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606 stories matching this filter · ← front page

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  • FDA staff raise concerns over Capricor’s Duchenne cell therapy as shares plunge; Legend CEO resigns, AstraZeneca reports pipeline woes
    Capricor Therapeutics saw its shares tumble by nearly two‑thirds after FDA reviewers highlighted serious concerns about the data supporting its experimental Duchenne muscular dystrophy cell therapy…
    BioPharma Dive · 17d agoRegulatoryNegative↗ source
  • Sarepta appoints former AbbVie executive Michael Severino as new CEO to drive turnaround
    Sarepta Therapeutics announced that Michael Severino will become its chief executive officer on July 28, succeeding Doug Ingram who plans to retire. Severino brings more than two decades of experi…
    BioPharma Dive · 17d agoNeutral↗ source
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  • Biotech confidence surges in 2026 as China leads growth and deal activity spikes
    Industry observers noted a marked shift in tone at two major 2026 biotech gatherings – the DIA China meeting in Shanghai and the BIO International Convention in San Diego – where participants expre…
    BioPharma Dive · 18d agoPositive↗ source
  • WHO publishes first interim list of medical device authorities; AstraZeneca explores AI to reduce late-stage risk
    The World Health Organization has issued its first interim list of medical device authorities, marking a step toward greater transparency in device regulation. The list is intended to guide manufac…
    raps · 18d agoRegulatoryNeutral↗ source
  • EMA commits to safeguarding stakeholder data; FDA advisory panel expands compounding peptide list
    The European Medicines Agency announced that it will assume ultimate responsibility for protecting information submitted by stakeholders through online meeting registrations and surveys, in line wi…
    raps · 18d agoRegulatoryNeutral↗ source
  • FDA issues three new guidances to expand eligibility criteria for cancer trials
    The FDA's Oncology Center of Excellence has released three final guidance documents aimed at widening the pool of patients who can enroll in oncology clinical trials. The guidances focus on three…
    raps · 18d agoRegulatoryNeutral↗ source
  • Study shows drug development and reimbursement timelines align across four major markets
    Researchers published a cross‑sectional analysis in JAMA Health Forum examining how long it takes for a drug to move from the start of clinical trials to receiving reimbursement approval. The anal…
    raps · 18d agoNeutral↗ source
  • Australia's TGA adopts 23 international scientific guidelines from EMA, ICH and FDA
    The Therapeutic Goods Administration (TGA) in Australia announced it has formally adopted 23 scientific guidelines. The guidelines come from the European Medicines Agency, the International Counci…
    raps · 18d agoRegulatoryNeutral↗ source
  • Nokia executive Pallavi Mahajan purchases 62,000 shares at $9.55 each
    Nokia reported an insider transaction by Pallavi Mahajan, a member of the senior management team. The filing indicates Mahajan bought 62,000 Nokia shares on July 24, 2026, at a price of $9.55 per…
    globenewswire health · 18d agoDealNeutral↗ source
  • Almac Clinical Services podcast details end-to-end clinical trial supply chain
    Almac Clinical Services released a six-part podcast that walks listeners through the clinical trial supply chain from protocol planning to patient delivery. The series, published by BioPharma Dive’…
    BioPharma Dive · 18d agoNeutral↗ source
  • Season 2 of The Progress Profile podcast spotlights Alzheimer’s research and patient-centered trial design
    The Progress Profile: Alzheimer’s Research in Focus returns for a second season, offering conversations about Alzheimer’s disease and brain health. In the premiere episode, Dr. John Harrison, Dr.…
    BioPharma Dive · 18d agoNeutral↗ source
  • Vaisala executive Vesa Pylvänäinen sells 1,582 shares at €56.92 each
    Vaisala Oyj disclosed a transaction by senior executive Vesa Pylvänäinen on July 23, 2026. He disposed of 1,582 ordinary shares of the company on the Nasdaq Helsinki market at an average price of…
    globenewswire health · 18d agoNeutral↗ source
  • Vaisala senior manager Vesa Pylvänäinen disposes 1,582 shares at €56.92 each
