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Novartis gets FDA ok for Ilaris

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%).

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http://www.european-biotechnology-news.com/news/news/2013-02/novartis-gets-fda-ok-for-ilaris.html

FinancingSwitzerlandEU

29.04.2016 Swiss bank Group UBS has raised US$471m (€412m) for the UBS Oncology Impact Fund, which was set up to invest in early-stage cancer treatments. The money raised by the fund, nearly half of which comes from investors in Asia, is the largest amount ever raised for such a cancer investment fund.

Industry reportGermany

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).

Clinical ResearchFrancePortugal

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.

Immuno-oncologyNetherlandsBelgium

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.

RegulatorySwitzerlandEU

20.04.2016 The US government is forking out up to US$100m to get Basilea Pharmaceutica’s broad-spectrum antibiotic ceftobiprole on the US market. In the EU, ceftobiprole is already available.

Immuno-oncologyUK

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.

FinancingSwitzerlandFranceEUGermanyDenmark

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.

Event ReviewSwitzerlandBelgiumEU

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.

FinancingGermanyNetherlandsEU

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.

Event ReviewGermanyEU

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.

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No liability assumed, Date: 02.05.2016