Novartis has announced the acquisition of 85% of a privately-held vaccine company in China, Zhejiang Tianyuan Bio-Pharmaceutical Co Ltd. Financial details were not disclosed. The company has an R&D and manufacturing site near Shanghai.
The European Medicines Agency’s management board has taken the unusual step of reminding its former executive director, Thomas Lönngren, of restrictions that apply to his professional activities for two years following his departure.
The Roche group said that its investigational hedgehog pathway inhibitor, vismodegib, which is being developed to treat advanced basal cell carcinoma, met its primary endpoint of overall response in a pivotal Phase 2 clinical study.
The European Medicine Agency’s main scientific committee has started safety reviews of three marketed medicines following reports of adverse events. The medicines are Revlimid, Vivaglobin and pioglitazone-containing drugs.
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.