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Rejection, approval & 2 moves to PhIII change Allergan conversation

 
• By Donna Young

For the third time, the FDA has rejected Allergan's experimental inhaled migraine drug dihydroergotamine, which has now changed its moniker from Levadex to Semprana.

For the third time, the FDA has rejected Allergan's experimental inhaled migraine drug dihydroergotamine, which has now changed its moniker from Levadex to Semprana.

But the agency also approved the company's new drug application (NDA) to market Ozurdex (dexamethasone intravitreal implant) as a treatment...

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More from Alimentary/Metabolic

Lilly Looks For Muscle-Sparing Candidates In Pact With Juvena

 
• By Joseph Haas

Deal Snapshot: Including its internal efforts with bimagrumab, Lilly has been seeking a muscle-sparing therapy to complement GLP-1 obesity drugs, such as Zepbound.

Novo Nordisk Teams With Deep Apple On Non-Incretin Obesity Approach

 
• By Joseph Haas

Novo Nordisk will partner with privately held Deep Apple to study a novel, non-incretin target that could be better suited than GLP-1s for long-term obesity treatment.

Metsera’s Amylin Analog Stars In Obesity Phase I

 
• By Joseph Haas

Intended as obesity monotherapy and for combination with the firm’s GLP-1 analog, MET-0233i showed best-in-class efficacy with placebo-like tolerability at low doses.

Regeneron Buys Tirzepatide-Like Product With Eye On Muscle-Preserving Combinations

 
• By Jessica Merrill

Regeneron is bringing in its own GIP/GLP-1 agonist, establishing a path to develop proprietary obesity drug combinations with its internal muscle-sparing drugs.

More from Therapy Areas

Supernus Secures Sage With CVR-Supported Deal

 
• By Jessica Merrill

Supernus agreed to pay $561m upfront plus a contingent value right that could add $234m to buy Sage, topping a previously rejected offer from Biogen.

BMS’s Breyanzi Stands To Further Expand Broad Lymphoma Coverage

 
• By Alaric DeArment

The drugmaker presented data at a lymphoma meeting showing strong efficacy for the CAR-T in marginal zone lymphoma, the second most common indolent lymphoma.

Early Blood Cancer Data Impresses As Incyte Plots Post-Jakafi Strategy

 
• By Kevin Grogan

First results for a first-in-class mutCALR-targeted therapy in essential thrombocythemia presented at EHA point to a lucrative future for the early-stage product.