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news.Meda files Acnex MAA in Europe
The company’s MAA includes 29 countries using a decentralised procedure (DCP). Registration in Russia, Turkey and the CIS countries will follow. Meda CEO Anders Lonner said Acnex is
The company’s MAA includes 29 countries using a decentralised procedure (DCP). Registration in Russia, Turkey and the CIS countries will follow. Meda CEO Anders Lonner said Acnex is
Initially, Stirling Products will manufacture 300kgs of tableted products and will gradually increase its production with the signing of more contracts which are now in process. Stirling Products’
The patent application covers methods to improve walking in patients with multiple sclerosis (MS) by administering 10mg of sustained release 4-aminopyridine (dalfampridine) twice daily. Acorda is marketing Ampyra
The test, developed through a non-exclusive license agreement under which Schering, a Merck affiliate, licensed certain patent rights claiming Interleukin (IL) 28B genetic markers to Quest Diagnostics. These
CHMP has recommended the approval for Dabigatran Etexilate in the member states of the EU as the prevention of stroke and systemic embolism in adult patients with nonvalvular
According to Roche, the FDA’s decision was supported by the positive results from a randomized, double-blind, Phase III study which demonstrated that 85% of children with SJIA receiving
Controlled substances are designated as Schedule I-V according to their medical use, potential for abuse and safety or dependence liability. Pharmatek CEO and CSO Jeffrey Bibbs said the
The company has signed a deal with Menarini for Turkey market, which has been already marketing TMX-67 under the brand name Adenuric in Europe since March 2010 under
The study is a randomized, double-blinded, controlled study of tivantinib plus erlotinib, versus placebo plus erlotinib in patients who have received prior treatment for advanced, non-squamous NSCLC. The
The study was conducted at 23 centers in the US and compared two doses of BC-3781 with Vancomycin in 207 patients with ABSSSI. In the study, BC-3781 demonstrated