FDA Adcom votes against ridaforolimus. TRGT Phase 3 fail. PATH NDA update + CXM AEGR news

Mar 21, 2012 No Comments by

NuPathe Inc. (NASDAQ: PATH) gave an update noting that it intends to submit its New Drug Application for its migraine patch (NP101) during 1H 2012.

Merck (NYSE: MRK) and ARIAD Pharmaceuticals, Inc., (NASDAQ:ARIA), announced today that the FDA Oncologic Drugs Advisory Committee (ODAC) voted 13 to 1 against the use of ridaforolimus for patients with metastatic soft-tissue sarcoma or bone sarcoma whose disease has not progressed after at least four cycles of chemotherapy.

Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR) announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for lomitapide, a once-daily, oral treatment for Homozygous Familial Hypercholesterolemia (HoFH).

Cardium Therapeutics (NYSE Amex: CXM) announced the initiation of the ASPIRE Phase 3 registration trial in the Russian Federation of Generx in patients with myocardial ischemia (insufficient blood flow in the heart due to coronary artery disease).

AstraZeneca and Targacept, Inc.(Nasdaq: TRGT) announced that it did not meet the primary endpoint in their Phase 3 RENAISSANCE 4 and RENAISSANCE 5 trials investigating TC-5214 in patients with major depressive disorder (MDD). The data showed that they did not meet the primary endpoint of change on the Montgomery-Asberg Depression Rating Scale (MADRS) total score after eight weeks of adjunct treatment with TC-5214 as compared to placebo. As a result, they will not be filing a NDA.

 

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About the author

Currently residing in New Zealand and employed in the education industry, Mr. A. Burden holds a M.Com in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.
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