Pharma Business - November 29, 2017
AstraZeneca’s regulatory submission for Tagrisso accepted
The European Medicines Agency has accepted a variation to the Marketing Authorisation Application (MAAv) for Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, for the 1st-line treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have […]
Careers article - November 21, 2017
Amsterdam selected as new location for EMA
Late yesterday afternoon the General Affairs Council of the European Union decided that the European Medicines Agency (EMA) will relocate to Amsterdam when it leaves London in 2019. The vote had to be determined by drawing the name of the new city out of a hat at random, after a tie between Amsterdam and Milan in […]
Pharma Business - October 9, 2017
AstraZeneca granted therapy designation
AstraZeneca has announced that the US Food and Drug Administration has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). “The Breakthrough Therapy Designation acknowledges not only Tagrisso’s potential as a 1st-line standard of care in advanced EGFR mutation-positive NSCLC, […]
New Market - October 2, 2017
Approval for Genmab’s DARZALEX in Japan
The Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the use of DARZALEX (daratumumab) in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma. D ARZALEX is being developed under an August 2012 agreement in which Genmab granted Janssen Biotech, Inc. an […]
Drug Development Pharma - October 2, 2017
EMA Validation for Camurus
The company’s marketing authorization application (MAA) for the investigational, weekly and monthly CAM2038 buprenorphine depots for the treatment of opioid dependence has been fully validated by the European Medicines Agency. The application, submitted on 26 July 2017, is now under assessment by the Committee for Human Medicinal Products (CHMP). “The validation of the MAA for CAM2038 […]
Pharma Business - September 11, 2017
Novo Nordisk announces conclusion of investigation of marketing practices
Novo Nordisk has reached a resolution with the US federal government and the states about an investigation launched in February 2011 concerning sales and marketing practices for Victoza, a medicine to treat type 2 diabetes. The investigation was disclosed by Novo Nordisk for the first time in a company announcement on 16 February 2011. The […]
