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2,329 stories matching this filter · ← front page

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  • California’s new CalRx insulin label aims for affordable access but faces slow rollout
    California launched a state‑branded insulin label, CalRx, this year to provide lower‑cost insulin to patients without insurance. The pens, marked with the state’s grizzly bear logo, are now stocked…
    STAT · 14h agoNeutral↗ source
  • Epilepsy drug from Ovid and Takeda receives fresh start under Perceptive-backed venture
    After about 26 months since two Phase 3 trials failed, the epilepsy treatment candidate originally developed by Ovid Therapeutics and Takeda has been removed from their pipelines. Investment firm…
    Endpoints · 4h agoDealNeutral↗ source
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  • Health secretary Kennedy pushes new addiction-treatment strategy in California, criticizes prior administration
    Health secretary Robert F. Kennedy Jr. traveled to California to present the Biden administration’s revised plan for addiction treatment, following a recent White House initiative on vaccine policy…
    STAT · 8h agoRegulatoryNeutral↗ source
  • Italy’s life‑science sector gains clinical strength and venture capital but still trails Europe’s leaders
    In a recent episode of BioSpace’s Denatured podcast, host Jennifer C. Smith‑Parker talks with Diana Saraceni of Panakès Partners and Fabrizio Calisti of Angelini Ventures about Italy’s life‑science…
    BioSpace · 11h agoNeutral↗ source
  • Patients with treatment-resistant depression weigh pros and cons of brain-implant devices
    A new study surveyed individuals with treatment-resistant depression about their preferences and concerns regarding implantable brain devices aimed at alleviating mood symptoms. Respondents highli…
    STAT · 14h agoNeutral↗ source
  • Commure ends referral payment program for its AI clinic tools
    Commure, a health-software firm valued at about $7 billion, announced it is ending the referral-payment arrangements it had with partners who promoted its artificial-intelligence products to medica…
    STAT · 59m agoNeutral↗ source
  • Cullinan tees up J&J fight—and $100M payday—as Taiho-partnered drug hits phase 3 cancer goal
    Taiho Pharmaceutical and Cullinan Therapeutics have celebrated a second phase 3 victory for their small-molecule EGFR inhibitor, teeing up the partners to challenge Johnson & Johnson in a lung canc…
    Fierce Biotech · 17h agoNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 8h agoLayoffsNegative↗ source
  • Seven deaths linked to Neurocrine’s Prader-Willi drug Vykat raise safety concerns
    Clinicians have warned that seven patients who received Neurocrine Biosciences' recently approved Prader-Willi syndrome therapy Vykat have died, prompting a new safety alert for the patient communi…
    BioSpace · 1d agoRegulatoryNegative↗ source
  • Definium’s oral LSD candidate DT120 shows strong anxiety reduction in Phase 3 trial
    Definium Therapeutics reported that its single‑dose oral LSD candidate DT120 achieved a statistically significant reduction in anxiety symptoms in a Phase 3 study of generalized anxiety disorder. T…
    BioSpace · 1d agoPositive readoutPositive↗ source
  • BridgeBio’s ATTR drug Attruby posts strong Q2 sales surge as Alnylam trims Amvuttra outlook
    BridgeBio Pharma reported that its transthyretin amyloidosis treatment Attruby generated $222.4 million in second‑quarter sales, more than triple the $71.5 million earned in the same period a year…
    BioSpace · 1d agoEarningsPositive↗ source
  • Replimune secures FDA approval for RP1 therapy in advanced melanoma as Eli Lilly reports strong Q2 earnings
    Replimune announced that the FDA has granted market approval for its oncolytic immunotherapy RP1, aimed at treating advanced melanoma. The decision follows two earlier rejections and a contentious…
    BioSpace · 1d agoApprovalPositive↗ source
  • Experts warn of deaths linked to Neurocrine's Vykat XR for Prader-Willi syndrome
    A coalition of specialists in Prader-Willi syndrome has raised serious concerns about the safety profile of Neurocrine Biosciences' drug Vykat XR. The experts point to a series of adverse events,…
