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The FDA has delayed Clovis Oncology’s bid to approve its new lung cancer treatment, asking for additional trial data that could see the March 30 PDUFA date extended. Read More
The board of directors of Brazil’s Anvisa has suspended the deadline for companies to submit data for a new drug tracking system and is repealing the system’s implementing legislation. Read More
A ruling by the Court of Justice of the European Union has clarified when drug patents expire, in a decision that could prove lucrative for drugmakers even though it adds only a few days of patent protection. Read More
Some of the world’s poorest nations have been granted an extended exemption from enforcing pharmaceutical patent protections by a World Trade Organization body overseeing intellectual property rights. Read More
To beef up scrutiny of drugs, India’s health ministry has proposed a roughly U.S. $277 million plan to overhaul the Central Drugs Standard Control Organization — by strengthening the inspections framework, establishing new national testing laboratories and firming up databases of products and clinical trials. Read More
The European Medicines Agency’s decision to redact certain personal and commercial information from clinical study reports before releasing them to a private citizen did not violate EU transparency policy, the European ombudsman says. Read More
The U.S. Food and Drug Administration issued eight warning letters to active pharmaceutical ingredient manufacturers during fiscal year 2015 — all of them to non-U.S. companies and all for data integrity issues. Read More
Japanese regulators are hoping to halve drug review times and speed up patient access to novel therapies by encouraging companies to file NDAs first in Japan, or in tandem with U.S. and EU submissions, under an approval pathway approved in April. Read More
With a growing number of biologics set to lose patent protection in coming years, a leading industry group is calling for regulatory reforms to encourage the development and approval of biosimilars. Read More
The European Medicines Agency’s EudraVigilance system for monitoring drug side effects and adverse events is about to undergo an overhaul, and regulators are readying drugmakers and national authorities with a new change plan. Read More