Swedish biotech pipeline getting bigger

Tuesday 19 June 2007

Swedish biotech companies increased their pipeline of drug candidates substantially in 2007 compared with a year earlier, according to a survey conducted by SwedenBio, an industry association, and two government agencies, Invest in Sweden Agency (ISA) and Vinnova.

EMEA guideline on first-in-man trials due out in July

Friday 15 June 2007

A guideline outlining how companies should prepare to conduct first-in-man studies of novel medicinal products in Europe, should be completed in July, 2007, according to Patrick Le Courtois, head of the Unit for Pre-Authorisation of Medicines for Human Use at the European Medicines Agency (EMEA).

Santaris presents data on new RNA antagonist

Wednesday 13 June 2007

Santaris Pharma A/S of Denmark announced at the June 2007 annual meeting of the American Society of Clinical Oncology in Chicago that its RNA antagonist for chronic lymphocytic leukaemia (CLL) showed promising results in an initial Phase I/II clinical trial.

Biotech CEOs take AIM and smile

Tuesday 12 June 2007

Light regulation, low cost and flexible admission criteria make the London Stock Exchange’s Alternative Investment Market (AIM) an attractive venue for small companies that want to issue shares for the first time, according to the chief executive officers of four life science companies that have issued IPOs on AIM since 2004.

European biotech revenues up 13% in 2006

Sunday 3 June 2007

The European biotechnology industry increased its revenues by 13% in 2006, while narrowing its losses. At the same time, spending on research and development increased, especially on the part of the 32 companies that made initial public offerings during the year.

UK regulator to post schedule for reviewing first-in-man trials

Wednesday 30 May 2007

Companies that want to know how quickly their applications for first-in-man trials will be evaluated in the UK will soon be able to go to the regulatory authority’s website for information on the review process, according to Elaine Godfrey of the Medicines and Healthcare products Regulatory Agency (MHRA).

Gordon Duff comments on the future of first-in-man trials

Friday 25 May 2007

Gordon Duff, a professor at the University of Sheffield School of Medicine and chairman of Britain's Commission on Human Medicines, said the Tegenero incident illustrates how little scientists understand about the safety of novel therapies. He said it is important that regulators in future share more information from preclinial studies of novel therapies.