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The FDA plans to require risk evaluation and mitigation strategies for opioid analgesics — including immediate, extended-release and long-acting formulations — to ensure the benefits outweigh the risks of misuse, abuse, addiction, overdose and death. Read More
Juno has filed a lawsuit against Kite Pharma for the alleged infringement of eight patent claims covering a cancer immunotherapy that uses a chimeric T cell receptor. Read More
Spain’s Agency of Medicines and Medical Devices has ordered Madrid vaccine maker Angulema to suspend manufacturing and recall drug batches over GMP deficiencies. Read More
The FDA issued X2 Zero a warning letter, after investigators observed several GMP violations at the company’s Texas facility and unspecified active ingredients in its supplements. Read More
The FDA handed Baoying County Fukang a warning letter after the company’s management withheld information from the agency and failed to maintain methods and controls in compliance with GMP standards. Read More
A group of Senate Democrats said they were willing to work with the incoming Trump administration to lower prescription drug prices and change the status quo. Read More