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  • Biogen’s early Phase 2 data supports tau-targeting Alzheimer’s approach
    Biogen has released early Phase 2 results for its experimental Alzheimer’s therapy diranersen, indicating that reducing tau protein levels may lead to cognitive benefits. The findings add to a lon…
    BioSpace · 2h agoPositive readoutPositive↗ source
  • Red Bull-funded studies downplay risks of mixing energy drinks with alcohol, shaping policy despite independent warnings
    An investigative report found that research funded by the energy‑drink maker contradicted the bulk of independent studies on the dangers of combining alcohol with caffeinated beverages. The funded…
    STAT · 3h agoRegulatoryNegative↗ source
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  • FDA advisory panel votes 9-3 against Capricor's Duchenne therapy deramiocel
    During an FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting, reviewers focused on the Phase 3 HOPE-3 trial's secondary cardiac endpoint and described the data as very fragile. The…
    BioSpace · 8h agoApprovalNegative↗ source
  • Caldera and Vidya secure $478M via reverse mergers to go public
    Caldera Therapeutics, a U.S. bispecific antibody biotech, announced a reverse merger with Nasdaq-listed Synlogic to become a public company. The deal includes a $278 million private placement from…
    BioSpace · 12h agoDealPositive↗ source
  • FDA advisory panel rejects Capricor’s Duchenne cardiomyopathy cell therapy
    A FDA advisory committee voted against Capricor’s cell therapy for Duchenne muscular dystrophy cardiomyopathy, with nine members opposing and three supporting the product. The therapy, called dera…
    Fierce Biotech · 13h agoRegulatoryNegative↗ source
  • FDA approves first freeze-dried plasma product for U.S. use
    The FDA has licensed Ezplaz Freeze Dried Plasma (FDP), marking the first freeze-dried plasma product cleared for use in the United States. The product is intended for adult patients who need plasm…
    fda press · 14h agoApprovalPositive↗ source
  • Novo Nordisk faces shareholder fraud lawsuit over undisclosed dosing changes in CagriSema Phase 3 trial
    New Jersey federal judge Robert Kirsch ruled that shareholders can pursue claims that Novo Nordisk misled investors about its Phase 3 study of the weight‑loss drug CagriSema. The plaintiffs allege…
    BioSpace · 18h agoRegulatoryNegative↗ source
  • FDA briefing hints tough road for Capricor and Replimune ahead of advisory committee meetings
    The FDA released briefing documents for upcoming advisory committee meetings concerning Capricor Therapeutics' Duchenne muscular dystrophy cell therapy and Replimune's advanced melanoma candidate.…
    BioSpace · 19h agoRegulatoryNeutral↗ source
  • Latigo's mid-stage trial shows non-opioid pill LTG-001 cuts post-surgery pain, outperforms placebo
    Latigo Biotherapeutics reported positive Phase 2 data for its experimental oral analgesic LTG-001, tested in patients who had undergone tummy-tuck surgery. The study enrolled 343 participants who w…
    STAT · 10h agoPositive readoutPositive↗ source
  • Trump administration ends Medicare drug plan subsidies, raising cost concerns ahead of midterms
    The White House announced that subsidies for private Medicare prescription drug plans will be discontinued, a move expected to increase premiums for many seniors. The policy shift comes as Democra…
    STAT · 16h agoRegulatoryNegative↗ source
  • Kyverna partners with ElevateBio to supply its autologous CAR-T therapy for autoimmune launches
    Kyverna Therapeutics has signed a five‑year manufacturing agreement with contract development and manufacturing organization ElevateBio. The deal makes ElevateBio the primary supplier of Kyverna's…
    BioSpace · 17h agoDealPositive↗ source
  • Benchmarking Clinical LLMs Proves Complex After Recent Nature Medicine Study
    The STAT AI Prognosis newsletter, written by health‑tech reporter Brittany Trang, looks at why evaluating new clinical large language models is difficult. A recent Nature Medicine paper compared s…
    STAT · 17h agoNeutral↗ source
  • Incyte drops early-stage JAK2 inhibitor to prioritize next-generation pipeline
