The UK Medical Research Council (MRC) is planning to spend £12 million over five years to create regional academic centres to investigate new methodologies for clinical trials.
Shares of Genmab A/S, which specialises in developing human antibodies for disease, retreated 6.8% to DKK 315 in early trading on the Nordic Stock Exchange on 29 January 2008 following a spike in the price a day earlier. The stock rose on rumours of a possible takeover bid by a large pharmaceutical or biotechnology company.
Medicines indicated for diabetes and containing rosiglitazone will be required to display a new warning on their labels stating that they should not be taken by patients with ischemic heart disease and/or peripheral arterial disease.
The UK regulator responsible for overseeing embryo research has decided to issue one-year licences to Kings College London and the University of Newcastle Upon Tyne to conduct research using embryos which have been created from some human and some animal material.
The European Medicines Agency (EMEA) is recommending that Thalidomide Pharmion (thalidomide) be approved for the treatment of multiple myeloma, a rare cancer of the bone marrow.
Novexel SA, a privately held French company that develops antibacterial and antifungal products, has licensed a beta-lactamase inhibitor, NXL104, to a subsidiary of Forest Laboratories Inc of the United States for €75 million plus milestone payments of potentially €75 million and “low double-digit” royalties on sales in North America.
The Top Institute Pharma (TI Pharma) of the Netherlands has decided to allocate €16 million over four years to co-develop with Sanaria Inc a malaria vaccine which is based on the concept of inducing immunity in humans through the use of a whole, attenuated malaria parasite.
Nycomed SCA SICAR, a privately held pharmaceutical company registered in Luxembourg and headquartered in Switzerland, has received approval from the US Food and Drug Administration (FDA) to market its asthma treatment, Alvesco, in the United States.
The European Medicines Agency (EMEA) and Health Canada have signed an agreement to exchange confidential information about the authorisation and safety of medicines. This is the latest in a growing number of bilateral agreements between regulators around the world, enabling them to share information submitted to them by companies and to react quickly to drug safety problems which could potentially affect the general public.
The European Medicines Agency’s Committee for Orphan Medicinal Products has recommended that nine medicines be given orphan designation, thus qualifying them for financial and regulatory incentives. The final decision on designation will be taken by the European Commission.