We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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