The consultation period has started for a guideline from the European Medicines Agency advising drug developers on the regulatory requirements for monoclonal antibody-containing medicines that claim to be similar to marketed biologics.
GlaxoSmithKline Plc has responded speedily to a new series of tax proposals from the UK government with a commitment to invest more than £500 million in manufacturing infrastructure in the country and to raise venture capital outlays.
Novartis International AG expects to make 30 regulatory submissions for new drugs before the end of 2012 as part of its plans to raise investment in original pharmaceutical research. Eight of these submissions will take place in 2010.
The European Medicines Agency’s scientific committee has issued a positive opinion for Pumarix, a mock-up vaccine that could be used in a new influenza pandemic. It is an adjuvanted vaccine that induces a response against the H5N1 antigen.
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.
At the request of the US Food and Drug Administration, Xanodyne Pharmaceuticals Inc has withdrawn the opioid, propoxyphene, from the US market.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 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 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.
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.