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  • FDA and CMS work to prevent regulatory clash as states move to test clinical AI
    Officials at the FDA and CMS are working behind the scenes to avoid a regulatory clash as more states plan to test artificial intelligence tools that perform clinical tasks. The tension arises fro…
    STAT · 11d agoRegulatoryNeutral↗ source
  • Bracco to invest $230M in new US contrast media plant, creating 200 jobs
    Bracco Diagnostics announced a $230 million investment to build its first U.S. manufacturing facility for injectable contrast media in Sanford, North Carolina. The plant is slated to create about…
    Fierce Biotech · 11d agoDealPositive↗ source
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  • Molecular Partners to cut up to 44% of staff as it shifts focus to radiotherapy pipeline
    Molecular Partners announced it will lay off up to 44% of its workforce, affecting as many as 55 positions, as the Swiss biotech redirects its limited cash toward a radiotherapeutic program. The c…
    Fierce Biotech · 11d agoLayoffsNegative↗ source
  • FDA rolls out new inspection coordination plan, lifts estradiol patch warning and HHS permits compounding of six peptides
    FDA's drug center and inspections office have agreed on a new concept of operations (ConOps) to better coordinate inspections and compliance activities. A U.S. senator introduced draft legislation…
    raps · 11d agoRegulatoryNeutral↗ source
  • AstraZeneca drops two early-phase prostate cancer programs
    AstraZeneca announced it is terminating development of two early-phase prostate cancer candidates, AZD9750 and AZD8359, as part of a quarterly pipeline review. AZD9750, an oral androgen-receptor d…
    Fierce Biotech · 11d agoNegative↗ source
  • Bambusa Therapeutics exceeds IPO target raising $169 million, while Aspen Neuroscience falls short with $141 million
    Bambusa Therapeutics announced that its initial public offering was upsized, selling more shares at the midpoint of its $15‑$17 range and raising about $168.9 million, exceeding the $150.4 million…
    Fierce Biotech · 11d agoDealNeutral↗ source
  • STAT+: Pharmalittle: We’re reading about AstraZeneca cost-cutting, Sun Pharma facility problems, and more
    AstraZeneca has launched a three-year cost-cutting program that aims to slice off $1.5 billion a year, with the savings reinvested in R&D.
    STAT · 11d agoRegulatoryNeutral↗ source
  • Acumen scraps sole asset after Alzheimer’s fail, plunging stock 80%
    Acumen will implement cash-saving strategies and assess its options after sabirnetug failed to beat placebo, leaving the biotech without a clinical program.
    BioSpace · 11d agoRegulatoryNeutral↗ source
  • Patient billed $1,756 after routine urgent-care visit for UTI at Texas clinic
    A woman in Allen, Texas thought she was getting a standard urgent‑care treatment for a urinary tract infection. She provided a urine sample, received a diagnosis and a prescription, and paid a mode…
    STAT · 11d agoNegative↗ source
  • Roche launches VENTANA BAP1 test to improve mesothelioma diagnosis
    Roche announced the global launch of its VENTANA BAP1 (SP527) test, an automated ready‑to‑use immunohistochemistry assay designed for differential diagnosis of mesothelioma. The assay targets the…
    Fierce Biotech · 11d agoPositive↗ source
  • Election stress linked to higher risk of arrhythmias and heart attacks, study finds
    Elections can create heightened stress that may affect cardiovascular health, according to recent research. The study highlights a link between the emotional strain of voting periods and increased…
    STAT · 10d agoNegative↗ source
  • Lancet series highlights men’s health paradox and rising urgent-care costs
    The Lancet has launched a new series examining why men consistently experience poorer health outcomes than women despite advantages in certain areas. The series points to gaps in research, screeni…
    STAT · 11d agoNegative↗ source
  • Vir Biotechnology appoints David Liu as chief medical officer
