NLS CHMP

Drug Development Pharma - March 10, 2015

CHMP Clears Drug Label Update

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for a label update of  H. Lundbeck A/S’s Brintellix® for its effect on certain aspects of cognitive function in patients with depression. This will be the first summary of the product characteristics of an antidepressant to […]

Drug Development Pharma - November 24, 2014

CHMP Approves Victoza

The Committee for Medicinal Products for Human Use (CHMP) today issued a positive opinion for the use of Victoza® (liraglutide) in adults with type 2 diabetes and moderate renal impairment. Once the European Commission approves the label expansion, physicians in the European Union will be able to prescribe Victoza®, a once-daily human glucagon-like peptide-1 (GLP-1) analogue, to […]

Biotech article - February 27, 2014

Active Biotech reported for economic crime

The Lund-based pharmaceutical company has been reported to the Swedish Economic Crime Authority. Active Biotech is accused to have to misinformed their investors. Allegedly, the firm was aware of the that the MS drug Nerventra should have been stopped but concealed it. On January 25, the company share went down dramatically on the stock market. […]

Drug Development Pharma - September 25, 2013

Otsuka and Lundbeck receive positive CHMP opinion for Abilify Maintena(r) in schizophrenia

Lundbeck and Otsuka today announced a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorization for Abilify Maintena (aripiprazole), an intramuscular (IM) depot formulation for the maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole. “Abilify Maintena has been available in the US for […]

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