Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avidity, Clearside, Genentech, GSK, Janssen Cilag, Minoryx, Precision, Revolution Medicines, Solid.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abivax, American Gene Technologies, Ani, Apnimed, GH Research, Lantern.
South Korea’s pharmaceutical manufacturing reached an all-time high of ₩32.86 trillion (US$23 billion) in 2024, representing a 7.3% increase from 2023 and the highest on record since the country began count in 1998.
Suzhou, China-based Kintor Pharmaceutical Ltd.’s KX-826 met the primary endpoint in a phase II trial for treating male adult androgenetic alopecia (AGA). Kintor is developing KX-826 (pyrilutamide), an androgen receptor inhibitor, for topical treatment of AGA as well as acne vulgaris.
Neurogene Inc.’s disclosure June 30 of its registrational trial design in Rett syndrome (RS) added spice to the space, where Taysha Gene Therapies Inc. is another closely watched player. The New York-based firm said Embolden will test NGN-401, a gene therapy for the treatment of females age 3 and older with RS. U.S. regulators have signed off regarding key aspects of Embolden’s structure.
Becoming the first approved treatment for chronic hand eczema in the U.S., Leo Pharma A/S’s Anzupgo (delgocitinib) received FDA clearance for an indication that affects 10% of adults worldwide. The cream, dosed at 20 mg/g and applied topically, will treat moderate to severe cases in those not responsive to, or unable to take, topical corticosteroids.
Astrazeneca plc seems on the way to expanding its presence in myasthenia gravis (MG) with positive “high-level” results from a global, randomized, double-blind, placebo-controlled phase III trial with once-weekly, self-administered gefurulimab in adults with anti-acetylcholine receptor antibody-positive, generalized disease.
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