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.
Biocon chairperson Kiran Mazumdar-Shaw says that venture capital firms have, with their risk-averse approach, "failed" the biotech sector in India. The executive draws attention to how "bold" venture funds that backed mRNA technology a decade ago were reaping gains today.
Serum to hold 15% in Biocon arm Biocon Biologics as part of a broad alliance that expects to leverage the partners' strengths and resources in vaccines and biologics. Pursuing opportunities based on the hot mRNA technology platform appears firmly on the table.