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.
28.11.2014 The first gene therapy for a rare genetic condition — UniQure's Glybera — is on its way to the European market. But there is a hefty price tag: Chiesi, responsible for the marketing of the orphan drug, is asking for a record price of €1.1m per patient.
25.11.2014 The European biotech IPO slump has finally come to an end. A brand new industry report shows that compared to previous years, the number of biotech IPOs more than doubled in 2014, with London and Paris exchanges leading the pack.
19.11.2014 It’s not every day that a company is pushed into the top ten of its sector, but that day has come for Actavis. Christmas came early for the new pharma giant after completing a US$66bn (€53bn) takeover battle for the Botox manufacturer Allergan.
18.11.2014 Merck KGaA and US rival Pfizer have signed a immuno-oncology alliance worth billions: Merck will share the development and commercialisation of its cancer antibody with its US partner – for €2.3bn.
14.11.2014 Cosily coinciding with World Diabetes Day on 14th November, French biopharma Les Laboratories Servier has struck a US$1bn deal with US pharma Intarcia Therapeutics for the exclusive rights to Intarcia’s unprecedented therapy for type 2 diabetes.
12.11.2014 Glitz and glamour are not words often used to describe science and mathematics. But once a year, celebrities from the science and showbiz world come together at the Breakthough Prizes, a glitzy television bash that honours scientists for their achievements. French life scientist Emmanuelle Charpentier was among this year’s winners.
04.11.2014 Galecto Biotech has entered an agreement with Bristol-Myers Squibb for the acquisition of the company and its lead drug, providing the Swedish company with the potential of reaching over US$400m.