The European Medicines Agency is inviting pharmaceutical companies to participate in a pilot project under which it will evaluate ‘adaptive licensing’ as a way of getting new medicines to patients earlier, under certain controlled situations.
A Phase 3 trial of a MAGE-A3 cancer vaccine has failed to significantly extend disease-free survival in patients with non-small lung cancer – the first and second co-primary endpoints, according to the developer GlaxoSmithKline Plc.
The UK government has decided to commit £55 million for the construction of a cell therapy manufacturing centre to support the commercialization of cell therapies, attract inward investment, and boost exports. The investment was announced on 19 March.
Bristol-Myers Squibb Company is set to gain access to new targets for the development of checkpoint inhibitors against cancer under a licensing deal with Five Prime Therapeutics Inc carrying an upfront payment of $20 million.
A Phase IV study of bosentan has failed to show that the drug significantly prolongs time to first morbidity or mortality in patients with pulmonary arterial hypertension (PAH) already receiving sildenafil. Bosentan (Tracleer) is marketed by Actelion Pharmaceuticals Ltd.
BioInvent International AB, which is developing three antibodies to treat cancer, plans to raise SEK 48.9 million (€5.5 million) with a rights offering on the NASDAQ OMX Exchange in Stockholm. The proceeds will support the company’s ongoing research.
DiaGenic ASA, a specialist in gene expression technology, is raising NOK 50 million (€6 million) with a rights offering on the Oslo Stock Exchange. The offering comprises 100 million new shares priced at NOK 0.50 per share.
Amgen Inc said that its oncolytic virus product, talimogene laherparepvec (TVEC), reduced the size of tumours in patients with metastatic melanoma during a recent Phase 3 trial. The data comes from a retrospective analysis of nearly 4,000 tumour lesions.
The French biotechnology company TxCell SA has signed an option agreement to license its lead cell therapy for inflammatory bowel disease (IBD) to Ferring International Center SA, and simultaneously announced plans to list its shares on Euronext Paris.
Inotrem SA, a French start-up with a new approach for treating sepsis, has raised €18 million in a Series A round, the largest early funding round in Europe so far this year. The company was co-founded in February 2013 by Jean-Jaques Garaud, formerly of Roche.