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.
Ablynx NV of Belgium is set to receive €3 million in milestone payments from Boehringer Ingelheim GmbH - its fifth such payment under a three-year old antibody research alliance with the German company. Payments now amount to €15 million.
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.
Novartis International AG said that it is discontinuing clinical development of a drug for non-small cell lung cancer, ASA404, following analysis of interim results from a Phase 3 trial that showed the drug was unlikely to extend the overall survival of patients.
Clovis Oncology Inc of Boulder, Colorado has signalled its confidence in an experimental drug for pancreatic cancer with the signing of a new development and commercialisation deal with the drug’s owner, Clavis Pharma ASA of Norway.
The Austrian vaccine producer, Intercell AG, nearly doubled its loss for the 2010 third quarter, a result that reflected adverse exchange rate movements, a decline in revenue and an increase in spending on late-stage clinical research.
Crucell NV has taken a provision of €22.8 million against its 2010 third-quarter results following the temporary suspension of shipments of two vaccines from a manufacturing facility in Korea that was found to be contaminated.
Schering-Plough Europe has withdrawn its European marketing authorisation application for the proposed asthma treatment, Zenhale (mometasone furoate/formoterol fumarate), the European Medicines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.
A spin-out from Leicester University in the UK has received institutional and venture capital funding to develop a haemostat, a product that stops bleeding. The project is being supported by the Wellcome Trust.
The Global Alliance for TB Drug Development has launched a clinical trial to test a novel three-drug regime for tuberculosis which, it says, shows promise for treating both drug-sensitive and multidrug-resistant forms of the disease.