Tag: Mylan
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Lupin & Mylan launch arthritis biosimilar, Nepexto in Germany
Nepexto is Lupin’s biosimilar etanercept approved for all indications of the reference product Enbrel. It is available as an injectable in an easy-to-use pre-filled pen and a pre-filled syringe...................
Mylan secures DCGI approval for its drug-resistant TB drug, Pretomanid
Pretomanid is only the third new anti-tuberculosis (TB) drug developed specifically for drug-resistant forms of the disease to be approved in more than 40 years. The approval comes as a result of Mylan’s global collaboration with non-profit drug development partner TB Alliance..................
Mylan initiates supply of Remdesivir in India, under brand name DESREM
The launch includes a 24/7 helpline for patients and healthcare practitioners to access information on Remdesivir and its availability...............
Biocon & Mylan announce positive CHMP opinion for Ogivri, biosimilar Trastuzumab
The endorsement by European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) opens up opportunities towards tapping approximately $1.9 billion market for the product in Europe...………….
Winners of the 2018 Mylan Hackathon announced
Over 200 number of people participated in this year’s Hackathon and winners who were selected from ‘professional hackers’ and ‘students’ categories won first prize of INR 100,000 and runner up prize of INR 50,000 respectively...………….
US FDA approves Mylan & Biocon’s biosimilar, Fulphila
Second FDA-approved biosimilar through the Mylan-Biocon collaboration,, Fulphila is expected to be the first biosimilar pegfilgrastim available in the U.S. to help patients with nonmyeloid cancers reduce the risk of infection...............
Biocon & Mylan’s biosimilar ‘Trastuzumab’ gets approval from Brazilian regulator
Co-developed by Biocon and Mylan, this is the first biosimilar Trastuzumab to be approved in Brazil and is indicated for the treatment of overexpressing HER2positive metastatic breast cancer. The product will be marketed by the Libbs Farmaceutica........
Biocon confident of resolving issues with USFDA over biosimilar ‘pegfilgrastim’
While the company is set to launch proposed biosimilar, Pegfilgrastim in the United States market, the US Food and Drug Administration has issued Complete Response Letter (CRL) to it seeking more data on the cancer drug..............
Russia & India embark on technology transfer for production of HIV...
The India's Mylan Laboratories and Russia's Nacimbio will be doing transfer of technology for the production of ready-made dosage forms and active pharmaceutical substances to treat HIV infections...................