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Latest From Sue Sutter
Roche, through Genentech, returns to the PhRMA fold after leaving the trade group in 2009; Gilead is a first-time member; both are retaining their BIO memberships as well.
As US FDA weighs fate of Takeda’s febuxostat, advisory committee members suggest REMS to ensure prescribers have informed benefit/risk conversation with patients, but agency staff highlight design and assessment challenges for such a program.
Continued availability of Takeda’s febuxostat should be restricted to second-line use in gout patients who cannot tolerate or fail allopurinol, advisory committee majority says, opposing market withdrawal; but panelists’ suggestion that a Risk Evaluation and Mitigation Strategy be put in place to ensure patients and prescribers discuss cardiovascular risks receives pushback from agency.
Advisory committee will discuss whether CARES postmarketing trial showing 34% increased risk of cardiovascular death for febuxostat warrants market withdrawal, use restrictions, or new labeling for the gout drug.
Daily round-up of news and notes from the 2019 J.P. Morgan Healthcare Conference in San Francisco: Biogen may be looking for gene therapy partner, Lilly CEO says Loxo is just the start, GSK plays up its BCMA, Amgen vows to put money into deals, Biohaven readies oral CGRP inhibitor to compete, and Roche talks value-based payments.