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In an Oct. 28-31 meeting, the EMA’s pharmacovigilance risk assessment committee (PRAC) warned against the use of Sanofi’s multiple sclerosis drug Lemtrada (alemtuzumab) in patients with certain heart, circulation, bleeding or auto-immune disorders besides multiple sclerosis. Read More
The Institute for Clinical and Economic Review (ICER) has questioned the cost-effectiveness of Novo Nordisk’s recently approved Type 2 diabetes treatment Rybelsus (oral semaglutide) compared to alternatives. Read More
A new draft guidance from the FDA encourages drugmakers to speed up development of Hepatitis D treatments for use in the U.S., offering recommendations for innovative trial designs, target populations and endpoints. Read More
Acting FDA Commissioner Ned Sharpless ends his six-month stint at the agency today, and the White House is expected to nominate oncologist Stephen Hahn to fill the permanent role. Read More