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.
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.
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.