27.09.2017
- There is a regulatory expectation that pharmaceutical companies will verify that the excipients produced by their suppliers are to an appropriate level of GMP. This has been...
05.10.2014
- Excipients, together with an active pharmaceutical ingredient (API), are formulated into a final drug that is either prescribed to a patient by a doctor or bought over-the-counter...
03.03.2014
- Generic drugmakers are actively campaigning against a rule proposed by the U.S. Food and Drug Administration (FDA) that would require them to change the prescribing information on...
07.06.2013
- U.S. health advisers voted on Thursday to recommend relaxing market restrictions on GlaxoSmithKline's diabetes drug Avandia, the former blockbuster at the center of one of the...
09.05.2013
- A U.S. House of Representatives panel advanced a bill on Wednesday on how the federal government should track prescription drugs as they move through the distribution chain, over...
01.05.2013
- Denmark's Novo Nordisk could see the U.S. launch of its biggest drug hope, a new long-acting insulin, delayed until 2018 while it conducts more tests to satisfy regulators, it said...
30.04.2013
- Europe's medicines regulator has been stopped from releasing clinical trial data about drugs made by AbbVie and Intermune, following a court ruling favouring the two U.S. companies...
05.04.2013
- After a lengthy fight, Swiss drugmaker Roche said it had agreed to hand over data from all clinical trials of its best-selling flu drug Tamiflu to a group of outside researchers...
