News

Novartis gets FDA ok for Ilaris
Enlarge image

BusinessSwitzerland

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%).

© eurobiotechnews.eu/tg

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

Stock MarketsIrelandUK

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.

LicencingDenmark

05.03.2015 Bavarian Nordic is outlicensing its Phase 3 prostate cancer immunotherapy Prostvac to pharma heavyweight Bristol Myers Squibb for a tidy €881m.

BusinessUK

03.03.2015 After weeks of speculation, AstraZeneca has announced its plans to spin out its early-stage antibiotic R&D. The decision marks the company’s aims to “sharpen its focus on three main therapy areas”.

GenericsEUUKHungaryGermanyItalyGreeceAustriaLuxembourgFranceSpain

26.02.2015 It is the first biosimilar monoclonal antibody in many European markets: Mundipharma and Hospira are launching Celltrion’s Remicade generic.

M&AUK

23.02.2015 British drug developer Heptares has been acquired by Japanese biopharma play Sosei for US$400m (€352m).

bioethanolGermanyUKBelgiumFrance

19.02.2015 The price of oil has been sliding for months, and the European bioethanol market is taking it hard. CropEnergies AG has now stopped production at its British unit Ensus UK.

BusinessFranceGermany

17.02.2015 After Christopher Viehbacher’s unceremonious ousting last year, Sanofi has been on the look out for a new CEO. Now, sources say Bayer’s Olivier Brandicourt is set to fill the position.

BusinessUKSwitzerland

12.02.2015 Glaxosmithkline is intent on bolstering its vaccine portfolio further and has bought all shares of Swiss development partner Glycovaxyn.

InvestmentsUKEU

10.02.2015 Interest in biotechnology is on the rise among British investors. Not just one, but two major financiers are planning investment funds in the field.

Events

All Events

Partner-Events

Planegg/Martinsried

1st Munich Biotech Pitch

Berlin (DE)

Proteomic Forum 2015

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • CYTOS1.30 CHF176.60%
  • MEDIGENE4.97 EUR9.23%
  • FORMYCON18.70 EUR7.47%

FLOP

  • VITA 345.30 EUR-5.36%
  • BIOFRONTERA1.98 EUR-4.35%
  • ADDEX3.06 CHF-3.16%

TOP

  • CYTOS1.30 CHF282.4%
  • WILEX3.23 EUR51.6%
  • FORMYCON18.70 EUR25.1%

FLOP

  • MOLOGEN5.13 EUR-16.0%
  • SANTHERA96.10 CHF-12.4%
  • MAGFORCE5.44 EUR-10.8%

TOP

  • SANTHERA96.10 CHF2339.1%
  • WILEX3.23 EUR429.5%
  • FORMYCON18.70 EUR142.9%

FLOP

  • MOLOGEN5.13 EUR-56.7%
  • PAION2.06 EUR-54.6%
  • CYTOS1.30 CHF-54.4%

No liability assumed, Date: 05.03.2015