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Viatris Keeping Powder Dry On Symbicort With Key Ruling Imminent

US-Based Firm Facing Second Suit With November Trial Scheduled

 
• By Dean Rudge

In the coming days, Viatris expects to hear back from a court in West Virginia over its legal tussle with AstraZeneca on Symbicort IP. The US-based player has intimated that it may launch the product dependent on the court’s verdict.

Court Ruling
Viatris is due to hear back on Symbicort imminently • Source: Alamy

Viatris remains in a “state of readiness” to launch its Breyna US generic version of AstraZeneca’s Symbicort (budesonide/formoterol fumarate dihydrate) pressurized metered dose inhaler, ahead of an imminent key patent-infringement ruling.

Meanwhile, the US-based player anticipates that a Phase III data readout for its proposed once monthly glatiramer acetate product, a follow-on to Teva’s Copaxone treatment for multiple sclerosis, will be...

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‘Obsessive’ Teva Aims For $800m Biosimilar Sales By 2027

 
• By Dean Rudge

Teva says it is now in the “accelerate growth” phase of its strategic roadmap, with global biosimilar launches set to help the firm achieve its goals.

Trump-Trimmed FDA Finally Releases A Batch Of PSGs – Back To Business As Usual?

 
• By Urtė Fultinavičiūtė

After half a year of silence, the US FDA has published 48 product-specific guidances for generic development. With critical staff laid off, will the health agency stick to its updated PSG publishing schedule?

Fresenius Adds To Denosumab Competitors In Europe

 
• By Dave Wallace

At a busy meeting of the CHMP, the EMA issued positive opinions for Fresenius Kabi’s denosumab rivals to Prolia and Xgeva, another denosumab biosimilar from Sandoz, a Tecfidera hybrid from Neuraxpharm and a Descovy generic from Viatris. Meanwhile, Ascend has withdrawn a teriparatide filing.

After Dasatinib Apotex Debuts US Tasigna Competition

 
• By Dean Rudge

Canada’s Apotex is continuing to spearhead generic competition in the tyrosine kinase inhibitor (TKI) space for chronic myelogenous leukemia, with the launch of the first generic version of Novartis’ Tasigna (nilotinib) blockbuster.

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Alvotech And Advanz Add Three More In €160m EU Partnership Expansion

 
• By Dean Rudge

Fresh from filing a proposed biosimilar to Xolair (omalizumab) in the UK, Alvotech and Advanz have shaken hands on a further deal to expand their partnership.

After Dasatinib Apotex Debuts US Tasigna Competition

 
• By Dean Rudge

Canada’s Apotex is continuing to spearhead generic competition in the tyrosine kinase inhibitor (TKI) space for chronic myelogenous leukemia, with the launch of the first generic version of Novartis’ Tasigna (nilotinib) blockbuster.

Abiogen And mAbxience Join Forces In Italy

 
• By Dave Wallace

Spanish biosimilars developer mAbxience has struck a deal with Italy’s Abiogen covering an undisclosed biosimilar for the Italian market.