PharmAthene Awarded Contract Of Up To $28.1 Million To Develop Next Generation Thermostable Anthrax Vaccine

ANNAPOLIS, Md., Sept. 10, 2014  -- PharmAthene, Inc. (NYSE MKT: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced today that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded the Company a contract, valued at up to $28.1 million if all contract options are exercised, for the development of a next generation anthrax vaccine based on the Company's proprietary rPA anthrax vaccine technology platform.

Various government agencies, including the Institute of Medicine, have acknowledged the need to develop and stockpile next generation anthrax vaccines employing modern vaccine technology, which offer the potential for improved safety, convenience, cost-effectiveness, and more rapid immunity.

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FDA Posts Briefing Materials for Advisory Committee Meeting Reviewing Natpara® for Hypoparathyroidism

Endocrinologic and Metabolic Drugs Advisory Committee meeting scheduled for September 12, 2014
PDUFA date for Natpara BLA is October 24, 2014

BEDMINSTER, N.J. -- NPS Pharmaceuticals, Inc. (NPSP), a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has posted briefing materials for the September 12 Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to review the company’s Biologics License Application (BLA) for Natpara® (rhPTH[1-84]). Natpara is a bioengineered replacement therapy for endogenous parathyroid hormone (PTH) that NPS Pharma has developed for the treatment of Hypoparathyroidism, a rare endocrine disorder characterized by insufficient levels of PTH.

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Can-Fite Issued Japanese Patent for CF102 in the Treatment of Liver Regeneration and Function Following Surgery

In preclinical studies, CF102 induces hepatocyte proliferation resulting in improved liver status

PETACH TIKVA, Israel, Sept. 5, 2014 -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (CFBI.TA), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer and inflammatory diseases, today announced the issuance of Patent No. 2010-529501, titled, "Method for inducing hepatocyte proliferation and uses thereof," by the Japanese Patent Office. The patent covers Can-Fite's clinical stage drug candidate, CF102, in the treatment of liver regeneration and function following liver surgery or other injury via inhibition of pro-apoptotic proteins, resulting in liver repair. A European Patent (No. 2227234) for this technology was issued earlier this year in the European Union.

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Prana receives FDA Orphan Drug Designation for PBT2 for Huntington Disease

MELBOURNE, Australia, Sept. 5, 2014 -- Prana Biotechnology (PBT.AX) has today announced the US Food and Drug Administration (FDA) has granted Orphan Drug designation to PBT2 for the treatment of Huntington Disease.

Orphan drug designation is granted by the FDA to promote the development of drugs for diseases affecting less than 200,000 people in the United States. Orphan drug designation entitles Prana to seven years of market exclusivity for the use of PBT2 in the treatment of Huntington disease; protocol assistance by the FDA to optimize drug development in the preparation of a dossier that will meet regulatory requirements; and reduced fees associated with applying for market approval.

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Mirati Therapeutics Initiates Phase 1 Study of MGCD516 for Non-Small Cell Lung Cancer and Other Advanced Solid Tumors

SAN DIEGO, Sept. 4, 2014 -- Mirati Therapeutics, Inc. (MRTX) today announced that the first patient has been dosed in its Phase 1 clinical study of MGCD516 in the treatment of patients with advanced solid tumors, with an initial focus on non-small cell lung cancer (NSCLC). MGCD516 is a Receptor Tyrosine Kinase (RTK) inhibitor with molecular targets that act as critical genetic drivers of cancer progression.

"This study is designed to identify an optimal dose and move quickly into expansion cohorts in selected patients who have genetic alterations of certain kinases including the Trk, RET and DDR RTK pathways," said Charles M. Baum, M.D., Ph.D., president and CEO of Mirati. "By focusing on patients that harbor these genetic drivers of disease, we believe MGCD516 will be more likely to demonstrate a high response rate in defined patient subsets, with the potential to support an accelerated development path."

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