The US Food and Drug Administration is expected to tell Roche by 17 December 2010 whether it will be able to approve the company’s two applications for Avastin (bevacizumab) to treat advanced HER2-negative breast cancer with chemotherapy.
The US Food and Drug Administration has announced a safety review of the diabetes drug, Actos (pioglitazone), on the basis of preliminary data on bladder cancer from a 10-year observational study of the drug. Takeda Pharmaceuticals is the manufacturer.
Novartis Europharm Ltd has withdrawn its application to market the hypertension treatment, Rasival (aliskiren and valsartan) in Europe, according to the European Medicines Agency. At the time of withdrawal, it was under review by the CHMP.
Johnson and Johnson is making an offer to acquire all the shares it doesn’t already own of Crucell NV for about €1.75 billion or at €24.75 per share. J&J currently owns 17.9% of Crucell.
Oxford Nanopore Technologies Ltd has strengthened its ties with Oxford University in the UK in order to explore new applications for its sequencing technology to the field of protein sensing.
The Food and Drug Administration has approved a new treatment for gout, Krystexxa (pegloticase), an enzyme that lowers uric acid levels by metabolising it into a harmless chemical excreted in urine. The developer is Savient Pharmaceuticals Inc.
Addex Pharmaceuticals Ltd has raised CHF 20 million (€15.4 million) through the issue of new, registered shares and zero coupon six-month, mandatory convertible notes to the Biotechnology Value Fund (BVF) LP of San Francisco, California
Genmab A/S, one of Europe’s oldest therapeutic antibody companies, has taken a new strategic direction with the decision, announced on 14 September 2010, to research antibody-drug conjugates with Seattle Genetics Inc of the US.
Genmab A/S has entered into a research collaboration with Seattle Genetics Inc to research and possibly co-develop monoclonal antibody conjugates for solid tumours. Financial details were not disclosed.
Evolva Holding SA reported a 21% increase in revenue in the 2010 first half, largely due to income from projects being carrying out for agencies of the US Department of Defense. The Switzerland-based company works in the area of synthetic biology.