Merck KGaA's Kuvan Receives Marketing Authorization in Europe
Merck KGaA and its Merck Serono division announced today that the European Commission has granted marketing authorization
for Kuvan® for the treatment of Hyperphenylalaninemia (HPA) in phenylketonuria (PKU) or BH4 deficient patients. Kuvan, which had previously received Orphan Medicinal Product designation from the European Medicines Evaluation Agency (EMEA), is the first drug approved in Europe for HPA due to PKU or BH4 deficiency.
Prof. Jonathan Knowles, Head of Group Research and member of the Corporate Executive Committee of Roche, will retire from Roche at the end of 2009. During 2009, he will facilitate a smooth transition of his responsibilities to Lee Babiss, Head of Pharma Research and Jean-Jacques Garaud, Head of Pharma Development.
Schering-Plough Corporation (NYSE: SGP) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending approval of the intravenous (IV) formulation of TEMODAL(R) (temozolomide) as an alternative to the already approved oral form of temozolomide in the EU.
GlaxoSmithKline (GSK) has signed an exclusive Cooperation Agreement with Shenzhen Neptunus Interlong Bio-Technique Co. Ltd. (NIBT) as a preliminary step in forming a Joint Venture (JV) between the two companies. The agreement outlines the proposed terms for establishing a JV company, which will seek to co-develop seasonal influenza vaccines and pre-pandemic/pandemic influenza vaccines, firstly targeting against strains of the virus specific to China, Hong Kong and Macau.