The European Commission has been overruled in a dispute over the authorisation of an orphan medicine, in a case that further clarifies the ‘well-established medical use’ criteria for approving new drugs for marketing in Europe.
Orexo AB of Sweden said that it has received US Food and Drug Administration approval for Zubsolv (buprenorphine/naloxone), a product to be used with counselling and psychosocial support to treat people suffering from opioid dependence.
Ten new medicines including GlaxoSmithKline’s Tafinlar (dabrafenib) for metastatic melanoma, and Sanofi SA’s Lemtrada (alemtuzumab) for multiple sclerosis have been recommended for marketing by the European Medicines Agency.
A proposal to fundamentally change the way clinical trial data is handled is now open for public debate.
The European Medicines Agency’s main scientific committee, the CHMP, is recommending approval of the cellular immunotherapy for prostate cancer, Provenge (sipuleucel-T). Provenge was approved by the Food and Drug Administration in 2010.
The US Food and Drug Administration has approved the first recombinant coagulation Factor IX product for the prophylaxis of bleeding in people with haemophilia B. The manufacturer is Baxter Healthcare Corporation.
Drisapersen, a candidate molecule for Duchenne muscular dystrophy (DMD), has received ‘breakthrough therapy’ status from the US Food and Drug Administration, according to GlaxoSmithKline Plc. Drisapersen is an antisense oligonucleotide.
The European Medicines Agency has decided to appeal against two interim decisions handed down by a European court in April that represent part of a legal challenge by AbbVie Inc and InterMune Inc to the agency’s transparency policy.
The US Food and Drug Administration has approved updates to the US labels for Tradjenta (linagliptin) and Jentadueto (linagliptin and metformin), treatments for Type 2 diabetes, in order to add pancreatitis to the warnings and precautions section of the labels, according to Boehringer Ingelheim Pharmaceuticals Inc and Eli Lilly and Company.
The US Food and Drug Administration has approved the first test that identifies the genotype, or strain, of the hepatitis C virus which is present in individuals with chronic HCV infection. It has been manufactured by Abbott Molecular Inc.