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1,946 stories matching this filter · ← front page

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  • Analysts see opportunity for Alnylam’s RNAi therapy after AstraZeneca/Ionis ATTR-CM trial fails
    AstraZeneca and its partner Ionis reported a disappointing Phase 3 result for the antisense drug Wainua in transthyretin amyloid cardiomyopathy (ATTR-CM). The unexpected outcome was a focal point o…
    Fierce Biotech · 11d agoNegative readoutNeutral↗ source
  • Electra Therapeutics files for Nasdaq IPO to fund phase 2/3 immunology and cancer programs
    Electra Therapeutics, based in South San Francisco, announced it has filed a registration statement to list its shares on the Nasdaq Global Select Market under the ticker ETRA. The company says th…
    Fierce Biotech · 11d agoDealPositive↗ source
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  • AstraZeneca's oral relaxin agonist shows positive phase 2b results in chronic heart failure
    AstraZeneca presented phase 2b data from its Luminara trial at the European Society of Cardiology Congress in Munich. The study evaluated the oral relaxin agonist AZD5462 in patients with chronic h…
    Fierce Biotech · 11d agoPositive readoutPositive↗ source
  • Personalized mRNA melanoma vaccine shows clinical success, reviving optimism for the platform
    Moderna and Merck reported positive results from a personalized mRNA vaccine designed to treat melanoma in a recent clinical study. The outcome is being hailed as a boost for mRNA technology, whic…
    STAT · 12d agoPositive readoutPositive↗ source
  • Experts urge FDA to boost transparency of complete response letters and refine master protocol guidance
    A recent paper in the Journal of Law and the Biosciences outlines ways the FDA could better disclose complete response letters to the public, aiming to increase transparency for stakeholders. Indu…
    raps · 12d agoRegulatoryNeutral↗ source
  • Radiopharmaceutical experts urge pharma to adopt bolder dosing despite safety concerns
    Louise Emmett and a group of radiopharmaceutical specialists argue that these modern radiation‑based drugs could dramatically improve cancer outcomes if used more aggressively. They say the therapi…
    STAT · 12d agoNeutral↗ source
  • Natera partners with Angiex to evaluate Signatera blood test in AGX101 cancer trial
    Natera announced a collaboration with biotech Angiex to assess its Signatera circulating tumor DNA blood test in the context of Angiex’s early‑stage clinical trial of AGX101. Angiex, based in Camb…
    Fierce Biotech · 12d agoDealPositive↗ source
  • Crystal Temptations Issues Allergy Alert on Undeclared Milk in Chocolatey Eyeballs
    Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run th…
    fda recalls · 11d agoRegulatoryNeutral↗ source
  • Pregnancy hormone explored as possible guide for cardiovascular drug development
    The STAT+ newsletter preview highlights a discussion about whether a hormone that regulates pregnancy could be leveraged to direct a new cardiovascular therapy. The piece also notes that researche…
    STAT · 11d agoNeutral↗ source
  • Industry and patient groups urge FDA to revise master protocol guidance
    Industry groups and patient advocacy organizations have written to the U.S. Food and Drug Administration asking for several revisions to its recently updated draft guidance on master protocols for…
    raps · 12d agoRegulatoryNeutral↗ source
  • Highlights from the European Society of Cardiology meeting and updates on radiopharmaceutical research
    The newsletter reports that the European Society of Cardiology convened in Munich, with Europe correspondent Andrew Joseph providing coverage of the event. The author contrasts the ESC’s rotating…
    STAT · 11d agoNeutral↗ source
  • India streamlines regulations for outsourced medical device sterilization
    The Indian government announced a simplification of the regulatory framework governing outsourced sterilization of medical devices. The move is part of a broader effort to make it easier for busine…
    raps · 12d agoRegulatoryPositive↗ source
  • Kofinas Olive Oil voluntarily recalls garlic-infused extra virgin olive oil over unapproved essential oil
