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DUBLIN – The EMA has diverged sharply from the FDA in denying approval of Puma Biotechnology Ltd.'s breast cancer drug, Nerlynx (neratinib). The EMA's Committee on Human Medicinal Products (CHMP) formally issued a negative opinion on the Puma application last week, on the grounds that it was uncertain that the modest clinical benefit seen in clinical trials – 94 percent of patients on the drug remained relapse-free for two years vs. 92 percent of patients on placebo – would be repeated in clinical practice. The drug, moreover, has a high burden of gastrointestinal side effects, including severe diarrhea, which can be difficult to manage.

DUBLIN – U.S. protectionism, the looming specter of Brexit and the European Union's increasingly vocal stance on Ireland's corporate tax regime should all be weighing on Ireland's export-oriented biopharma sector at present, but the mood during the opening plenary of the Biopharma Ambition Conference Wednesday was upbeat, if not buoyant.

DUBLIN – The EMA had three big wins this week in the Court of Justice of the European Union, which has upheld its transparency policy and thrown out legal challenges from PTC Therapeutics Corp., the animal health arm of Merck & Co. Inc., and Pari Pharma GmbH. All of the companies were ordered to pay the agency's costs, as well as their own. In addition, EUCope, a Brussels-based lobby group for midsized pharma and biotech firms, which was supporting PTC's action, was also ordered to pay its own costs.

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