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  • Medical groups issue new flu, Covid and RSV vaccination guidance for upcoming winter season
    Professional organizations representing pediatricians, family physicians, obstetricians and other clinicians released joint vaccination guidelines on Wednesday for the upcoming respiratory illness…
    STAT · 5d agoNeutral↗ source
  • ARPA-H grants funding to biotech firms developing custom RNA therapies amid broader biotech updates
    ARPA-H is providing grants to several biotech companies to develop custom RNA therapeutics, aiming to accelerate personalized medicine. Roche has licensed a tri‑specific antibody, adding a new mod…
    STAT · 5d agoNeutral↗ source
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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 · 5d agoRegulatoryPositive↗ 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 · 5d 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 · 5d agoNeutral↗ 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 · 5d 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 · 5d agoNeutral↗ 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 · 6d 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 · 6d 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 · 6d 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 · 6d 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 · 6d agoCRLNegative↗ 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 · 6d agoDealNegative↗ 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 · 6d agoDealNeutral↗ source
  • FDA clears Stryker’s surgical cockpit that integrates Apple Vision Pro VR headset
    FDA has given clearance for Stryker's new surgical cockpit system that incorporates Apple's Vision Pro VR headset, marking a regulatory milestone for the integration of consumer VR technology in th…
    STAT · 6d agoRegulatoryPositive↗ source
  • Study finds Paxlovid ineffective for treating long Covid
    A recent study reported that the antiviral Paxlovid did not provide measurable benefit for patients suffering from long Covid symptoms. Researchers observed no significant improvement compared with…
    STAT · 6d agoNegative readoutNegative↗ source
  • House set to vote on stopgap bill that could block White House plan to politicize NIH grants
    Congressional leaders are preparing to vote on a Senate stopgap funding bill that would temporarily block the White House's proposal to place political appointees in charge of NIH research grants.…
    STAT · 6d agoRegulatoryPositive↗ source
  • Arsenal Biosciences cuts 99 jobs as it pivots to in-vivo CAR-T therapy
    Arsenal Biosciences announced a major restructuring, laying off 99 employees, which represents the majority of its workforce across all teams and locations. The company is ending development of it…
    Fierce Biotech · 6d agoLayoffsNegative↗ source
  • Alumis' lupus trial misses endpoints, but company eyes phase 3 in IFNGS‑high subgroup
    Alumis reported that its phase 2b study of the TYK2 inhibitor envudeucitinib failed to meet both the primary and secondary efficacy endpoints in patients with moderate to severe systemic lupus eryt…
    Fierce Biotech · 6d agoNegative readoutNegative↗ source
  • Novocure cyberattack exposes data of over 1,400 U.S. patients and staff
    Novocure disclosed a cyberattack in an SEC filing, saying unauthorized access to some information systems was discovered in mid‑August. The breach exposed internal patient ID numbers for more than…
    Fierce Biotech · 6d agoNegative↗ source
  • Opinion: Trump administration’s paperwork surge hampers science and health care
    The opinion piece argues that the Trump administration has expanded paperwork requirements, making it harder for scientists and Medicaid recipients to access services. Citing a federal estimate th…
    STAT · 6d agoNegative↗ source
  • FDA releases draft guidance on evaluating drug behavior in patients with liver impairment
    The FDA has issued a draft guidance outlining how sponsors should design and analyze studies that assess the pharmacokinetics and pharmacodynamics of medicines in individuals with hepatic impairmen…
    raps · 6d agoRegulatoryNeutral↗ source
  • FDA urges validation of digital health endpoints and clear missing-data plans
    FDA officials highlighted key practices for sponsors using digitally derived endpoints from digital health technologies. They said endpoints must be validated for the specific patient population t…
    raps · 6d agoRegulatoryNeutral↗ source
  • Trump unveils pricing agreements with midsize biotech firms; Novartis halts CAR-T trial after patient deaths
    The White House announced that President Trump has struck new pricing agreements with a group of midsize biotechnology companies, aiming to adjust drug costs. Novartis disclosed that it is pausing…
    raps · 6d agoDealNeutral↗ source
  • House passes stopgap bill to block White House plan for political control of federal research grants
    The House approved a temporary funding measure that blocks a White House proposal to let political appointees oversee federal research grants. The measure passed 370‑48 and mirrors a Senate bill p…
    STAT · 6d agoRegulatoryNeutral↗ source