced a three-year cost-saving programme designed to free cash for its late-stage research and development pipeline while moving its research headquarters. The plan targets annual savings…
    Fierce Biotech · 4d agoNeutral↗ source
  • Boston Scientific unveils major restructuring, plots job cuts amid savings drive
    Medical device maker Boston Scientific has been a prolific dealmaker this year but is now taking a step back as it looks to make changes internally.
    Fierce Biotech · 4d agoLayoffsNegative↗ source
  • Trump administration proposes four-year visa cap for foreign PhD students and postdocs, sparking science community concerns
    The Department of Homeland Security announced a new rule that limits the stay of international graduate students and postdoctoral researchers in the United States to four years on nonimmigrant visa…
    STAT · 3d agoRegulatoryNegative↗ source
  • As pharma descends on China for deals, BIOSECURE Act raises intellectual property risk
    When signing a biotech licensing deal in China, experts say that pharma’s patent attorneys need to understand the geopolitical risk of the BIOSECURE Act.
    BioSpace · 4d agoDealNeutral↗ source
  • FDA advisory panel debates allowing compounding pharmacies to produce seven peptides
    The FDA’s advisory committee spent two days reviewing whether compounding pharmacies should be permitted to manufacture a set of seven peptide products. The discussion involved both committee membe…
    Endpoints · 3d agoRegulatoryNeutral↗ source
  • After PCOS became PMOS, there’s hope for new awareness among Black and Latina women
    Growing awareness of a painful endocrine disorder now named PMOS is good news for women of color, who have high prevalence and low diagnosis.
    STAT · 4d agoRegulatoryNeutral↗ source