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A pharmacy chain brought class action suits against 13 generics manufacturers — including Mylan, Sandoz, and Teva — claiming they conspired to raise prices of six drugs, including blood pressure medications, antidepressants and corticosteroids. Read More
The World Health Organization published its biennial update to its list of essential medicines, adding therapies for hepatitis C, HIV and leukemia, as well as new advice on combating antimicrobial drug resistance. Read More
An FDA investigation into serious quality problems at a Florida pharmaceutical company revealed a litany of unsound practices in the manufacture of experimental drugs. Read More
The FDA hit multiple manufacturers with extensive Form 483s, including an Ohio outsourcing facility where failures to adhere to GMP and overall sterility, cleaning and quality control issues proved to be problems repeated from an inspection a year before. Read More
The European Medicines Agency answered the most pressing questions related to the United Kingdom’s exit from the European Union, making it clear UK-made products would be subject to import quality inspections — and that companies in the UK may have to relocate their pharmacovigilance work and personnel to comply with regulations. Read More
Significant GMP violations and repeating problems at U.S. companies across the drug supply chain lead the FDA to issue warning letters, including a lack of product testing at an Oklahoma drug manufacturer. Read More