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1,277 stories matching this filter · ← front page

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  • Attovia, Braveheart Bio, and Vogenx aim to raise over $500M through combined IPOs
    Attovia Therapeutics, Braveheart Bio and Vogenx have each filed IPO paperwork, setting price ranges that together target more than $500 million in gross proceeds from public investors. Braveheart…
    Fierce Biotech · 3mo agoDealNeutral↗ source
  • EFPIA urges EU lawmakers to further cut clinical trial approval timelines under Biotech Act
    The European Federation of Pharmaceutical Industries and Associations (EFPIA) has asked EU legislators to go beyond the modest reductions in clinical trial approval times that are currently being c…
    raps · 3mo agoRegulatoryNeutral↗ source
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Nephrology760
  • Legend Biotech CEO Ying Huang resigns abruptly, board taps interim leader
    Legend Biotech announced that its chief executive, Dr. Ying Huang, has stepped down unexpectedly, leaving the role vacant. Huang, who moved from chief financial officer to CEO in 2020 after a cust…
    Fierce Biotech · 3mo agoNeutral↗ source
  • Ukrop’s Homestyle Foods voluntarily recalls six baked goods over possible aluminum fragments
    Ukrop’s Homestyle Foods, a Richmond, Virginia based company, announced a voluntary recall of six baked products after a routine inspection found a small piece of aluminum in the baking pan. The re…
    fda recalls · 3mo agoCRLNegative↗ 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 · 3mo 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 · 3mo agoApprovalPositive↗ 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 · 3mo 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 · 3mo 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 · 3mo agoDealPositive↗ 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 · 3mo 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 · 3mo agoDealNeutral↗ source
  • Vertex pays $28 million upfront to AbCellera for autoimmune T-cell engager collaboration
    Vertex Pharmaceuticals has entered a collaboration with AbCellera, paying an upfront sum of $28 million to access the latter’s T-cell engager platform for autoimmune disease programs. Under the ag…
    Fierce Biotech · 3mo agoDealNeutral↗ source
  • Merck briefly lists, then removes, phase 2 trial of PD-1xVEGF bispecific with TROP2 ADC
    Merck & Co. posted a clinical trial listing for a phase‑2 study combining its PD‑1xVEGF bispecific antibody (MK‑2010) with the TROP2‑directed antibody‑drug conjugate sac‑TMT. The listing, shown as…
    Fierce Biotech · 3mo agoNeutral↗ source
  • 529 Commerce recalls Rooted in Rare Aquafaba Powder over possible undeclared egg allergen
    529 Commerce, LLC of Parkland, Florida announced a recall of its Rooted in Rare brand Aquafaba Powder. The recall includes 3,860 units packaged in 4‑oz and 12‑oz flexible foil pouches that were so…
    fda recalls · 3mo agoRegulatoryNegative↗ source
  • Publix recalls all GreenWise Organic frozen blueberries and mixed berries over potential E. coli O145 contamination
    Publix announced a recall of all lots of GreenWise Organic Whole Blueberries and Whole Mixed Berries because the products may be contaminated with Escherichia coli O145:H28. The strain is a Shiga…
    fda recalls · 3mo agoCRLNegative↗ source
  • Hansoh and GSK's B7-H3 ADC shows progression-free survival benefit in phase 3 osteosarcoma trial in China
    Hansoh Pharmaceutical, in partnership with GSK, announced that its B7‑H3‑directed antibody‑drug conjugate (ADC) met the primary endpoint in a phase 3 study of relapsed osteosarcoma patients in Chin…
    Fierce Biotech · 3mo agoPositive readoutPositive↗ source
  • Atea’s hepatitis C combo matches Gilead’s Epclusa in phase 3 trial
    Boston-based biotech Atea Pharmaceuticals reported that its once-daily hepatitis C combination of bemnifosbuvir and ruzasvir performed on par with Gilead's Epclusa in a pivotal phase 3 study. The…
    Fierce Biotech · 3mo agoPositive readoutPositive↗ source
  • Eli Lilly climbs to top of Norstella’s Pipeline-to-Patient Productivity Index, beating 24 peers
    Eli Lilly has risen to the top of Norstella’s inaugural Pipeline-to-Patient Productivity Index, a new benchmark that rates large global biopharma firms on research productivity, market access and c…
    Fierce Biotech · 3mo agoPositive↗ source
  • Altimmune’s pemvidutide cuts heavy drinking days in phase 2 AUD trial
    Altimmune announced that its experimental dual GLP-1/glucagon receptor agonist pemvidutide reduced heavy drinking in a phase‑2 study of alcohol use disorder. In the 24‑week Reclaim trial, particip…
    Fierce Biotech · 3mo agoPositive readoutPositive↗ source
  • Boston Scientific launches multi-year restructuring plan, foresees $500 million annual savings and job cuts
    Boston Scientific announced a global restructuring program that will run from this year through 2029, aiming to streamline its supply chain and reorganize functions. The plan involves moving certa…
    Fierce Biotech · 3mo agoLayoffsNeutral↗ source
  • GSK launches three-year £1.9bn savings plan to boost late-stage R&D and relocate research HQ
    GSK announced a three-year cost-saving programme designed to free cash for its late-stage research and development pipeline while moving its research headquarters. The plan targets annual savings…
    Fierce Biotech · 3mo agoNeutral↗ source
  • Industry urges FDA to clarify and broaden QSP guidance for first-in-human dose selection
    Industry stakeholders have asked the U.S. Food and Drug Administration for more detailed guidance on using quantitative systems pharmacology (QSP) to select first-in-human doses in phase-1 studies.…
    raps · 3mo agoRegulatoryNeutral↗ source
  • FDA draft guidance seeks clearer, more flexible QSP dose selection for first-in-human trials
    Industry groups have asked the FDA for more clarity in a draft guidance that outlines how sponsors can use quantitative systems pharmacology (QSP) to select doses for first-in-human studies. The r…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Incyte drops phase-1 JAK2 inhibitor to focus on next-generation candidates
    Incyte announced it is abandoning its phase-1 JAK2V617F inhibitor, INCB160058, which was being tested in patients with myeloproliferative neoplasms. The decision was disclosed in the company's sec…
    Fierce Biotech · 3mo agoNegative readoutNegative↗ source
  • Acrosian launches AI-focused biometrics CRO targeting pharma and biotech
    Acrosian has been introduced as a new contract research organization built for the AI era. The firm is founded by Benjamin Jackson, Soumitra Chowdhury and Vladimir Mats, who previously created the…
    Fierce Biotech · 3mo agoPositive↗ source