The new draft guidance for clinical decision support (CDS) software is in part a response to the 21st Century Cures Act, and the FDA Bakul Patel said on a Nov. 4 webinar, "we heard the feedback loud and clear" on the previous draft, and thus the agency must "get this policy to a place where it balances patient safety" and the need to avoid unnecessary roadblocks between developers and the market.
BEIJING – Chinese drug regulators granted conditional approval to Shanghai Green Valley (Group) Co. Ltd.'s marine-derived oligosaccharide, GV-971, to treat Alzheimer's disease (AD), but required further trials to prove the drug's efficacy after marketing.
Redhill Biopharma Ltd. CEO Dror Ben-Asher told BioWorld that the 2 million patients targeted by just-approved, delayed-release Talicia, previously known as RHB-105, for adult infection by Helicobacter pylori represents "the baseline where we start our promotion," and there's an opportunity to help many more patients. "When you combine the high prevalence of roughly 100 million Americans infected and more than half of the world's population with the association with gastric cancer, it's a major public health concern," he said. About 800,000 people worldwide die every year from gastric cancer, and about 90% of cases are caused by H. pylori.
MELBOURNE, Australia – Although Australia's Therapeutic Goods Administration (TGA) approved its first CAR T therapy in 2018, the country is lacking a system to reimburse those advanced therapies, and industry is calling on government to revalue gene therapies so that patients can access them.
The U.S. FDA's breakthrough devices program continues to rack up new designations, this latest one for Shréis Scalene Sciences LLC's Cytotron device. The noninvasive whole-body system, which is intended to break down or interrupt the growth of malignant tumors, is already CE marked and available in the European Union.
The U.S. Court of Appeals for the Federal Circuit has decreed that the regulations governing appointment of judges to the Patent Trial and Appeal Board (PTAB) violate the U.S. Constitution – a decision that gives a medical device maker a new bite at patent litigation, but which also raises the question of whether a large number of PTAB decisions will have to be relitigated.
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