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  • 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 · 3mo 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 · 3mo agoPositive↗ source
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  • 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 · 3mo 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 · 3mo agoNegative↗ source
  • China's biotech surge highlights work-life tension for industry leaders
    China's biotechnology sector is accelerating, prompting discussions about the demanding work culture among its leaders. Shefali Agarwal, the US‑based chief executive of Sironax, said she works lon…
    Endpoints · 3mo agoNeutral↗ 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo agoRegulatoryNeutral↗ source
  • BioNTech appoints Sobi's Guido Oelkers as new CEO, to start by Feb 1 2027
    BioNTech announced that Guido Oelkers, currently a leader at Swedish biotech company Sobi, will become its next chief executive officer. Oelkers is expected to take over the role no later than Feb…
    Endpoints · 3mo agoNeutral↗ 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 · 3mo 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 · 3mo agoRegulatoryNeutral↗ source
  • HHS Secretary RFK Jr. defends Trump admin, critiques vaccine research while endorsing measles vaccine
    HHS Secretary Robert F. Kennedy Jr. gave an interview on August 3, 2026 in which he reiterated his support for the Trump administration and voiced criticism of current vaccine research practices.…
    Endpoints · 3mo agoNeutral↗ 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 · 3mo agoNeutral↗ 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 · 3mo 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 · 3mo 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 · 3mo agoNegative↗ source
  • AstraZeneca and Bristol Myers Squibb reportedly in talks on a mega merger
    AstraZeneca is said to be discussing a possible merger with Bristol Myers Squibb, according to a Financial Times report published on Sunday. The combination would rank among the largest consolidat…
    Endpoints · 3mo agoDealNeutral↗ 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 · 3mo 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 · 3mo agoRegulatoryNeutral↗ source
  • Alnylam’s stock continues to fall as weekly roundup highlights Q2 earnings across biopharma
    The August 1 edition of Endpoints Weekly opens with a look at the latest biopharma earnings season. Alnylam Therapeutics is highlighted for a continued decline in its share price, reflecting ongoi…
    Endpoints · 3mo agoEarningsNegative↗ source
  • Novo Nordisk's late-stage anti-inflammatory heart drug fails Phase 3 trial
    Novo Nordisk announced that its experimental anti-inflammatory compound designed to target cardiovascular inflammation did not meet its primary endpoint in a Phase 3 trial. The study was intended…
    Endpoints · 3mo 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 · 3mo 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 · 3mo agoEarningsNegative↗ source