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Viatris Welcomes FDA Date On Slow-Release Copaxone Product

Collaboration With Mapi Penned In 2018; Firm Plans Filing In Europe

 
• By Dean Rudge

Viatris and Mapi have moved a step closer to realizing the US launch of their 505(b)(2) once- monthly glatiramer acetate product, a follow-on to Teva’s Copaxone treatment for multiple sclerosis.

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• Source: Shutterstock

Viatris and partner Mapi Pharma are set to find out in the first quarter of 2024 whether they can move ahead with their proposed once-monthly glatiramer acetate product, a follow-on to Teva’s Copaxone treatment for multiple sclerosis, after the ‘GA Depot 40mg’ asset was accepted for review by the US Food and Drug Administration.

News of the filing follows Mapi Pharma unveiling in September last year positive top-line results from its GA Depot Phase III clinical trial assessing the efficacy, safety and tolerability of the product

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Teva’s Uzedy Continues Surge As Olanzapine LAI Filing Nudges Closer

 
• By Dean Rudge

Teva underlined that it was “very pleased with this franchise we’re building and what we’ll bring to the care of patients with schizophrenia,” as it looks ahead to filing its olanzapine new drug application in the second half of 2025.

BGMA Becomes Medicines UK

 
• By Dave Wallace

The UK generics and biosimilars industry will now be represented by Medicines UK, the new name for the former British Generic Manufacturers Association.

Iconovo Slims Down As It Focuses On Commercialization

 
• By Dave Wallace

As its need for development resources declines, Iconovo is cutting staff to save money as it moves to the commercialization stage for its portfolio of off-patent inhaled products.

How To Make The Most Of Your GGB Awards Entries

 
• By Dave Wallace

With the Global Generics & Biosimilars Awards 2025 taking place in Frankfurt this October, we bring you five key pieces of guidance to help ensure that your entries stand out from the competition.

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