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Hikma Snaps Up Insys Sprays As Part Of US Drive Towards Differentiation

 
• By Aidan Fry

By acquiring global rights to epinephrine and naloxone nasal spray candidates from Insys, Hikma is following its strategy of moving its non-injectable Generics business segment in the US towards differentiated products.

Nasal_Spray
Hikma is looking to bring anaphylaxis treatment epinephrine and the opioid overdose drug naloxone to the US market as unit-dose nasal sprays • Source: Shutterstock

Hikma Pharmaceuticals has signed an agreement to acquire for $17.0m pipeline epinephrine and naloxone nasal sprays and a complementary manufacturing platform from Insys Therapeutics, which recently filed for bankruptcy. Both the epinephrine and naloxone sprays are intended for approval through the US Food and Drug Administration’s hybrid 505(b)(2) regulatory pathway.

Speaking exclusively to Generics Bulletin immediately after announcing the deal, Hikma’s CEO Siggi Olafsson described the Insys assets acquisition as...

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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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Bakers And Fishermen: How Biosimilars Manufacturers Are Bridging The Skills Gap

 
• By Dave Wallace

At Medicines for Europe’s annual conference in Brussels, executives from Polpharma Biologics and Gedeon Richter spoke about the challenges in finding biosimilars manufacturing staff with the right backgrounds – and how they are looking to other industries to bridge the skills gap.

US Federal Circuit Says No To Teva And Viatris On Remanded Invega Sustenna Appeal

 
• By Dean Rudge

Just days after Viatris was frustrated in its attempts to challenge IP protecting Janssen’s Invega Trinza, the US Federal Circuit has rejected the firm’s and Teva’s bid to invalidate a patent shielding the one-month version of the brand, Invega Sustenna.

Lupin And Zentiva Throw Hat Into The Ring On Biosimilar Cimzia

 
• By Dave Wallace

The announcement by Lupin and Zentiva of a development and commercialization deal on a certolizumab pegol biosimilar candidate has revealed a new potential challenger to Alvotech’s AVT10, previously thought to be the only Cimzia rival in development.