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Federal judges—and not juries—should say what constitutes “clear evidence” that the FDA would likely have rejected changes to a drug’s label, the Supreme Court ruled Monday in a decision that could have far-reaching impact on preemption cases. Read More
Oklahoma AG Mike Hunter is claiming that the drug companies’ opioid business constitutes a public nuisance and is demanding millions in damages. Read More
The World Health Organization released draft guidelines advising regulators to test the wastewater of drug plants to keep antibiotics out of the environment—and it says wastewater treatment should be part of good manufacturing practices. Read More
Pharmacy benefits managers breathed a sigh of relief last week when the Trump administration backed off proposals that would set Medicare drug prices based on the discounts offered by the benefits managers. Read More
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended limiting prescriptions of Xeljanz and cancelling fenspiride’s marketing authorization, citing safety concerns. Read More
Health Canada is increasing fees for drug sponsors and will peg ongoing increases to inflation, the agency said in a final report on the planned changes. Read More
The agency says it will work hard to keep the minutes confined to “a summary of general concepts that were discussed, while excluding information” that might reveal a company’s important secrets. Read More
Akcea received a complete response letter from the FDA last year, citing concerns about the drug causing dangerous dips in patients’ platelet counts. Read More