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Showing posts from April, 2021

History of Daratumumab

Daratumumab (Darzalex) falls under the anti-cancer medication. It is involved in order to bind to the CD38, which is overexpressed in the multiple myeloma cells. It was originated by Genmab, but it is currently being jointly developed by Genmab along with the J&J subsidiary named Janssen Biotech, which acquired the global commercialization rights to the Daratumumab from Genmab. In the month of August, 2012, Janssen Biotech announced the agreement of Global License and Development for investigational anti cancer agent daratumumab.  In the month of May, 2013, daratumumab received breakthrough therapy designation in the double refractory MM from the U.S. FDA.  In the month of February, 2015, Genmab has announced the preliminary outcomes in phase-II study of daratumumab in the double refractory multiple myeloma. In the month of June, 2015,  Janssen initiated the rolling submission of BLA for daratumumab in order to treat patients with multiple myeloma.  In the month of September 2015,

History of Tofacitinib

Tofacitinib (xeljanz) falls under the janus kinase (JAK) inhibitors, discovered and developed by the National Institutes of Health and Pfizer. It is a kind of small molecule, rather than a biologic.  The potential significance of JAK3 inhibitor was foremost originated in the laboratory of John O'Shea, an immunologist at the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health (NIH). In the year of 1994, the NIH approached Pfizer for establishing a public private partnership in order to assess and reach market experimental compounds. Initially, Pfizer has declined the partnership, but around a couple of years later Pfizer agreed for the partnership, following the removal of an National Institutes of Health policy mentioning that the price of market of a product resulting from the such partnership would require in order to be commensurate with the investment of the public taxpayer revenue and the health as well as safety requires

ENZALUTAMIDE HISTORY

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Enzalutamide medication is the only medication of second-generation NSAA which is approved to date. Enzalutamide is a nonsteroidal antiandrogen used for the treatment of patients with castration-resistant prostate cancer , and metastatic castration- sensitive prostate cancer.  In 1995, Bicalutamide (Casodex) introduced and approved by the NSAA for the treatment of prostate cancer because of its effectiveness, safety, and suitability. Bicalutamide has had a worldwide medication for prostate cancer. Enzalutamide (years back called MDV3100) was first detailed by Charles Sawyers and Michael Jung in 2006 at the University of California, Los Angeles. Enzalutamide evaluated from 200 combinations of nonsteroidal antiandrogen prostate cells as a model. At the same time of approval, the medication was conducting other randomized tests, placebo-controlled, phase III trial in asymptomatic or delicate symptomatic patients with chemotherapy-naive (mCRPC). The main objective was to evaluate the effic