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  • Windward Bio raises $225 million in IPO to fund Chinese-sourced respiratory drug program
    Windward Bio, backed by Sanofi, completed its initial public offering at the $225 million target, selling 10.3 million shares at $17 each. The proceeds will be used to advance two respiratory drug…
    Fierce Biotech · 10h agoDealPositive↗ source
  • Setbacks in two heart disease trials raise questions about future cardiovascular drug research
    A recent episode of The Readout LOUD highlighted the disappointing results of two high-profile heart disease drugs, noting that both failed to demonstrate benefit in recent studies. The failures w…
    STAT · 1h agoNegative readoutNegative↗ source
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  • Oura to acquire telehealth firm Counsel Health, raising conflict-of-interest concerns for Eli Lilly
    Oura, known for its smart rings, announced it will purchase Counsel Health, a telehealth startup that connects patients with clinicians for GLP-1 prescriptions. The acquisition will give Counsel c…
    STAT · 5h agoDealNeutral↗ source
  • Virtuoso Surgical receives FDA De Novo clearance for robotic bladder lesion removal system
    Virtuoso Surgical's Virtuoso Endoscopy System received FDA De Novo authorization, marking the first device in a new classification for electromechanical surgical technologies that use robotic instr…
    Fierce Biotech · 10h agoApprovalPositive↗ source
  • Senators propose bill to limit conflicts of interest on preventive services task force
    Two senators, Angus King of Maine and Elizabeth Warren of Massachusetts, announced legislation aimed at tightening conflict‑of‑interest rules for the U.S. Preventive Services Task Force, the panel…
    STAT · 40m agoRegulatoryNeutral↗ source
  • ObesityWeek 2026 to showcase amylin pathway and emerging weight-loss mechanisms
    ObesityWeek 2026 starts Saturday in Washington, DC, gathering weight-loss experts and biopharma companies with metabolic assets. The meeting will highlight the amylin pathway and other emerging me…
    BioSpace · 1h agoNeutral↗ source
  • Investigation reveals U.S. fertility clinics offering unproven three-parent IVF to older women despite safety concerns
    The probe began after a British couple reported that they had paid a U.S.-based firm, International Fertility Group, large sums to travel abroad for an experimental fertility method that is not per…
    STAT · 5h agoNegative↗ source
  • Gubra appoints ex-HHS official Brett Giroir as co-CEO after sudden exit of Markus Rohrwild
    Gubra, the Danish obesity partner of AbbVie and Boehringer Ingelheim, announced a leadership change following the abrupt departure of its CEO, Markus Rohrwild. The company will operate under a co…
    Endpoints · 2h agoNeutral↗ source
  • Senator-elect Abdul El-Sayed vows to rebuild trust in science amid rising measles and other health threats
    Senator-elect Abdul El‑Sayed is set to become the first epidemiologist to serve in the U.S. Senate, a timing that coincides with a series of public‑health challenges across the country. More than…
    STAT · 5h agoNeutral↗ source
  • New Alzheimer’s biomarker tests raise existential concerns for people without symptoms
    Jason Karlawish, a professor of medicine and neurology at the University of Pennsylvania, reflects on the personal impact of learning one may develop Alzheimer’s before any symptoms appear. He fram…
    STAT · 5h agoNeutral↗ source
  • Regeneron posts positive phase 2 data for baloncibart in nervous system disorder, eyes pivotal trial
    Regeneron has posted positive phase 2 data on baloncibart in postural orthostatic tachycardia syndrome, teeing the biotech up to start a potentially pivotal trial in the first half of 2027.
    Fierce Biotech · 11h agoNeutral↗ source
  • Local schools launch experiments to curb teen phone addiction
    A teacher in Milwaukee asked her digital journalism class to write about their relationship with devices, uncovering disturbing accounts of constant phone use and online abuse. The students descri…
    STAT · 5h agoNegative↗ source
  • American Cancer Society updates prostate cancer screening guidance
    For the first time in 16 years the American Cancer Society (ACS) has updated its guideline for prostate cancer screening as it drives to boost detection of the disease before it spreads.
