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Japanese regulators are weighing whether the agency will need to begin approving some drugs based on Phase II trial data as they implement approval processes for personalized drug products.
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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
The drug pricing authority in India has published a compilation of the price caps for 509 drugs, effective Jan. 31, to give drugmakers a single source of pricing information. 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
The FDA wants to expand the use of biomarkers to speed up drug development and is asking for feedback on ones that have the most promise of benefiting drugmakers in the near term. Read More
The FDA has again found Upsher-Smith Laboratories’ testosterone gel Vogelxo therapeutically equivalent to Auxilium’s Testim — knocking down Auxilium’s citizen petition demanding higher hurdles for 505(b)(2) NDAs aimed at its therapy. Read More