INTERMEDICS THIRD-PARTY CERTIFICATION OF GMP COMPLIANCE
This article was originally published in The Gray Sheet
INTERMEDICS THIRD-PARTY CERTIFICATION OF GMP COMPLIANCE is under way in response to a July 27 warning letter from FDA requesting the certification. The warning letter, which followed a March 7 to April 26 inspection of the company's pacemaker manufacturing facility in Angleton, Texas, cites the company's repeated deviations from good manufacturing practice regulations.
You may also be interested in...
Officials from the US Food and Drug Administration cited their reasons for refusing to review new applications for companies with unresolved data integrity failures.
However, Vaccinex sees possible efficacy for SEMA4D inhibition in later-stage Huntington’s as well as Alzheimer’s disease. Pepinemab is also being studied with Keytruda in head-and-neck cancer.
In last year’s acquisition, Bristol Myers Squibb agreed to pay Celgene investors another $9 per share based on three approvals, including idecabtagene vicleucel (bb2121) by 30 March 2021.