Eight new investigational medicines have been recommended for orphan designation by a committee of the European Medicines Agency. Sponsors of orphan-designated products may be eligible for grants and regulatory fee reductions.
A closely-held UK company with an early-stage oncology programme has reached agreement to be acquired by Roche for up to $175 million. The deal, which was announced on 15 April 2008, includes an upfront cash payment of $160 million plus a milestone payment of $15 million which is due upon the start of Phase 2 trials of its oncology programme.
Paion AG, a Frankfurt Stock Exchange-listed developer of treatments for stroke and other thrombotic diseases, made an agreed bid on 10 April 2008 for all the share capital of CeNeS Pharmaceuticals Plc, a developer of products for pain, anaesthesia and neurology. CeNeS is listed on the Alternative Investment Market in London.
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.