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  • 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 · 1mo 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 · 1mo agoRegulatoryPositive↗ source
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  • 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 · 1mo agoRegulatoryNegative↗ source
  • Biogen beats revenue expectations, lifts investor confidence with 3% sales rise
    Biogen reported $2.7 billion in revenue for the April‑June quarter, a 3% increase year over year, surpassing analysts' consensus estimate of $2.5 billion. Adjusted earnings per share came in at $3.…
    BioPharma Dive · 1mo agoEarningsPositive↗ source
  • FDA reviewers doubt Replimune’s melanoma therapy as shares tumble 40%
    Replimune's shares fell nearly 40% after FDA reviewers released briefing documents expressing skepticism about its experimental melanoma drug RP1. RP1 has been rejected twice before; the company l…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • FDA advisory panel rejects Capricor's Duchenne heart-cell therapy deramiocel
    An FDA advisory committee voted 9-3 to reject Capricor Therapeutics' experimental cell therapy deramiocel for Duchenne-related cardiomyopathy. The panel said the data did not provide substantial ev…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • MapLight Therapeutics' mid-stage schizophrenia trial shows modest improvement but shares plunge two-thirds
    MapLight Therapeutics announced that its experimental schizophrenia drug met its primary endpoint in a mid-stage study, delivering an average 4.5‑point reduction on the PANSS symptom scale after fi…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • Vertex and AbCellera team up to develop next-generation T-cell engagers for autoimmune diseases
    Vertex Pharmaceuticals has entered a partnership with AbCellera to create next-generation T-cell engagers aimed at autoimmune diseases. AbCellera will receive an upfront payment of $28 million, wit…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Caldera Therapeutics merges with Synlogic, secures $278M to advance inflammation drug
    Caldera Therapeutics, a startup founded seven months ago with $112.5 million of venture funding, announced a merger with Synlogic, a company that previously went public via a reverse merger. The a…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Claris Bio raises $118M Series B and appoints new CEO to advance eye-drug for limbal stem cell deficiency
    Claris Bio, a New Jersey biotechnology company, announced a $118 million Series B financing round co-led by Samsara BioCapital and Catalio Capital Management, with participation from Sofinnova Inve…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • GSK announces $2.5 billion annual cost-cutting plan to offset upcoming patent cliff
    GSK disclosed in its latest quarterly earnings that it will launch a three-year restructuring aimed at saving about £1.9 billion ($2.5 billion) each year. The plan is intended to cushion the impac…
    BioPharma Dive · 1mo agoLayoffsNeutral↗ source
  • FDA’s AI push faces uncertainty after key leaders depart
    The FDA has been pushing artificial intelligence across the agency, unveiling a large-language-model tool called Elsa to help draft and summarize review reports and announcing plans to use agentic…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Argenx to buy Forte Biosciences for up to $2.2 billion, adding experimental CD122 drug FB102
    Argenx announced it will acquire Forte Biosciences in a transaction valued at up to $2.2 billion. The purchase price is set at $77 per Forte share, roughly a 41% premium to the previous closing pr…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • MapLight shares plunge 66% after mid-stage schizophrenia trial shows modest benefit but raises competitive concerns
    MapLight Therapeutics announced results from its mid‑stage trial of an experimental schizophrenia drug. The study enrolled adults experiencing an acute exacerbation of psychotic symptoms. The twic…
    BioPharma Dive · 1mo agoPositive readoutNegative↗ source
  • FDA staff raise concerns over Capricor’s Duchenne cell therapy as shares plunge; Legend CEO resigns, AstraZeneca reports pipeline woes
    Capricor Therapeutics saw its shares tumble by nearly two‑thirds after FDA reviewers highlighted serious concerns about the data supporting its experimental Duchenne muscular dystrophy cell therapy…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • Sarepta appoints former AbbVie executive Michael Severino as new CEO to drive turnaround
    Sarepta Therapeutics announced that Michael Severino will become its chief executive officer on July 28, succeeding Doug Ingram who plans to retire. Severino brings more than two decades of experi…
    BioPharma Dive · 1mo agoNeutral↗ source
  • Biotech confidence surges in 2026 as China leads growth and deal activity spikes
    Industry observers noted a marked shift in tone at two major 2026 biotech gatherings – the DIA China meeting in Shanghai and the BIO International Convention in San Diego – where participants expre…
    BioPharma Dive · 1mo agoPositive↗ source
  • Almac Clinical Services podcast details end-to-end clinical trial supply chain
    Almac Clinical Services released a six-part podcast that walks listeners through the clinical trial supply chain from protocol planning to patient delivery. The series, published by BioPharma Dive’…
    BioPharma Dive · 1mo agoNeutral↗ source
  • FDA advisory panel votes to expand use of four untested peptides despite safety concerns
    An FDA advisory committee narrowly voted to recommend adding four peptides to the agency's 503A Bulks List, a registry that would allow compounding pharmacies to use them in custom medications. The…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • Sanofi stops development of eczema drug amlitelimab after mixed trial results
    Sanofi announced on Friday that it is halting further development of amlitelimab for atopic dermatitis, a drug it had once promoted as a potential successor to its blockbuster Dupixent. The compan…
    BioPharma Dive · 1mo agoNegative↗ source
  • Novo Nordisk seeks injunction to halt Eli Lilly's obesity drug ads
    Novo Nordisk filed a motion in a New Jersey federal court asking for a preliminary injunction that would stop Eli Lilly's advertisements for its obesity treatments. Novo claims the ads are mislead…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ 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 · 1mo agoDealPositive↗ 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 · 1mo agoRegulatoryPositive↗ source
  • GSK secures FDA approval for lung-cancer drug Jideytro after $10.6 billion Nuvalent acquisition
    GSK received FDA clearance for Jideytro, a therapy for patients with metastatic non‑small cell lung cancer that have ROS1 gene alterations and have already been treated with another targeted drug.…
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • Arrowhead’s plozasiran cuts triglycerides up to 81% in late-stage trials, shows promise for severe hypertriglyceridemia
    Arrowhead Pharmaceuticals reported positive data from two late-stage studies of its RNA-based drug plozasiran in adults with severe hypertriglyceridemia. The trials used a subcutaneous injection e…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source