The U.S. FDA issued new guidance for the development of non-opioid analgesics for chronic pain indications, with specific details on trial design, patient populations and meaningful outcomes, including reducing the nation’s reliance on opioids.
Less than two months after receiving priority review status for an NDA, Johnson & Johnson won U.S. FDA approval of Inlexzo, its intravesical gemcitabine-releasing system previously known as TAR-200, to treat adults with Bacillus Calmette-Guérin-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors.
Following a May phase II readout and a recent presentation of Tourmaline Bio Inc.’s long-acting anti-IL-6 IgG2 monoclonal antibody, pacibekitug, for atherosclerotic cardiovascular disease (ASCVD), Novartis AG offered $1.4 billion, or $48 per share, to buy the barely 4-year-old company. Previously shelved by Pfizer Inc., which had been developing it for autoimmune disorders, pacibekitug fell into the hands of New York-based Tourmaline through a May 2022 license agreement. In addition to the Tranquility phase II trial in ASCVD, the company’s lead product is also in the phase IIb Spirited trial for thyroid eye disease, a readout for which is expected in early 2026.
About two years since its founding, new company Radiance Biopharma Inc. signed a deal in which it could pay up to $1.165 billion to Novatim Immune Therapeutics Co. Ltd. for global rights outside of certain Asian countries to a bispecific nanobody antibody-drug conjugate that targets c-MET and EGFR to treat solid tumors.
About two years since its founding, new company Radiance Biopharma Inc. signed a deal in which it could pay up to $1.165 billion to Novatim Immune Therapeutics Co. Ltd. for global rights outside of certain Asian countries to a bispecific nanobody antibody-drug conjugate that targets c-MET and EGFR to treat solid tumors.
Following positive data from competitors earlier this year, United Therapeutics Corp. rolled out impressive and unexpected phase III results of nebulized Tyvaso (treprostinil) for idiopathic pulmonary fibrosis (IPF), setting the stage for an sNDA filing with the U.S. FDA next year. If approved for the indication, United, of Silver Spring, Md., and Research Triangle Park, N.C., could tap into what analysts say is a $4 billion-plus market.
Partly focused on delivery challenges that have limited the reach of RNA medicines, new biotech company Axelyf Inc. closed a $2.6 million seed round to support development of its AXL technology and to advance lead autoimmune candidate AXL-003.
Amid the increasingly competitive myasthenia gravis drug development space, siRNA candidate cemdisiran met phase III endpoints, with the monotherapy showing numerically higher results than a combination product. Regeneron Pharmaceuticals Inc., which has a worldwide license to cemdisiran from Alnylam Pharmaceuticals Inc., plans to file for U.S. approval in generalized myasthenia gravis, a rare and chronic autoimmune disease leading to life-threatening muscle weakness, in the first quarter of 2026.
Partly focused on delivery challenges that have limited the reach of RNA medicines, new biotech company Axelyf Inc. closed a $2.6 million seed round to support development of its AXL technology and to advance lead autoimmune candidate AXL-003.
