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Mexican regulators laid out rules for older biosimilars registered prior to Oct. 19, 2011, when the country’s biosimilarity rules were first established, mandating that companies conduct clinical trials to prove biosimilarity. Read More
The FDA on Monday granted accelerated approval to Novartis’ Farydak, the first histone deacetylases inhibitor for use in treating multiple myeloma. Read More
Drugmakers will be able to make major changes to their products faster under a new European Medicines Agency policy of scheduling new variations reviews weekly rather than monthly. Read More
Three European industry groups are asking the European Commission to block an Italian law that encourages off-label drug use, saying it is driven entirely by economics at the expense of patient health. Read More
Novartis has agreed to divest all of its BRAF and MEK inhibitor drug assets in order to move forward with its $16 billion acquisition of GlaxoSmithKline’s oncology portfolio. Read More
The branded version of Gilead’s pricey blockbuster hepatitis C therapy Sovaldi is expected on Indian pharmacy shelves in the second quarter of this year, distributed under an exclusive licensing agreement with Mylan’s Indian subsidiary. Read More
The agency is sponsoring research into BE testing for long-acting periodontal drugs and developing methods for assessing generic injectables. Read More