Sanofi-Aventis SA has fixed the terms of its offering of $7 billion of US dollar-denominated notes which will finance its acquisition of Genzyme Corp. The French multinational is acquiring the US company for about $20.1 billion.
The European Medicines Agency has launched an online registry which, for the first time, gives the public access to information on interventional clinical trials in the European Union that heretofore has only been available to the regulatory authorities in the member states.
Merck & Co Inc and Sanofi-Aventis SA have abruptly ended their agreement to create a joint animal health venture citing difficulties in getting approval from antitrust authorities in different jurisdictions in the world.
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.