In the first trial verdict of thousands of similar suits, a federal jury ordered AbbVie to pay $150 million to a man who claimed the company’s testosterone drug AndroGel caused…

With just over two months left in the program, the FDA finalized a question-and-answer guidance for GDUFA I, covering ANDA reviews, inspections and self-identification of facilities. Source: Drug Industry Daily

The Reagan-Udall Foundation unveiled an online directory of dozens of pharmaceutical company policies on expanded access to investigational therapies. Source: Drug Industry Daily

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.…

The FDA issued a revised version of its ICH-developed guidance on completing the clinical overview section of the Common Technical Document, including more details on risk-benefit submissions. Source: Drug Industry…

Samsung Bioepis and Merck announced the U.S. launch of Renflexis (infliximab-abda), a biosimilar of Janssen’s Remicade (infliximab). Source: Drug Industry Daily

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.…

The FDA does not intend to object to an institutional review board waiving informed consent requirements for certain clinical investigations considered to be “minimal risk,” according to a new agency…

On June 30, FDAnews, which provides global regulatory information for executives in the clinical research, biopharmaceutical and medical device industries, was acquired by WIRB-Copernicus Group (WCG). Source: Drug Industry Daily

Data integrity, recordkeeping and drug trial oversight violations feature in the UK Medicines and Healthcare products Regulatory Agency’s latest report on good clinical practice inspections. Source: Drug Industry Daily