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  • Insulet launches full U.S. release of Omnipod Discover data platform for Omnipod 5 users
    Insulet announced that its Omnipod Discover platform is now fully available across the United States. The web-based service is built to work with the company’s Omnipod 5 automated insulin delivery…
    Fierce Biotech · 8d agoPositive↗ source
  • Stakeholders urge FDA to adopt flexible approach for psychedelic drug regulation
    Various individuals and groups have submitted comments urging the U.S. Food and Drug Administration to be flexible in regulating psychedelic medicines that could treat major depressive disorder and…
    raps · 8d agoRegulatoryNeutral↗ source
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  • Roche signs $1.2B partnership with China’s Rona for obesity drug as Stryker pours $400M into CMR Surgical
    Roche has entered a $1.2 billion agreement with Chinese firm Rona to advance an obesity treatment, targeting the growing market for weight‑loss therapies in China. The deal will combine Roche’s dr…
    raps · 8d agoDealPositive↗ source
  • Doctors donate heavily to fellow physicians running for office amid Medicare overhaul debate
    Doctors are contributing sizable amounts to political candidates who are also physicians, according to a STAT+ report. The donations come as Congress prepares its first major overhaul of Medicare…
    STAT · 8d agoNeutral↗ source
  • Paragon Labs hires former Apogee leadership after AbbVie acquisition and spins out hypertension unit
    Paragon Labs announced it has brought several former Apogee Therapeutics executives onto its senior team following AbbVie's $10.9 billion purchase of Apogee. The incoming leaders include Michael H…
    Fierce Biotech · 8d agoDealNeutral↗ source
  • North Carolina public worker health plan faces court challenge over provider restrictions
    The latest Health Care Inc. newsletter highlights a growing dispute over a health plan that covers North Carolina’s public employees and retirees. Employers often try to reduce health care costs b…
    STAT · 8d agoRegulatoryNeutral↗ source
  • FTC and seven states seek contempt order against Martin Shkreli for breaching pharma work ban
    The FTC, joined by seven states, filed a petition with a federal court asking that Martin Shkreli be held in contempt for allegedly violating a court order that bars him from any involvement in the…
    STAT · 8d agoRegulatoryNegative↗ source
  • Lancet study assesses performance of Google’s diagnostic chatbot AMIE
    STAT’s Health Tech newsletter highlighted a recent evaluation of Google’s diagnostic chatbot AMIE that was published in The Lancet. The article notes that the study examined how well the chatbot c…
    STAT · 8d agoNeutral↗ source
  • Nurix halts development of BTK degrader zelebrudomide after phase 1 review
    Nurix announced it will discontinue clinical development of its BTK degrader zelebrudomide, also known as NX-2127, following completion of enrollment in a phase 1 trial for aggressive non‑Hodgkin l…
    Fierce Biotech · 8d agoNegative↗ source
  • Veteran infectious disease journalist Helen Branswell dies at 69
    Helen Branswell, a veteran reporter covering infectious diseases, died on Tuesday at age 69. Her sister said the cause was complications from cancer. Branswell was known for clear, nuanced coverag…
    STAT · 8d agoNeutral↗ source
  • Physicians Face Learned Helplessness From Training Culture, Says STAT+ Columnist
    Frances Mei Hardin, a former ENT surgeon, launches a new STAT+ column called Chief Complaint, where she examines challenges confronting doctors today. She highlights a striking example: some resid…
    STAT · 8d agoNegative↗ source
  • Botched lethal injection of Christa Pike raises questions about execution protocols
    An execution attempt on death-row inmate Christa Pike failed, leaving her alive after the lethal injection protocol was administered. The incident has been described as the most severe botched exec…
    STAT · 8d agoNegative↗ source
  • BMS reports phase 3 successes in IPF drug and neuroendocrine tumor radiotherapy
