Hyperion Notified That FDA Will Not Meet the PDUFA Action Date for Ravicti(TM)

Hyperion Therapeutics, Inc. (HPTX) said that the U.S. Food and Drug Administration (FDA) has advised the Company not to expect a final action by the Prescription Drug User Fee Act (PDUFA) action date of January 23, 2013. The agency explained it is continuing to work on label and post-marketing requirements in connection with Hyperion's New Drug Application (NDA) for Ravicti(TM) (glycerol phenylbutyrate) for the treatment of Urea Cycle Disorders (UCD).

Neuralstem Receives FDA Approval To Commence Spinal Cord Injury Trial

NSI-566 to be tested in patients with chronic spinal cord injury

Neuralstem, Inc. (NYSE MKT: CUR) announced that it received approval from the United States Food and Drug Administration (FDA) to commence a Phase I safety trial of its lead cell therapy candidate, NSI-566, in chronic spinal cord injury patients. This open-label, multi-site study, will enroll up to eight patients with thoracic spinal cord injuries (T2-T12), who have an American Spinal Injury Association (AIS) A level of impairment,  between one and two years after injury. AIS A impairment refers to a patient with no motor or sensory function in the relevant segments at and below the injury, and is considered to be complete paralysis.

PharmAthene Announces Delaware Supreme Court Hears Oral Arguments In Its Litigation With SIGA Technologies

PharmAthene, Inc. (NYSE MKT: PIP) announced that the Delaware Supreme Court heard oral arguments today related to both parties' appeal in the Company's on-going litigation against SIGA Technologies.  SIGA appealed the final judgment in favor of PharmAthene issued by the Delaware Court of Chancery on May 31, 2012, in which PharmAthene was awarded 50% of the net profits over a period of ten years from all sales of SIGA's smallpox antiviral therapeutic, Arestvyr™ (formerly ST-246^®) and related products, after SIGA receives the first $40 million in net profits, as well as a portion of the Company's attorney's fees and other costs.   In response to SIGA's appeal, PharmAthene cross-appealed, challenging other aspects of the trial court's ruling.

LifeMap Sciences, a Subsidiary of BioTime, Inc., Announces the Release of MalaCards Version 1.02

LifeMap Sciences, Inc., a subsidiary of BioTime, Inc. (NYSE MKT: BTX), announced today the release of MalaCards version 1.02 on January 7. The new release is available at www.malacards.org. MalaCards is a new database of human diseases and their annotations that is modeled on the architecture and richness of the popular GeneCards^® database of human genes. LifeMap Sciences holds the exclusive worldwide license to market MalaCards and GeneCards^® from Yeda Research and Development Company Ltd., the commercial arm of the Weizmann Institute of Science. MalaCards contains computerized “cards” classifying information relating to a wide array of human diseases. This novel research tool will aid researchers in studying the roles of genes and cells in disease processes. MalaCards and GeneCards^® were developed, and are continuously enhanced by ongoing research, by the bioinformatics team at the Department of Molecular Genetics at the Weizmann Institute of Science in Israel, with Professor Doron Lancet, head of the Crown Human Genome Center, and team leader Marilyn Safran.