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1,608 stories matching this filter · ← front page

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  • BioNTech appoints Sobi CEO Guido Oelkers as new chief, founders to launch separate mRNA biotech
    BioNTech announced that Guido Oelkers, current chief executive of Swedish Orphan Biovitrum (Sobi), will assume the role of CEO in early 2027. The move follows the earlier decision of co‑founders U…
    BioSpace · 8d agoNeutral↗ source
  • BioNTech appoints Guido Oelkers as new CEO, succeeding cofounder Ugur Sahin
    BioNTech announced that Guido Oelkers will become its chief executive officer, taking over from cofounder Ugur Sahin. Oelkers comes from Swedish biopharma Sobi, where he led the company, and bring…
    STAT · 8d agoNeutral↗ source
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BlossomHill Therapeutics targets $112 million IPO to fund EGFR lung-cancer drug BH-30643
BlossomHill Therapeutics, a San Diego oncology biotech, announced plans for an initial public offering to raise about $112 million. The company intends to sell 7.8 million shares at $15-$17 each,…
Fierce Biotech · 8d agoDealPositive↗ source
  • In-patient cardiac pre-hab program launched to keep heart-transplant candidates fit while awaiting surgery
    Patients waiting in the hospital for a heart transplant often lose strength and can become ineligible for the procedure as their fitness declines. To address this, Dr. Radha Gopalan at Banner‑Univ…
    STAT · 8d agoPositive↗ source
  • Biologics surge drives CMOs and CDMOs to boost sterile fill-finish and prefilled syringe capacity
    Biologics, biosimilars and GLP-1 therapies are increasing demand for sterile injectable products, prompting contract manufacturers to expand capacity. CMOs and CDMOs are adding fill-finish, lyophi…
    BioSpace · 8d agoPositive↗ source
  • FDA releases new guidances on adhesive performance and skin irritation studies for transdermal generic drugs
    The U.S. Food and Drug Administration has issued two new guidances that address transdermal or topical delivery systems for generic drugs. One is a final guidance that outlines how to assess adhesi…
    raps · 8d agoRegulatoryNeutral↗ source
  • Michigan reports first two U.S. deaths linked to cyclospora outbreak
    State health officials said two people died in Michigan, marking the first confirmed U.S. deaths from cyclospora, a microscopic parasite. Both victims had pre‑existing health conditions that may h…
    STAT · 8d agoNegative↗ source
  • Amgen discloses cybersecurity breach affecting patient data
    Amgen reported a cybersecurity incident that resulted in the exfiltration of protected patient health information and other proprietary data stored in cloud services managed by third‑party provider…
    BioSpace · 8d agoRegulatoryNegative↗ source
  • Biotech leaders urge faster IND process as FDA launches TrialBlazer pilot
    The U.S. Department of Health and Human Services has introduced Operation TrialBlazer, a pilot program aimed at simplifying the investigational new drug (IND) application and approval process. The…
    BioSpace · 8d agoRegulatoryNeutral↗ source
  • TGA seeks industry input on adopting 11 international scientific guidelines in Australia
    The Therapeutic Goods Administration announced it will consider incorporating eleven internationally recognised scientific guidelines into the Australian regulatory framework. The agency has opene…
    raps · 8d agoRegulatoryNeutral↗ source
  • FDA issues new guidances on adhesive performance and skin irritation testing for generic transdermal drugs
    The U.S. Food and Drug Administration has released two new guidances that address transdermal and topical delivery systems for generic drugs. One guidance, issued as final, focuses on how manufact…
    raps · 8d agoRegulatoryNeutral↗ source
  • FSMB leaders say AI not ready for independent medical licensing
    The Federation of State Medical Boards issued an opinion that artificial‑intelligence tools are not yet suitable for independent medical licensure. The board argues that a medical license is more…
    STAT · 8d agoRegulatoryNeutral↗ source
  • Medical schools debate AI scribes as teaching tools versus learning crutches
    Hospitals have rapidly adopted AI-powered note-taking tools, saying they reduce physician burnout and boost revenue. Medical schools, however, are cautious. While they want graduates to be comfort…
    STAT · 8d agoNeutral↗ source
  • FDA releases new guidances on adhesives and skin irritation testing for transdermal drug products
    The U.S. Food and Drug Administration has issued two new guidances that focus on transdermal and topical delivery systems used for generic medicines. One guidance, finalized, provides recommendati…
    raps · 8d agoRegulatoryNeutral↗ source
  • New York Senate advances assisted-dying bill as Nebraska Medicaid work rules spark coverage losses
    The New York Senate moved forward with legislation that would allow assisted dying, marking a significant step toward legalizing the practice in the state. In Nebraska, the recent implementation o…
    STAT · 8d agoNeutral↗ source
  • Boticelli Foods recalls Bettergoods pistachio nut butter over possible Salmonella contamination
    Boticelli Foods of Melville, New York announced a recall of one lot of Bettergoods Pistachio Nut Butter, a 6.7‑oz (190 g) product identified by UPC 194346207961 and lot number LB028ACP04. The reca…
    fda recalls · 8d agoRegulatoryNegative↗ source
  • After 5-month wait, BioNTech announces Sobi CEO will take on top job at mRNA company
    One of the most closely watched vacancies in biopharma has now been filled, with Sobi CEO Guido Oelkers, Ph.D., moving across to take up the top job at mRNA pioneer BioNTech.
