Acacia gets 2nd FDA rejection as manufacturing fault drags on

fiercebiotech | April 03, 2019

Acacia Pharma has suffered its second FDA rejection in seven months. The British drug developer moved quickly to bounce back from the complete response letter (CRL) it received in October, only to be hit with a second rejection after its contract manufacturer failed to resolve the problems.
After disclosing the first CRL for post-operative nausea and vomiting drug Barhemsys last year, Acacia continued to prepare to introduce the drug in the first half of 2019 in the belief the problems behind the rejection would be quick to resolve. Acacia told investors the issue was limited to one regulatory compliance deficiency at the third party that produces the active ingredient in Barhemsys, and that the FDA had no qualms with the quality of the drug or the R&D data included in the submission. Within one month of the CRL, the contract manufacturer submitted a plan to fix the problem and Acacia refiled for FDA approval of Barhemsys. Shares in Acacia rose sharply in March and April in anticipation of the May 5 PDUFA decision.

Spotlight

Chimeric antigen receptor T-cell (CAR-T) therapies have been generating increased interest over the past few years at the American Society of Hematology’s (ASH) Annual Meeting, and 2017 was no different. We noticed this buzz spilled over into the online social media discussions as well. This infographic takes a closer look at the social posts surrounding the event to see what topics were raised, and what opinions and perspectives were shared.

Spotlight

Chimeric antigen receptor T-cell (CAR-T) therapies have been generating increased interest over the past few years at the American Society of Hematology’s (ASH) Annual Meeting, and 2017 was no different. We noticed this buzz spilled over into the online social media discussions as well. This infographic takes a closer look at the social posts surrounding the event to see what topics were raised, and what opinions and perspectives were shared.

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