We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Small and medium-sized drugmakers will be able to pay lower — and in some cases, no — fees for certain postauthorization activities under new incentives announced Tuesday by the European Medicines Agency. Read More
Advocates for minorities and other patient groups that are underrepresented in clinical trials want the FDA to create incentives for drugmakers that include those groups in studies and become more aggressive in delaying drugs that don’t include them. Read More
Drugmakers must now give Brazil’s ANVISA a full year’s warning before withdrawing a product from the market if the withdrawal could result in a drug shortage. Read More
The European Medicines Agency has backed off of several controversial limitations that it was contemplating imposing on sponsors designing trials for treatments for chronic primary immune thrombocytopenia (ITP). Read More
Novartis said Monday it has halted the Phase III trial of its chronic heart failure drug LCZ696 after being notified by a data monitoring committee that the drug met its composite primary endpoint of delayed cardiovascular death and reduced heart failure hospitalizations. Read More
The FDA has outlined the annual fees that large drug compounders that register as outsourcing facilities will have to pay the agency under new federal law. Read More
Massachusetts last week became the first state to ban Zogenix’s controversial painkiller Zohydro, a move that could lead other states to follow suit. Read More
The FDA Friday approved Janssen Pharmaceuticals’ Topamax for the prevention of migraines in adolescents, the first such drug for this age group. Read More
Drugmakers seeking certification that their products comply with the European Pharmacopoeia will soon face a two-step process for having their applications approved by the European Directorate for the Quality of Medicines & HealthCare. Read More
An FDA proposal to only allow stool for fecal matter transplants (FMT) from donors known to patients or their physicians has come under heavy fire from critics who argue it will actually make the procedure more risky and shut down stool banks. Read More