The agency warned against use of AbbVie's Mavyret, Gilead Sciences' Vesovi and Merck's Zepatier in patients with moderate to severe liver disease amid reports of 63 patients with liver decompensation, with some cases being fatal.
The study, by US and Korean researchers, found Guardant360's detection of MSI-H/dMMR "highly concordant" with that of standard tissue biopsy, including in a subset of gastric cancer patients who responded to immunotherapy.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Recarbrio was approved for treating complex urinary tract and intra-abdominal infections among adult patients who have limited or no therapy options.
District Court Judge Amit Mehta ruled Monday that the Department of Health and Human Services lacked the authority to impose the rule, which it adopted in May.
Amgen, Eli Lilly and Merck - plus the Association of National Advertisers - said in a complaint filed Friday that the law would mislead consumers, overstep the government's authority and violate the First Amendment.
The four companies are collaborating under a program that stems from a law that Congress passed in 2013 to develop an electronic pharmaceutical tracking system.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
The KEYNOTE-119 study failed to show a survival benefit in TNBC patients. The news comes two months after the FDA gave accelerated approval to a rival, Roche's Tecentriq.
Adam Schechter, an adviser to Merck's CEO, said at the Veeva Summit Tuesday that many primary care diseases - such as cardiovascular disease and Alzheimer's - still have significant unmet needs.
The deal, expected to close in the second quarter of this year, would bolster Merck's therapeutic vaccine capabilities, an analyst wrote.
The company said it had shared data from the Phase III study with the FDA. However, per FDA regulations, there is a risk that the accelerated approval for hepatocellular carcinoma could be withdrawn.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
Although blockchain faces regulatory hurdles and skepticism, its potential as a shared, yet secure ledger system to improve the pharmaceutical supply chain integrity and clinical trials is making it attractive for experimentation and investment by drugmakers.
Lower costs for capital and sequencing, a friendlier regulatory and reimbursement environment and growth in precision medicine are among driving factors.
Merck, Volans-I, Softbox and AT&T are working with Direct Relief to test the drone system, which will deliver medicines to remote areas of the island.