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US Court of Appeals Upholds Gilenya Compound Patent, Dealing A Blow To Ezra Ventures

 
• By Dean Rudge

Upholding the validity of Novartis’ Gilenya compound patent, a US Court of Appeals ensures that US-based Ezra’s generic fingolimod hydrochloride product will stay off the market until at least 2019. Generics players challenging the blockbuster multiple-sclerosis brand's patents have had mixed fortunes thus far.

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Gilenya compound patent is upheld as valid • Source: Shutterstock

Ezra Ventures remains barred from launching its generic of Novartis’ Gilenya (fingolimod hydrochloride) capsules until at least next year, after a US Court of Appeals affirmed that the originator’s key compound patent was valid through the end of its five-year patent extension.

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Jazz Agrees To Fork Out $145m To Resolve Most Xyrem ‘Pay-For-Delay’ Claims

 
• By Dean Rudge

Jazz has agreed a nine figure settlement agreement in the US with purchasers of its Xyrem blockbuster following claims that it illegally delayed generic competition to the blockbuster treatment for narcolepsy via patent-litigation settlement agreements with several ANDA sponsors.

Kabi Pens Agreement To Launch Generic Exparel In 2030 – With A Volume Limit

 
• By Dean Rudge

With sales of $550m last year and a high barrier to entry, Exparel marks an intriguing target for abbreviated new drug application sponsors. Having shot down a US patent last year and won US FDA approval for its ANDA, Jiangsu Hengrui’s US eVenus Pharmaceutical Laboratories subsidiary and partner Fresenius Kabi have just reached a settlement agreement.

Viatris Puts Pen To Paper On $335m Opioid Settlement Agreement

 
• By Dean Rudge

Following recent agreements signed by Hikma and Amneal, Viatris has become the latest company to reach a cash settlement resolving allegations that its practices fuelled the US’ deadly opioid epidemic.

Spanish Authorities Investigate Sandoz Over Information-Sharing

 
• By Dave Wallace

Spanish competition regulator the CNMC has announced an investigation into Sandoz and its Bexal subsidiary – as well as Alliance Healthcare España and Bluetab Solutions – over sharing sensitive commercial information relating to pharmacy orders for generics.

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Henlius And Outlook Move Forward With Ophthalmic Bevacizumab

 
• By Dave Wallace

Henlius has reported progress in its development of a bevacizumab product for treating ophthalmic diseases, with its Essex-partnered HLX04-O candidate meeting its primary endpoint in a Phase III trial. Meanwhile, Outlook Therapeutics has taken another shot at getting its own ophthalmic bevacizumab approved in the US after resubmitting its filing.

Kabi Pens Agreement To Launch Generic Exparel In 2030 – With A Volume Limit

 
• By Dean Rudge

With sales of $550m last year and a high barrier to entry, Exparel marks an intriguing target for abbreviated new drug application sponsors. Having shot down a US patent last year and won US FDA approval for its ANDA, Jiangsu Hengrui’s US eVenus Pharmaceutical Laboratories subsidiary and partner Fresenius Kabi have just reached a settlement agreement.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.