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  • FDA lifts hold on Aardvark Therapeutics' ARD-101 after safety study shows no cardiac events
    FDA has lifted the clinical hold on Aardvark Therapeutics' ARD-101 after the company completed an additional safety study. The new data showed no cardiac events, addressing the concerns that prompt…
    BioSpace · 17d agoCRLPositive↗ source
  • Roche bets up to $813M on Zymeworks’ lung cancer trispecific T cell engager
    Roche will pay Zymeworks $55 million upfront plus another $40 million once the partnership asset enters Phase 1b development and up to $718 million in additional milestones.
    BioSpace · 18d agoDealNeutral↗ source
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  • Drug safety group petitions FDA to block marketing of unapproved compounded peptides; bipartisan bill seeks clinical trial reforms
    A drug safety advocacy group has filed a citizen petition with the FDA, asking the agency to stop the marketing of compounded peptide products that lack approval. A bipartisan group of lawmakers h…
    raps · 18d agoRegulatoryNeutral↗ source
  • Experts urge cultural shift and standards to unlock real-world evidence potential in medtech
    At The MedTech Conference in Boston, experts highlighted the need for a cultural shift to build trust between regulators and medtech firms when using real-world evidence (RWE) for device marketing.…
    raps · 18d agoNeutral↗ source
  • Gilead shops in IL-23, inking $1.3B upfront I&I deal with China’s PepStar
    Gilead Sciences has picked up a new inflammatory disease program from China’s PepStar Therapeutics to pair with the Phase 2 inflammatory bowel disease asset emvistegrast.
    BioSpace · 17d ago↗ source
  • FDA uncages Aardvark’s Prader-Willi study after new data cleared safety concerns
    After cardiac safety signals led to a full clinical hold on Aardvark Therapeutics’ studies of ARD-101, the biotech conducted an additional safety study, in which no cardiac events were detected. Aa…
    BioSpace · 17d ago↗ source
  • FDA uncages Aardvark’s Prader-Willi study after new data cleared safety concerns
    After cardiac safety signals led to a full clinical hold on Aardvark Therapeutics’ studies of ARD-101, the biotech conducted an additional safety study, in which no cardiac events were detected. Aa…
    BioSpace · 17d ago↗ source
  • FDA approves GSK-Ionis antisense drug Hibsago, opening functional-cure market for hepatitis B
    The U.S. Food and Drug Administration has granted approval to Hibsago (bepirovirsen), a partnership product of GSK and Ionis Pharmaceuticals, marking the first antisense oligonucleotide cleared for…
    BioSpace · 18d agoApprovalPositive↗ source
  • Roivant's brepocitinib cuts steroid use in non-infectious uveitis in Phase 3 trials
    Roivant Sciences and its subsidiary Priovant reported that their TYK2/JAK inhibitor brepocitinib met all primary and secondary endpoints in two identical Phase 3 studies (Clarity‑1 and Clarity‑2) i…
    BioSpace · 19d agoPositive readoutPositive↗ source
  • AbbVie’s HS drug lutikizumab meets Phase 3 goal but falls short of analyst expectations
    AbbVie reported that its investigational IL‑1α/β inhibitor lutikizumab achieved the primary endpoint in the Phase 3 INTREPID study for hidradenitis suppurativa, a chronic inflammatory skin disease…
    BioSpace · 18d agoNegative readoutNegative↗ source
  • FDA approves GSK hepatitis B drug; EQT to acquire Qiagen for $10.8 billion
    The U.S. Food and Drug Administration has granted approval to GlaxoSmithKline's new hepatitis B therapy, marking a regulatory milestone for the company. Private-equity firm EQT announced a definit…
    raps · 19d agoPositive↗ source
  • Merck and Moderna cancer vaccine data leak shows modest benefit, shares slide
    A data leak ahead of the European Society of Medical Oncology meeting revealed early results for the personalized cancer vaccine intismeran autogene combined with Merck's Keytruda. The information…
    BioSpace · 18d agoNegative readoutNegative↗ source
  • Biohaven's ataxia drug resubmission accepted by FDA, shares surge 36%
