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The FDA is turning up the heat on pharmaceutical firms for a range of GMP violations, firing off warning letters to three companies over issues ranging from data integrity to risk management. Read More
The Bangladesh High Court has targeted 34 drug firms for ignoring an earlier ban on their products, demanding that they immediately recall their products. Read More
The Chinese FDA has made sweeping reforms to the country’s nine-year-old drug registration rules, looking for industry feedback on a range of drug approval related revisions. Read More
The UK’s drug pricing watchdog has recommended reimbursement of Novartis’ innovative drug Cosentyx for ankylosing spondylitis, but only if it provides it at a discount. Read More
In the absence of industry pushback, an FDA final rule on manufacturing procedures and dating processes for biologics will take effect as planned on Sept. 16. Read More
The FDA wants drugmakers to use clinical remission as their primary endpoint when conducting trials for short-term ulcerative colitis therapies. Read More
Industry continues to be divided on whether to include interchangeability statements on biosimilar labels, with Amgen taking the lead in support and Merck taking the lead against in comments on the FDA’s March draft biosimilar labeling guidance. Read More