The US Food and Drug Administration has given an accelerated approval for a new treatment for metastatic melanoma that combines two licenced GlaxoSmithKline Plc medicines which block signalling in different sites of the same molecular pathway.
Avillion LLP, a company set up by two venture capital groups to undertake late-stage clinical development on behalf of third parties, has signed a deal with Pfizer Inc to conduct a Phase 3 trial of the US company’s leukaemia drug bosutinib.
Immunocore Ltd of Oxford, UK has secured its third partnership with a major pharmaceutical company relating to the exploitation of its recombinant T-cell receptor technology platform – this time with MedImmune, the biologics unit of AstraZeneca Plc.
Santaris Pharma A/S of Denmark has entered into a strategic alliance with Roche to discover and develop RNA-targeted medicines using locked nucleic acid technology which has been developed by Santaris.
GW Pharmaceuticals Plc has raised $87.9 million in a follow-on offering of an earlier initial public offering on Nasdaq. The funds will be used to support the clinical development of a childhood epilepsy product.
A fund operated by Gilde Healthcare Partners BV has acquired a majority interest in Viroclinics Biosciences BV, a 2001 spin-out from the virology department at the Erasmus Medical Centre in Rotterdam, the Netherlands.
Lombard Medical Technologies Plc is planning to delist its shares in London and make an initial public offering on the Nasdaq market in New York. The company said this will give it access to a larger pool of investors familiar with its market.
Nextech Invest Ltd of Switzerland has led a $25 million Series B financing round for a young US biotech company that is developing kinase inhibitors for genomically-defined cancer subsets. Blueprint Medicines Corp is located in Cambridge, Mass.
A Phase 3 study of an experimental treatment for chronic lymphocytic leukaemia and small lymphocytic lymphoma has been stopped early on efficacy grounds. The treatment, Imbruvica (ibrutinib) has been developed by Janssen Research & Development LLC.
The US Food and Drug Administration has issued a complete response letter (CRL) to Sanofi SA saying it can’t approve the company’s supplemental Biologics License Application for Lemtrada (alemtuzumab) for relapsing multiple sclerosis.