The U.S. Supreme Court unanimously upheld the FDA’s relaxed regulation of the abortion drug mifepristone when it ruled June 13 that the organizations challenging those changes lacked the standing to do so.
Following a phase II/III failure, Stamford, Conn.-based Cara Therapeutics Inc. discontinued its only pipeline program, that of oral difelikefalin for moderate to severe pruritis in adults with notalgia paresthetica, placing the company’s future in question.
Urogen Pharma Ltd. shares (NASDAQ:URGN) closed June 13 at $17.50, up $4.78, or 37%, on word of an 82.3% 12-month duration of response data by Kaplan-Meier estimate from its phase III Envision study with UGN-102. The finding was made in in low-grade, intermediate-risk, non-muscle invasive bladder cancer patients who achieved complete response at three months after the first instillation of the drug for intravesical solution.
Chinese artificial intelligence (AI)-driven drug discovery firm Quantumpharm Inc., also known as Xtalpi, began trading on the Hong Kong stock exchange June 13, listing under a new special technology listing track that lured it away from an IPO in the U.S.
Even though the treatment options that exist for acute myeloid leukemia (AML) are growing, the clinical outcome of patients is still unfavorable. In AML dysregulation of the tyrosine kinase receptors, including RAS, RAF, MEK and ERK, and of the Aurora kinase family (AURK) exists, are both tied to AML development and progression.
Molecure SA has confirmed the in vitro activity of a molecule binding to a new mRNA target within its mRNA discovery platform. This represents the discovery of another class of molecules binding to a second mRNA biological target, which has been confirmed in in vitro assays.
The U.S. FTC’s campaign against the Orange Book listing of patents claiming device components gained momentum when a federal judge in New Jersey ordered Teva Pharmaceuticals USA Inc. to delist five device patents pertaining to its Proair HFA (albuterol sulfate) inhaler.
After delivering animal data to show that inhibiting the NLRP3 inflammasome induces weight loss in mice, Nodthera Ltd. has now demonstrated this effect translates to humans. In a phase Ib/II study of NT-0796, an orally available, brain-penetrant drug, subjects in both the active and placebo arms all lost weight, due to the calorie-restricted diet they received in the 28-day trial.
Ipsen SA picked up U.S. FDA accelerated approval for its Genfit SA-licensed elafibranor, making it the first new drug in eight years for treating primary biliary cholangitis, though a potential competitor lurks just around the corner.
After the phase IIa failure at lowering intraocular pressure to a statistically significant degree with SBI-100, Skye Bioscience Inc. is dropping work with the ophthalmic emulsion, meant to treat primary open-angle glaucoma or ocular hypertension. Resources are turning to the firm’s metabolic program, which includes nimacimab, targeting the cannabinoid 1 receptor, due to start a phase II trial in obesity during the third quarter of this year.
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