Biogen, the ALS Association and Columbia University Medical Center Collaborate to Drive Understanding of Genetic Influence in ALS

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CAMBRIDGE, Mass.–(BUSINESS WIRE)–Biogen (NASDAQ: BIIB), the ALS Association and Columbia University Medical Center (CUMC) today announced a new collaboration to better understand the differences and commonalities in the ALS disease process and how genes influence the clinical features of the disease. The project, “Genomic Translation for ALS Clinical care” (GTAC), will involve a combination of next generation genetic sequencing and detailed clinical phenotyping in 1500 people with ALS. The goal of the project is to provide a basis for the development of precision medicine, or more individually tailored therapies for ALS. read more

Pfenex Inc. Awarded HHS Contract Valued At Up To $143.5 Million For The Advanced Development Of Next Generation Anthrax Vaccine

SAN DIEGO, Aug. 17, 2015 /PRNewswire/ — Pfenex Inc. (NYSE MKT: PFNX), announced today it has signed a five year, cost plus fixed fee contract valued at up to $143.5 million with the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS), for the advanced development of Px563L, a mutant recombinant protective antigen anthrax vaccine.  read more

OncoSec Announces First Patient Enrolled in Phase II Clinical Trial Evaluating Combination of ImmunoPulse™ IL-12 and Anti-PD-1 Treatment

SAN DIEGO, Aug. 18, 2015 /PRNewswire/ — OncoSec Medical Incorporated (“OncoSec”) (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today announced enrollment of the first patient into the Phase II Investigator Sponsored Trial led by the University of California, San Francisco (UCSF) to assess the anti-tumor activity, safety, and tolerability of the combination of OncoSec’s investigational therapy, ImmunoPulse™ IL-12, and Merck’s approved anti-PD-1 agent, KEYTRUDA® (pembrolizumab), in patients with unresectable metastatic melanoma. The primary endpoint is the best Overall Response Rate (bORR) of the combination regimen in patients whose tumors are characterized by low numbers of tumor-infiltrating lymphocytes (TILs).  read more

Mylan Confirms First-to-File Patent Challenge Relating to Zytiga(R)/Expects to be eligible for 180 days of marketing exclusivity-

HERTFORDSHIRE, England and PITTSBURGH, Aug. 18, 2015 /PRNewswire/ — Mylan N.V. (Nasdaq: MYL) today confirmed that the company has been sued by BTG International Ltd., Janssen Biotech, Inc., Janssen Oncology, Inc., and Janssen Research & Development, LLC in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Abiraterone Acetate Tablets, 250 mg. This product is the generic version of Zytiga®, which is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.  read more

 

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