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759 stories matching this filter · ← front page

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  • Leo International Precision Health allocates 3.77 million bonus shares to PC Beteiligungsgesellschaft
    Leo International Precision Health AG announced that PC Beteiligungsgesellschaft mbH will receive 3,772,368 bonus shares. The allocation stems from a capital increase funded by the company’s own r…
    globenewswire health · 24d agoNeutral↗ source
  • Leo International Precision Health AG grants 78.8 million free shares to board member Leo Wang after capital increase
    Leo International Precision Health AG announced that Mr. Leo Wang, a member of its supervisory board, will receive 78,844,000 free shares. The allocation stems from a capital increase approved by…
    globenewswire health · 24d agoNeutral↗ source
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  • Leo International Precision Health AG allocates 78.8 million bonus shares to board member Leo Wang
    Leo International Precision Health AG disclosed that its board member Leo Wang will receive a large allocation of bonus shares. The allocation totals 78,844,000 shares, issued from the company’s o…
    globenewswire health · 24d agoNeutral↗ source
  • Leo International Precision Health allocates 3.77 million bonus shares to PC Beteiligungsgesellschaft following capital increase
    Leo International Precision Health AG announced the allocation of 3,772,368 bonus shares to PC Beteiligungsgesellschaft mbH. The allocation stems from a capital increase funded from the company’s o…
    globenewswire health · 24d agoRegulatoryNeutral↗ source
  • Novo Nordisk's heart drug ziltivekimab fails Phase 3 trial, raising doubts on inflammation-targeted therapies
    Novo Nordisk announced that its experimental cardiovascular drug ziltivekimab did not meet the primary endpoint in a Phase 3 study. The trial was designed to see if the drug could lower the inciden…
    BioPharma Dive · 27d agoNegative readoutNegative↗ source
  • ResMed issues correction for Astral ventilators due to electrical component failure risk
    ResMed has released a correction for certain Astral ventilators after identifying a faulty electrical component that could interrupt therapy and cause serious injury or death. The FDA classifies t…
    fda medwatch · 27d agoRegulatoryNegative↗ source
  • Resilience and Eli Lilly commit $750 million to expand Cincinnati GLP-1 injectable production
    Resilience and Eli Lilly announced a joint $750 million investment to expand drug manufacturing capacity in Cincinnati. The expansion will add at least 400 jobs and increase Resilience's workforce…
    BioPharma Dive · 27d agoDealPositive↗ source
  • Madrigal spends $255 million on multiple MASH drug deals to complement Rezdiffra
    Madrigal Pharmaceuticals is expanding its MASH pipeline by acquiring several assets that could be used alongside its lead candidate, Rezdiffra. In early 2026 the company paid $50 million to Pfizer…
    Fierce Biotech · 27d agoDealPositive↗ source
  • Novo Nordisk's ziltivekimab fails phase 3 trial, jeopardizing CKD program
    Novo Nordisk reported that its phase 3 Zeus trial of the IL‑6 ligand antibody ziltivekimab did not meet its primary endpoint, a setback for the drug's development. The study enrolled more than 6,3…
    Fierce Biotech · 27d agoNegative readoutNegative↗ source
  • Apnimed upsizes IPO to $192 million to fund launch of oral sleep‑apnea drug
    Apnimed, a Massachusetts‑based biotech, announced an upsized initial public offering that now includes 12 million shares priced at $16 each, generating $192 million in gross proceeds. This amount e…
    Fierce Biotech · 27d agoDealPositive↗ source
  • Abiomed recalls 14Fr Low Profile Introducer Kits over thrombus risk
    The FDA has issued an early alert about a recall of Abiomed 14Fr Low Profile Introducer kits, which are used with Impella CP devices. The recall follows a higher‑than‑expected rate of complaints i…
    fda medwatch · 27d agoCRLNegative↗ source
  • Sanofi CEO pledges to rebuild trust and expand partnership with Regeneron
    Sanofi's new chief executive, Belén Garijo, told analysts that restoring the relationship with longtime partner Regeneron is a top priority. She said the company wants to be more transparent and to…
    BioPharma Dive · 27d agoNeutral↗ source
  • Trump administration proposes 340B rebate pilot for 2027, hospitals push back
