Stockwatch: The Lexicon Of Biotech Survival
Silver Linings Like Positive Cardiovascular Outcome Studies Rarely Focus On The Clouds
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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Mundipharma has announced the European Commission’s extension of the indications for Invokana to include renal outcomes data from the Phase III CREDENCE study.
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.
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.