The European Medicines Agency should focus on real-world evidence and big data to assess the impact of the agency’s pharmacovigilance activities on industry. Source: Drug Industry Daily

Scott Gottlieb has met with the chair of the Senate committee presiding over his confirmation as the next FDA commissioner, Sen. Lamar Alexander (R-Tenn.). Source: Drug Industry Daily

The EMA’s Committee for Medicinal Products for Human Use is recommending EU approval of six drugs for treating a range of conditions from rare forms of cancer to chronic heart…

The EMA is recommending that the European Commission suspend the sales of more than 300 generic drug formulations that were approved from flawed bioequivalence studies conducted at two of Micro…

FDA warning letters to foreign drug and API manufacturing facilities have increased more than tenfold so far this year compared to the same period in 2016. Source: Drug Industry Daily

House Republicans withdrew their plan to repeal the Affordable Care Act March 24, depriving drugmakers of billions of dollars in tax breaks. Source: Drug Industry Daily

Because no drugs exist for delayed graft function prevention, the FDA yesterday issued guidance to help foster discussion between drugmakers and the agency on developing drugs to treat the problem.…

More than half of unapproved applications for clinical trials require more information, the MHRA said in new guidance to industry. Source: Drug Industry Daily

An industry group and two drugmakers have filed U.S. Supreme Court briefs backing Amgen’s request that a Federal Circuit ruling be partially affirmed to mandate that biosimilar makers share information…

Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.) have not halted their investigation into the pricing of Emflaza, pursuing its sale from Marathon to PTC Therapeutics. Source: Drug Industry…