12.11.2012 - An FDA panel says that Danish Novo Nordisk’s new recombinant insulins pose certain risks but still approves them. The benefit is evident, it states.
A federal advisory panel backed the long-acting insulin degludec by Novo Nordisk A/S. However, it said the company should conduct a post-approval study to address concerns about a possible increased risk of cardiovascular events such as heart attacks and strokes. The decision was not unanimous. Four of the 12 committee members voted against the approval. The proponents felt that the benefits outweigh the risks. The products were Tresiba insulin Degludec, a long-acting insulin analogue, and Ryzodeg, a combination of 70% insulin Degludec and 30% Novo Nordisk's NovoLog (insulin aspart). When balanced with comparators, both drugs are very efficient at reducing hypoglycemia.
The Danish company has already prepared a trial to meet FDA criteria. It has designed as a five-year cardiovascular outcomes trial that would enrol 7,500 type II diabetes patients. The FDA's endocrinologics and metabolic drugs advisory panel is composed of non-FDA medical experts. In Europe, insulin degludec recently received market approval. Recombinant insulins are used to treat diabetes, a disease that is characterised by the body's inability to either make or properly use insulin. Some manufactured insulins – such as Lilly’s Humulin or Novo Nordisk’s Novalin – have already lost patent protection. Others, like Humalog (Eli Lilly), Levemir and Novalog (both Novo Nordisk), and three of Sanofi’s four patents on Lantus , will follow in the next two years. With the advent of recombinant insulin biosimilars, Novo Nordisk is wise to develop a successful successor in the market.
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