The European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that seven products be approved for sale in Europe, including two biosimilar medicinal products and one generic.
Clinicians and representatives of industry say that the requirements for conducting clinical trials in the European Union need to be altered so that the cost of doing research is reduced.
The chairman of Allergy Therapeutics Plc said he expects the FDA hold on its clinical trials of Pollinex Quattro to be lifted in due course.
A committee of the European Medicine Agency has recommended that six drugs, including one generic medicine, be authorised for marketing in the European Union.
The UK Medical Research Council (MRC) said that it will fund a research project from the North East England Stem Cell Institute that involves partially financing in vitro fertilisation (IVF) treatments for women who donate their surplus eggs for stem-cell research.
A committee of the European Medicine Agency has recommended that 17 new products qualify for financial and regulatory incentives because they meet the European criteria for orphan medicines. Orphan products are intended to treat serious or life-threatening diseases that affect not more than 5 out of 10,000 persons in the European Union. Producers of orphan designated drugs may be eligible for grants and regulatory fee reductions.
Scientists should be allowed to create hybrid embryos, combining some human and some animal material, in order to try and derive a new source of embryonic stem cells for research, according to the UK Human Fertilisation and Embryology Authority (HFEA).
The European Medicines Agency has taken the first step towards implementing new European-wide procedures for testing medicines in children.
A new European guideline outlining how companies and regulators can identify and mitigate risks associated with the first studies in humans of novel medicinal products is due to take effect on 1 September 2007.
The UK government has decided to change its 50-year old system for indirectly setting the price of drugs sold to the National Health Service (NHS).