BeNeLuxBelgiumNetherlandsLuxembourg

FDA rejects Rhucin BLA and asks for additional clinical data

01.03.2011

Leiden/San Diego – Bad news for the Dutch Pharming Group and its partner Santarus Inc, who wants to market the heriditary angioedema treatment Rhucin (INN conestat alfa) in North America – the FDA said on Monday, that the companies’ BLA submitted in December was not sufficiently complete to enable a critical medical review of the EU approved recombinant human C1 inhibitor that is produced in milk of transgenic rabbits. In its „refusal to file” letter, the FDA said that the studies submitted had a insufficient number of subjects to support the proposed dose and lacked prospective validation of the visual analog scale used in measuring the clinical effects of the drug. The FDA asked to include the data of an ongoing Phase IIIb clinical study in any future BLA submission for Rhucin. Under the terms of the partnership, Pharming will be responsible for conducting and paying for the current Phase IIIb clinical study with Rhucin (Ruconest),. The drug was recommended in Europe after doubts about its efficacy. Rhucin is also under development for follow-on indications, i.e. antibody-mediated rejection (AMR) and delayed graft function (DGF) following kidney transplantation.




BeNeLuxBelgiumNetherlandsLuxembourg

16.12.2011

Mechelen - Galapagos NV confirms its status as one of Europe best drug discovery companies. The Belgian biotech received €4 million as the first milestone payments from French Servier for the discovery of new targets for...

BeNeLuxBelgiumNetherlandsLuxembourg

15.12.2011

Munich/Groningen/Penzberg – For ten years, the application of image-guided surgery with tumour-specific fluorescent dyes has been limited to animal studies, because no one could predict safety or bio­distribution of such targeted...

BeNeLuxBelgiumNetherlandsLuxembourg

02.12.2011

Zwijnaarde/Rotterdam – In vivo camelid antibody specialist arGEN-X BVBA has baged €27.5 million of fresh capital for development of its preclinical monoclonal antibody pipeline. The round B financing of the 3 year-old company,...

BeNeLuxBelgiumNetherlandsLuxembourg

28.11.2011

Brussels/Ghent – Belgian researchers have demonstrated that tumour cells secrete the angiogenesis factor VEGF to create a microenvironment that fosters proliferation of cancer stem cells. In mice with squamous cell carcinoma,...

BeNeLuxBelgiumNetherlandsLuxembourg

23.11.2011

Mechelen – Belgian drugmaker Galapagos NV has reported impressive results of a proof-of-concept trial with its oral janus kinase 1 blocker GLPG0634 + Methothrexate in patients with active rheumatoid arthritis. In the 24 patients...

BeNeLuxBelgiumNetherlandsLuxembourg

18.11.2011

Naarden – Enzyme replacement therapies specialist Oxyrane NV raised €20 million in a series D round of financing. The therapies are designed to treat lysosomal storage diseases, a class of more than forty rare inherited diseases....

BeNeLuxBelgiumNetherlandsLuxembourg

14.11.2011

Hilden/Venlo – Sample and assay technologies provider Qiagen N.V. is set to eliminate about 10% of its current global workforce of 3,800 employees. The company says the cuts are one result of implementing a project aimed at...

BeNeLuxBelgiumNetherlandsLuxembourg

09.11.2011

New York/Ghent - Big brother is gone. Belgian biotech Ablynx regained the rights for nanobodies targeting TNF-alpha from Pfizer. The US- pharma outfit decided it did't want ATN-103, even though it met its goal in a mid-stage...

BeNeLuxBelgiumNetherlandsLuxembourg

25.10.2011

Amsterdam - The second blow could be the ultimate one. Amsterdam Molecular Therapeutics received a second negative opinion for Glybera to treat lipoprotein lipase (LPL) deficiency. The European Medicines Agency's (EMA) Committee...

BeNeLuxBelgiumNetherlandsLuxembourg

13.10.2011

Bilthoven – The current impact of hospital acquired infections with multi-resistant bugs is lower than suggested by startling news articles. According to a study of Dutch researchers, bloodstream infections caused by...

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