The European Medicine Agency’s main scientific committee has issued positive opinions for three new medicines, including a new oral contraceptive. In addition, it has given a positive assessment to a C1 inhibitor that is similar to a marketed product.
A Phase 2 study of a gene therapy for Parkinson’s disease has met its primary endpoint for efficacy and demonstrated safety. The results have been published on-line in The Lancet Neurology, according to the sponsor, Neurologix Inc.
The European Medicines Agency and the US Food and Drug Administration have announced plans to increase the efficiency of the drug regulatory process by evaluating, in parallel, the quality components of certain new drug applications.
Novartis said that its Janus kinase (JAK) inhibitor, ruxolitinib, has met its primary endpoint of significantly reducing spleen size in patients with myelofibrosis, a blood cancer characterised by bone marrow failure, in a second Phase 3 trial.
GlaxoSmithKline Plc said top-line results from the second of three Phase 3 trials of an investigational drug designed to improve the symptoms of patients with advanced Parkinson’s disease had shown an improvement in symptoms versus the control.
Chroma Therapeutics Ltd is set to receive $5 million upfront from Cell Therapeutics Inc of Seattle, Washington has part of a co-development and licensing agreement for the candidate cancer drug, tosedostat. The drug is being tested in AML.
Tolerx Inc and GlaxoSmithKline Plc announced that a Phase 3 trial of otelixizumab for patients with new-onset Type 1 diabetes did not meet the primary efficacy endpoint of change in C-peptide, a marker of beta cell function, at 12 months.
Sanofi-Aventis SA and its partner, Regeneron Pharmaceuticals Inc, have announced that their Phase 3 trial of the candidate drug, aflibercept, for second-line treatment of non-small cell lung cancer, combined with docetaxel, did not extend overall survival.
The US Food and Drug Administration announced that it has taken action against the Johnson & Johnson subsidiary, McNeil-PPC, for failing to comply with current good manufacturing practice requirements at three sites.
Bavarian Nordic A/S is considering a rights issue to help finance a Phase 3 trial of its therapeutic vaccine for prostate cancer, Prostvac. The Danish company earlier reached an agreement with the FDA on the design and endpoints for a pivotal study.