News

At the request of the US Food and Drug Administration, Xanodyne Pharmaceuticals Inc has withdrawn the opioid, propoxyphene, from the US market. The drug trades under the names, Darvon and Darvocet.

The Roche Group plans to discontinue research and early development of potential RNA interference (RNAi) therapeutics as part of a portfolio review designed to reduce costs. Its partner, Alnylam, said the decision wouldn’t impact its future plans.

The US Food and Drug Administration has approved denosumab (Xgeva: Amgen Inc) to help prevent skeletal-related events in patients with bone metastases from solid tumours. The antibody is a RANK ligand inhibitor.

The UK speciality pharmaceutical company, BTG Plc, has announced an agreed bid to acquire Biocompatibles International Plc, which produces drug-eluting bead products, for a combined cash and share bid valued at £177.2 million.

The US Food and Drug Administration has approved Halaven (eribulin mesylate) to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease. The developer is Eisai Inc.

An advisory committee to the US Food and Drug Administration has recommended that the agency approve a new drug for the treatment of lupus, Benlysta (belimumab). The developers are GlaxoSmithKline Plc and Human Genome Sciences Inc.

ReNeuron Group Plc has treated the first patient in a Phase 1 trial of a new stem-cell therapy that has been developed to treat patients left disabled by an ischaemic stroke. The trial is taking place in Glasgow, Scotland.

Wilex AG has announced the acquisition of certain diagnostics assets from Siemens Healthcare Diagnostics which trade under the name, Oncogene Science. The assets include marketable diagnostic kits and laboratories in Cambridge, Massachusetts.

4SC AG expects to take its lead oncology product, a pan histone deacetylase (HDAC) inhibitor, into the clinic in colorectal cancer before the end of this year. This follows encouraging Phase 2 data in liver cancer, the product’s lead indication.

The US Food and Drug Administration said that the majority of pharmaceutical and biotechnology companies it regulates are meeting their post-marketing commitments as required under the 2007 Food and Drug Administration Amendments Act.