In India, Drugs for COVID Are Being Tested, Approved in Ways That Should Worry Us 25/05/2021
Representative photo: analuisa gamboa/Unsplash
Mumbai: Since the start of the COVID-19 pandemic last year, researchers around the world have evaluated scores of drugs and therapeutic techniques for the disease. Even according to the Clinical Trial Registry of India (CTRI), researchers in the country are testing everything from inhaled camphor and ajwain to Viagra.
This may be desperation, given the brutality of India’s second COVID-19 outbreak. It is also worthwhile in more ways than one to repurpose existing drugs to treat COVID-19.
However, in most cases, a substantial profit motive isn’t too far away. Together with India’s opaque drug regulation apparatus and its propensity to approve substances on little to no evidence – especially during the pandemic itself – these clinical trials warrant a closer look.
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March 12, 2021
On Thursday in the District of Delaware, Pfizer Inc. and its subsidiaries filed a complaint against Micro Labs Ltd. and its subsidiary, alleging infringement of its patents for drug Xeljanz.
Pfizer holds the new drug application (NDA) for 10 mg tofacitinib citrate tablets, under the brand name Xeljanz, used to treat adults with ulcerative colitis, the complaint said. The patents-in-suit corresponding to Xeljanz are U.S. Patents Nos. RE41,783 and 6,965,027, which are set to expire Dec. 8, 2025, and March 25, 2023, respectively, according to the Food and Drug Administration’s (FDA) patent publication, the Orange Book.
According to the complaint, Micro Labs sent a letter Feb. 1 to notify Pfizer that it had submitted an abbreviated new drug application (ANDA) seeking FDA approval to market and sell 10 mg tofacitinib citrate tablets. The defendant claimed in the letter that its generic product would not infringe on the patents-in-suit, arguing th
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