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  • Frazier Life Sciences raises over $1.1 billion for its small-mid-cap biotech fund, total commitments now $2.8 billion
    Frazier Life Sciences announced that it has added more than $1.1 billion in new capital to its public fund that targets small and mid‑size biopharma companies. The infusion brings the fund's total…
    BioSpace · 1mo agoDealPositive↗ source
  • FDA grants de novo clearance to Powerful Medical’s AI tool for detecting severe heart attacks on EKGs
    The U.S. Food and Drug Administration issued a de novo classification for Powerful Medical’s AI algorithm that analyzes electrocardiograms to identify severe heart attacks. This clearance allows th…
    STAT · 1mo agoRegulatoryPositive↗ source
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  • EU Advocate General backs pharma in fight over wastewater treatment cost
    An EU Advocate General has recommended annulling part of a directive that obliges drug and cosmetics makers to fund at least 80% of wastewater treatment costs. The directive, which took effect ear…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Yarrow Bioscience raises $150M as AbbVie reports positive menstrual migraine trial results
    Yarrow Bioscience, based in New Haven, announced pricing of a $150 million equity offering at $26 per share, roughly $2.50 below the previous closing price. The capital raise will provide addition…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Trade group warns stalled biosimilar development could forfeit billions in savings
    A trade association that represents generic drug makers and biosimilar developers released a new report warning that progress on biosimilar products has slowed. The group says the slowdown threaten…
    Endpoints · 1mo agoNegative↗ source
  • RA Capital backs four biotech rounds in September as Novartis shares tumble after trial setbacks
    RA Capital Management participated in four biotech financings in September, including Series A rounds for Solstice Oncology and Tectora Therapeutics, as well as co-leading a $56 million round for T…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Novartis investors grow wary as drug setbacks spark scrutiny of M&A strategy
    Investors in Novartis are intensifying their examination of the company’s recent dealmaking after a series of setbacks involving drugs that were brought in through mergers and acquisitions. The hei…
    STAT · 1mo agoNegative↗ source
  • Karyopharm Secures One-Month Debt Extension While Awaiting Xpovio Decision
    Karyopharm Therapeutics, facing cash constraints, has negotiated a temporary reprieve on a $15.8 million debt that was due. Under the agreement, lenders and noteholders will refrain from enforceme…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • ALS research pivots to biology-driven biomarkers to capture disease heterogeneity
    ALS drug development is moving beyond traditional measures such as survival time and the ALS Functional Rating Scale. Researchers are now adding biology‑focused approaches that aim to reflect the f…
    Fierce Biotech · 1mo agoPositive↗ source
  • Takeda R&D chief Andy Plump to retire in 2027 as Novo Nordisk names Alex Hoffman global research head
    Takeda announced that its head of research and development, Andy Plump, will step down in June 2027. Plump, who joined Takeda from Sanofi in 2015 and has led R&D since December 2018, will retire af…
    Endpoints · 1mo agoNeutral↗ source
  • FDA pushes back decision on Exelixis' zanzalintinib and Roche's Tecentriq combo for metastatic colorectal cancer
    The FDA announced a delay in its decision on the approval of Exelixis' oral kinase inhibitor zanzalintinib when used with Roche's Tecentriq for metastatic colorectal cancer. The agency said it nee…
    Fierce Biotech · 1mo agoRegulatoryNegative↗ source
  • FDA leadership stabilizes under new CBER and CDER heads and appoints first AI deputy commissioner
    At the Food and Drug Administration, Karim Mikhail and Michael Davis have been confirmed as the permanent heads of the Center for Biologics Evaluation and Research and the Center for Drug Evaluatio…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • U.S. declares end to record cyclospora outbreak linked to iceberg lettuce
    U.S. health officials announced Friday that the nation’s largest cyclospora food‑poisoning outbreak is officially over. The outbreak, which affected 21 states, was tied to contaminated iceberg lett…
    STAT · 1mo agoNeutral↗ source
  • Alzheon seeks up to $500M in new financing after Phase 3 setback for Alzheimer’s drug
    Alzheon, a biotech based in Framingham, Massachusetts, has been pursuing an Alzheimer’s therapy for more than a decade. Its lead candidate recently failed to achieve the primary goals in a Phase 3…
    Endpoints · 1mo agoDealNeutral↗ source
  • Owkin and Servier partner to use AI platform K Pro for oncology discovery and trial design
    Owkin, an AI drug-discovery CRO, has entered a new agreement with French pharmaceutical company Servier to license its AI scientist, K Pro, for use in Servier’s oncology research and clinical trial…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Pro-vaccine advocates urged to add celebration to messaging after new safety data confirms flu, Covid-19 and RSV shots
    Public‑health communications consultant Adam Zimmerman argues that vaccine advocacy has lost its festive spirit and needs more fun to engage the public. He recalls the 1955 "vaccine party" when th…
    STAT · 1mo agoPositive↗ source
  • CMS guidance lets states use tier system to exempt medically frail Medicaid recipients from work requirements
    The Centers for Medicare and Medicaid Services issued new guidance that permits individual states to apply a tiered approach when deciding which Medicaid enrollees qualify as medically frail and th…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • mRNA cancer vaccines’ biggest barriers to market
    Manufacturing hurdles are just one challenge the industry must overcome to commercialize personalized mRNA cancer vaccines.
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Boycott Targeting American Diabetes Association Expands to Include Medical Journal
    A new boycott has been launched against the American Diabetes Association (ADA). The campaign also calls on a medical journal to join the effort, signaling broader criticism of the organization. T…
    STAT · 1mo agoNegative↗ source
  • FDA plans study on barriers to women's enrollment in pregnancy exposure registries and announces PRV fee rates
    The Food and Drug Administration said it will conduct research into perceived barriers that limit women’s participation in pregnancy exposure registries. It also released the fee schedule for prio…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA grants three-month review extension for Exelixis' metastatic colorectal cancer candidate
    Exelixis, a California drug developer, has provided the FDA with additional safety and efficacy data for its experimental therapy aimed at treating metastatic colorectal cancer. The agency respond…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Alloy Therapeutics appoints Venkat Krishnamurthy as chief scientific officer of genetic medicines unit
    Alloy Therapeutics announced the hiring of Venkat Krishnamurthy as chief scientific officer for its genetic medicines division. Krishnamurthy previously held the same role at Flashpoint Therapeuti…
    STAT · 1mo agoNeutral↗ source
  • Thoracic surgeon warns that 9/11 exposure continues to cause lung cancer and mesothelioma decades later
    Raja Flores, a thoracic surgeon at Mount Sinai, treats patients whose illnesses trace back to the dust and fumes of the World Trade Center collapse. He describes how many former first responders an…
    STAT · 1mo agoNeutral↗ source
  • BioSpace to Host Webinar on Using Podcasts, Webinars and Thought Leadership for Pharma Marketing
    BioSpace announced a webinar that will walk PR, communications and marketing teams through the use of podcasts, webinars and thought‑leadership programs to raise executive visibility in biotech and…
    BioSpace · 1mo agoNeutral↗ source
  • Whole Foods recalls Cabricharme cheese after undisclosed egg protein found
    Whole Foods Market announced a recall of its Fromagerie Coop de Mean Cabricharme cheese after testing revealed the presence of egg lysozyme, an egg-white protein that was not listed on the label.…
    fda recalls · 1mo agoRegulatoryNegative↗ source