Posted in:News Global Approvals for Insulin Glargine Promise a More Affordable, Long-Acting Treatment for Diabetes By Caitlin M. Wilmot April 3, 2018 Comments are off Last week, Mylan N.V. and Biocon Ltd. announced that their jointly-developed insulin glargine biosimilar, Semglee™, received marketing... Read more Tagged with: Abasaglar™, Biocon, Eli Lilly, FDA, Insulin glargine, Lantus®, Lusduna™, Merck, Mylan, Sanofi, Semglee™, trastuzumab http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:Legal Sanofi Files Suit Against Merck Sharp & Dohme Over Second NDA for Insulin Glargine Biologic: A Look at the Differences in Biosimilar Approval Pathways By Nicole DeAbrantes October 19, 2017 Comments are off On August 8, 2017, Sanofi-Aventis (“Sanofi”) filed a patent infringement suit in the United States District Court for the District of... Read more Tagged with: 351(k) pathway, 505(b)(2), BLA, District Court, Guidance, Merck, NDA, Patent Dance, Sanofi http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:News Samsung Bioepis and Merck Launch Renflexis® in the U.S. By C. Nichole Gifford August 9, 2017 Comments are off On July 24, 2017, Samsung Bioepis and Merck & Co., Inc. announced the launch of Renflexis® (infliximab-abda) in the United States. ... Read more Tagged with: Infliximab, Janssen, Merck, News, Remicade®, Renflexis®, Samsung Bioepsis http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:News FDA Grants Tentative Approval for Merck’s Insulin Glargine By C. Nichole Gifford July 25, 2017 Comments are off Merck & Co., Inc. (“Merck”) announced last week that the FDA has granted tentative approval for its insulin glargine injection... Read more Tagged with: Diabetes, Follow-on biologic, Insulin glargine, Lantus®, Legal, LUSDUNA™ Nexvue™, Merck, News, Sanofi http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus