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Shortly after receiving an FDA warning letter for major quality deficiencies, Indian drugmaker was slammed for data integrity issues and GMP violations by the World Health Organization. Read More
The UK’s National Institute for Health and Care Excellence has recommended against reimbursing Vertex Pharmaceuticals’ cystic fibrosis drug Orkambi, saying benefits related to lung function were unlikely to be clinically significant. Read More
Merck won a key court victory late Tuesday with a jury concluding that two of Gilead Science’s blockbuster drugs infringe patents held by Merck & Co. and Ionis Pharmaceuticals. Read More
The FDA has unveiled enhanced warnings for opioid pain medications that will affect 141 generic and 87 innovative immediate-release opioid products, which account for roughly 90% of all prescription opioids. Read More