More than two years after the U.S. FDA shocked Intercept Pharmaceuticals Inc. with its rejection of obeticholic acid to treat fibrosis due to nonalcoholic steatohepatitis (NASH), the company has announced data it said will form the basis of a NDA refile in the disease for which there is no approved therapy. Read More
Three serious adverse events have led the U.S. FDA to place a clinical hold on Diamedica Therapeutics Inc.’s phase II/III study of DM-199, a synthetic form of human tissue kallikrein-1 for treating acute ischemic stroke. The blood pressure in three participants dropped to a significantly low level shortly after receiving an I.V. dose of the therapy. All three bounced back to normal within minutes of stopping the I.V. Read More
Attention has turned to Cytomx Therapeutics Inc.’s CX-2029 candidate after the company held up its program with the CD166-directed antibody-drug conjugate CX-2009, based on phase II data in patients with hormone receptor-positive/HER2-non-amplified breast cancer.
Sumitovant Biopharma Ltd. subsidiary Urovant Sciences GmbH is out-licensing overactive bladder (OAB) treatment vibegron to Pierre Fabre Médicament to register and commercialize the drug in the EU, U,K, and Switzerland. Under the terms of the deal, Basel, Switzerland-based Urovant will receive up to $75 million in up-front payments, regulatory and sales milestones and royalties, while Urovant will retain full commercialization rights to vibegron in the U.S. and certain other markets. Read More
Beigene Ltd. has formed a partnership with Innorna Co. Ltd. to jointly develop messenger RNA (mRNA)-based therapeutics. Shenzhen, China-based Innorna will get an undisclosed up-front payment and is also eligible to receive additional payments based on development, regulatory and commercial milestones, as well as tiered royalties. Beigene will maintain exclusive global rights to the mRNA candidates co-developed in the deal. Read More
A few weeks ago, the odds of the deeply divided U.S. Congress passing drug pricing reforms that would allow direct Medicare negotiation seemed pretty slim. But those odds improved significantly July 6 when Senate Democrats reached a compromise on their version of the pricing provisions included in the Build Back Better bill, H.R. 5376, passed by the House last November. Read More
New hires and promotions in the biopharma industry, including: Ariceum, Emergent, Evolveimmune, Eyenovia, Kinaset, Piramal, Tevogen, Tscan, Ventus. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Gnubiotics, Homology, Immunome, Intravacc, Kalvista, Kamada, Mnemo, Pfizer, Plakous, Ring, Roivant, Sollievo, Touchlight, Turnstone, Vast, Walden. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Biogen, Chinook, Coherus, Junshi, Inflarx, Kazia, Olix, Pyramid, Roche, Sensorion, Takeda, Titan, Turnstone. Read More
