News

FDA greenlights Roche's Actemra
Enlarge image

BusinessSwitzerland

FDA greenlights Roche's Actemra

02.05.2013 - Hoffmann La-Roche’s US subsidiary Genentech has gained approval for its IL-6-R blocking arthritis antibody Actemra in children.

Tocilizumab is now authorised for marketing in the US as a treatment of polyarticular juvenile idiopathic arthritis (PJIA). The medicine can be used in children two years of age and older with active disease as a monotherapy or in combination with methotrexate. 

Polyarticular juvenile idiopathic arthritis affects approximately 30 in every 100,000 children. The chronic disease is characterised by inflammation in five or more joints within the first six months of the disease and most commonly affects the small joints in the body such as the hands and feet. 

The label extension of Roche’s Interleukin-6 receptor antagonist is based on data from the combined open label/double blind Phase III CHERISH study. A total of 91% of patients taking the humanised monoclonal antibody plus methotrexate and 83% of those taking tocilizumab alone achieved an ACR 30 response at week 16 compared to baseline. In the randomized double-blind placebo-controlled withdrawal phase of the trial, 26% of patients in the Actemra arm experienced disease flares compared to 48% in the placebo arm. 

Infections, which were in part fatal, were the most common serious adverse events over 40 weeks. Other serious side effects include perforation of the stomach and intestines, changes in blood test results (including low white blood cell count, low platelet count, increase in certain liver function tests, and increase in blood cholesterol levels), hepatitis B infection becoming an active infection again, and nervous system problems. Actemra affects the immune system and may increase a patient's risk of certain cancers.  

© eurobiotechnews.eu/tg

http://www.european-biotechnology-news.com/news/news/2013-02/roche-gets-green-light-for-il-6-r-blocker.html

BusinessIreland

07.07.2015 Irish pharma play Allergan plc. is boosting its eye care business by acquiring US-American medtech company Oculeve. Included in the deal are Oculeve’s dry eye disease development programmes.

BusinessSwitzerland

03.07.2015 Biotech giant Biogen is investing CHF1bn in a new pharmaceutical production plant in the Swiss town of Luterbach. Noted as one of the world’s oldest biotech firms, Biogen will create up to 400 jobs at the new plant.

R&DNetherlandsSpainAustria

02.07.2015 Dutch biotech Amarna and Austrian Biomarker research centre CBmed have joined forces to develop several immunotherapies, including therapies against cancer and diabetes type 2. The joint venture will develop Amarna’s next generation viral vector platform.

M&ASwitzerland

30.06.2015 Pharma giant Novartis has bumped up its neuroscience portfolio with the recent purchase of Australian biotech Spinifex for a US$200m upfront payment plus US$500 in milestone payments. The acquisition is centred on Spinifex’ mid-stage pain drug EMA401.

Personalised MedicineGermany

25.06.2015 German immunotherapy expert BioNTech AG has partnered up with Europe’s largest engineering company Siemens to construct a manufacturing site for BioNTech’s personalised cancer vaccine.

Bioelectronic researchSweden

24.06.2015 Swedish scientists have created artificial neurons that are capable of mimicking the function of human nerve cells. The researchers hope that, once minituarised, they may one day be used to restore disturbed neural function.

FinancingLuxembourgItalySwitzerland

23.06.2015 Cosmo Pharmaceuticals is floating its majority-owned subsidiary Cassiopea at the Swiss Stock Exchange, with the aim to raise between CHF150m and CHF200m.

EventEUGermany

22.06.2015 For the 31st time, the ACHEMA has drawn the global chemical engineering and the process industry to Frankfurt. Although still overshadowed by petrol, the biobased economy is getting ready to step out into the limelight.

EventEU

17.06.2015 At the BIO convention in Philadelphia, the biotech industry celebrates new gene and cell therapies, and hails its unlikely superheroes.

ResearchUKSwitzerland

16.06.2015 Northern Ireland’s biopharma Almac Discovery is partnering up with Roche subsidiary Genentech in a two-year joint research programme to discover and develop cancer treatments.

Events

All Events

Current issue

All issues

Product of the week

Products