Eight new medicines, including a new treatment for lung cancer from Boehringer Ingelheim GmbH and a new therapy for chronic obstructive pulmonary disease from Novartis, have received positive opinions from the EMA’s main scientific committee.
Glucagon-like peptide-1 based drugs for Type 2 diabetes do not pose new safety concerns, specifically in relation to an increased risk of pancreatic adverse events, the European Medicines Agency announced on 26 July 2013.
The US Food and Drug Administration has approved Boehringer Ingelheim’s Gilotrif (afatinib) for patients with metastatic non-small cell lung cancer whose tumours express specific epidermal growth factor receptor (EGFR) gene mutations.
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.