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.
25.08.2015 Oslo Cancer Cluster is inaugurating its NOK1bn (€107m) Innovation Park. None other than Norwegian prime minister Erna Solberg officially opened the doors to the research park on August 24th.
21.08.2015 Novartis Pharma AG has secured all remaining rights to antibody hopeful ofatumumab. Seller GlaxoSmithKline is set to receive up to US$1bn (€919m) for the treatment for MS and other autoimmune indications.
11.08.2015 Biotech bug controllers Oxitec has been bought by US biotech Intrexon Corporation for $160m (€145m). The Oxford University spin-out specialises in environmentally friendly technology to control pests such as mosquitoes, which cause dengue fever and other diseases.
04.08.2015 In a deal worth US$65m upfront, AstraZeneca is again teaming up with long-time partner Isis Pharmaceuticals Inc., this time to discover and develop RNA antisense drugs for cardiovascular, metabolic and renal diseases.
The BioShake series contains high-speed mixer and thermal mixer for small and very small volumes in microplates and reaction tubes and allows for the first time high precise and efficient mixing in the microliter scale for a wide range of applications. more