Advanced Cell Technology Inc has announced the dosing of the first patients in each of its two Phase 1/2 clinical trials for eye disorders using retinal pigment epithelial cells derived from human embryonic stem cells (hESCs).
The US Food and Drug Administration has issued a draft guidance for companies that are developing diagnostic tests intended to be used with targeted drug therapies. The document gives the agency’s approach towards the review of these products.
Amgen Inc is set to pay Micromet Inc €10 million upfront as part of a collaboration to research the company’s bi-specific antibody technology against three undisclosed solid tumour targets. Micromet is based in the US but has a research facility in Germany.
Ipsen SA and The Salk Institute for Biological Studies of the US are renewing for another three years, their research collaboration to explore the biology of proliferative and degenerative diseases. Financial details were not disclosed.
A French developer of an artificial heart for patients with heart failure, has announced plans to raise additional capital through a rights issue with preferential rights for existing shareholders. Proceeds will support clinical development of the device.
The European Medicines Agency said it is reviewing the cardiovascular risk of the anti-arrhythmic medicine, Multaq (dronedarone) from Sanofi SA, following the company’s announcement on 7 July that it was halting a Phase 3b trial of the drug.
The US Food and Drug Administration has approved the Boostrix vaccine, currently available for adolescents and adults, for use in people 65 years and older for the prevention of tetanus, diphtheria and pertussis.
Venture-capital backed SuppreMol GmbH has announced the start of a Phase 2a study of a recombinant protein for systemic lupus erythematosus. This follows FDA approval in March of an antibody therapeutic for lupus from GSK, the first new drug for the disease since 1955.
In a deal that underscores growing interest in cancer immunotherapy, Bristol-Myers Squibb Company (BMS) has agreed to pay $35 million upfront for rights to an early-stage monoclonal antibody that targets receptors on cells of the innate immune system. The developer of the antibody is Innate Pharma SA of Marseilles, France.
A novel monoclonal antibody that is said to have the potential to neutralise most group 2 influenza A viruses has been described in a paper in the journal Science. The research was conducted by Crucell NV and The Scripps Research Institute of the US.