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PLC Systems, Inc.

http://www.plcmed.com

Latest From PLC Systems, Inc.

Intravenous Tramadol CRL Casts Shadow On Avenue’s Cipla Deal

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.

Value-Added Medicines Complete Response Letters

Intravenous Tramadol CRL Casts Shadow On Avenue’s Cipla Deal

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.

Policy & Regulation Drug Review

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.

US FDA Performance Tracker Approvals

Edwards: Will a Biotech Deal Strategy Work For a Device Company?

More than two years after being spun-out as Baxter's cardiovascular group, Edwards Lifesciences is establishing its identity as an independent company. A large part of this initial process has focused on which product lines to retain, which to divest, and what new areas to get into. Edwards emerged in the unusual position of having market leadership positions in several product areas, most significantly heart valves. But slow growth in those markets is limiting the extent to which they can drive overall company growth. Edwards' new strategy is to focus on advanced--stage cardiovascular disease with its primary customers being cardiac surgeons. Resource-constrained following the spin-out, the company is relying on a strategy unusual for device companies--alliance, rather than acquisitions--to expand its product offerings. But as the treatment of cardiovascular disease continues to rely increasingly on interventional techniques, the challenge for Edwards is to build a sustainable, broad-based business around selling to cardiac surgeons.

Medical Device Strategy
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