News

Governments in the industrialised world have revolutionized drug development over the past 25 years with the introduction of orphan legislation encouraging companies to invest in new products to treat rare diseases. Legislation in the US,  Europe, Japan and elsewhere gives incentives to companies to start looking after the medical needs of patients with rare, but life-threatening diseases. The concept of ‘orphan’ derives from the fact that these patients had previously been ‘orphaned’ by the pharmaceutical industry.

The number of new applications for marketing authorisations in the first half of 2008 was steady compared with a year earlier, but requests for scientific advice increased by 28% over the same period, the European Medicines Agency said in its latest statistical overview of the pharmaceutical market.

The European Medicines Agency and the US Food and Drug Administration have agreed to expand the number of occasions on which they exchange confidential commercial data to include information about advanced-therapy medicines and medicines derived from nanotechnology as well as pharmacovigilance information.

Oxford BioMedica Plc said that it has reached agreement with the US Food and Drug Administration to amend the design of a Phase 3 study of its gene-based therapeutic vaccine for renal cancer, TroVax.

Advances in technology have led to an increase in the number of business models being employed by biotechnology companies in Europe. But not all of these models will survive, according to Valérie Sabatier of the University of Grenoble.

Developments taking place in molecular biology today will lead to entirely new classes of medicines within five years and revolutionise medical practice, according to Jonathan Knowles, head of research at Roche.

Roche has announced plans to jointly develop an early-stage monoclonal antibody against cancer with Genentech Inc and its wholly-owned Swiss unit, GlycArt  Biotechnology AG.  The molecule was discovered by GlycArt, a spin-out of the Swiss Federal Institute of Technology in Zurich. GlycArt was acquired by Roche in July 2005.

An international consortium led by Crucell NV of the Netherlands has received a contract valued at up to $70 million from the US National Institutes of Allergy and Infectious Diseases (NIAID) to develop a multivalent vaccine against the Ebola and Marburg viruses. The NIAID is part of the National Institutes of Health (NIH), one of the world’s largest funders of medical research.

Governments in the European Union are being urged to choose the most effective new medicines in deciding which products to subsidise under their publicly-funded health systems.

Ark Therapeutics Group Plc has been told by the UK National Health Service that its diagnostic test for detecting early stage peripheral autonomic neuropathy in the feet of diabetic patients has been accepted for reimbursement.