NicOx (COX.PA (NICXF.PK) received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for naproxcinod, which is seeking approval for the relief of the signs and symptoms of osteoarthritis. The FDA indicated that one or more long-term controlled clinical trials should be conducted to evaluate the cardiovascular and gastrointestinal safety profile of the drug. NicOx plans to discuss the CRL with FDA and a Marketing Authorization Application (MAA) submitted in December 2009 is currently under review by the European Medicines Agency (EMA).

PROLOR Biotech (AMEX:PBTH) is developing hGH-CTP (Human Growth Hormone-Carboxyl Terminal Peptide) as a bio-better formulation of human growth hormone (hGH) with longer-acting characteristics for potential dosing every 1-2 weeks. The Company announced yesterday that it initiated a Phase 2 clinical trial and expects to complete the study by year-end. The dose-escalating study will be conducted in approximately 50 patients on daily hGH therapy and will replace the daily injections with single weekly injections of hGH-CTP.

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MELA Sciences (NASDAQ:MELA) Announces Delay in FDA Advisory Panel

Posted: 21 Jul 2010 01:53 PM PDT

After normal trading hours had closed MELA announced the following disappointing news: MELA Sciences Announces FDA Needs More Time to Arrange Panel Meeting to Review MelaFind(R) PMA Application MELA announced today that the U.S. Food and Drug Administration (FDA) has informed the company that it is moving the General and Plastic Surgery Devices [...]

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