News

Evotec AG and Bayer Pharma AG have entered into a five-year collaboration to develop three clinical candidates for endometriosis, a painful gynecological condition.

The US Food and Drug Administration has approved a new indication for Humira (adalimumab) to include the treatment of moderate-to-severe ulcerative colitis in adults. It is the seventh US approval for the drug which is marketed by Abbott Laboratories.

The US Food and Drug Administration has approved Stivarga (regorafenib), a multi-kinase inhibitor, to treat patients with metastatic colorectal cancer. Developed by Bayer AG, the drug was approved under the agency’s priority review procedure.

UCB SA said that a Phase 2b study of its candidate antibody for rheumatoid arthritis, olokizumab, met its primary endpoint. But there was no improvement in efficacy when the drug was compared with tocilizumab (Actemra).

Swedish Orphan Biovitrum (Sobi) has told analysts that its recombinant clotting factor product for haemophilia B achieved positive results in a Phase 3 trial, paving the way for a regulatory filing in the US in the first half of 2013.

Noxxon Pharma AG of Germany has started a Phase 2a study of an oligonucleotide-based drug in patients with multiple myeloma, a disease that accounts for about 1% of all cancers. The 28-patient, multi-center study is being conducted in Europe.

The US Food and Drug Administration has said it will review its regulatory guidelines and consult experts on clinical trial design in a renewed push to stimulate the development of new antibiotic drugs – a public health priority.

The chief financial officer of Epigenomics AG is to double up as acting chief executive as the company moves to shore up its share price and prepare for a regulatory submission of its lead diagnostic. CFO Thomas Taapken will assume the two jobs on 1 October.

Sanofi SA has announced plans to eliminate about 900 jobs in France by 2015 through voluntary measures. The plans are less severe than suggested in the summer by trade unions who would have been affected by the move.

SkyePharma Plc said that bondholders have approved a major debt refinancing that will lighten its short-term liquidity commitments. Separately, the company confirmed that it is due €4 million following the launch of flutiform in Germany.