News

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.

Ark Therapeutics Plc of Britain, which specialises in developing orphan drugs in the areas of vascular disease, cancer and wound-care, is acquiring Lymphatix Oy, a closely held Finnish company that develops therapies for modulating the growth and function of lymphatic vessels.

The US Food and Drug Administration (FDA) has notified ReNeuron Group Plc that its investigational new drug (IND) application to start a Phase 1 clinical study of a stem cell therapy in patients with stroke remains on ‘clinical hold,’ but ReNeuron said it is confident that the therapy can be taken into clinic this year.

Lifeline Scientific Inc., a U.S. manufacturer of kidney transporters, has finally been able to complete its initial public offering on the Alternative Investment Market of the London Stock Exchange after at least two postponements because of adverse market conditions.

Addex Pharmaceuticals Plc has entered into an exclusive, global licensing agreement with Merck & Co. to develop a candidate drug for treating schizophrenia and other undisclosed indications. The deal is potentially valued at up to $700 million, the company said.