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European biotech companies are calling on the European Commission to address inconsistencies in the labeling and naming of biosimilars as a way to enhance monitoring and acceptance of the rapidly growing product sector. Read More
The Indian government is mulling a proposal from a local research institute to launch an online registry of foreign and domestic drugs with the aim of improving transparency about the country’s medicines supply. Read More
India’s Central Drugs Standard Control Organization is establishing a panel of experts to review existing forms and procedures and recommend ways to shorten and simplify the drug application process. Read More
The Office of the U.S. Trade Representative is conducting a review of India’s intellectual property regime that focuses in large part on pharma IP issues, including access to affordable medicines. Read More
Pharmaceutical intellectual property rights remain a significant sticking point in a proposed draft of the massive Trans-Pacific Partnership trade pact leaked in October. Read More
Oversight of the EU’s medicines policy will remain under the health directorate, in an about face from plans, announced in September, to shift responsibility to the industry directorate. Read More
The European Medicines Agency is expanding its public database for reporting suspected adverse drug reactions, adding roughly 1,700 additional products to the site. Read More
European regulators say they are prepared to start a continual assessment of data on experimental Ebola treatments as soon as they receive each submission, in an effort to speed approvals. Read More
The Justice Department has launched a probe into potential anticompetitive practices of the generic drug industry, adding more scrutiny to generic drug pricing that already is under investigation by Congress. Read More
European drug safety officials last week recommended lower dosing levels on Amgen’s angina drug Procoralan to lessen risks of heart problems, including heart attacks and excessively low heart rates. Read More