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Hikma's CRL Proves GSK's Witty Was Right: Generic Advair Is Hard

 
• By Jessica Merrill

FDA issued a complete response letter for Hikma's ANDA to market a generic version of GSK's Advair, the second application to be rejected by FDA.

Hikma Pharmaceuticals PLC's ANDA for a generic version of GlaxoSmithKline PLC's Advair Diskus (salmeterol/fluticasone) received a complete response letter from FDA that was designated "major," just like a rival drug from Mylan NV. The announcement May 11 by Hikma's development partner Vectura Group PLC on VR315 makes the launch of an interchangeable generic in 2017 highly improbable.

Hikma and Vectura said they will provide an update on the application as soon as practicable after reviewing the CRL...

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Wegovy’s Win In MASH Gives Novo A Much-Needed Edge Over Lilly

 
• By Manas Mishra

Just days after discontinuing a Phase III trial for a separate MASH compound, Novo Nordisk has secured the US FDA’s accelerated approval for Wegovy to treat the fatty liver disease.

Pipeline Watch: Seven Approvals And Five Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Tonix Ready To Revive Fibromyalgia Market With Tonyma

 
• By Joseph Haas

The first new drug for fibromyalgia since 2009, Tonyma is a reformulation of cyclobenzaprine intended for chronic therapy. Tonix said the drug targets non-restorative sleep.

Insmed Targets $5bn-Plus Market With Brinsupri For Bronchiectasis

 
• By Mandy Jackson

The US FDA approved Insmed’s second product, the DPP1 inhibitor Brinsupri (brensocatib) for non-cystic fibrosis bronchiectasis. The company launched the drug immediately with a list price of $88,000 per year.

More from Scrip

Pipeline Watch: Seven Approvals And Five Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Indegene Exec On DTP Distribution As A ‘Tactical Solution’, Feasibility Of MFN Model

 
• By Anju Ghangurde

Senior Indegene executive William Lobb talks about complexities of the direct-to-patient distribution model in the US and underlines that it isn’t a comprehensive healthcare fix. The feasibility of MFN pricing and why it may be “catastrophic” to the industry were some of the other topics discussed.

Quick Listen: Scrip’s Five Must-Know Things

 
• By Ian Haydock

In this week's episode: a look at the likely top drugs in 2030; Lilly CEO advocates US/Europe pricing rebalance; Insmed sees $5bn-plus market for Brinsupri; royalty deals go mainstream; Phase III win sets stage for Epkinly label expansion.