    Fierce Biotech · 8d agoNeutral↗ source
  • Nominations Open for 2026 Fiercest Women in Life Sciences, Deadline Sept 18
    Nominations are now open for the 2026 Fiercest Women in Life Sciences, an annual report that spotlights women making significant contributions across pharma, biotech, medtech, academia, venture cap…
    Fierce Biotech · 8d agoPositive↗ source
  • Neurologist Who Diagnoses ALS Patients Receives Own Diagnosis, Reflects on Impact of Disability
    Dr. Christopher Campos, a neurologist and assistant professor at UC Davis Health, disclosed that he was diagnosed with amyotrophic lateral sclerosis (ALS) in 2025 after a decade of delivering the s…
    STAT · 8d agoNegative↗ source
  • Michigan Supreme Court permits state probe into Eli Lilly insulin pricing
    A divided Michigan Supreme Court on Friday ruled that the state attorney general can move forward with an investigation into Eli Lilly’s insulin pricing. The 4-to-3 decision overturned a lower-cou…
    STAT · 9d agoRegulatoryNegative↗ source
  • Senate stopgap bill temporarily blocks White House plan to politicize federal research grants
    Senate leadership released text of a bipartisan continuing resolution that would fund the government through Dec. 11 and include a provision blocking the White House's proposal to place political a…
    STAT · 8d agoRegulatoryNeutral↗ source
  • Novo Nordisk's heart drug ziltivekimab fails Phase 3 trial, raising doubts on inflammation-targeted therapies
    Novo Nordisk announced that its experimental cardiovascular drug ziltivekimab did not meet the primary endpoint in a Phase 3 study. The trial was designed to see if the drug could lower the inciden…
    BioPharma Dive · 11d agoNegative readoutNegative↗ source
  • Novo Nordisk’s IL-6 drug ziltivekimab misses Phase 3 cardiovascular endpoint, shares drop 9%
    Novo Nordisk announced that its IL-6 inhibitor ziltivekimab did not meet the primary goal in a late-stage Phase 3 trial aimed at lowering major cardiovascular events. The ZEUS study enrolled patie…
    BioSpace · 11d agoNegative readoutNegative↗ source
  • Alnylam cuts TTR franchise guidance, market cap loses $10.8B as shares tumble 28%
    Alnylam announced a reduction in its full-year revenue outlook for its transthyretin (TTR) franchise, trimming the midpoint by $200 million. The company now projects TTR therapy sales of $4.2 bill…
    BioSpace · 11d agoEarningsNegative↗ source
  • Capricor CEO hints at possible lawsuit after FDA panel rejects Duchenne cardiomyopathy therapy
    An FDA Cellular, Tissue, and Gene Therapies advisory committee voted 9-3 against recommending Capricor Therapeutics' cell therapy deramiocel for Duchenne muscular dystrophy cardiomyopathy. The pane…
    BioSpace · 11d agoRegulatoryNegative↗ source