Lupin said the European Commission (EC) has approved mexiletine for the symptomatic treatment of nondystrophic myotonic (NDM) disorders in adults. Non-dystrophic myotonic disorders are a group of rare, inherited neuromuscular disorders which cause the inability to relax muscles following voluntary contraction. Lupin’s NaMuscla reduces myotonia...
EUROPE
EU accepts Biocon, Mylan’s application for cancer biosimilar pegfilgrastim
Indian pharma company Biocon and its partner Mylan said EU authorities have accepted for review their applications for approving cancer treating biosimilars trastuzumab and pegfilgrastim submitted after completing corrective actions. The applications were resubmitted last month after being pulled in August in response to audit...
Dr Reddy’s says EU approves production at Duvvada plant in Andhra
Pharma major Dr Reddy’s Laboratories said European Union authorities have again allowed it to produce drugs for sale in the EU region at its Duvvada factory in Andhra Pradesh. In its inspection conducted in September, the Regulatory Authority of Germany (Regierun von Oberbayern) had made...
Biocon, Mylan apply again for EU approval for cancer drugs trastuzumab, pegfilgrastim
Biocon said its partner Mylan has resubmitted the marketing application for two substances used to treat cancer — trastuzumab and pegfilgrastim — before European authorities after making changes to their production facilities. The drug applications before the European Medicines Agency (EMA) were withdrawn in August...
Hexaware Technologies opens new operations center in Bucharest
Hexaware Technologies Limited, a BPO and Digital services provider, said it has expanded its delivery presence in the European region by opening of its latest Global Delivery Centre in Bucharest, Romania. The Bucharest Global Delivery centre is situated in a prime location and in close...
Government signs MoU with University of Latvia for Ayurveda research
A memorandum of understanding was signed between the Central Council for Research in Ayurvedic Sciences (CCRAS) and University of Latvia to provide a structured framework for taking forward academic research activities in Ayurveda. An Ayurveda professor will be sent to the University through deputation. University...