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  • 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 · 3mo agoDealPositive↗ 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 · 3mo agoNeutral↗ source
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  • FDA advisory panel backs experimental Replimune melanoma therapy after two prior rejections
    An FDA advisory committee voted 10‑to‑3 to recommend the use of an experimental Replimune treatment for patients with advanced melanoma. The panel’s recommendation marks a shift after the agency p…
    STAT · 3mo agoPositive readoutPositive↗ 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 · 3mo agoRegulatoryNegative↗ source
  • Trump administration revises 340B rebate pilot, sparking hospital backlash
    The Health Resources and Services Administration announced a revision to the 340B drug pricing program’s rebate pilot, slated to begin on Jan 1, 2027. Under the new rules, participating manufactur…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Senate advances Erica Schwartz’s CDC director nomination to full Senate vote
    The Senate Health Committee approved Erica Schwartz as the nominee for CDC director, securing bipartisan support that included every Republican member and Democrat Tim Kaine. With the committee’s…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Opinion: Limb girdle muscular dystrophy patients face a maddening reality
    “Too often, regulatory tools authorized to speed patient access to breakthrough treatments are being used in ways that even prevent approval,” writes Kat Bryant Knudson.
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Syphilis cases rise among unhoused drug users at San Diego-Tijuana border as researchers face NIH limits and penicillin shortage
    Researchers at the University of California San Diego have been working for years to build trust with unhoused people who use drugs on both sides of the San Diego‑Tijuana border. Their outreach has…
    STAT · 3mo agoNegative↗ source
  • ADA’s reputation erodes after controversial physician expulsions at annual meeting
    In a recent opinion piece, Adam Marcus and Ivan Oransky reflect on how their view of the American Diabetes Association (ADA) has shifted. Nine years ago they lauded the organization for defending a…
    STAT · 3mo agoNegative↗ source
  • Authors rebut mischaracterization of their 2023 Lancet Covid study in recent op-ed
    The authors of a 2023 Lancet analysis on the United States Covid response wrote to correct a recent First Opinion piece that they say misrepresented their work. While they welcome calls for additio…
    STAT · 3mo agoNegative↗ source
  • Bexorg names Bruce Car as new chief scientific officer
    Bexorg announced the appointment of Bruce Car as its chief scientific officer, according to a recent STAT+ column that tracks personnel moves in the pharmaceutical sector. Car joins Bexorg to lead…
    STAT · 3mo agoPositive↗ 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo agoRegulatoryPositive↗ source
  • Rising oil prices could lift manufacturing costs of an HIV drug, Unitaid report says
    Rising oil prices, driven in part by geopolitical tensions, have raised concerns about the stability of medicine supply chains. Analysts note that higher energy costs can translate into increased p…
    STAT · 3mo agoNeutral↗ source
  • FDA panel rejects Capricor's Duchenne drug, citing insufficient efficacy data
    The U.S. Food and Drug Administration advisory committee voted 9-to-3 against a Capricor Therapeutics candidate for Duchenne muscular dystrophy. The panel said the clinical data did not provide sub…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Ebola cases approach key milestone as vaccine candidates draw near completion
    The latest update on the Ebola outbreak indicates that the number of cases is approaching a significant threshold, while vaccine development efforts are reported to be close to delivering a usable…
    STAT · 3mo agoNeutral↗ 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 · 3mo 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 · 3mo 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 · 3mo agoNegative readoutNegative↗ source
  • GSK signs up to $110 million AI data partnership with Relation
    GSK announced a research collaboration with AI-focused biotech Relation, valued at up to $110 million. Under the agreement Relation will produce large-scale datasets that capture how human cells r…
    Fierce Biotech · 3mo agoDealPositive↗ source