Intravenous Tramadol CRL Casts Shadow On Avenue’s Cipla Deal
Avenue 'Very Surprised' After Safety Concern Raised By FDA
Avenue’s two-stage deal with an arm of Cipla faces uncertainty following a US Complete Response Letter for its intravenous tramadol. The US firm says it is "very surprised" with the potential safety concern raised and plans to seek a meeting with the agency at the earliest to resolve the issue.
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Keeping Track: Gavreto, Sogroya Bring Annual CDER Novel Approvals To 40; New Analgesic Products Make It Past US FDA
The latest drug approval news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Curon thinks tenalisib can offer a differentiated and safe new therapy for hematologic cancers such as multiple forms of lymphoma. Axis and PharmaEssentia team up on TCR therapy R&D in Taiwan.
The head of global vaccine and plasma segments, bioprocessing, at German multinational Merck discusses key aspects around evolving vaccine manufacturing to improve the efficiency and speed of response during a pandemic. Pre-existing manufacturing platforms, the executive says, could compress process development work and fast-track scale-up.