13.05.2013 - Swiss Novartis AG has gained authorisation from the FDA to market its IL-2beta blocker Ilaris in childhood arthritis.
The market approval of Novartis’ immune system blocker canakinumab comes only two weeks after the FDA has cleared Roche’s first-in-class IL-6 receptor blocker Actemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in children aged 2 years and older.
SJIA is a rare, debilitating form of arthritis in children that worsens over time and affects approximately 30 in 100,000 children. The approval of the Novartis once monthly subcutaneously administered human monoclonal antibody was based on two Phase III trials. The first one showed that 84% of patients treated achieved ACR30 versus 10% in the placebo arm at day 15. In an open-label part of the other study, 92 of 128 patients attempted corticosteroid tapering. 57 were able to reduce their use of corticosteroids, and 42 completely discontinued corticosteroids.
Roche had reported that 83% of patients that took its monthly intravenously administered IL 6 receptor antagonist tocilizumab as monotherapy achieved an ACR 30 response at week 16 compared to baseline. Additionally, Actemra-treated children experienced significantly fewer disease flares (26%) compared to placebo-treated patients (48%).
27.04.2016 More revenue, more jobs, more financing, more R&D expenditure – all signs point towards sustainable growth in the German biotech sector. These are the results of the most recent company survey 2016, published by biotechnologie.de. The report was once again conducted alongside the biotech standards defined by the organisation for economic cooperation and development (OECD).
21.04.2016 An expert panel’s final report on the fatal drug trial earlier this year in France states that the death of one of the participants was most likely caused by the drug’s toxicity and not by any violation of the rules.
21.04.2016 For up to US$685m (€606m), Dutch ArgenX has outlicensed its human antibody programme ARGX-115 to AbbVie. The pre-clinical immuno-oncology candidate targets a protein believed to contribute to immunosuppressive effects of T-cells.
19.04.2016 British drug developer Heptares Therapeutics and mAb maker Kymab Ltd have partnered up in yet another immuno-oncology collaboration. The companies plan to discover antibody meds targeting a superfamily of receptors.
15.04.2016 Not every company is put off by the current stock market climate. Swiss biopharma company GeNeuro has gone public at Euronext Paris, raising €33m in the process. Others, meanwhile, have to find different ways to raise money.
13.04.2016 Despite political disturbances, 2015 was a good year for the biotech scene in Switzerland. Net sales increased by 5.1% to CHF5,133m and 400 additional people found jobs in the sector. As usual, the new numbers were presented at the annual Swiss Biotech Day – which set new records as well.
12.04.2016 German-Dutch life science investment specialist Forbion Capital Partners has raised more than €180m for its venture capital fund Forbion Capital Fund III. Once more the money will primarily go to European start-ups.
08.04.2016 Do you win by being innovative?, was the question asked at this year’s DIA Euromeeting in Hamburg. In a relaxed and cooperative atmosphere, regulators, physicians and patients had ample opportunity to interact with the healthcare industry.
07.04.2016 Pfizer and Allergan have called off their merger, cancelling plans to relocate the US pharma giant to Ireland to avoid US taxation. The US government has put a spoke in Pfizer’s wheels - an unfair move, Allergan says.