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The response letter is for Merck’s sNDAs for cholesterol drugs Zetia and Vytorin to reduce the risk of cardiovascular events in patients with coronary heart disease. Read More
Drug giant AstraZeneca has scored a big win in Europe, reeling in marketing authorization for Zurampic for patients with gout and a new dose of the heart medication Brilique. Read More
The UK’s National Institute for Health and Care Excellence delivered a stinging rebuke to Alexion Pharmaceuticals, saying it would not reimburse Kanuma for the treatment of lysosomal acid lipase deficiency until more evidence could support it. Read More
Notification requirements under the federal biosimilars law are getting renewed attention with two recent court filings: one, a petition to the U.S. Supreme Court, and the other an amicus brief before the U.S. Court of Appeals for the Federal Circuit. Read More
An NHS England spokesperson has confirmed that the agency will investigate whether more than 130 NHS staff involved in assessing drugs were also paid as consultants by drugmakers. Read More