Dr Richard Barker, the director general of the Association of the British Pharmaceutical Industry , says the National Institute for Health and Clinical Excellence should not set drug prices as part of the coalition government's planned value-based ...
The Department of Health in England and Wales has said it will look at the price rises of a "small number" of generic medicines 1 . "We are aware that the prices of a small number of medicines have risen in recent times and we are reviewing what ...
Top level regulators in Europe have rejected a recommendation that the European Medicines Agency create a dedicated sub-committee to deal with the current overload of applications for generic and biosimilar drugs that are awaiting review via its ...
The US Food and Drug Administration is pressing on with efforts to gather input on how its next prescription drug user fee programme should be framed and consider how performance failures associated with its current user fee programme, PDUFA IV, can ...
The US Department of Health and Human Services has called for the Food and Drug Administration to improve its oversight of foreign clinical trial data after finding that sponsors rely ?heavily? on such data to support their marketing applications ...
New European Union rules on the use of animals in medical experiments ? including more flexible authorisation procedures and promoting alternatives to animal testing ? are expected to be approved in September after the European Commission said it ...
The US Supreme Court has agreed to review Matrixx Initiatives Inc v Siracusano, a case that has the potential to determine which adverse event reports a drug maker must disclose to shareholders to avoid securities suits 1 . Specifically, the case ...
Problems relating to the mechanism in which manufacturers supply drugs to wholesalers in the UK are resulting in many patients still not receiving the medicines they need when they need them. This was the consensus at the general meeting of the ...
The US Food and Drug Administration?s paediatric advisory committee will meet on 21 June to discuss paediatric-focused safety reviews for 13 drugs, including four proton pump inhibitors 1 . The four PPIs are: AstraZeneca?s Nexium (esomeprazole) and ...
The European Ombudsman has asked the European Medicines Agency to review its transparency policy so that the public may have access to suspected serious drug adverse reaction reports, regardless of the form in which they are held 1 ,2 . The EMA has ...
An Australian court has admitted a petition challenging the validity of a patent for a human gene (BRCA1) associated with breast cancer 1 ,2 . The case ? filed against the three co-owners of the BRCA1 patent (Myriad Genetics, Centre de recherche du ...
A contentious report by the US government?s trade watchdog that reviews its trading partners? intellectual property rights protection policies appears to tread more softly in its demands than it has in previous years, according to some ...
European Court of Justice advocate general Yves Bot has sought to offer clarification for the granting of supplementary protection certificates in European Union accession countries 1 ,2 . In his opinion on Kirin Amgen v State Patent Bureau of the ...
