The European Medicines Agency is set to publish a new guideline advising drug developers on the regulatory requirements for monoclonal antibody-containing medicines that claim to be similar to other, previously marketed products.
Boehringer Ingelheim GmbH has signed a collaboration and licensing agreement with the Vienna-based F-Star Biotechnologische Forschungs-und Entwicklungsges to jointly discover new antibody-derived therapies.
Paion AG has published headline data from a Phase 2b clinical trial of its short-acting sedative remimazolam which, it says, showed the drug performed better than the standard of care, midazolam, in patients undergoing colonoscopy.
At the request of the US Food and Drug Administration, Xanodyne Pharmaceuticals Inc has withdrawn the opioid, propoxyphene, from the US market.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.