    Biohaven’s experimental drug troriluzole, being developed for spinocerebellar ataxia, was previously rejected by the FDA because the agency questioned the design of the registrational trial. The co…
    BioSpace · 18d agoRegulatoryPositive↗ source
  • Biotech sector logs 31 IPOs in 2026, with four more slated, still far below 2021 boom
    Biotech IPO activity has accelerated this year, with 31 companies completing public offerings so far, according to BioSpace data. This figure exceeds the totals from each of the previous four year…
    BioSpace · 18d agoDealNeutral↗ source
  • Investors Re-evaluate Kidney Disease as New Cell and Gene Therapy Strategies Emerge
    In a recent episode of BioSpace's Denatured podcast, the CEOs of ProKidney and Nephrogen discussed why kidney disease has long been a difficult indication for cell and gene-based medicines. The co…
    BioSpace · 19d agoPositive↗ source
  • Merck to showcase three late-stage TROP2 ADC trials at ESMO 2026, VP says payload is in the "Goldilocks zone"
    At the European Society for Medical Oncology meeting in 2026, Merck will present three late-stage trials of its TROP2‑directed antibody‑drug conjugate sac‑TMT, developed in partnership with Kelun‑B…
    BioSpace · 19d agoPositive↗ source
  • FDA issues warning letters to Baxter and Olympus over GMP and QSR violations
    The U.S. Food and Drug Administration sent formal warning letters to Baxter International and Olympus Medical Systems. The letters allege that both companies failed to meet required good manufactu…
    raps · 19d agoRegulatoryNegative↗ source
  • Biopharma firms curb hiring as $100,000 H-1B visa fee limits foreign talent
    The U.S. Department of Homeland Security’s recent increase of the H-1B visa filing fee to $100,000 has made it much more expensive for biopharma employers to sponsor foreign-born scientists and eng…
    BioSpace · 19d agoRegulatoryNeutral↗ source
  • Roche’s pipeline trim claims Poseida’s off-the-shelf CAR T asset
    Aside from RG6540, Roche also discontinued a host of other early-stage assets, including an antisense oligonucleotide for Alzheimer’s disease and a small-molecule candidate for geographic atrophy.
    BioSpace · 19d agoRegulatoryNeutral↗ source
  • Key career moves that propelled three BioSpace 40 Under 40 honorees to biotech leadership
    BioSpace highlighted three members of its 40 Under 40 list, asking them to describe pivotal moments that shaped their biotech careers. Lex Johnson, chief platform officer at Dispatch Bio, said the…
    BioSpace · 19d agoPositive↗ source
  • EMA opens consultation on platform trial methodology; MHRA to recognize CE-marked devices indefinitely
    The European Medicines Agency is launching a public consultation to gather feedback on the methodological aspects of confirmatory platform clinical trials. The agency seeks input from researchers,…
    raps · 19d agoRegulatoryNeutral↗ source
  • Natural Grocers recalls 2‑pound organic mung beans over possible glass contamination
    Vitamin Cottage Natural Food Markets, Inc. in Lakewood, Colorado announced a recall of Natural Grocers brand organic 2‑pound mung beans because of potential glass contamination. The recall follows…
    fda recalls · 18d agoRegulatoryNegative↗ source
  • WinCo Foods recalls hoagie rolls after undisclosed sesame ingredient
    WinCo Foods of Boise, Idaho announced a recall of its brand hoagie rolls because sesame was not listed on the label. The rolls, identified by UPC 2-70552-00649-2 and bearing best-by dates from Sep…
    fda recalls · 18d agoCRLNeutral↗ source
  • US patients skip half of new high-cost drugs as prices surge past $250K
    A new report from the Institute for Clinical and Economic Review and West Health finds that only about one-third of patients prescribed newly launched medicines actually fill them within 30 days, w…
    BioSpace · 20d agoNegative↗ source
  • FDA approves GSK‑Ionis hepatitis B functional cure, Hibsago, targeting undetectable virus after six months
    The FDA has approved bepirovirsen, an antisense oligonucleotide from GSK and Ionis, for chronic hepatitis B infection. It will be sold under the brand name Hibsago. The therapy is described as a f…
    BioSpace · 20d agoApprovalPositive↗ source