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  • Biotech reverse mergers surge 1,600% in Q3, matching number of IPOs in 2026
    Biotech companies are turning to reverse mergers as a faster, less volatile route to the public markets. In the third quarter of 2026, 17 reverse mergers were completed or announced, a 1,600% incre…
    BioSpace · 11d agoDealNeutral↗ source
  • EMA starts voluntary data-sharing pilot to boost confidence in new approach methods and cut animal testing
    The European Medicines Agency announced a voluntary data submission pilot that allows drug developers to upload data generated by new approach methodologies (NAMs). The pilot is designed to build…
    raps · 11d agoRegulatoryPositive↗ source
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  • FDA alerts AVID Medical users to correct convenience kits containing recalled sodium chloride ampules
    The Center for Devices and Radiological Health has posted an Early Alert warning that certain AVID Medical convenience kits may contain sodium chloride ampules recalled by Huons Co. AVID Medical h…
    fda medwatch · 11d agoRegulatoryNeutral↗ source
  • ADA internal review refutes censorship and police involvement allegations after conference ejections
    The American Diabetes Association (ADA) completed an internal review following the removal of several members from its scientific sessions in New Orleans. The review concluded that there was no cen…
    STAT · 11d agoNeutral↗ source
  • Experts urge next DSM to consider algorithmic influence on eating disorders
    Jessica Scheer, CEO of the National Eating Disorders Association, and Riley Nickols, a sports psychologist, argue that the upcoming DSM revision, expected in 2030, must address how digital algorith…
    STAT · 11d agoNeutral↗ source
  • Medline issues correction for convenience kits with potentially non-sterile BD ChloraPrep applicators
    Medline has sent a correction notice after the FDA identified that some BD ChloraPrep applicators included in its convenience kits may not be sterile. The agency says the devices could cause tempo…
    fda medwatch · 11d agoCRLNeutral↗ source
  • Former ARPA-H director launches startup to solve AI's basic challenges in health care
    A former director of the U.S. Advanced Research Projects Agency for Health has founded a new company focused on fixing what he calls the "dumb problems" of artificial intelligence in medicine. The…
    STAT · 11d agoNeutral↗ source
  • Ig Nobel Prizes move to Zurich as organizers cite US immigration concerns
    The Ig Nobel Prizes, a tongue-in-cheek science award, will be held outside the United States for the first time since they began in 1991. Organizers said the move to Zurich, Switzerland, reflects…
    STAT · 11d agoNeutral↗ source
  • Moderna and Merck's mRNA cancer vaccine extends survival in phase 3 melanoma trial
    Merck and Moderna reported that their personalized mRNA cancer vaccine improved patient outcomes in a late-stage study. The phase 3 INTerpath-001 trial enrolled 1,137 patients who had surgery to r…
    Fierce Biotech · 12d agoPositive readoutPositive↗ source
  • Novartis halts CD19 CAR-T trial after three deaths, Bristol Myers also pauses similar program
    Novartis announced a pause to its CD19-directed CAR-T cell therapy trials after three patients experienced fatal immune reactions. The company said the deaths were linked to a severe cytokine relea…
    Endpoints · 12d agoCRLNegative↗ source
  • Novartis and BMS pause CAR-T trials after fatal immune syndrome cases
    Novartis has halted several immunology and neurology studies of its CAR T candidate rapcabtagene autoleucel after three patients experienced fatal immune effector cell‑associated hemophagocytic syn…
    BioSpace · 12d agoRegulatoryNegative↗ source
  • Roche signs $1.53 billion licensing deal with Simcere for preclinical B-cell antibody
    Roche announced a licensing agreement with China's Simcere Zaiming, paying $75 million upfront and potentially up to $1.53 billion in total, for worldwide rights to a preclinical trispecific antibo…
    Fierce Biotech · 12d agoDealPositive↗ source
  • GSK's mRNA flu vaccine shows stronger immune response than standard shots in phase 2, prompting phase 3 launch
