Tagged with Approval

USA 59 novel drugs were approved in the USA in 2018, representing a leap from the 46 approved in 2017 and 22 approved in 2016. 19 of the 59 drugs (32 percent) have been designated ‘first-in-class’ and 34 of the 59 drugs (58 percent) were approved to treat rare or “orphan”…

Canada In total there were 27 new active substances (NASs) approved in Canada in 2018, 18 prescription pharmaceutical drugs and 9 biologics. In terms of companies that saw particular success last year, Merck (MSD outside of the US and Canada) had three prescription drugs approved, as did Swiss-headquartered Vifor Pharma. Global…

Tunisia Senda Bahri Hicheri, director of the National Control Laboratory of Tunisia (LNCM), is looking forward to helping Tunisian pharmaceutical players thrive by allowing them to profit from both shorter market access times and an upcoming accreditation for the laboratory. In this interview, she explains the key role the LNCM is…

Pharma The following chart illustrates the various bottlenecks restraining the development of France’s pharmaceutical industry, including lack of investment, fewer new molecules than other European countries, disappointing performance in biological drugs, and long waiting times for drug approval. Click here to read more articles and interviews from France, and to download the…

Pharma Alexander Zehnder discusses Sanofi’s sizable contribution to the Italian economy, manufacturing in Italy, and the country’s labyrinthine drug approval processes. What have been your main areas of focus and priorities since your appointment as head of Sanofi’s Italy and Malta operations in October 2014? Sanofi is in the midst of a transition from…

distribution The Argentinian healthcare system is subject to rules, in which delivery agreements for medicines to health insurance agents undergo health funders guidelines and other regulations imposed by the Superintendency of Health Services Office. Dr. Raúl Pistorio, Executive Director of Farmalink, the company responsible for this process, discusses this peculiar regulatory arrangement.…