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.
Oxford Genome Sciences (UK) Ltd has entered into a strategic collaboration with Amgen Inc to discover, develop and commercialise therapeutic antibodies for the treatment of cancer. Financial terms were not disclosed.
Lundbeck A/S has agreed to take over the development of desmoteplase, a candidate product for stroke, from Paion AG of Germany following a re-analysis of a failed Phase 3 study that showed the drug still had potential for treating patients with acute ischemic stroke.
The management and supervisory boards of 4SC, a German drug discovery and development company, are recommending that shareholders reject a takeover bid from Santo Holding (Deutschland) GmbH, an investment company owned by one of Germany’s wealthiest families. Santos Holding had 31.28% of 4SC on 3 December 2007.