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The European Medicines Agency issued an updated action plan to encourage advanced therapy medicinal products (ATMPs) — including the release by year’s end of draft guidelines for clinical trial sponsors. Read More
The European Medicines Agency’s updated guidelines on good pharmacovigilance practices took effect Nov. 8 — urging sponsors to pay particular attention to symptoms subjects may be unable to communicate. Read More
The Trump administration’s newly negotiated trade deal with Canada and Mexico threatens to keep American drug prices high, two dozen-plus consumer, health, trade and other organizations warned in a letter to the U.S. Trade Representative. The 29 groups — including the Association for Accessible Medicines (AAM) and the AARP — claim some provisions in the proposed NAFTA overhaul are inconsistent with U.S. law. Read More
Two prominent UK drug organizations say they’re “generally supportive” of MHRA’s contingency plans if the UK exits the EU on March 29 without a deal, but expressed concern about orphan drugs and centrally authorized product licenses, among other issues. Read More
The PTO’s Patent Trial and Appeal Board invalidated two patents for Sanofi’s cash cow Lantus (insulin glargine) siding with Mylan in its inter partes review proceedings. Read More
The FDA withdrew a proposed rule on Thursday that would have allowed generic drugmakers to independently update and distribute revised labeling to reflect new safety data. Read More
Kripke argued the risk controls are needed because the drugs increase a patient’s risk of all-cause mortality and numerous serious conditions. Read More
“ICH Q12 is recognizing that too many changes require regulatory reporting and often at too high a reporting level, stifling innovation and creating potential global supply challenges,” Eli Lilly said. Read More