    Vir Biotechnology announced the hiring of David Liu as its new chief medical officer. Liu joins the company after serving as chief medical officer at Nuvation Bio, where he held the same position.…
    STAT · 10d agoNeutral↗ source
  • Third Rock partner’s brain cancer diagnosis highlights personal impact of biotech drug development
    Jigar Raythatha, a partner at Third Rock Ventures, was diagnosed with a rare form of brain cancer in 2023 after a routine MRI. On the same day his diagnosis was confirmed, Servier announced posit…
    Fierce Biotech · 11d agoPositive↗ source
  • 1834 measles letter highlights historic roots of today's anti-vaccine sentiment
    Jim Downs, a medical historian, examined a 1834 letter from Jane Butt in a London journal while at Yale's medical library, noting the date matches 192 years later. Butt described a measles outbrea…
    STAT · 11d agoNeutral↗ source
  • Merck projects continued investment and growth as Keytruda patent expires
    Merck reported third‑quarter results on an investor call, saying sales expectations were above forecasts thanks to strong performance of subcutaneous Keytruda and the pulmonary arterial hypertensio…
    BioSpace · 11d agoEarningsPositive↗ source
  • Eli Lilly lifts guidance by $10 billion as GLP‑1 sales outpace expectations
    Eli Lilly said its latest financial guidance is $10 billion higher than previously forecast, driven by strong sales of its GLP‑1 medicines. The company’s commercial performance has repeatedly excee…
    BioSpace · 11d agoEarningsPositive↗ source
  • Voters demand action on soaring health-care costs, boosting support for Medicare for All
    Recent polls show Americans increasingly worried about the rising cost of health care, with many saying it is their top financial concern. Voter anger is directed at politicians, who are seen as f…
    STAT · 12d agoNegative↗ source
  • Dren Bio raises $350 million to advance rare blood cancer antibody
    Dren Bio, a California biotech, announced a $350 million financing round to fund late‑stage development and commercial preparation of its lead therapy, a CD94‑targeting monoclonal antibody known as…
    BioSpace · 11d agoDealPositive↗ source
  • BioMarin signs up to $475 million licensing deal for new Fabry disease enzyme therapy
    BioMarin announced a licensing agreement to acquire rights to a long‑acting enzyme replacement therapy candidate for Fabry disease, paying $70 million upfront and up to $405 million in development…
    Fierce Biotech · 12d agoDealPositive↗ source
  • Biopharma manufacturing cuts slated to affect over 4,000 workers, with BioNTech leading layoffs
    Companies investing billions to reshore drug production are trimming staff at manufacturing sites, with ten biotech and pharma firms planning cuts that could affect more than 4,000 employees. BioN…
    BioSpace · 12d agoLayoffsNegative↗ source
  • Gilead places partial clinical hold on two KITE-753 CAR-T trials in diffuse large B-cell lymphoma
    Gilead announced on its third-quarter earnings call that it has placed a partial clinical hold on two CAR-T trials for KITE-753 targeting diffuse large B-cell lymphoma (DLBCL). The hold affects th…
    Fierce Biotech · 11d agoRegulatoryNegative↗ source
  • Federal rule forces PBMs to disclose fees and rebates to employers
    The Trump administration finalized a regulation that will require pharmacy benefit managers (PBMs) to reveal the various fees and compensation they receive from drugmakers, consultants and other pa…
    STAT · 11d agoRegulatoryPositive↗ source
  • Ono Pharma halts ONO-1110 development for depression and anxiety after five Phase 2 failures, continues pain studies
    Ono Pharma announced that its endocannabinoid modulator ONO-1110 failed to demonstrate efficacy in five Phase 2 trials, prompting the company to stop development for depression and social anxiety.…
    BioSpace · 12d agoNegative readoutNegative↗ source
  • Vertex kidney disease drug faces infection risk scrutiny ahead of FDA decision
    Vertex's kidney disease therapy is expected to receive FDA approval, with the agency's decision scheduled for Nov 30. A previously undisclosed pause rule has drawn attention, raising concerns abou…
    STAT · 12d agoRegulatoryNeutral↗ source