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.
Elan Corporation Plc is refinancing its long-term to take advantage of low interest rates. If successful, the offering would eliminate the Dublin-based company’s long-term, high-interest debt and pave the way for refinancing on better terms.
Wellington Partners has raised €70 million for a new life science fund that will support early-stage European companies – with an emphasis on medical devices, diagnostics and drug-device
MorphoSys AG said its candidate antibody for rheumatoid arthritis targeting granulocyte macrophage-colony stimulating factor (GM-CSF) has shown an unusually high efficacy score at four weeks in a Phase 1b/2a clinical study.
The European Medicines Agency’s CHMP is recommending that Avastin (bevacizumab) be given approval for use in combination with chemotherapy to treat women with recurrent, platinum-sensitive ovarian cancer.