    Bristol Myers Squibb announced that two of its phase 3 trials have met primary endpoints, marking important milestones as the company seeks growth beyond its patent expirations. The Aloft-IPF stud…
    Fierce Biotech · 9d agoPositive readoutPositive↗ source
  • Roche reports updated eye drug data and FDA filing acceptance, targets July 2027 decision
    Roche Genentech has presented new data from its eye disease trials, a year after a mixed Phase 3 readout, and noted that the FDA has accepted its filing for vamikibart with a decision slated for Ju…
    Fierce Biotech · 9d agoRegulatoryPositive↗ source
  • Tortugas Neuroscience's obuprazine shows significant improvement in phase 2b schizophrenia trial in China
    Tortugas Neuroscience, a biotech founded by former Sage Therapeutics staff with $106 million in funding, reported positive data from a phase 2b study of its schizophrenia candidate obuprazine, lice…
    Fierce Biotech · 9d agoPositive readoutPositive↗ source
  • FDA approves new treatments for persistent herpes and schizophrenia; Steris to acquire Xodus Medical for $2.1 billion
    The U.S. Food and Drug Administration has granted approvals for two new drugs, one targeting persistent herpes infections and another for the treatment of schizophrenia. The herpes indication addr…
    raps · 9d agoApprovalPositive↗ source
  • FDA finalizes guidance aligning biosimilar post-approval manufacturing changes with global standards
    The U.S. Food and Drug Administration has issued its final guidance on how biosimilar manufacturers can implement post-approval changes to their production processes. The new recommendations bring…
    raps · 9d agoRegulatoryNeutral↗ source
  • Merck’s deeper dive into efficacy, safety of $1.3B eye disease drug raises fears of ‘limited’ potential
    Merck & Co. has poured out its Brunello data, revealing a mix of undifferentiated efficacy and concerning safety that led analysts to predict “limited competitive potential” in diabetic macular ede…
    Fierce Biotech · 9d agoRegulatoryNeutral↗ source
  • Japan's PMDA Issues Guidance to Safeguard Participants in Generic Bioequivalence Trials
    The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has released new guidance aimed at protecting healthy adult volunteers who take part in generic bioequivalence studies. The document…
    raps · 9d agoRegulatoryNeutral↗ source
  • Europe’s share of clinical trials falls 13.5% as Asia’s research footprint expands
    The latest data show a 13.5% drop in the number of clinical trials authorized in the EU and EEA compared with pre-pandemic levels. At the same time, Asian countries have increased their share of g…
    raps · 9d agoNeutral↗ source
  • Americans show higher trust in science than most countries, survey finds
    A new Wellcome Global Monitor survey of people in 140 countries found that 52% of Americans say they have a lot of trust in science, compared with just 26% globally. Only 40% of Americans reported…
    STAT · 10d agoNeutral↗ source
  • Parkinson’s-focused Aspen and bispecific biotech Bambusa plan IPOs
    Parkinson’s disease cell therapy-focused Aspen Neuroscience and bispecific biotech Bambusa Therapeutics are the latest drug developers to eye up a public listing.
    Fierce Biotech · 11d ago↗ source
  • Half-century after IL-2 discovery, its impact on HIV, cancer and blood safety is highlighted
    Robert Gallo marks the 50-year anniversary of the 1976 paper that described interleukin-2, one of the first cytokines identified and essential for T-cell growth. He notes that IL-2 enabled the dis…
    STAT · 12d agoPositive↗ source
  • Hengrui secures $15.2 billion Bristol Myers deal and pivots to co-development with Western partners
    Hengrui Pharmaceuticals has become a leading source of innovative drugs in China, outpacing many peers in the current licensing boom. In May the company signed a $15.2 billion licensing pact with…
    Fierce Biotech · 12d agoDealPositive↗ source
  • FDA flags safety concern after four deaths in schizophrenia drug trial
    The U.S. Food and Drug Administration issued a warning after four participants died while receiving an experimental treatment for schizophrenia in a clinical study. The agency described the observ…
    STAT · 12d agoRegulatoryNegative↗ source