The US Food and Drug Administration has approved the Roche group’s antibody-drug conjugate, trastuzumab emtansine, for HER2-positive metastatic breast cancer, ushering in a new drug class linking an antibody with a cytotoxic drug.
The European Medicines Agency is recommending approval of a new hexavalent vaccine developed by Sanofi Pasteur that is designed to protect infants against diphtheria, tetanus, pertussis, Hepatitis B, poliomyelitis and Haemophilus influenzae type B (Hib).
H. Lundbeck A/S is set to elect Håkan Björklund, the former chief executive of Nycomed GmbH, as its new chair as the company accelerates efforts to launch new products and increase its pipeline activity. Both revenue and EBIT profit declined in 2012.
The UK-based drug discovery company Domainex Ltd has announced plans to raise £1.5 million in new capital to support its kinase-based drug development programmes for cancer and a variety of inflammatory diseases. The round is being led by Longbow Capital LLP.
UCB SA has signed an agreement with US-based ConfometRX Inc to discover new drugs to treat neurological diseases by targeting the G-protein coupled receptor (GPCR) family of proteins. GPCRs are the largest family of signaling proteins in the human genome.
Sphere Fluidics Ltd of the UK, which has developed technology to analyse single cells, has raised $2.5 million in a Series A round from a syndicate led by 24Haymarket of London. The company’s technology comes from the chemistry department of Cambridge University.
4SC AG has expanded its collaboration with BioNTech AG with the signing of a research agreement to discover new compounds against cancer. The three-year agreement is being executed through 4SC’s wholly-owned research unit 4SC Discovery GmbH.
The US regulatory review of Zealand Pharma A/S’s new drug for Type 2 diabetes, lixisenatide, is set to begin following the Food and Drug Administration’s acceptance of a registration file from the company’s partner, Sanofi SA. Lixisenatide is a GLP-1 receptor agonist.
The US Food and Drug Administration has approved a second indication for the Novartis immunosuppressant everolimus: to prevent organ rejection in adult liver transplant patients. The same indication was approved in Europe in late 2012.
Clavis Pharma ASA expects to report top-line Phase 3 results for its compound for acute myeloid leukaemia (AML) by the end of the first quarter. The compound, elacytarabine, is a derivative of cytarabine- the licensed AML chemotherapy.