Two drugs were pushed back by the EMA last week, with a recommendation that Ocaliva, currently the only second line standard of care for treating primary biliary cholangitis, be withdrawn from the market, and a refusal to grant conditional approval for masitinib in the treatment of amyotrophic lateral sclerosis.
Yuhan Corp., of Seoul, South Korea, has inked a ₩150 billion (US$108.6 million) deal with Korean biotech Ubix Therapeutics Inc. to gain exclusive global rights to UBX-103, Ubix’s oral small-molecule androgen receptor degrader for prostate cancer. Yuhan also announced July 1 that it gained the U.S. FDA’s nod to start a phase I study of a Gaucher disease drug candidate called YH-35995.
In a ruling delivered June 28, the U.S. Supreme Court brought an end to four decades of a practice of judicial deference to federal government agencies in litigation under the Chevron doctrine, a practice that some argue has enabled regulatory mischief.
Syntheticmr AB received CE marking for its next-generation brain imaging solution, SyMRI Neuro. The company hopes that version 15 of its SyMRI software, which provides quantitative data, automatic tissue segmentation and adjustable contrast weighted images from a scan, will transform diagnostic imaging.
A trio of regulators devised a series of good machine learning practices in 2021, a key point of consideration for many algorithms that will eventually be used in thousands of medical applications in the coming years.
Kbio Inc. has obtained IND clearance from the FDA for EV68-228-N, a human monoclonal IgG1 against the capsid of enterovirus D68 (EV-D68) designed as an intravenous therapeutic for the treatment of acute flaccid myelitis.
Circle Pharma Inc. has submitted an IND application to the FDA for CID-078, a first-in-class cyclin A/B RxL inhibitor. Pending approval, the company plans to initiate a phase I trial in patients with advanced solid tumor malignancies.
SCG Cell Therapy Pte Ltd. has gained FDA clearance of its IND application to initiate a phase I/II trial of SCG-142, a novel next-generation human papillomavirus (HPV) E7-specific T-cell receptor-engineered T (TCR T)-cell therapy for patients with HPV-associated solid tumors.
CSL Behring’s expensive hemophilia B gene therapy is to be reimbursed by the U.K. National Health Service, after the company agreed to an outcomes-based payment scheme. The therapy, Hemgenix (etranacogene dezaparvovec), which has a U.K. list price of £2.6 million (US$3.3 million), was approved under a managed access scheme, in which data will be collected over five years to enable both the long-term effectiveness, and any adverse liver toxicity caused by the transgene, to be monitored.
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