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Mayne Lines Up Two, But Misses Out On Myring

 
• By Aidan Fry

Mayne Pharma intends in January to introduce novel formulations of itraconazole and halobetasol in the US; but the Australian firm has been hit in its attempt to bring the Myring generic to the US market.

Itraconazole
Mayne Pharma will soon launch a reformulation of itraconazole in the US • Source: Shutterstock

Mayne Pharma plans during January 2019 to launch both its Tolsura (itraconazole) 65mg capsules and its Lexette (halobetasol) 0.05% foam in the US. But the Australian company’s move to bring the Myring (etonogestrel/ethinylestradiol) generic of Merck & Co’s NuvaRing contraceptive to US consumers has been dealt a blow after the US Food and Drug Administration (FDA) issued a complete response letter (CRL), Mayne’s development partner Mithra has revealed.

Approved by the FDA on 11 December, somewhat earlier than Mayne’s previous forecast of “early calendar year 2019”, Tolsura employs...

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European Industry Calls For Support As It Juggles Multiple Challenges

 
• By Dave Wallace

At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.

One Month Remains To Enter GGB Awards 2025

 
• By Dave Wallace

With the August 1 deadline looming for entries to the Global Generics & Biosimilars Awards 2025, contenders have just one month left to submit their achievements.

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 
• By Eliza Slawther

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

‘Disappointed’ Lipella Seeks Alternatives Following Nasdaq Delisting

 
• By Dean Rudge

Clinical-stage reformulation specialist Lipella Pharmaceuticals has insisted that “our commitment to our shareholders, our mission, and our clinical goals has not changed” after its common stock was delisted from the Nasdaq Capital Market.

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