1. Scrip
  2. >>Therapy Areas
  3. >>Alimentary/Metabolic

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 for diabetic macular edema (DME) in adults with an artificial...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Alimentary/Metabolic

A Short History Of MASH Deals, Culminating In GSK/Boston Pharma

 
• By Joseph Haas

Both high-profile failures and small investments that are yielding success so far characterize the dealmaking in MASH over the past 15 years or so.

Novo Nordisk’s CEO Forced Out After Falling Behind In GLP-1 Battle

 
• By Andrew McConaghie

Company surprises investors with Jørgensen's exit but insists its strategy will not change.

Multiple Launches Help Lilly’s Japan Growth

 
• By Ian Haydock

Lilly saw solid growth for its business in Japan last year on the back of several new launches and is building its obesity and Alzheimer's portfolios in the country.

Novo Nordisk Looks To Septerna For Oral Obesity Options

 
• By Mary Jo Laffler

Deal Snapshot: The Danish drugmaker is partnering with GPCR drug discovery expert Septerna to develop multiple small molecules for cardiometabolic targets.

More from Therapy Areas

New Vaccine Framework Avoided Worst-Case Scenario, Analysts Say

 
• By Joseph Haas

The new US FDA vaccine guidelines introduced on 20 May might cause financial woes for Moderna, but overall vaccine makers should not be as impacted as feared.

Merck KGaA Plans Phase III For Enpatoran After Mixed Phase II Lupus Data

 
• By Jessica Merrill

The Phase II study testing the novel TLR7/8 inhibitor met the primary endpoint in a cohort of patients with cutaneous lupus erythematosus and systemic lupus erythematosus with rash, but did not in patients with SLE.

PureTech’s IPF Candidate Ready For Phase III After Efficacy Win

 
• By Andrew McConaghie

Coming one day after Boehringer’s underwhelming data, PureTech’s tweaked molecule, deupirfenidone, shows promise in slowing idiopathic pulmonary fibrosis.