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Recent Industry Update

• Case Study: USFDA approval of AbbVie’s RINVOQ (upadacitinib)
• GSK grants exclusive technology license for Ebola vaccines to Sabin Vaccine Institute
• Turalio: USFDA approval of first therapy for rare joint tumor
• Case Study: The Mylan-Upjohn,Pfizer Merger
• Take a Self Competency Test in European Drug Regulatory Affairs
• Strides Pharma received USFDA warning letter for significant violations of CGMP regulations for finished pharmaceuticals
• Case Study : Rituxan – A Brand which Pharma Industry reckon
• In which class should be register the food supplement?
• Cipla’s JV with Jiangsu Acebright Pharma in China
• US FDA grants priority review status to Novartis’ sickle cell molecule crizanlizumab
• Case Study: Gilead and Galapagos – R&D collaboration
• How data integrity related problems should be addressed in Pharmaceutical and Biopharmaceutical Industry?
• AstraZeneca’s Forxiga gets EMA positive opinion for DECLARE-TIMI 58 cardiovascular outcomes data
• US FDA warning letter: Repackers distributing API for violations of cGMP violation requirements
• Gilead introduces Asia Pacific Rainbow Grants program
• Case Study: EC’s conditional marketing approval to Libtayo for advanced CSCC
• What is Conditional marketing authorisation by European Medicine Agency?
• List of USFDA approved Biosimilar [till date]
• US FDA approves Pfizer’s Biosimilar Zirabev
• What is USFDA Tentative Approval?
• Case Analysis: Insight on AbbVie’s acquisition of Allergan
• Glenmark’s licensing deal with Novartis to distribute three respiratory drugs in Brazil
• What is CRL – Complete Response Letter by USFDA?
• Case Study: Vyleesi™ (Bremelanotide Injection) for HSDD in Premenopausal Women
• FDA Approval of sNDA for DEXTENZA for the Treatment of Ocular Inflammation Following Ophthalmic Surgery
• A triple-combination therapy for COPD – Breztri Aerosphere’s of AstraZeneca received approval in Japan
• Case Study: Why Pfizer acquiring Array Biopharma?
• Case analysis: 483 observations – Data Integrity issues in Aurobindo Pharma’s finished dosage formulation plant
• USFDA Approves Amgen’s Trastuzumab Biosimilar, Kanjinti
• What is vertical integration?