CHTP advised to conduct additional trial. OSUR FDA Approval. NVO terminates PCRX agreement. MNOV October FDA meeting.PTN raises cash + SPPI
Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) received advice from the FDA regarding further development of Northera (droxidopa) in the U.S. The FDA advised that the company conduct an additional trial to demonstrate that droxidopa has a significant and persistent effect’ on symptoms of neurogenic orthostatic hypotension.
OraSure Technologies, Inc. (Nasdaq:OSUR) today announced that the U.S. Food and Drug Administration today approved the OraQuick In-Home HIV Test, the first over-the-counter, self-administered HIV test kit to detect the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). The OraQuick In-Home HIV Test is designed to allow individuals to collect an oral fluid sample by swabbing the upper and lower gums inside of their mouths, then place that sample into a developer vial, and obtain test results within 20 to 40 minutes. A positive result with this test does not mean that an individual is definitely infected with HIV, but rather that additional testing should be done in a medical setting to confirm the test result. Similarly, a negative test result does not mean that an individual is definitely not infected with HIV, particularly when exposure may have been within the previous three months.
Pacira Pharmaceuticals, Inc.(NASDAQ:PCRX) received from Novo Nordisk (NVO) a notice of termination of the Development and License Agreement dated January 14, 2011. Under the agreement, Pacira granted exclusive rights to Novo under certain of its patents and know-how to develop, manufacture and commercialize formulations of a Novo proprietary drug using its DepoFoam drug delivery technology. The agreement is being terminated due to Novo’s decision to discontinue development of the proprietary drug subject to the agreement.
MediciNova, Inc. (Nasdaq:MNOV) announced that an End-of-Phase 2 meeting pertaining to the development of MN-221 for the treatment of acute exacerbations of asthma has been scheduled with FDA for October 22, 2012. Phase 2 data released in May, 2012, showed that it did not meet its primary endpoint.