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  • FDA launches new office in CDER to modernize clinical trials
    The FDA announced the creation of a new office within its Center for Drug Evaluation and Research (CDER) dedicated to modernizing clinical trials. The office aims to accelerate the design and exec…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Eli Lilly signals entry into aesthetics market with plans to acquire skin, body and hair treatments
    Eli Lilly is indicating an interest in expanding into the aesthetics sector, according to a recent job posting. The company appears to be seeking opportunities to add products that address skin agi…
    Endpoints · 1mo agoNeutral↗ source
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  • Study finds modest rise in youth opioid medication use but declining six-month retention
    Researchers examined Medicaid and insurance claims for Americans aged 13 to 25 diagnosed with opioid use disorder between 2016 and 2023. The analysis, published in JAMA Network Open, aimed to asses…
    STAT · 1mo agoNeutral↗ source
  • Congo Ebola outbreak kills over 4,000 as treatment center burned and health workers protest unpaid wages
    The Congo health ministry reported that the Ebola outbreak has claimed more than 4,000 lives out of 8,300 confirmed cases since it was declared in May. The death toll makes it the fastest‑growing E…
    STAT · 1mo agoNegative↗ source
  • Eli Lilly rolls out LillyDirect to ship Mounjaro directly to Australian patients, sparking pharmacist concerns
    Eli Lilly announced a new service called LillyDirect that will deliver its diabetes drug Mounjaro straight to the homes of patients in Australia, bypassing the traditional pharmacy channel. The mo…
    STAT · 1mo agoNeutral↗ source
  • Researchers claim small molecules could reprogram cells, hinting at a future anti‑aging pill
    Scientists have identified tiny compounds that appear to reset cells to a more youthful condition, according to a recent report featuring David Sinclair’s lab. The molecules work by altering cellul…
    Endpoints · 1mo agoPositive↗ source
  • Regeneron explores pairing its obesity drug with lipid-lowering therapy to differentiate in crowded GLP-1 market
    The pipeline of GLP-1 based medicines is delivering increasingly strong weight-loss results, prompting many companies to seek ways to stand out as the market fills. Regeneron said it is looking at…
    Endpoints · 1mo agoPositive↗ source
  • Moderna appoints former executive Juan Andres as COO as Neurocrine reshuffles leadership; Pharming CEO steps down after board dispute
    Juan Andres, a former Moderna executive, will return from retirement to assume the role of chief operating officer on Oct. 5. His deep familiarity with the company is seen as valuable as Moderna ad…
    Endpoints · 1mo agoNeutral↗ source
  • NIH awards all grant money but delays and opaque decisions hinder researchers, cuts health disparity funding
    The National Institutes of Health announced that it has allocated the full amount of its grant budget for fiscal year 2026, but the timing and transparency of award decisions have been problematic…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Abbott begins U.S. sales of SimpleScreen CRC, an FDA-approved blood test for average-risk colorectal cancer screening
    Abbott has started commercial sales in the United States of SimpleScreen CRC, a blood‑based test cleared by the FDA for colorectal cancer screening in adults 45 years and older who are at average r…
    Fierce Biotech · 1mo agoPositive↗ source
  • Gate CEO sees expanded $870M pact with Lilly as ‘vote of confidence’ in biotech’s platform
    Eli Lilly has been pushing at an open door by tacking on $870 million in biobucks to its existing collaboration with Gate Bioscience.
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Summit Therapeutics partners with AstraZeneca and Daiichi Sankyo on cancer trial; Eccogene hits $50 million milestone
    Summit Therapeutics announced a partnership with AstraZeneca and Daiichi Sankyo to evaluate its Trop-2‑directed antibody‑drug conjugate in a clinical trial. The collaboration will involve joint de…
    Endpoints · 1mo agoDealPositive↗ source
  • Pharmacist urges law to modernize 340B discounts for multi-use orphan drugs
    A pharmacist argues that current legislation lags behind the evolving use of orphan-designated medicines, many of which now serve multiple therapeutic indications. The piece highlights the 340B dr…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Geneticist Mary-Claire King awaits Nobel call after pioneering BRCA discovery
    STAT spoke with geneticist Mary-Claire King, whose discovery of the BRCA1 and BRCA2 cancer mutations three decades ago has become a landmark in oncology. King recalled being invited to give a semi…
    STAT · 1mo agoPositive↗ source
  • Key criteria for selecting a biologics CDMO: reliability, cost, technology and partnership fit
    Choosing the right contract development and manufacturing organization is a strategic move for biotech and biopharma firms, as it can speed development and lower regulatory risk. The top priority…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Immunotherapy startup Adecto shuts down, citing risk-averse funding climate
    Adecto Pharmaceuticals, a Boston-based immunotherapy biotech founded in 2014 by Tufts researchers, announced it is closing after 12 years. The company had been developing AD100, a monoclonal antib…
    Fierce Biotech · 1mo agoNegative↗ source
  • NIH launches streamlined website consolidating 700 sites into eight thematic hubs
    NIH announced a new version of its public website that reorganizes content from more than 700 separate sites into eight thematic hubs. The hubs cover health, research, data, clinical studies, rare…
    STAT · 1mo agoPositive↗ source
  • SonoThera appoints former BridgeBio chief medical officer Adam Shaywitz
    STAT+ columnist Ed Silverman notes that the pharmaceutical industry continues to see staff changes, with a regular feature highlighting individual moves. SonoThera announced the hiring of Adam Sha…
    STAT · 1mo agoNeutral↗ source
  • Doctor urges marathon organizers to adopt evidence-based heat-stroke plans as climate change raises temperatures
    A physician who treated a runner for heat stroke at the New York City Marathon says the event highlighted how extreme heat can overwhelm existing medical preparations. He urges marathon organizers…
    STAT · 1mo agoNeutral↗ source
  • STAT+: Pharmalittle: We’re reading about the 340B drug pilot program, an obesity drug disappointment, and more
    The U.S. approved 10 drugmakers to participate in a 340B pilot program that will allow them to offer rebates, instead of upfront discounts, to certain providers
    STAT · 1mo ago↗ source
  • Sanofi to pay $1 billion upfront to expand antibody partnership with Regeneron
    Sanofi announced it will provide Regeneron with a $1 billion upfront payment to broaden their existing antibody collaboration. The agreement is timed as the patent protection for Dupixent, the joi…
    Endpoints · 1mo agoDealNeutral↗ source
  • Sanofi pays Regeneron $1 billion upfront to co-develop four early-stage immunology assets
    Sanofi has agreed to pay Regeneron an upfront fee of $1 billion to partner on four early‑stage immunology programs, a move intended to capture the success of their joint Dupixent antibody. Dupixen…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Medicare Advantage plans to raise out-of-pocket costs and cut benefits for 2027 enrollees
    Medicare Advantage insurers are set to increase out-of-pocket expenses for seniors enrolling in 2027 plans. The changes include higher cost‑sharing, reduced coverage for dental and other services,…
    STAT · 1mo agoNegative↗ source
  • Science journal launches special issue on women’s health, spotlighting menopause and chronic pain
    Science announced a new special issue dedicated to women’s health, released on Thursday. The collection brings together research on topics ranging from menopause to chronic pain, aiming to raise aw…
    STAT · 1mo agoPositive↗ source
  • Eli Lilly, Novo, AbbVie and Boehringer showcase new obesity drug data at European meeting
    The European Association for the Study of Diabetes held its annual meeting in Milan, drawing obesity and metabolic disease experts and providing a platform for drugmakers to present emerging weight…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source