The UK government has reached an agreement in principle with the pharmaceutical industry to create incentives for primary care physicians to prescribe new medicines in exchange for a voluntary 2% reduction in the prices charged to the National Health Service (NHS) for branded medicines.
There has been a gradual, but fundamental shift in the way regulatory agencies interact with the pharmaceutical industry, so that it is now commonplace for companies to meet with regulators before drug development gets into full swing.
The European Medicines Agency (EMEA) is recommending that marketing authorisations be granted for new treatments for neuromuscular block and nosocomial pneumonia. It also recommended that extensions of indications for three marketed cancer drugs be approved.
Two drug applications that were under review by the European Medicine Agency’s main scientific committee have been withdrawn by their sponsors following the committee’s request for more data.
Five new investigational medicines have been recommended for designation as orphan medicinal products by a committee of the European Medicines Agency. Producers of orphan-designated products may be eligible for grants and regulatory fee reductions.
The UK House of Commons defeated opponents of a proposal to allow research using hybrid embryos. As a result, research involving hybrids will be allowed under a bill that updates the UK Human Fertilisation and Embryology Act 1990.
The Innovative Medicines Initiative (IMI) has launched its first call to researchers to submit proposals to work with the pharmaceutical industry to investigate ways of speeding up the drug development process.
The European Medicines Agency has recommended that five new medicines be given marketing authorisations.
Eight new investigational medicines have been recommended for orphan designation by a committee of the European Medicines Agency. Sponsors of orphan-designated products may be eligible for grants and regulatory fee reductions.
In another step to require prompt reporting of clinical trial data, the US Food and Drug Administration (FDA) has sent a letter to GlaxoSmithKline demanding that the company supply a full report on the results of postmarketing studies conducted for the diabetes drug, Avandia (rosiglitazone maleate). The demands are contained in a Warning Letter dated 25 March 2008 to Jean-Pierre Garnier, GSK’s chief executive officer. The letter has been posted on the FDA’s website, www.fda.gov.