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.
27.07.2016 In view of the Brexit, research academies across Britain are calling for a “bold commitment” from the government. The Royal Society President urges the UK government to underwrite the research of British scientists applying for EU funding.
20.07.2016 Belgian molecular diagnostics company Biocartis Group NV has raised €55m and will use the funds mainly to expand manufacturing capacities for its PCR-based molecular diagnostics system Idylla.
19.07.2016 It is Europe’s first gene therapy company to float on Euronext: Gensight raised €40m in its IPO. And it is not the only French company that has taken the leap in an uncertain market climate – Alzheimer’s expert Pharnext also went public.
18.07.2016 When NASA blasted off to the International Space Station on Monday morning, it had UK tech on board. A miniature DNA sequencer from Oxford Nanopore will be used to keep an eye on the ISS atmosphere – and may even analyse alien DNA one day.
13.07.2016 Cell Medica has acquired Swiss antibody specialist Delenex Therapeutics. The deal nets the British cellular therapeutics developer Delenex’ proprietory antibody fragment platform Pentrabody.
12.07.2016 Vienna-based vaccine specialist Themis Bioscience GmbH has secured broad access to a promising virus vaccine vector tech by extending its license agreement with French Institut Pasteur. Its goal: to develop a Zika vaccine.
07.07.2016 Californian biopharma Medivation has agreed to confidential negotiations with its suitors, in particular the French pharmaceutical company Sanofi, which aggressively has buffeted the cancer therapy specialist for months.
06.07.2016 The European Commission started an investigation into Illumina’s and Sequenom’s 2014 patent agreement, UK-competitor Premaitha Health said. The two US companies had agreed to pool their Noninvasive Prenatal Testing IP.
04.07.2016 Cinfa Biotech is shuffling for position on the lucrative biosimilar market. The Spanish-German company has published positive results in a study for a pegfilgrastim copycat with 172 healthy volunteers in Germany.
JANUS® G3 Automation Workstations deliver real-time and future adaptability in throughput, capacity, and dynamic volume range from 0.5 μl to 5000 μl for consistent and reproducible sample preparation more