Check Your Competency in Data Integrity
Data Integrity refers to maintaining and assuring the accuracy and consistency of data over its entire product life-cycle. Over the last few years several, FDA... Read More
Novartis’s Multiple Sclerosis Drug Mayzent received USFDA approval
Swiss pharma giant Novartis snagged regulatory approval in the United States for its new multiple sclerosis treatment Mayzent (siponimod) and plans to... Read More
European Medicines Agency recommends marketing authorization approval of Bayer’s Baycox Iron injection for piglets
The Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency has, by consensus, adopted a positive opinion recommending... Read More
EU regulation and directive – key differentiation
Posted on28 Mar 2019
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Regulations have binding legal force throughout every Member State and enter into force on a set date in all the Member States.... Read More
DCGI making it mandatory to include warning in the package insert and promotional literature SGLT2 inhibitor drugs
SGLT2 inhibitors SGLT2 inhibitors, medicines that lower blood sugar by causing kidneys to remove sugar from the body through urine, include drugs... Read More
Lilly, ImmuNext licensing deal for R&D collaboration
Eli Lilly and Company and ImmuNext, Inc. announced a global licensing and research collaboration focused on the study of a preclinical novel... Read More
Insignht on USFDA approval of Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women
The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD)... Read More
Johnson & Johnson’s Spravato (esketamine) For Treatment-Resistant Depression
The U.S. Food & Drug Administration Tuesday approved Johnson & Johnson’s ketamine-derived nasal spray Spravato for treatment-resistant depression. The approval means ketamine—an... Read More
GSK’s Advair Loss of Exclusivity (LOE) and Mylan’s Wixela Inhub generic entry
Mylan has launched its generic version of GlaxoSmithKline’s respiratory blockbuster, Advair, at a 70% discount compared with the GlaxoSmithKline’s respiratory blockbuster, Advair. ... Read More