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Stockwatch: The Lexicon Of Biotech Survival

Silver Linings Like Positive Cardiovascular Outcome Studies Rarely Focus On The Clouds

Executive Summary

Lexicon’s announcement of two positive cardiovascular outcome studies was tempered by the realization that its drug is not approved in the US, nor in Europe in the diabetic populations studied.

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EC Approves Extended Invokana Indication On Renal Outcomes In DKD

Mundipharma has announced the European Commission’s extension of the indications for Invokana to include renal outcomes data from the Phase III CREDENCE study.

Benefits Outweigh Risks As Europe Okays Sanofi’s Zynquista, Despite Unresolved FDA CRL

As the US approval of Sanofi’s type 1 diabetes drug looks to be likely pushed back for another two years, EU approval means the drug can begin to gain market share on the other side of the Atlantic.

AZ's Forxiga Gets Type 1 Diabetes EU Okay As Sanofi Suffers US Setback

Forxiga is the first oral medicine approved in the EU as an adjunct to insulin for type 1 diabetes and the regulatory boost for AstraZeneca comes as Sanofi gets a CRL from the FDA for Zynquista.

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