    Incyte announced it is terminating development of its early-stage oral JAK2 inhibitor, INCB160058, after a Phase 1 study in myeloproliferative neoplasms. The company said the decision reflects the…
    BioSpace · 18h agoNegative↗ source
  • Novo Nordisk loses bid to dismiss lawsuit over CagriSema trial readout
    U.S. District Judge Robert Kirsch in New Jersey refused to dismiss most of the securities lawsuit filed by investors after Novo Nordisk’s CagriSema readout. While the judge found the plaintiffs’ cl…
    Fierce Biotech · 20h agoNegative readoutNegative↗ source
  • Processa Pharma acquires Vidya Therapeutics, gaining oral BTK inhibitor VT-7208
    Processa Pharmaceuticals announced an all‑stock acquisition of Vidya Therapeutics, a Florida biotech developing an oral BTK inhibitor called VT‑7208. VT‑7208 is being positioned as a next‑generati…
    Fierce Biotech · 20h agoDealPositive↗ source
  • Caldera Therapeutics completes reverse merger with Synlogic, secures $278 million financing
    Caldera Therapeutics, a Massachusetts biotech founded last year, announced a reverse merger with Nasdaq-listed Synlogic, giving it a public listing. The transaction includes a $278 million financi…
    Fierce Biotech · 22h agoDealPositive↗ source
  • Former VA Secretary argues the Veterans Health Administration can boost US biotech competitiveness against China
    The piece, authored by former Veterans Affairs Secretary David Shulkin, positions the VA as a critical component of America’s biotechnology ecosystem alongside HHS and the Department of Defense. H…
    STAT · 22h agoNeutral↗ source
  • Study finds clinical chatbots lag behind general AI models in accuracy, sparking debate among doctors
    Hundreds of thousands of U.S. physicians are using clinical large language model tools marketed by firms such as OpenEvidence, Doximity and UpToDate as safer alternatives to generic AI chatbots. A…
    STAT · 22h agoNegative readoutNegative↗ source
  • Biotech earnings season kicks off as Agios reports Phase 2 setback for sickle-cell drug
    The second‑quarter earnings window has begun, and analysts are zeroing in on a handful of biotech companies with high‑profile catalysts. Smaller biotechs are increasingly opting to launch their pr…
    BioSpace · 1d agoNegative readoutNeutral↗ source
  • FTC sues Hims & Hers for misleading consumers and privacy violations
    The Federal Trade Commission, joined by Utah and California, filed a lawsuit against Hims & Hers, a direct-to-consumer telehealth provider, alleging deceptive business practices. The complaint say…
    STAT · 12h agoRegulatoryNegative↗ source
  • Biogen shifts M&A strategy as Apellis acquisition pushes revenue above analyst expectations
    Biogen officially began reporting revenue from the $5.6 billion acquisition of Apellis in the second quarter, shaking up analysts’ consensus estimates and leading to a beat.
    BioSpace · 16h agoDealNeutral↗ source
  • Fugitive Discovered Working Under Alias in Biotech Industry Amid Legal Battles Involving AstraZeneca and Lilly
    A Rhode Island fugitive who had been on the most-wanted list was recently uncovered as having worked under a false identity in the biotech sector. The revelation raised questions about how the ind…
    STAT · 17h agoNegative↗ source
  • Nanoparticle-loaded chemotherapy crosses blood-brain barrier in mice after glioblastoma surgery, study shows
    Researchers at the University of Manchester have demonstrated that a standard chemotherapy drug can reach the brain when packaged in liposome nanoparticles and given shortly after tumor removal in…
    Fierce Biotech · 19h agoPositive↗ source
  • Biogen CEO says company will pause new acquisitions and focus on developing existing pipeline
    Biogen's chief executive Christopher Viehbacher told analysts during the second-quarter earnings call that the company will slow its merger and acquisition activity for the foreseeable future. Aft…
    Fierce Biotech · 20h agoDealNeutral↗ source
  • BioSpace launches dashboard to track performance of U.S. biotech IPOs in 2026
    BioSpace introduced a new IPO dashboard that monitors U.S. biotech companies that went public in 2026. The tool will be refreshed weekly with the latest closing prices and will add any newly liste…
    BioSpace · 19h agoNeutral↗ source