Guilford Gliadel Wafer
This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryAn sNDA for Gliadel (carmustine wafer) will be reviewed by the Oncologic Drugs Advisory Committee Sept. 11 for first-line use to significantly prolong survival and maintain overall function as measured by preservation of Karnofsky performance status and neurologic function in patients with malignant glioma undergoing primary or recurrent surgical resection. The supplemental application was submitted in April and is receiving priority review. Guilford estimates that the first-line indication would triple the potential patient population for the drug from 3,500 to 10,000-12,000. Gliadel currently is approved for recurrent glioblastoma multiforme
You may also be interested in...
Drug companies in the EU explain how a new pilot scheme on national-level scientific advice service can benefit drug developers.
India’s Indoco Remedies is looking for healthy revenue growth in the coming fiscal year after beating market estimates with a 70.4% year-on-year jump in after-tax profit in its financial third quarter, propelled by strong revenues from domestic and international markets.
The Committee on Energy and Commerce of the US House of Representatives has requested a set of documents from the FDA in order to assess whether the agency is doing enough to address the challenge of approving complex generics within its existing authorities, or whether additional authority is needed.