An advisory committee of the US Food and Drug Administration has backed a new ophthamic medicine, ocriplasmin, from ThromboGenics NV of Belgium saying it should be granted approval to treat an eye disease known as symptomatic vitreomacular adhesion.
Sanofi reported second quarter revenue of €9.1 billion, a gain of 3.9% or €346 million from the year earlier figure. Remarkably, the French pharmaceutical company was able to keep its operating costs at very close to those a year earlier.
Roche reported a respectable gain in sales in the first half year, but burgeoning research and development costs put its operating result under pressure. Nevertheless the company retained its full-year forecast of a high single digit increase in core earnings per share.
Apogenix GmbH said that a final analysis of data from its Phase 2 proof-of-concept trial of a new drug for glioblastoma, APG101, confirmed the agent’s therapeutic effect as well as its safety and tolerability. The trial recruited 84 patients in 25 centres in Europe.
Competition from generics, coupled with a poor economic environment, squeezed AstraZeneca Plc in the second quarter as operating profit dropped sharply on both a reported and a core basis, after adjustments for one-off items such as restructuring.
Lower drug sales in the US, and especially in Europe, contributed to a decline in turnover and operating profit at GlaxoSmithKline Plc in the second quarter. Despite this, the UK group is proposing to increase its interim dividend and to proceed with a further buy-back of its shares.
Pfizer Inc has announced the failure of the first of four studies of a prospective antibody treatment for patients with mild-to-moderate Alzheimer’s disease who carry the ApoE4 genotype. The other three studies are still ongoing.
Cell Medica Ltd, which is on track to commercialise its first cell therapy in Europe next year, has secured a £17 million equity investment from a group of long-term investors to support its European activities and to finance new operations in Texas.
BioInvent International AB, which creates antibodies for cancer and other indications, has had a difficult year so far. Two of its clinical trials were stopped and a third programme was returned by the licensee. Restructuring was inevitable.
After more than two years of deliberations, the European Medicines Agency has decided to recommend approval of the first ever gene therapy. The treatment, Glybera, is indicated for the treatment of patients with a rare inherited enzyme disorder.