    Vaisala Corporation disclosed that senior manager Vesa Pylvänäinen sold a portion of his holdings. The disposal involved 1,582 shares of Vaisala A shares, with a volume‑weighted average price of €…
    globenewswire health · 18d agoNeutral↗ source
  • Nokia senior manager Pallavi Mahajan buys 62,000 shares at $9.55 each
    Nokia disclosed that senior manager Pallavi Mahajan filed a transaction notice under the EU Market Abuse Regulation. The notice, dated July 24, 2026, records Mahajan's purchase of 62,000 Nokia sha…
    globenewswire health · 18d agoRegulatoryNeutral↗ source
  • Nokia senior manager Patrik Hammarén acquires 43,293 shares at €8.44 each
    Nokia Corporation disclosed that senior manager Patrik Hammarén purchased shares of the company. The acquisition was made on July 24, 2026 and involved a total of 43,293 shares at a unit price of…
    globenewswire health · 18d agoRegulatoryNeutral↗ source
  • Nokia board member Timo Ihamuotila reports share purchases across multiple markets on July 24, 2026
    Nokia Oyj disclosed an insider transaction by board member Timo Ihamuotila, filed under the market abuse regulation article 19 as an initial notification. The first purchase was made on the BEUP m…
    globenewswire health · 18d agoNeutral↗ source
  • Nokia board member Timo Ihamuotila purchases 33,700 shares at around €8.45 each
    On July 24, 2026, Timo Ihamuotila, a member of Nokia Corporation's board, executed multiple share purchases. He acquired 24,340 shares on the BEUP venue at a price of €8.4449 per share. Additiona…
    globenewswire health · 18d agoNeutral↗ source
  • Nokia executive Patrik Hammarén reports share purchase of 43,293 shares at €8.44 each
    Nokia Oyj disclosed a leadership transaction filed under market abuse regulation article 19. The filing lists senior executive Patrik Hammarén as the reporting person. The transaction involved a t…
    globenewswire health · 18d agoDealNeutral↗ source
  • Danske Bank reports share sales by APMH Invest under its buyback program
    On July 27, 2026, Danske Bank A/S filed a market-abuse regulation report detailing changes in share ownership. The filing shows that APMH Invest A/S sold shares of Danske Bank on a pro-rata basis…
    globenewswire health · 18d agoRegulatoryNeutral↗ source
  • Danske Bank reports ongoing share sales by APMH Invest under its buy-back program
    Danske Bank A/S filed a notification on 27 July 2026 regarding transactions made by persons required to report under the EU Market Abuse Regulation. The bank’s share buy-back program continues, an…
    globenewswire health · 18d agoRegulatoryNeutral↗ source
  • FDA advisory panel votes to expand use of four untested peptides despite safety concerns
    An FDA advisory committee narrowly voted to recommend adding four peptides to the agency's 503A Bulks List, a registry that would allow compounding pharmacies to use them in custom medications. The…
    BioPharma Dive · 21d agoRegulatoryNegative↗ source
  • Sanofi stops development of eczema drug amlitelimab after mixed trial results
    Sanofi announced on Friday that it is halting further development of amlitelimab for atopic dermatitis, a drug it had once promoted as a potential successor to its blockbuster Dupixent. The compan…
    BioPharma Dive · 20d agoNegative↗ source
  • Novo Nordisk seeks injunction to halt Eli Lilly's obesity drug ads
    Novo Nordisk filed a motion in a New Jersey federal court asking for a preliminary injunction that would stop Eli Lilly's advertisements for its obesity treatments. Novo claims the ads are mislead…
    BioPharma Dive · 21d agoRegulatoryNegative↗ source
  • FDA advisory panel recommends adding peptides BPC-157 and KPV to bulk compounding list
    An FDA advisory committee voted 8-6, with one abstention, to recommend that two experimental peptides – BPC-157 for ulcerative colitis and KPV for wound and inflammatory conditions – be placed on t…
    raps · 21d agoRegulatoryNeutral↗ source
  • FDA advisory panel adds six peptides to compounding bulk drug list, rejects one
    The FDA’s advisory committee concluded a two-day meeting on Friday, reviewing seven peptide drug substances for inclusion on the agency’s bulk-drug compounding list. Committee members voted to add…
    raps · 21d agoRegulatoryNeutral↗ source