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

07.03.2012

The first of February marked a milestone for Leverkusen-based Bio­frontera AG in more ways than one. It was the first day that Ameluz, the firm’s first approved product, could be sold in German pharmacies. It was also the date...

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07.03.2012

Darmstadt – German pharmaceutical and chemical company Merck KGaA has set a downbeat tone for 2012. CEO Karl-Ludwig Kley said the recently launched cost-cutting programme and tough economic conditions will weigh on profits this...

GermanyGermany

05.03.2012

Mainz/Leuna – Two biotech concepts were amongst the winners of the recent third round of the Excellence Cluster initiative, which is funded by the German Ministry for Research. In Mainz the champagne corks popped especially loud...

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05.03.2012

German Merck KGaA has closed a licencing agreement with US-based Threshold Pharmaceuticals Inc. The cooperation centres around the hypoxia­-activated drug TH-302, which is currently being studied in a global Phase III study....

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29.02.2012

Munich – Looking back with satisfaction and bent on a prize for good behaviour, German biopharmaceutical company Wilex AG reported yesterday on the fiscal year 2011 and outlined the shores in sight. The 2011 total revenue was...

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17.02.2012

Brussels – European cartilage researchers intensify their cooperation. The 'gristle network' comprises scientists from Belgium, France, Germany and Luxembourg. Its members plan to meet regularly to exchange views and information...

27.01.2012

Thousand Oaks/Munich - Bling bling for blinatumomab. It is a compliment for the European life sciences scene and sad news at the same time. Amgen Inc., the world's largest biotechnology company, agreed to buy Micromet Inc., an...

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20.01.2012

Martinsried - SHELTER is responsible for the fact that the stocks of 4SC behaved like a rodeo horse on Thursday. The shares rose in several stages up to 63%, only to settle at a mere 43% rise at the end of the day. SHELTER is a...

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17.01.2012

Ludwigshafen – BASF Plant Science GmbH, the agrochemistry and biotech arm of the world-largest chemistry company, thinks that it has outstayed its welcome in Europe. Over the next two years, most of the green biotechnology...

GermanyGermany

10.01.2012

Munich - It is the accolade for Micromet. The German company, which is listed on the U.S. stock exchange, announced today that it has entered into a Cooperative Research and Development Agreement (CRADA) with the renowned US...

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