Archive

BY KEITH NUTHALL
THE EUROPEAN Commission has proposed the potentially toxic solvents trichlorobenzene (TCB) and toluene should not be used to make adhesives, where their concentration is 0.1 per cent or more of the finished product by mass. If the European Union (EU) Council of Ministers agrees, these adhesives could not be used or sold in the EU.…

BY MONICA DOBIE
RESEARCHERS at America’s St Louis University are destroying tumours with genetically engineered viruses that infect cancer cells whilst leaving healthy cells unharmed. Results published in the journal Cancer Research have claimed cancer cells are destroyed when the viruses reproduce themselves.…

BY KEITH NUTHALL
THE EUROPEAN Medicines Agency (EMA) has released guidelines on the control of impurities of pharmacopoeial substances, (http://www.emea.eu.int/pdfs/human/qwp/152904en.pdf) and also a concept paper for a guideline on the requirements regarding quality aspects of a clinical trial authorisation request (http://www.emea.eu.int/pdfs/human/qwp/154204en.pdf).…

BY KEITH NUTHALL
THE EUROPEAN Court of Justice (ECJ) has clarified European law over how different one pharmaceutical product must be from another to require a fresh market approvals and hence additional patent protection. It intervened in a case between Novartis Pharmaceuticals and the UK’s Medicines Control Agency, regarding drugs marketed by Sang Stat UK Ltd and Imtix-Sang Stat UK Ltd.…

BY KEITH NUTHALL
THE EUROPEAN Bank for Reconstruction Development (EBRD) is lending Euro 22 million to Serbia & Montenegro’s largest pharmaceutical producer Hemofarm a.d. to launch operations in Russia, its largest export market. The money will help Hemofarm buy new equipment and build a packaging and production pharmaceutical plant in Obninsk, 100 km south-west of Moscow.…

BY KEITH NUTHALL
A MUTUAL recognition agreement on good pharmaceutical manufacturing practice struck between Japan and the European Union (EU) will come into force on May 29, allowing certain medicines to be traded then sold without additional testing or certification. These include standard, homeopathic and vitamin treatments as listed in the agreement’s annexe, and the scope will be reviewed in the future.…

BY KEITH NUTHALL
THE NEWLY renamed European Medicines Agency (EMA) has launched asked for comments on a ‘road map to 2010: preparing the ground for the future’. It outlines the agency’s strategy to “further develop as one of the world’s foremost regulatory authorities for medicinal products, which is public health oriented, science-driven and transparent”.…

BY MONICA DOBIE
BOTOX injections – generally used to diminish wrinkles – have been found to successfully relieve symptoms of enlarged prostate and urinary problems without serious side affects according to new research presented at the American Urological Association. It is unclear how the drug works but researchers think it is because it relaxes tight muscles around the prostate and urinary tract.…

Keith Nuthall
EXISTING European Union (EU) legislation that allows member countries to maintain widely divergent rates of excise duty will not soon face formal proposals from the European Commission for reforms promoting greater harmonisation, Brussels has admitted. In a note released ahead of yesterday’s EU Council of Ministers for finance (ECOFIN), the Commission confirmed that a report on alcohol excise was under discussion amongst officials.…

BY KEITH NUTHALL
THE EUROPEAN Commission has – as predicted in just-drinks.com – ducked proposing comprehensive harmonisation of European Union (EU) alcohol excise duty rates in a formal report on the issue. That said, Brussels has proposed rates are rounded up from levels agreed for 1993’s establishment of the European single market.…