    The Health Resources and Services Administration announced a new pilot that would shift some 340B drug discounts to rebate payments starting in 2027. The proposal follows a previous attempt earlie…
    BioPharma Dive · 26d agoRegulatoryNegative↗ source
  • FDA announces reorganization and CTAGTAC votes on Duchenne muscular dystrophy and melanoma therapies
    The FDA disclosed a major internal reorganization aimed at streamlining its operations and improving efficiency across its divisions. The agency’s Cellular, Tissue, and Gene Therapies Advisory Com…
    raps · 27d agoRegulatoryNeutral↗ source
  • FDA releases draft guidance on container closure and device components for biosimilar combination products
    The FDA issued draft guidance aimed at helping sponsors develop container closure systems and device constituents for biosimilar and interchangeable biosimilar combination products. The guidance f…
    raps · 27d agoRegulatoryNeutral↗ source
  • Alnylam shares tumble nearly 30% after cutting revenue outlook for key amyloidosis drugs
    Alnylam Pharmaceuticals saw its market value drop about 30%, roughly $12 billion, after it lowered its revenue forecast for its leading amyloidosis treatments. The company had previously expected…
    BioPharma Dive · 27d agoEarningsNegative↗ source
  • Johnson & Johnson secures option to acquire in-vivo CAR-T developer Sail Biomedicines for up to $2.6 billion
    Johnson & Johnson announced a strategic partnership with Sail Biomedicines, a Flagship Pioneering‑backed startup, that includes an upfront cash payment and an equity investment. The initial paymen…
    BioPharma Dive · 28d agoDealPositive↗ source
  • FDA advisory panel backs Replimune's melanoma therapy RP1, raising approval prospects
    Advisors to the U.S. Food and Drug Administration voted 10-3 in favor of Replimune's experimental melanoma treatment, RP1, despite lingering scientific concerns about the data presented. The panel…
    BioPharma Dive · 27d agoRegulatoryPositive↗ source
  • FTC Sues Hims & Hers for Alleged Illegal Sharing of Patient Data and Deceptive Billing
    The Federal Trade Commission has filed a lawsuit against Hims & Hers, a California‑based telehealth company, accusing it of violating privacy laws. The complaint says the firm used tracking pixels…
    BioPharma Dive · 28d agoRegulatoryNegative↗ source
  • Bristol Myers pushes Cobenfy Alzheimer’s psychosis readout to early 2027 after enrollment delays
    Bristol Myers Squibb said the Phase 3 readout for its Cobenfy Alzheimer’s psychosis program will be postponed to early 2027. The company had previously expected data from the three Adept trials to…
    Fierce Biotech · 28d agoNegative readoutNegative↗ source
  • J&J invests $785M in Sail Biomedicines, secures option to buy for $2.58B
    Johnson & Johnson has agreed to pay $785 million up front to Sail Biomedicines, including a $465 million equity infusion and up to $140 million in milestone payments. The agreement also gives J&J a…
    Fierce Biotech · 28d agoDealPositive↗ source
  • Replimune's melanoma virus therapy wins FDA advisory committee vote after two rejections
    Replimune's oncolytic virus RP1, also called vusolimogene oderparepvec and Tudriqev, has been rejected twice by the FDA. Today an advisory committee voted 10 to 3 that the candidate shows enough ef…
    Fierce Biotech · 28d agoRegulatoryPositive↗ source
  • BMS CEO says firm not pressured to pursue acquisitions despite quiet M&A year
    BMS chief executive Chris Boerner told analysts on the second‑quarter earnings call that the company’s robust late‑stage pipeline means it does not feel any compulsion to chase deals. The firm has…
    Fierce Biotech · 28d agoDealNeutral↗ source
  • Labcorp reports Q2 sales of $3.73 billion, lifts full-year revenue outlook despite missing consensus
    Labcorp announced second‑quarter revenue of $3.73 billion, up from $3.53 billion a year earlier, driven by strong performance across its core businesses. The Diagnostics division grew 5.5% to $2.9…
    Fierce Biotech · 28d agoEarningsNeutral↗ source
  • Takeda drops its second celiac disease candidate, TAK-101, after unimpressive phase 2 results
    Takeda said it is halting development of TAK-101, its second candidate for celiac disease, after a phase 2 study failed to meet expectations. TAK-101 is a nanoparticle that carries gliadin, a glut…
    Fierce Biotech · 28d agoNegative readoutNegative↗ source