    LMSI LLC/Kofinas Olive Oil announced a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil because it contains a garlic essential oil not approved for culinary use. The pro…
    fda recalls · 11d agoCRLNeutral↗ source
  • Study reports up to 25% of sampled NFL players had CTE at death, sparking calls for league-wide action
    Researchers in the Boston area examined the brains of a sample of former NFL players and found that about one quarter showed signs of chronic traumatic encephalopathy at death. The authors noted th…
    STAT · 12d agoNegative↗ source
  • FDA approves Mimrylo, a weekly injection for polycythemia vera, developed by Protagonist and sold by Takeda
    The Food and Drug Administration has approved a new therapy for polycythemia vera, a rare blood cancer that causes an overproduction of red blood cells. The drug, known as rusfertide, will be mark…
    STAT · 12d agoApprovalPositive↗ source
  • Alnylam defends its heart failure silencers after AstraZeneca's ATTR-CM trial miss
    AstraZeneca reported that its experimental drug Wainua failed to meet its primary endpoints in a study of transthyretin amyloid cardiomyopathy (ATTR-CM). The setback raised concerns about the thera…
    STAT · 12d agoNeutral↗ source
  • Novartis IL-6 antibody pacibekitug cuts inflammation markers in Phase 2 study
    A Phase 2 trial called TRANQUILITY showed that pacibekitug, an IL-6‑targeting antibody acquired by Novartis, reduced several biomarkers of inflammation in participants. The reductions were sustain…
    STAT · 14d agoPositive readoutPositive↗ source
  • Northwest Naturals recalls frozen cat and dog chicken diets over possible Salmonella and Listeria contamination
    Northwest Naturals of Portland, Oregon announced a voluntary recall of two frozen pet food products after detecting possible bacterial contamination. The recall includes 53 cases (1,272 lb) of fro…
    fda recalls · 14d agoCRLNegative↗ source
  • AstraZeneca’s ATTR-CM Silencer Trial Fails to Show Benefit Over Existing Stabilizer Therapy
    AstraZeneca announced that its Phase 3 trial of a silencer drug for transthyretin amyloid cardiomyopathy (ATTR-CM) did not meet its primary endpoints. The study showed no additional clinical benefi…
    STAT · 15d agoNegative readoutNegative↗ source
  • AusperBio secures $120 million Series C to push hepatitis B antisense therapy into Phase 3
    AusperBio Therapeutics announced it has closed a $120 million Series C financing round aimed at moving its hepatitis B antisense oligonucleotide candidate toward late‑stage trials and eventual mark…
    Fierce Biotech · 14d agoDealPositive↗ source
  • Cytokinetics reports positive pivotal trial results for aficamten in non-obstructive hypertrophic cardiomyopathy
    Biotech Cytokinetics disclosed full data from a pivotal study of its drug aficamten in patients with non-obstructive hypertrophic cardiomyopathy (nHCM). The trial met both primary endpoints, showin…
    STAT · 14d agoPositive readoutPositive↗ source
  • Roche pays $190 million for rights to Hanmi's UCN2 analog targeting obesity with muscle-preserving effects
    Roche's Genentech unit has agreed to pay $190 million upfront for rights to HM17321, a urocortin‑2 analog developed by South Korea’s Hanmi Pharmaceutical, covering markets outside South Korea. The…
    Fierce Biotech · 15d agoDealPositive↗ source
  • Genentech pays $45M upfront to DualityBio for ADC platform targeting resistant cancers
    Genentech has agreed to pay DualityBio $45 million upfront for rights to its antibody‑drug conjugate (ADC) technology, with the agreement offering more than $1 billion in potential milestone paymen…
    Fierce Biotech · 15d agoDealPositive↗ source
  • AstraZeneca and Ionis report unexpected failure of heart disease drug in trial
    AstraZeneca and Ionis disclosed that their collaborative heart disease drug did not meet primary endpoints in a recent trial, marking a surprise setback. The companies detailed the trial results,…
    STAT · 14d agoNegative readoutNegative↗ source
  • BioNTech-Genentech halts colorectal cancer vaccine trial after higher death rate in vaccine arm
    BioNTech and Genentech stopped a phase 2 trial of their personalized mRNA vaccine BNT122 in patients with stage 2 or 3 colorectal cancer after an independent data safety monitoring board found more…
    Fierce Biotech · 14d agoNegative readoutNegative↗ source