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The UK’s drug pricing watchdog has recommended that the National Health Service reimburse for Amgen’s melanoma therapy Imlygic, provided that the company lowers the price. Read More
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