Tagged with drug

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…

Canada The Top 10 bestselling patented medicines in Canada for 2017. Janssen sold CND 938.1 million of its Remicade treatment for gastroenterology, rheumatology and dermatology indications, making up a full 5.6% of all patented medicine sales in Canada. In second place was Abbvie’s Humira with CND 701.9 million of sales and…

Europe 125 medicines for rare diseases were approved by the EMA between 2004 and 2014, of which 71 were granted orphan drug status. This chart shows the availability of 112 of these drugs across European countries. The largest number of medicines for rare diseases were in continuous use in Germany and…

Turkey Abidin Gulmus, founder and chairman of Gen Ilaç, describes the company’s impressive journey to become Turkey’s principle orphan drug distributor and shares his vision for leveraging the company’s domestic expertise to expand their reach into foreign markets.   Gen Ilaç is one of the fastest growing Turkish success stories although…

Korea Korean Pharma company, Hanmi has won orphan drug status this week from the US Food and Drug Administration (FDA) for HM43239, a drug for the treatment of acute myeloid leukaemia (AML).   The endorsement of FDA’s Orphan Drug Designation (ODD) — invented to smooth the development of therapies for life-threatening…

Innovation Patient groups oftentimes serve as the authority on a specific disease when it comes to advancing research.   “Without patient perspective, there is no good medical product development,” Rachel Sherman, the FDA’s principal deputy commissioner proclaimed during her keynote at last week’s NORD’s Rare Disease & Orphan Products Breakthrough Summit.…

Brazil Cristina Dislich Ropke, CEO of Phytobios, a company that helps multinational and local companies turn Brazilian biodiversity into medicinal products, highlights the company’s exceptional perseverance in studying the Brazilian biodiversity at times when legal uncertainties threatened the development of this segment. She also expands on the drug development center founded…

Poland Mirosław Zieliński, president of the Polish National Forum for the Therapy of rare diseases (ORPHAN), the representative voice for 35 Polish rare disease associations, discusses the implications of the introduction of a national rare disease plan and the need to improve rare disease diagnostics. Furthermore, he highlights the importance of…

Switzerland Thierry Mauvernay, president and delegate of the board of Debiopharm, discusses the Swiss Group’s development over its 38 years of history, its unique business strategy, and how new trends such as personalized medicine and digitalization are being embraced moving forward.   Our goal is not to become much bigger, but…

Indonesia Agus Heru Darjono, President Director at Metro Drug Indonesia, highlights the opportunities in the Indonesian Third Party Commercialization sector and emphasizes the importance of building the best team in order to successfully perform in an ever-changing market like Indonesia. Can you briefly speak towards the history as well as the…

Mexico Marco Cid, Director General of Investigacion Biomedica, shares how he successfully launched an innovative clinical research center (CRC) despite a challenging regulatory environment. He speaks about the inspiration behind his business model, the necessity of building a strong rapport with authoritative entities in the market, as well as fostering a…