GermanyGermany

Merck announces withdrawal of MS drug from markets after FDA safety concerns

23.06.2011

Darmstadt – Germany’s Merck KGaA will stop marketing of its multiple sclerosis (MS) pill cladribine (Movectro) in Australia and Russia where it has been already approved. The decision came several month after the US Food and Drug Administration said the company had to provide more data to demonstrate a positive benefit-risk ratio. Merck said yesterday that is was very unlikely to address the FDA requirements without carrying out additional costly clinical trials. Last autumn, the European Medicines Agency finally rejected authorisation of the symptomatic treatment of relapsing-remitting MS in Europe, the largest intended market of the drug, due to occurrence of cancer in some patients involved in a clinical trial. "The FDA feedback was consistent with the feedback previously received from the European Medicines Agency," the company said. Merck's cladribine, a chlorinated purine nucleoside analogon, which induces apoptosis after integration into the DNA, had initially been regarded as a formidable contender in the race with Novartis to bring the first oral treatment against MS to the market. Novartis received US authorisation for its sphingosine-1-phosphate receptor modulator fingolimod (Gilenya) last autumn, challenging the US$ 10 billion market share of MS injectables. The occurrence of cancer casts a bad light on cladribine, approved as a injectable treatment for hair cell leukemia.

GermanyGermany

27.10.2011

Leverkusen - Bayer Pharma has a lucky streak. The pharma division of the German chemical giant announced positive Phase III results from regorafenib in colorectal cancer. “We are extremely encouraged by the result of this...

GermanyGermany

24.10.2011

Leverkusen - A short statement from the European Medicines Agency (EMA) and a big step for the German biotech Biofrontera. The agency issued a favourable opinion on Biofrontera's marketing approval application for its drug for...

GermanyGermany

14.10.2011

Leverkusen/San Francisco - Bayer HealthCare and Onyx Pharmaceuticals will not to court over Nevaxar. The two companies reached an agreement related to regorafenib, a late-stage oncology compound. Regorafenib is an oral...

GermanyGermany

11.10.2011

Ingelheim/Ridgefield –Boehringer Ingelheim’s COPD treatment Combivent Respimat has been approved by the U.S. Food and Drug Administration (FDA) for the US market. The new, propellant-free inhaler product for the beta adrenergic...

GermanyGermany

01.10.2011

Rostock – German researchers say overexpression of one of the 49 transport proteins that shuttle substances over the blood-brain barrier could be the key to treating Alzheimer’s disease. In mice, the group headed by Jens Pahnke...

GermanyGermany

27.09.2011

Rehovot/Monheim – Bayer Crop Science may be a step closer to introducing desirable traits in wheat. In the collaboration with Israeli Evogene Ltd. the German company has reached a milestone. Utilising Evogene‘s proprietary...

GermanyGermany

22.09.2011

Willich – Brasilian biopolymer producer Braskem and German bioplastics compounding specialist FKuR GmbH, have signed a compounding agreement for green polyethylene. The tailor-made product will be a first in Europe, according...

GermanyGermany

08.09.2011

Leverkusen - It was a black Tuesday for Bayer. After rumours were leaked out that the FDA has doubts over the German pharmaceutical company's potential blockbuster Xarelto, the shares temporarily dropped as much as 17 percent....

GermanyGermany

06.09.2011

Bad Homburg - German VC firm Creathor venture announced the first closing of its Creathor Venture Fund III. Now, the company is poised to mete out €51million of fresh capital to start-ups. Life science companies will be among the...

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