    Fierce Biotech · 6h ago↗ source
  • Eli Lilly’s Mounjaro and Merck’s oral PCSK9 inhibitor win FDA nod amid string of cardiovascular trial setbacks
    The cardiovascular drug development landscape entered the American Heart Association’s Scientific Sessions with a mix of optimism and disappointment. Recent months have seen several late‑stage tria…
    BioSpace · 19h agoRegulatoryNeutral↗ source
  • Neurosterix raises $105M Series B to advance oral M4 schizophrenia drug and adds former Karuna leaders
    Neurosterix, a spinout from Addex Therapeutics, announced a $105 million Series B financing. The round was led by RTW Investments with participation from GV, Janus Henderson Investors and others. A…
    BioSpace · 22h agoDealPositive↗ source
  • Scientists release detailed basal ganglia cell map, uncover new neuron linked to schizophrenia
    Scientists from a large international collaboration have created the most detailed map of the basal ganglia, a brain region that coordinates movement and emotion. The effort profiled over 25 millio…
    STAT · 22h agoPositive↗ source
  • Bristol Myers Squibb reshuffles R&D leadership as chief research officer departs and CMO takes over combined unit
    Bristol Myers Squibb announced a restructuring of its research and development organization, merging the separate research and development divisions into a single unit. The new combined R&D unit w…
    Fierce Biotech · 23h agoNeutral↗ source
  • Pfizer secures up to $1.5 billion from Blackstone to fund berobenatide obesity drug development
    Pfizer announced a financing arrangement with Blackstone Life Sciences that could provide up to $1.5 billion to support the development of berobenatide, an obesity drug acquired from Metsera. The…
    BioSpace · 1d agoDealPositive↗ source
  • FDA’s fast-track voucher program appears to be discontinued, report finds
    A recent report indicates that the FDA’s expedited voucher program, launched to speed approval of certain drugs, has not issued any new vouchers in the six months since former commissioner Marty Ma…
    Endpoints · 19h agoRegulatoryNegative↗ source
  • Eros Apothecary recalls Candy Power For Man honey supplement after undisclosed tadalafil found
    Eros Apothecary of Indio, California announced a recall of its Candy Power For Man Organic Honey dietary supplement after FDA testing revealed the presence of undeclared tadalafil. Tadalafil is th…
    fda recalls · 22h agoCRLNegative↗ source
  • EnGene reports improved bladder cancer data after May setback
    EnGene, a biotech developing a bladder cancer therapy, released new data that appear more encouraging than the results disclosed in May. The May data had shown limited durability, causing a sharp…
    Endpoints · 22h agoPositive readoutPositive↗ source
  • BioNTech spends $205 million to buy Scholar Rock’s FDA priority-review voucher as J&J scales back in Norway
    BioNTech announced it has purchased an FDA priority review voucher from Scholar Rock for $205 million. The voucher, which can be used to accelerate the regulatory review of a future drug, was origi…
    Endpoints · 22h agoDealPositive↗ source
  • Senate debate looms over Heidi Overton’s potential FDA nomination
    The article raises the question of whether Heidi Overton will be nominated to head the FDA and how the Senate might respond. It notes that a committee chair typically schedules a confirmation vote…
    STAT · 23h agoRegulatoryNeutral↗ source
  • Merck KGaA records €366 million impairment on Lonza CDMO sale as PharmaLogic acquires Lantheus' manufacturing unit
    Merck KGaA disclosed a €366 million ($405.8 million) impairment loss tied to the sale of its contract development and manufacturing organization (CDMO) business to Lonza, according to its third‑qua…
    Endpoints · 23h agoDealNegative↗ source
  • New documents spark fresh concerns over Medicare's AI prior-authorization pilot
    New documents have been released that raise additional questions about Medicare's experiment using artificial intelligence to handle prior-authorization requests. The pilot, which seeks to automat…
    STAT · 23h agoRegulatoryNegative↗ source