    Endpoints · 1d agoRegulatoryNegative↗ source
  • Study finds cancer patients now wait longer for treatment than a decade ago
    A new analysis of more than 2.7 million cancer cases shows that the interval between diagnosis and the start of therapy has grown over the past ten years. The researchers examined records from a na…
    STAT · 1d agoNegative↗ source
  • Neurocrine's Prader-Willi drug Vykat XR linked to multiple deaths and serious side effects
    A group of physicians and experts in Prader-Willi syndrome warned clinicians about safety concerns with Vykat XR, a drug approved by the FDA in March 2025 to reduce the intense hunger in patients w…
    STAT · 1d agoRegulatoryNegative↗ source
  • AI monitoring tool could generate up to 82-fold ROI in phase-3 oncology trials, study finds
    An analysis by the Tufts Center for the Study of Drug Development found that an artificial-intelligence clinical monitoring agent can produce an estimated 82-fold return on investment in phase-3 on…
    Fierce Biotech · 1d agoPositive↗ source
  • Former Pfizer chemist launches Khartis Therapeutics with $95M to develop oral thyroid eye disease drug
    Robert Hoffman, a veteran Pfizer chemist who previously co‑founded XinThera, announced the launch of Khartis Therapeutics. The new company, formed in 2024 with other former XinThera leaders, aims t…
    Fierce Biotech · 1d agoDealPositive↗ source
  • AbCellera, Silence and InduPro secure major funding rounds as AbCellera completes $200M share sale
    Vancouver based biotech AbCellera announced a $200 million share offering after meeting its efficacy targets in a Phase 2 hot flashes trial. The capital raise follows the company achieving its pred…
    Endpoints · 1d agoDealPositive↗ source
  • Definium's LSD pill shows significant anxiety reduction in Phase 3 trial
    Definium Therapeutics announced results of a Phase 3 trial testing its LSD‑based pill DT120 in patients with generalized anxiety disorder. The study enrolled 214 participants who received a single…
    STAT · 1d agoPositive readoutPositive↗ source
  • Sentynl inks up to $475M licensing deal to commercialize Mereo’s alvelestat for rare lung disease
    Sentynl Therapeutics, a subsidiary of Zydus Lifesciences, signed an agreement to obtain exclusive U.S. rights to market alvelestat, Mereo BioPharma’s investigational therapy for alpha-1 antitrypsin…
    BioSpace · 1d agoDealPositive↗ source
  • WHO and DRC move to fast-track Phase 3 Ebola vaccine trial, starting with Merck’s Ervebo
    The World Health Organization and authorities in the Democratic Republic of the Congo are negotiating to speed up the launch of a multi‑armed Phase 3 trial of Ebola vaccines. The effort targets th…
    STAT · 1d agoCRLPositive↗ source
  • Fifth Circuit Court Rules in Favor of Providers on No Surprises Act Arbitration, May Increase Payments
    The U.S. Court of Appeals for the Fifth Circuit issued a decision that sides with health-care providers in a lawsuit over the No Surprises Act. The case stemmed from a 2022 Texas Medical Associati…
    STAT · 1d agoRegulatoryPositive↗ source
  • WHO calls Trump’s vaccine policy order misguided, warns it could increase needle shots and disease risk for children
    WHO Director-General Tedros Adhanom Ghebreyesus and other senior officials criticized a new U.S. executive order that seeks to overhaul the childhood vaccination schedule. The order, signed by Pre…
    STAT · 1d agoRegulatoryNegative↗ source
  • FDA outlines new onshoring incentives and meeting types for generic drug applicants under GDUFA IV
    The FDA released its GDUFA IV commitments, indicating that review timelines for generic drug submissions will remain largely consistent through 2032, mirroring the schedule of the previous five yea…
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • Eli Lilly sues six U.S. entities over illegal retatrutide sales, urges broader crackdown
    Eli Lilly announced legal action against six U.S. entities accused of selling its experimental obesity drug retatrutide on the black market. The lawsuits target compounding pharmacies, medical spa…
    BioSpace · 1d agoRegulatoryNeutral↗ source