1. Scrip
  2. >>Business
  3. >>Manufacturing

Another FDA 'No' For Acacia Over Unresolved Facility Deficiencies

 
• By Kevin Grogan

Confusion reigns at the UK firm as a second attempt to get approval for its nausea and vomiting treatment Barhemsys floundered following an insufficient resolution of manufacturing deficiencies at the supplier of the drug.

Typewriter
More bad news for Acacia • Source: Shutterstock

Investors have lost patience with Acacia Pharma Ltd., sinking the UK firm's stock after it suffered a second rejection from the US Food and Drug Administration for the post-operative nausea and vomiting (PONV) therapy Barhemsys, once again as a result of problems at the contract drug manufacturer.

Acacia was hit with its first complete response letter from the FDA in October 2018 which identified deficiencies that had...

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 Manufacturing

Sanofi Cements RSV Dominance As Merck & Co Rival Awaits FDA D-Day

 
• By Kevin Grogan

The French company will start shipping its blockbuster shortly to meet expected strong demand in the 2025–26 RSV season.

Loss Of Exclusivity Product Launches To Fuel Aurobindo’s FY26 Europe Growth

 
• By Vibha Ravi

Aurobindo is banking on launches of loss of exclusivity products and biosimilars to fuel sales in Europe as it awaits a US announcement on tariffs and predicts high single-digit growth overall during FY26 for now

How Much Does Biopharma Contribute To The US Economy?

 
• By Jessica Merrill

A new IQVIA report highlights how the sector benefits the US through metrics like the economy, employment and health.

Lupin CEO On Trump’s Most Favored Nation Policy, Tariffs, Firm’s Five-Year Plan

 
• By Vibha Ravi

Lupin CEO Vinita Gupta speaks on Trump’s most favored nation policy, the Inflation Reduction Act’s “pill penalty” and other developments in the US, a major market for the company. The company also outlines a five-year plan focused on complex generics and technology platforms.

More from Business

Santen Sees Potential In Myopia Market After Ryjunea Approval

 
• By Kevin Grogan

The low-dose atropine eye drop slowed the progression of pediatric myopia by 30%.

Will Pfizer Walk Away From Arvinas After PROTAC Disappointment?

 
• By Andrew McConaghie

Arvinas and Pfizer have just filed the potential first-in-class protein degrader vepdegestrant, but its diminished commercial prospects after mixed Phase III data mean Pfizer could exit.

Finance Watch: Vera Raises Debt, Taysha And Trevi Price Offering After Big Trial Wins

 
• By Mandy Jackson

Public Company Edition: Public company funding in 2025 is down from 2024, but after recent positive data readouts Vera accessed up to $450m in new debt, while Taysha and Trevi grossed $200m and $100m, respectively, in stock offerings. Meanwhile, Keros, Stealth and others cut jobs.