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(MedPage Today) -- The FDA approved the small-molecule inhibitor pimicotinib (Pimjetmi) for selected patients with symptomatic tenosynovial giant cell tumor (TGCT) and high surgical risk. An oral selective inhibitor of colony stimulating factor...
Hims & Hers struck a deal with Eli Lilly to offer the drugmaker’s branded obesity treatments through its online health and wellness platform.
Brepocitinib produced dramatic improvement in patients with cutaneous sarcoidosis, a condition lacking any very effective therapy, in a small phase II trial presented in Orlando. The dual-acting TYK2/JAK1 inhibitor, marketed as Lisraya, was tested in a trial the excerpt describes only as small, without giving a patient count or effect size.
Regulators approved asundexian, marketed as Sunharbo, as the first factor XIa inhibitor for secondary stroke prevention. The FDA announced the decision on Monday; the drug is an oral, direct, small-molecule inhibitor of FXIa. The excerpt does not state how this changes care for patients.
(MedPage Today) -- Reductions in hepatitis B surface antigen (HBsAg) were observed with a novel small interfering RNA (siRNA) therapy in patients with chronic hepatitis B virus (HBV) infection, according to a phase II study. Among patients randomized...
Federal Medicare regulators have finalized rules codifying the drug price negotiation framework created by the Inflation Reduction Act. The action locks in that framework while drugmakers continue to press repeated legal challenges in court.
Researchers reported mixed results from a trial testing CAR T-cell therapy in rheumatoid arthritis. Data presented at a conference in Orlando suggested RA responds less consistently to the approach than lupus and certain other autoimmune conditions have.
(MedPage Today) -- Results from the TroFuse-005 trial presented at the annual European Society for Medical Oncology congress showed that the investigational antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) significantly improved...
Siggy launched from stealth as an AI-enabled virtual mental health startup. It combines therapy, prescription management and AI for intake and between-visits support.
(MedPage Today) -- In patients treated with resmetirom (Rezdiffra), early responses in blood and imaging biomarkers were associated with resolution of metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis improvement, according to...
Argenx acquired Unnatural Products for $550 million, adding a macrocyclic peptide discovery platform for oral peptide drugs. The deal introduces a modality new to Argenx, whose immunology research had centered on antibodies.
Executives from Noom, Omada, Virta and Twin Health discussed moving beyond the pill in their GLP-1 strategies during a panel. They also addressed whether their companies will exist two to three years from now.
Nkarta will present initial clinical data for its natural killer cell therapy in two disorders, myositis and systemic sclerosis, during the American College of Rheumatology annual in Orlando this week. The biotech is part of a growing group of companies developing therapies that
Regulators granted accelerated approval to Johnson & Johnson’s Rybrevant Faspro for advanced head and neck cancer. The bispecific antibody was initially approved for treating certain lung cancers.
Healthcare AI systems keep changing after deployment, often unexpectedly, even when developers leave the model untouched. That post-approval drift, rather than the initial regulatory review, is where the hard problem sits.
Servier’s sevasemten failed a pivotal test in Becker muscular dystrophy. New results in the pivotal cohort did not reach statistical significance, though the small molecule had met a Phase 2 goal. Servier acquired the drug through its purchase of Edgewise Therapeutics’ muscular dystrophy assets.
Flagship Pioneering unveiled Etcelera, a new startup formed by combining three of the firm’s portfolio companies. Etcelera’s approach to drug R&D focuses on “causal intelligence,” which Flagship defines as predicting and understanding cause and effect in biology. The post Flagshi
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