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At the request of the US Food and Drug Administration, Xanodyne Pharmaceuticals Inc has withdrawn the opioid, propoxyphene, from the US market.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.
The US Food and Drug Administration has issued its first approval for a drug to treat lipodystrophy, a condition in which excess fat develops in different areas of the body, most notably around the liver, stomach and other abdominal areas.
Schering-Plough Europe has withdrawn its European marketing authorisation application for the proposed asthma treatment, Zenhale (mometasone furoate/formoterol fumarate), the European Medicines Agency announced.
The US Food and Drug Administration has approved Kombiglyze, a new Type 2 diabetes drug that combines saxagliptin and metformin XR in a single tablet, according to the drug’s sponsors, AstraZeneca Plc and Bristol-Myers Squibb Co.