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The European Medicines Agency is recommending halting sales of 700 drugs that were approved based on testing data provided by CRO GVK Biosciences, following an inspection that found the Hyderabad, India, firm manipulated echocardiogram data. Read More
The White House released a joint statement by President Barack Obama and Indian Prime Minister Narenda Modi pledging to negotiate a harmonized approach to intellectual property protections and establish standard definitions for what is patentable. Read More
The European Medicines Agency plans to bar sales of 700 drugs that were approved based on testing data provided by CRO GVK Biosciences, following an inspection that found the Hyderabad, India, firm manipulated echocardiogram data. Read More
A federal appeals court has upheld a lower court ruling that allowed Lupin to manufacture a generic of one of ViiV Healthcare’s HIV therapies, while blocking Teva’s ANDA of a related drug. Read More
The FDA last week granted final approval to Mylan and Watson for generic versions of Pfizer’s blockbuster arthritis drug Celebrex, allowing the companies to share 180-day exclusivity with Teva. Read More
The House Energy & Commerce Committee, which oversees the FDA, is planning an overhaul of agency procedures to increase orphan drug development, streamline clinical trials oversight and give industry incentives to find new uses for old drugs. Read More
Mylan and Sandoz need only FDA approval to launch their generic versions of Teva’s blockbuster MS drug Copaxone, after a federal judge refused Teva’s request to block generic entry. Read More
Israeli drugmaker Teva says it has uncovered questionable business practices at its operations in Russia, Eastern Europe, Latin America and elsewhere, in violation of the Foreign Corrupt Practices Act, the U.S. antibribery law. Read More