What is difference between 351(a) vs. 351(k) pathway?

Recent Industry Update

• Pharma acquisition case study: Lundbeck to acquire Alder BioPharmaceuticals for US$ 1.95 billion
• Insight on submission of USFDA sBLA of Tremfya (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA)
• Mitsubishi Tanabe Pharma, Daiichi Sankyo enters licensing agreement for ALS treatment agent edaravone in Brazil
• Alexion’s inlicensing deal for Amyloidosis Candidate In Japan
• Insight on Boehringer Ingelheim’s new indication approval for Ofev to slow the rate of decline in pulmonary function in patients with Ssc-ILD
• Sanofi India announces sale of its Ankleshwar facility to Zentiva
• What are DACH region? Which countries are part of DACH region?
• Strides Pharma acquires stake in Fairmed Healthcare for extensive growth in DACH region
• GSK to acquire Celiac-Focused Sitari Pharmaceuticals
• Takeda recalled of NATPARA (a parathyroid hormone) in US
• Sandoz to commercialize proposed multiple sclerosis biosimilar natalizumab
• Boehringer Ingelheim’s KRAS and Lupin’s MEK inhibitor compound (LNP3794) – Licensing, development and Commercialization Agreement
• Sumitomo Dainippon and Roivant’s strategic alliance to develop new medicine
• GSK, INNOVAX and Xiamen University’s Global co-developmennt alliance for cervical cancer vaccine
• Insight on USFDA approval of new add-on drug, Nourianz (istradefylline), to treat off episodes in adults with Parkinson’s disease
• Pharma brand acquisition case study: Amgen to acquire Celgene’s Otezla
• 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