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

29.03.2012

Brussels – Promethera Biosciences has completed a Series B financing round, generating proceeds of €23.6m. The Belgian cell therapy company secured a capital increase of €17m from its new investors, among them the venture arms...

BeNeLuxBelgiumNetherlandsLuxembourg

19.03.2012

Leuven – Biopharmaceutical company ThromboGenics has entered into an agreement with Alcon Inc., a division of Novartis for the commercialisation of its product ocriplasmin in all markets outside the U.S. ThromboGenics said it...

BeNeLuxBelgiumNetherlandsLuxembourg

07.03.2012

Amsterdam Molecular Therapeutics has announced a financial manoeuvre aimed at getting the biotech out of a hopeless situation. The assets and – more importantly – the liabilities of the drug developer will be acquired by a newly...

BeNeLuxBelgiumNetherlandsLuxembourg

20.02.2012

Amsterdam - Amsterdam Molecular Therapeutics has announced a financial manoeuvre which is aimed to get the biotech out of a dead end. The assets and – more importantly – the liabilities of the drug developer will be acquired by...

BeNeLuxBelgiumNetherlandsLuxembourg

10.02.2012

Glasgow/Leuven - With a little help from the EU, two biotech companies are banding together to develop the first stem cell therapy against rheumatoid arthritis. UK-based Sistemic will work with TiGenix to develop the Belgian's...

BeNeLuxBelgiumNetherlandsLuxembourg

25.01.2012

Amsterdam – Two elephants in the biofuels business join forces. Dutch food and chemicals group Royal DSM and POET, LLC, a US-based ethanol producer, announced a plan to build a commercial cellulosic ethanol plant. POET–DSM...

BeNeLuxBelgiumNetherlandsLuxembourg

13.01.2012

Heerlen - Royal DSM N.V will be the industrial partner to the Panoptes consortium, which aims to develop novel drug delivery technology for the posterior eye segment. The four year project is supported by EUR4m in funding from...

BeNeLuxBelgiumNetherlandsLuxembourg

04.01.2012

Leiden - Dutch Pharming Group NV has taken a further step to secure sound financing even beyond the recent milestone payments. The drug developer announced that it has entered into a financing of approximately €8.4 million by...

BeNeLuxBelgiumNetherlandsLuxembourg

16.12.2011

Ghent – Just days after US pharmaceuticals giant Pfizer pulled out of a rheumatoid arthritis pact with Ablynx NV, the Belgian biopharmaceutical company expanded its relationship with Merck Serono. Ablynx has now entered into a...

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