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Celgene reached a civil settlement with the Department of Justice and 28 states, as well as Washington D.C. and the city of Chicago, agreeing to pay $280 million to resolve a case over off-label marketing claims for two cancer treatments — Thalomid (thalidomide) and Revlimid (lenalidomide). Read More
The Reagan-Udall Foundation unveiled an online directory of dozens of pharmaceutical company policies on expanded access to investigational therapies. Read More
Eighteen patients filed a lawsuit against Merck, claiming its shingles vaccine Zostavax caused them to contract shingles and, in two cases, to develop persistent nerve pain related to the virus. Read More
A new party platform unveiled by Democrats on Monday includes new measures to lower the cost of prescription medications, target drug industry gouging and require drugmakers to justify price increases. Read More
The agency plans to use the pilot to assess industry’s ability to meet the DSCSA’s requirements, including identifying illegitimate products and preventing diversion. Read More
The PTO’s Patent Trial and Appeal Board rejected five Mylan challenges to patents held by UCB Pharma and Pfizer covering the overactive bladder treatment Toviaz. Read More
The HHS arm that oversees the discounted drug pricing program has made some improvements to its operations since 2011 but it lacks regulatory authority to make other needed changes. Read More
Following Hospira’s recall last month of sterile sodium bicarbonate injections, the FDA has extended the expiration dates for more than 90 lots to help alleviate a critical shortage of injectable drugs. Read More