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4,103 stories matching this filter · ← front page

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  • Democrats weigh limits of health-care reforms after midterm win
    In the days after their sweeping midterm victories, House and Senate Democrats are debating the scope of possible health-care actions. Party leaders agree on rolling back the Medicaid cuts impleme…
    STAT · 1d agoRegulatoryNeutral↗ source
  • Global liver experts agree on definition of acute-on-chronic liver failure
    Liver doctors from many countries have reached a common definition for acute-on-chronic liver failure, a serious complication that occurs when an existing liver disease is suddenly worsened by an a…
    STAT · 1d agoPositive↗ source
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  • CVS split into two entities fails to address core issues in pharmacy benefit management
    CVS Health is one of the largest U.S. companies, serving hundreds of millions of Americans and generating about $400 billion in annual revenue. It touches nearly every step of the drug supply chain…
    STAT · 1d agoNegative↗ source
  • ARPA-H teams meet FDA within two months of launching autonomous clinical AI program
    Multiple teams in ARPA-H's Advocate program, which focuses on autonomous clinical AI tools, have already held an initial informational meeting with the FDA. The meeting took place less than two mo…
    Endpoints · 13h agoRegulatoryNeutral↗ source
  • Trump's MFN drug pricing agreements complicate new drug launches
    President Donald Trump announced nine new agreements with drug manufacturers on Aug. 31, extending the “most favored nation” (MFN) pricing framework. Under MFN, U.S. prices for participating drugs…
    Endpoints · 14h agoRegulatoryNegative↗ source
  • FDA requires GLP-1 drug labels to include warning about rare eye disease
    The FDA has issued a directive to manufacturers of GLP-1 therapies, instructing them to revise product labeling. The label change must highlight an increased risk of a rare ocular condition that c…
    Endpoints · 14h agoRegulatoryNeutral↗ source
  • Phase 3 trial shows Zealand-Boehringer obesity drug survodutide does not raise cardiovascular death risk
    The Phase 3 SYNCHRONIZE-CVOT study found that survodutide, the joint obesity therapy from Zealand and Boehringer Ingelheim, was non‑inferior to placebo for cardiovascular death, indicating no added…
    BioSpace · 15h agoPositive readoutNeutral↗ source
  • American Heart Association meeting reports neutral outcomes for inflammation and Lp(a) trials
    The American Heart Association's scientific sessions in Chicago highlighted a theme of neutral findings across cardiovascular research. Two high profile trials, ZEUS targeting inflammation and HOR…
    STAT · 17h agoNeutral↗ source
  • Heron sells assets to CorMedix for $145M upfront, Faeth shares plunge
    Heron Therapeutics announced it has sold a portfolio of assets to CorMedix for an upfront cash payment of $145 million. The transaction gives CorMedix additional product candidates and expands its…
    Endpoints · 18h agoDealNeutral↗ source
  • Zura Bio’s Phase 2 trial of tibulizumab fails, shares plunge
    Zura Bio announced that its experimental drug tibulizumab did not meet efficacy endpoints in a Phase 2 study of a painful skin disorder. The company said that both dose levels performed no better t…
    Endpoints · 20h agoNegative readoutNegative↗ source
  • Gene therapy sponsors urged to address six GMP manufacturing considerations early
    SK pharmteco’s chief technical officer Tatiana Nanda explained that gene therapy sponsors need to think about manufacturing issues well before reaching GMP production. She told BioSpace that early…
    BioSpace · 1d agoNeutral↗ source
  • Pentagon removes WuXi AppTec from Chinese military companies list, but risk of redesignation remains
    The U.S. Department of Defense announced that WuXi AppTec, a Shanghai-based contract research and manufacturing firm, has been taken off the Pentagon’s list of Chinese entities tied to the People’s…
    Endpoints · 15h agoRegulatoryNeutral↗ source
  • Trump administration issues new guidelines to curb AI-driven bioweapon threats
    The White House announced a set of guidelines aimed at preventing the misuse of artificial intelligence in creating biological weapons. Officials said the rapid advances in AI-driven drug discovery…
    STAT · 21h agoRegulatoryNeutral↗ source
  • AI chatbots may help men share emotions, study suggests
    AI chatbots are not therapists, but they can offer a low‑pressure space where men feel less judged when discussing personal concerns. The article follows Luca, who drove across Europe to be with h…
    STAT · 1d agoNeutral↗ source
  • Bill Ackman Announces Ambitious Initiative to Advance Brain Research
    Billionaire investor Bill Ackman has unveiled a new, bold plan aimed at transforming brain research. The initiative is driven by a personal tragedy that has motivated him to seek breakthroughs in…
    STAT · 14h agoPositive↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 19h agoLayoffsNegative↗ source
  • STAT+: Trump administration removes WuXi AppTec from its Chinese military list
    The Trump administration has removed WuXi AppTec, a key partner for the pharma industry, from its list of “Chinese military companies” operating in the U.S.
    STAT · 13h ago↗ source
  • Update: FDA investigates Novartis' Zolgensma following 9 cases of tumors in treated patients
    After Novartis confirmed the reports of tumors in patients who have been treated with the spinal muscular atrophy gene therapy, the FDA will determine if any regulatory action is needed for Zolgens…
    BioSpace · 19h ago↗ source
  • STAT+: Pharmalittle: We’re reading about a Novartis heart drug, BIO fighting a Trump program, and more
    Novartis is largely abandoning a drug once considered a potential blockbuster after a study found it had little promise for preventing heart attacks and deaths
    STAT · 19h ago↗ source
  • Recent heart-drug trials miss endpoints, raising doubts about AI-driven drug design
    Two large clinical studies presented at the American Heart Association meeting this weekend failed to show any benefit for experimental heart‑attack and stroke therapies, underscoring the difficult…
    STAT · 2d agoNegative readoutNegative↗ source
  • Vir Biotechnology reports positive results for hepatitis D combo in first pivotal trial
    Vir Biotechnology announced that its chronic hepatitis D treatment met its primary goal in the first of three late‑stage studies. The trial evaluated a once‑monthly combination therapy that include…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • Study finds training bystanders and responders does not boost survival after sudden cardiac arrest
    Sudden cardiac arrest kills about 350,000 people in the United States each year, and only one in ten victims survive. Survival depends heavily on rapid CPR and defibrillation by nearby bystanders o…
    STAT · 1d agoNegative↗ source
  • Fresh & Ready Foods recalls 2,414 Fresh To You sausage, egg & cheese biscuit sandwiches over possible Listeria contamination
    Fresh & Ready Foods LLC of Renton, Washington announced a recall of 2,414 Fresh To You sausage, egg and cheese biscuit sandwiches after testing indicated a potential contamination with Listeria mon…
    fda recalls · 2d agoNegative↗ source
  • FDA opens investigation into Novartis' Zolgensma after cancer cases reported
    The U.S. Food and Drug Administration announced on Friday that it is opening a formal investigation into the gene-therapy product Zolgensma, marketed by Novartis for spinal muscular atrophy. The a…
    Endpoints · 2d agoRegulatoryNegative↗ source
  • Biotech Trade Group BIO Sues Over Medicare GLOBE Pricing Pilot
    BIO and two California biotech trade groups have filed a lawsuit in federal court to stop the Medicare GLOBE pilot that would tie US drug prices to those in peer nations. The complaint argues the…
    STAT · 2d agoRegulatoryNegative↗ source