13.02.2013 - The FDA has rejected market authorization of Novo Nordisk’s long-acting insulin Tresiba and demands a complete new cardiovascular safety study.
The FDA asked the Danish insulin-maker to complete a cardiovascular safety study of the long-acting insulin in 7,500 patients before granting market authorisation. The decision on Tresiba comes just a few weeks after the European Medicines Agency had given the green light for the once daily insulin degludec.
Most analysts don't expect Novo to have databefore 2016, offering market leader Sanofi more years to sell its blockbuster Lantus without a challenge from Tresiba. Sanofi made about 20% of its revenues with Lantus (US$6.6bn) last year – more than 50% of the global diabetes market. The FDA's complete response letter also caught Novo's related Ryzodeg in the regulatory net, which was also backed by the expert panel.
03.07.2015 Biotech giant Biogen is investing CHF 1bn in a new pharmaceutical production plant in the Swiss town of Luterbach. Noted as one of the world’s oldest biotech firms, the new plant will create up to 400 jobs.
02.07.2015 Dutch biotech Amarna and Austrian Biomarker research centre CBmed have joined forces to develop several immunotherapies, including therapies against cancer and diabetes type 2. The joint venture will develop Amarna’s next generation viral vector platform.
30.06.2015 Pharma giant Novartis has bumped up its neuroscience portfolio with the recent purchase of Australian biotech Spinifex for a US$200m upfront payment plus US$500 in milestone payments. The acquisition is centred on Spinifex’ mid-stage pain drug EMA401.
24.06.2015 Swedish scientists have created artificial neurons that are capable of mimicking the function of human nerve cells. The researchers hope that, once minituarised, they may one day be used to restore disturbed neural function.
22.06.2015 For the 31st time, the ACHEMA has drawn the global chemical engineering and the process industry to Frankfurt. Although still overshadowed by petrol, the biobased economy is getting ready to step out into the limelight.
12.06.2015 The high-potential cancer immunotherapy market is fiercely fought, and small companies have trouble making their mark. Nordic companies Targovax and Oncos have joined forces to create a Nordic immuno-oncology champion named Polaris.
METTLER TOLEDO now offers a new family of high-precision weighing platforms that provide superior accuracy and reliability in harsh industrial conditions with flexibility to be used for many applications. more