EMA prepares to release trial data
A proposal to fundamentally change the way clinical trial data is handled is now open for public debate.
Regulation & Policy
CHMP recommends Provenge
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.
FDA approves new haemophilia product
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.
FDA assigns ‘breakthrough therapy’ status to drisapersen
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.
EMA to appeal transparency order
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.
BI, Lilly update labels of diabetes drugs
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.
FDA approves first genotyping test for HCV
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.
EMA and HTA network extend collaboration
The European Medicines Agency (EMA) and health technology experts in Europe have extended a collaboration under which they are examining ways to bridge the gap between how drugs are approved for marketing, and later assessed for reimbursement.
CHMP delivers positive opinions on six new medicines
Six new medicines have been recommended for marketing in Europe by the European Medicines Agency, including a new treatment for patients with multiple myeloma, a rare and incurable cancer of the bone marrow.
FDA approves two new melanoma drugs
The US Food and Drug Administration has approved two new drugs from GlaxoSmithKline Plc for patients with metastatic melanoma linked to specific gene mutations. These are the third and fourth melanoma drugs to be approved since 2011.