drug regulation in india

Recent Articles

• Insight on 2019 USFDA New Drug Approval
• Insight on J&J’s TB mass awareness campaign in India
• CUTX-101 of Fortress Biotech gets US FDA rare pediatric disease designation to treat Menkes disease
• What is Edible security tag?
• Acquisition in Pharma: Why Astellas to acquire Xyphos Biosciences?
• US FDA issued CRL to ViiV Healthcare for use of cabotegravir and rilpivirine long-acting regimen for treatment of HIV
• US FDA issues Complete Response Lette to Takeda’s Entyvio for maintenance therapy in adults with ulcerative colitis
• What is ISO 15197:2013 certification?
• Copromotion deal for Japan – Gilead and Eisai in RA therapy filgotinib
• Insight on USFDA approval of Allergan’s Ubrelvy
• Insight on Alteogen’s non-exclusive licensing deal for ALT-B4 to a top 10 global pharma
• Pharma Strategic Deal: Astellas Pharma to acquire Audentes Therapeutics for about $3 billion
• Pharma Business Development – Competency Test. Check your competency
• Case study: Novartis to acquire The Medicines Company for $9.7 billion, get hold of inclisiran, a cholesterol drug
• What is USFDA Purple Book? What it’s significance?
• USFDA approved Pfizer’s Abrilada, a biosimilar of Humira
• Pfizer’s Upjohn and Mylan merged business entity will be namea as Viatris
• Bayer and Dewpoint Therapeutics co-development deal for cardiovascular and gynecological diseases
• Sandoz to Acquire Japanese Biz of AGI
• Selumetinib NDA Submission for Neurofibromatosis Type 1 (NF1) granted Priority Review