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.
24.03.2015 Poland has announced the closing of a new venture capital fund at US$42m (€32m). The fund, which is the first of its kind in Poland, is dedicated to the Life Sciences with a strong connection to Central and Eastern Europe.
23.03.2015 A BASF-led consortium aims to decrease bio-based production costs using industrial biotechnology. The Horizon2020 funded consortium is the sixth project of the SPIRE Public Private Partnership and has a budget of €14m.
17.03.2015 Pharma giants GlaxoSmithKline (GSK) and Johnson & Johnson (J&J) will be key collaborators in a new global fund for dementia research to address the rising threat posed by dementia and Alzheimer’s disease.
12.03.2015 With around 1,400 companies and 2,400 participants, the springtime counterpart of BIO-Europe enjoyed a successful premiere in France this year. The overall mood of the European biotech industry was positive, and the French hosts in particular reported new initiatives.
10.03.2015 The Gates Foundation has dipped into its purse to bring infectious diseases vaccines to the poorest countries. German vaccine specialist CureVac is set to receive US$52m for their mRNA platform technology.
05.03.2015 The IPO wave in the biotech sector shows no signs of slowing down. An Irish life sciences fund set up by former Elan executives plans to raise €325m with its IPO, whilst Summit Therapeutics has announced its IPO pricing of US$34m on Nasdaq.