Medical Tidbits

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Asterias Biotherapeutics Added To Russell 2000®, Russell 3000®, Russell Global and Russell Microcap® IndexesAsterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company focused on the emerging field of regenerative medicine, today announced that it has been added to the Russell 2000®, Russell 3000®, Russell Global and Russell Microcap® indexes following Russell Investments’ (“Russell”) reconstitution of its comprehensive set of U.S. and global equity indexes after the close of the U.S. markets on June 26, 2015. Each June, Russell completely rebalances its indexes, known as a reconstitution, to reflect market changes in the past year.

DaVita HealthCare Partners Recognized as a Top Green Company in U.S. by Newsweek

DENVER, June 30, 2015 /PRNewswire/ — DaVita HealthCare Partners Inc. (NYSE: DVA), one of the nation’s largest and most innovative health care communities, today announced that the company was recognized by Newsweek Green Rankings as a 2015 Top Green Company in the U.S. The company has appeared on the list every year the award program has run since 2009.

Aridis Pharmaceuticals Receives FDA Fast Track Designation for Aerucin™ for Treating Hospital-Acquired and Ventilator-Associated Pneumonia

SAN JOSE, Calif., June 30, 2015 /PRNewswire/ — Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel therapies for infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to its fully human monoclonal antibody Aerucin™ for the treatment of hospital-acquired and ventilator-associated pneumonia caused by Pseudomonas aeruginosa.  Aridis completed enrollment and dosing in a Phase 1 clinical study of Aerucin. Results are expected in the fourth quarter of this year.

Vu Truong, Ph.D., Founder and CEO of Aridis, stated, “We are pleased to receive Fast Track designation for Aerucin as it provides an accelerated development and regulatory review pathway, and if approved, may lead to expedited availability of Aerucin to critically ill patients with hospital-acquired and ventilator-associated pneumonia. This is an encouraging milestone for Aridis and is in line with our strategy to obtain Fast-Track, Orphan Drug, Qualified Infectious Diseases Product (QIDP), and Breakthrough Therapy designations for some or all of our product candidates.”

Telesta Therapeutics Submits Biologics License Application to the U.S. FDA

Telesta Therapeutics Inc. (TSX:TST; PNK:BNHLF) announced today that it has submitted electronically, through its U.S. agent, a Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) for MCNA[1]. MCNA is Telesta’s novel biologic immunotherapeutic for the treatment of high-risk non-muscle invasive bladder cancer patients who have failed first-line BCG therapy.

Telesta also announced today that they have received from the FDA a waiver exempting Telesta from the payment of the $US2.3 million BLA application fee.

The FDA has a 60-day filing review period to determine whether Telesta’s BLA submission for MCNA is complete and acceptable for filing, whether MCNA will be designated for priority review or standard review and whether an advisory committee meeting will be scheduled. Their decisions on these items will be communicated to Telesta in the FDA’s official filing communication known as the “Day-74 letter”. Telesta will communicate the FDA’s filing decisions upon receipt.

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