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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...................

DCGI’s green signal to Mylan’s launch of Avonza in India

The new drug by Mylan offers an innovative, reduced-dose alternative first-line regimen for people being treated for HIV/AIDS in India.........

Biocon & Mylan’s proposed biosimilar ‘Trastuzumab’ gets USFDA nod

The US-FDA Oncologic Drugs Advisory Committee has unanimously recommended approval of Mylan and Biocon’s proposed cancer targeting biosimilar, Trastuzumab.............

USFDA accepts Mylan & Biocon’s proposed biosimilar Pegfilgrastim for review

The development marks the second successful biologics license application (BLA) for filing of the partnership in the United States of America...

US-FDA accepts Mylan & Biocon’s joint application on biosimilar Trastuzumab

While the Biologics License Application (BLA) for MYL-1401O has been accepted by the United States FDA, if approved, it has the potential to be the first biosimilar Trastuzumab in the US....