The US Food and Drug Administration has issued a ‘complete response letter’ to Novartis for its proposed treatment for gouty arthritis, canakinumab, requesting additional data on the drug’s benefit-risk profile in difficult-to-treat patients.
The US Food and Drug Administration has approved a new personalised medicine, Xalkori (crizotinib) together with a diagnostic, for the treatment of patients with late-stage non-small cell lung cancer who have abnormalities of the ALK gene.
Milestone payments from collaborations contributed to a 27% rise in revenue to €12.8 million at Ablynx NV in the first half of 2011. Meanwhile, the company’s technology achieved its first clinical proof-of-concept in a trial for rheumatoid arthritis (RA) during the period.
The US Food and Drug Administration has approved Shire Plc’s new drug for acute attacks of hereditary angioedema, Firazyr (icatibant), the third treatment to be approved by the US regulator for this disease.
Clavis Pharma ASA has decided to expand the scope of its Phase 3 trial of the compound, elacytarabine for acute myeloid leukaemia, to include patients over the age of 65 with a poor prognosis. Top-line data are expected in the 2012 fourth quarter.
Aleva Neurotherapeutics SA of Lausanne, Switzerland has raised €9.5 million in a Series A round to support development of its implant technology for deep brain stimulation which would complement drug therapy for major neurological disorders.
A new UK spin-out dedicated to the technology of DNA repair has received £6 million in Series A funding from a venture capital syndicate led by Sofinnova Partners. The technology comes from the laboratory of Prof Stephen Jackson.
UK-listed Ark Therapeutics Plc has reported revenue of £0.4 million for the first half of 2011, unchanged from a year as it shifted its business strategy to bio-manufacturing and early-stage research and sold its wound-care business.
Novo A/S and SV Life Sciences have committed £8 million in a Series A round to a new UK ophthalmology company that has a portfolio of preclinical assets which are expected to be developed for diabetic macular edema.
GlaxoSmithKline Plc has spun out technology for the treatment of hearing disorders into a new company called Autifony Therapeutics Ltd. The company is receiving £10 million in Series A funding from Imperial Innovations and SV Life Sciences.