    GSK reported that its experimental mRNA seasonal influenza vaccine generated higher immune responses than both standard and high-dose flu shots in a phase-2 study involving nearly 1,000 adults. Th…
    Fierce Biotech · 12d agoPositive readoutPositive↗ source
  • Roche partners with China's Simcere Zaiming on $1.5 billion T-cell engager for B-cell diseases
    Roche announced a licensing agreement with Simcere Zaiming, a subsidiary of China's Simcere Pharmaceutical Group, to develop a trispecific T-cell engager called SIM0660. The deal includes an upfro…
    BioSpace · 12d agoDealPositive↗ source
  • GSK to begin Phase 3 trial of mRNA seasonal flu vaccine after strong Phase 2 results
    GSK announced it will start a Phase 3 study of its mRNA vaccine targeting seasonal influenza. The move follows Phase 2 data that showed the candidate produced higher immune responses than traditio…
    Endpoints · 12d agoPositive readoutPositive↗ source
  • Novartis reports positive multiple sclerosis results with its BTK inhibitor
    Novartis announced that its BTK inhibitor has shown a positive outcome in a multiple sclerosis study, marking a notable advance for the company in this therapeutic area. The result highlights the…
    STAT · 12d agoPositive readoutPositive↗ source
  • Novartis' Rhapsido shows safety edge and relapse reduction in Phase 3 multiple sclerosis trials
    Novartis reported results from two identical Phase 3 studies of its BTK inhibitor Rhapsido in patients with multiple sclerosis. The trials showed the oral pill lowered the annualized relapse rate…
    Endpoints · 12d agoPositive readoutPositive↗ source
  • Medtronic recalls Bravo CF reflux monitoring capsule after 184 serious injuries reported
    Medtronic has issued a recall of its Bravo CF esophageal pH monitoring capsule, a wireless device used to assess acid reflux. The recall follows an FDA early alert after the company identified a pr…
    Fierce Biotech · 12d agoCRLNegative↗ source
  • Boston Scientific stops sales of Imager II catheters after tip defect linked to two injuries
    Boston Scientific issued a letter on August 24 advising customers to remove all Imager II angiographic catheters from use or sale after discovering a manufacturing problem. The problem involves re…
    Fierce Biotech · 12d agoCRLNegative↗ source
  • ARPA-H grants up to $125M to accelerate on-demand custom RNA therapy manufacturing
    ARPA-H announced a new funding initiative aimed at speeding the creation of personalized RNA medicines. The agency will provide up to $125 million in total awards. Five research groups were select…
    Endpoints · 12d agoDealPositive↗ source
  • Eli Lilly's 2026 acquisitions boost over 50 biotech venture investors
    Eli Lilly announced its thirteenth acquisition of 2026, continuing a busy year of dealmaking for the drugmaker. The transactions have involved at least fifty different venture capital firms, sendi…
    Endpoints · 12d agoDealPositive↗ source
  • Trump administration announces new drug pricing pledges, but details remain undisclosed
    On Monday the Trump administration said a second group of pharmaceutical companies had agreed to cut drug prices to levels similar to those in other countries. The companies involved have pledged t…
    STAT · 12d agoDealNegative↗ source
  • Roche partners with Simcere Zaiming on trispecific T cell engager, $75M upfront
    Roche announced a collaboration with Chinese biopharma Simcere Zaiming to develop a trispecific T cell engager aimed at cancer therapy. The agreement includes an upfront payment of $75 million to…
    Endpoints · 12d agoDealPositive↗ source
  • GSK to start Phase 3 trial of mRNA flu vaccine after strong mid-stage results
    GSK announced it will begin a Phase 3 trial of its mRNA-based influenza vaccine, with enrollment slated to start in September. In a Phase 2 study of 971 adults, the investigational vaccine, which…
    BioSpace · 12d agoPositive readoutPositive↗ source
  • Novartis and Bristol Myers Squibb pause cell therapy trials; $480K cancer drug price now routine, new pricing deals announced
    Novartis and Bristol Myers Squibb have announced pauses in several of their cell therapy trials, citing operational considerations. The pauses affect multiple programs but the companies did not det…
    STAT · 12d agoDealNeutral↗ source