Drug Development Pharma - June 12, 2014
Nordic Nanovector gets green light for Betalutin
The Norwegian company’s lead product candidate has been granted orphan designation in Europe. The European Medicines Agency (EMA) and the European Commission (EC) has now granted Betalutin orphan designation for treatment of follicular lymphoma in Europe. According to Nordic Nanovector, this will provide the company several advantages, The master travel anyone lisbon iowa singles stay […]
Drug Development Pharma - June 10, 2014
Medivir launches Olysio in the Nordic countries
Medivir has announced that its NS3/4A protease inhibitor Olysio will be available in all of the Nordic countries within the next few weeks. Treatment with Olysio began in Sweden in late May, followed by Finland and Denmark, where the first patients recently began their treatment. “It is immensely gratifying to now be able to offer a new […]
Drug Development Pharma - May 30, 2014
BioInvent sells back to Alligator Bioscience
BioInvent has sold back all its rights to drug development candidate ADC-1013 to former partner Alligator Bioscience for an undisclosed sum. BioInvent has manufactured ADC-1013 (a FIND optimized n-CoDeR antibody) and the company has announced that it will fulfill the remaining CMC activities required to supply drug product to the First-in-Human study, expected to commence […]
Drug Development Pharma - May 26, 2014
EU approves Eli Lilly-Boehringer diabetes drug
The European Commission has granted marketing authorization for Jardiance (empagliflozin) tablets. It is a sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of type 2 diabetes mellitus (T2D) to improve glycemic control in adults in Europe. The European Commission approved JARDIANCE 10 and 25 mg once daily tablets for use when diet and exercise […]
Drug Development Pharma - May 23, 2014
CHMP says no to Laquinimod
Teva Pharmaceutical and Active Biotech has announced that the Committee for Medicinal Products for Human Use’s confirmed its earlier opinion to recommend against approval for the treatment of relapsing-remitting multiple sclerosis in the European Union at this time. According to a statement from Active Biotech, both companies remain committed to the NERVENTRA (laquinimod) clinical development program for […]
Drug Development Pharma - May 15, 2014
Green light for Oasmia’s production facility
The company’s manufacturing facility in Uppsala, Sweden, has been approved for manufacture of cytostatics by the Swedish Medical Products Agency. The approval concerns manufacture for sales in the EU. With this approval, the Medical Products Agency has confirmed that Oasmia’s manufacture of cytostatics meets the requirements of current Good Manufacturing Practice (cGMP) and Oasmia now has a […]
