Regulation & Policy

BioInvent International AB of Sweden has started a Phase 1 study in the US of its monoclonal antibody, BI-505, in patients with advanced multiple myeloma. The drug has been granted orphan status by both the US Food and Drug Administration and the European Medicines Agency. Patients in the trial will be treated with intravenous doses of the drug every other week for a 28-day period with the possibility of extending the treatment until the condition deteriorates again. BI-505 binds to the adhesion protein, ICAM-1, which is over-expressed in several tumours but is not usually expressed in normal tissue. It is being developed to treat multiple myelomas that express this protein. Multiple myeloma is a cancer of the plasma cells.

Health ministers of the European Union have asked regulatory authorities to provide scientific support for developers of antibiotics to replace those that are no longer effective. However, no money was put on the table

The European Medicines Agency has given a negative opinion to a proposed gene therapy developed by Ark Therapeutics Group Plc for malignant brain cancer, saying the product failed to show efficacy. Ark said it will appeal against the decision.

The European Medicines Agency has given a positive opinion to a new fertility treatment developed by NV Organon of the Netherlands, now part of Merck & Co, that can be used as part of an assisted reproductive technology programme.

The European Commission is asking companies and others involved in clinical trials  in Europe to give their views about whether the rules governing these trials should be changed.

The European Medicines Agency has rejected an application from Roche to extend the use of its cancer drug Avastin (bevacizumab) for the new indication of relapsed glioblastoma. It said there was insufficient evidence of the medicine’s benefits.

BioCity Nottingham, a bioscience incubator in Britain’s East Midlands, has entered into collaboration agreements with three US regional science parks to promote better transatlantic opportunities for small biotech businesses.

There has been a recent surge in new confirmed cases of progressive multifocal leukoencephalopathy (PML) associated with the multiple sclerosis drug, Tysabri (natalizumab), with the 24^th case reported to the EMEA on 25 October.

  The European Medicines Agency is recommending that two new medicines, one of which is a radiopharmaceutical, be granted marketing authorisations. It has also given the go-ahead for new indications for four currently licensed treatments.

The European Medicines Agency has announced a review of the multiple sclerosis drug, Tysabri (natalizumab), in light of reports of 23 cases where patients taking the drug have developed a rare brain infection known as progressive multifocal leukoencaphalopathy (PML).