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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

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.

M&AIrelandEU

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.

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