The European Parliament has approved new legislation on animal testing that requires, among other things, EU member states to assess the animal welfare implications of each scientific experiment carried out under their jurisdiction to ensure that ...

The US Supreme Court is being urged to overturn an appeals court decision that held that life sciences companies could be sued under the Securities Exchange Act for not publicly disclosing scattered adverse event reports about their products, even ...

The European commission has announced a delay in adopting the new version of the clinical trials authorisation form that drug companies use for seeking permission from different EU member states to carry out human drug trials 1 ,2 . The updated ...

The European Medicines Agency's human drugs evaluation committee, the CHMP , is to meet on 8 September to discuss the ongoing benefit:risk review of Avandia and two other diabetes medicines containing rosiglitazone, which has been linked with a ...

The European Parliament has approved new legislation on animal testing that requires, among other things, EU member states to assess the animal welfare implications of each scientific experiment carried out under their jurisdiction to ensure that ...

The European commission has announced a delay in adopting the new version of the clinical trials authorisation form that drug companies use for seeking permission from different EU member states to carry out human drug trials 1 ,2 . The updated ...

The Irish Medicines Board has adopted a new procedure to manage the growing number of marketing authorisation applications being submitted by pharmaceutical companies under the European Union's decentralised procedure with Ireland as the reference ...

The US Food and Drug Administration has become more conservative in allowing evidence from non-inferiority clinical trials when considering approval of new drugs, the Government Accountability Office has found 1 . Non-inferiority trials are ...

The European Medicines Agency's human drugs evaluation committee, the CHMP , is to meet on 8 September to discuss the ongoing benefit:risk review of Avandia and two other diabetes medicines containing rosiglitazone, which has been linked with a ...

The US Food and Drug Administration has issued guidance explaining how and why manufacturers of biological products should submit their lot distribution reports (LDRs) electronically rather than as paper submissions 1 . The guidance, which follows ...

India's department of industrial policy and promotion (DIPP) has put out a "discussion paper" on the controversial subject of compulsory licences, aimed at developing a "predictable environment" for the use of such measures in the area of medicines ...

SÚKL , the Czech State Institute for Drug Control, has issued a list of medicines that might be subject to a 31 December 2010 sunset clause that will invalidate their marketing authorisations based on their consumption or quantity on the market 1 ,2 ...

In what has implications for the US biosimilar sector, a federal judge has denied a request by sanofi-aventis for a preliminary injunction that would have directed the US Food and Drug Administration to suspend and withdraw its approval of a generic ...

Just when it seemed it was finally on the home straight, the proposal for a single European Union patent and a unified European patent court looks like hitting another major hurdle after a leaked opinion from the European Court of Justice said that ...

The countries negotiating the proposed international Anti-Counterfeiting Trade Agreement (ACTA) have said that they are committed to "resolving remaining substantive issues" at the next round of talks, which are to take place in Japan in September 1 ...