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Mylan commences supply of remdesivir in India under brand name DESREM
expresspharma
July 21, 2020
Mylan announced the commercial launch of its remdesivir under the brand name DESREM for COVID-19 treatment in India. It will manufacture DESREM in its injectable facility in Bangalore.
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Mylan Initiates Recall of One Lot of Daptomycin for Injection
americanpharmaceuticalreview
July 20, 2020
Mylan announced its U.S.-based Mylan Institutional business is conducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial due to the presence of particulate matter found in ...
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Mylan Secures Regulatory Approval for Remdesivir Lyophilized Powder for Injection in India
americanpharmaceuticalreview
July 15, 2020
Mylan announced that the Drug Controller General of India (DCGI) has approved its remdesivir 100 mg/vial for restricted emergency use in India as part of the DCGI's accelerated approval process to address urgent, unmet needs amid the evolving ...
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Mylan Shareholders Approve Proposed Combination with Upjohn
americanpharmaceuticalreview
July 10, 2020
Mylan announced its shareholders overwhelmingly voted to approve the proposed transaction combining Mylan and Upjohn, a division of Pfizer, at the company's general meeting of shareholders.
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Mylan gets approval for emergency use of remdesivir for Covid-19
pharmaceutical-technology
July 08, 2020
Mylan has secured regulatory approval from the Drug Controller General of India (DCGI) for restricted emergency use of 100mg/vial remdesivir lyophilized powder to treat Covid-19.
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Mylan to launch DESREM at Rs 4800 per vial
expresspharma
July 07, 2020
Mylan will manufacture remdesivir in India at its injectables facilities, which also make product for the US.
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Mylan gets approval to make and market remdesivir
expresspharma
July 03, 2020
Jubilant, BDR and Dr Reddy's Labs have also awaiting permission from CDSCO to manufacture and market the drug in India and are still awaiting due permission.
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Mylan Wins District Court Decision against Biogen's Tecfidera Patent
americanpharmaceuticalreview
June 30, 2020
Mylan announced the U.S. District Court for the Northern District of West Virginia invalidated Biogen's Tecfidera® patent, U.S. Patent No. 8,399,514, for lack of written description.
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Biocon and Mylan receive US FDA approval for Semglee, an insulin glargine injection
expresspharma
June 12, 2020
FDA approval marks a significant milestone to help increase access and affordability of insulin for the millions of Americans living with diabetes-1.
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Lupin and Mylan receive European Marketing Authorization for Nepexto, Biosimilar Etanercept
expresspharma
June 05, 2020
A a phase 3 clinical study in patients with moderate-to-severe active rheumatoid arthritis confirmed equivalence of Nepexto to Enbrel in terms of efficacy, safety and immunogenicity.