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The list of Chinese pharmaceutical companies in the FDA’s crosshairs keeps on growing, with the agency hitting two drugmakers for GMP violations and another for refusing an inspection. Read More
A second FDA inspection of niche drugmaker Sri Krishna in almost 10 years has turned up a bevy of complaints regarding the company’s quality control systems and the accuracy of its data. Read More
To bridge the gulf between the promise of biosimilars on drug pricing and the reality, payors should incentivize biosimilar utilization, a new report states. Read More
The UK’s National Institute for Health and Care Excellence has recommended reimbursement for PTC Therapeutics’ Translarna for the treatment of Duchenne muscular dystrophy. Read More
The FDA has thrown a wrench into Chiasma’s plans to market Mycapssa, the company’s acromegaly candidate, issuing a complete response letter that asks for more data. Read More