News

In another step to require prompt reporting of clinical trial data, the US Food and Drug Administration (FDA) has sent a letter to GlaxoSmithKline demanding that the company supply a full report on the results of postmarketing studies conducted for the diabetes drug, Avandia (rosiglitazone maleate). The demands are contained in a Warning Letter dated 25 March 2008 to Jean-Pierre Garnier, GSK’s chief executive officer. The letter has been posted on the FDA’s website, www.fda.gov.

A US District Court has permanently enjoined the US Patent and Trademark Office (PTO) from putting into effect new rules that would have limited the number of times an inventor could amend claims in a patent application.

The UK government is expected to issue proposals this summer to strengthen the national law governing drug safety in the wake of alleged abuses of the current legislation by GlaxoSmithKline, producer of the antidepressant, Seroxat (paroxetine). Proposals to amend the UK law are being readied by the government with the help of the Medicines and Healthcare products Regulatory Agency (MHRA), which recently concluded a four-year investigation into whether GSK withheld certain clinical trial data pertaining to Seroxat.

The privately-held Danish company, NsGene A/S, said that it has successfully implanted a biodelivery device that secretes nerve growth factor into the brain.

ITI Life Sciences, a Scottish agency that finances medical research, is making £2 million to £5 million available for synthetic biology projects over a period of 18 to 36 months.

The European Patent Office (EPO) has started to apply more stringent criteria to the applications it reviews, including those from the medical sciences.

A closely-held German company with financial support from the Max Planck Society is looking at a new formulation for a therapy based on raft technology, following the product’s achievement of clinical proof of concept in February 2008.

Evotec AG, the German developer of treatments for nervous disorders, is forecasting a revenue increase of 3 to 9 percent in 2008 before any income from out-licensing.

MediGene AG has acquired exclusive rights to a European Patent relating to lipid complexes that can destroy endothelial cells. Originally granted to the University of California, the patent covers technology used in MediGene’s lead cancer product, EndoTAG-1. This technology is being used to develop other products as well, the company said.

The European Medicines Agency has decided that for the time being, there is no need to change the prescribing information for abacavir, a nucleoside reverse transcriptase inhibitor, which is used in combination with other antiviral medicines to treat patients with HIV. This follows the release of data from a large study which suggested that recent use of abacavir may be linked with an increased risk of myocardial infarction, the agency said in a press release issued on 2 April 2008.