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Recent Industry Update

• New Drug Approval Case Study: USFDA approval of Galderma’s Aklief cream
• Prometheus Biosciences collaboration deal with Takeda for targeted therapies for IBD
• Biocon, Mylan launch first insulin glargine biosimilar, Semglee in Australia
• USFDA approval of Rituxan, in combination with glucocorticoids, for the treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in paediatric patients 2 years of age and older
• AstraZeneca divests Losec (omeprazole) and associated brands rights to Cheplapharm Arzneimittel GmbH
• What is indication splitting licensing in pharmaceutical and bio-pharmaceutical business?
• Bactiguard entered Licensing deal for Orthorthopedic trauma implants with Zimmer Biomet
• AstraZeneca to launch QTERN in India with DCGI marketing authorization approval
• FDA approved Rybelsus (semaglutide): first oral GLP-1 treatment for type 2 diabetes
• Bayer received EU marketing authorization for the precision oncology treatment Vitrakvi (larotrectinib)
• Clovis in-licensing deal for cancer program from 3B Pharmaceuticals
• Biocon Ltd acquired a R&D facility from Pfizer
• 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