The European Medicines Agency has given positive opinions for four medicines, one of which is AstraZeneca’s Iressa (gefitinib), a targeted treatment for non-small cell lung cancer. The positive opinion follows an earlier application withdrawal.
Reform of the patent system in Europe is once more on the political agenda. On 24 March 2009, the European Commission set in motion a procedure that will give it authority to negotiate the creation of a unified patent litigation system for the European Union.
The European Medicines Agency has given positive opinions to four new medicines, but it has turned back applications for two, one of which was a proposed treatment for cystic fibrosis.
The US National Institutes of Health (NIH) will be issuing new guidelines on how scientists should conduct research using embryonic stem cells following President Barack Obama’s decision to lift restrictions on federal funding of this research.
When is information about a pharmaceutical product neutral, and when does it cross the line to become promotional? This question is stimulating a debate in Brussels about a new legislative proposal that would give pharmaceutical companies more opportunity to communicate directly with consumers about their prescription-only medicines.
Merck Sharp & Dohme Ltd, which is the UK subsidiary of Merck & Co, has withdrawn its marketing authorisation application for the cancer treatment, Vorinostat MSD (vorinostat) from the European Medicines Agency.
France’s medicine regulator, Agence française de sécurité sanitaire des produits de santé (Afssaps), has approved the gene therapy product, Cerepro (sitimagene ceradenovec), for use on a named-patient basis in France.
The European Medicine Agency’s Paediatric Committee has approved plans from 11 companies to investigate their new drugs for use in children.
About one third of the marketing authorisation applications from small and medium-sized companies (SMEs) in Europe are failing to get approved, despite opportunities for assistance from the European regulator in the registration process.
Geron Corporation of Menlo Park, California, has announced that its application to test an embryonic stem cell therapy for spinal cord injury in humans has been approved by the US Food and Drug Administration. It is the first regulatory approval of a human trial involving embryonic stem cells, which have the ability to differentiate into any of the more than 200 specialised cells in the human body.