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European drug companies and transparency advocates alike are praising the clinical trials legislation advancing through the EU Parliament, with Europe’s largest pharma lobbying group saying the proposal as it now stands will dramatically improve clinical trial efficiency in the EU. Read More
FDA approval of Stallergene’s under-the-tongue Oralair could be a huge boon for patients who suffer from hay fever and rake in billions more for the drugmaker, whose drug is already available in over two dozen countries. 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
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
Teva scored a legal victory Monday when the U.S. Supreme Court agreed to hear its appeal of a lower court ruling invalidating a patent for the drugmaker’s blockbuster multiple sclerosis drug Copaxone. 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