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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
The UK’s National Institute for Health and Care Excellence on Friday gave a preliminary nod to two diabetic macular edema products, paving the way for their eventual inclusion in the government’s formulary. Read More
Postmarket monitoring results on Hospira’s biosimilar of Janssen’s Remicade continue to show comparable patient response to the reference, the generics maker says. Read More
The European Medicines Agency is establishing a task force to implement common standards for identifying medicines across EU member states, and will require industry and regulators to comply with them beginning in July 2016. Read More