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Wockhardt’s CEO Habil Khorakiwala has characterized the FDA’s recent findings of nine Form 483 observations at its manufacturing plant in Shendra, India as minor, and predicted that the agency’s concerns would be resolved within a few months. Read More
A three-judge panel for the U.S. Court of Appeals for the Federal Circuit has upheld two Depomed patents, enabling it to resume its lawsuit against Purdue Pharma. Read More
In its second move this week to tackle the growing opioid epidemic, the FDA is outlining what tests sponsors of abuse-deterrent generic opioids should submit. Read More
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