GW Pharmaceuticals Announces Positive Phase 3 Pivotal Study Results for Epidiolex® (cannabidiol)
- Published: 14 March 2016
- Written by Editor
SYDNEY, March 8, 2016 - Benitec Biopharma Limited (ASX: BLT; NASDAQ: BNTC; NASDAQ: BNTCW) is pleased to announce that BB-HB-331, a DNA-directed RNA interference (ddRNAi) therapy targeting the hepatitis B virus (HBV), demonstrates robust and durable suppression of HBV in vivo following a single administration.
Benitec's ddRNAi technology is a unique combination of gene silencing using RNA interference coupled with the long term therapeutic potential of gene therapy. BB-HB-331 is comprised of an AAV8 capsid and recombinant DNA engineered to express three short hairpin RNA (shRNA) that target and inhibit viral RNA expressed from three well conserved regions across multiple HBV genotypes.
BOSTON-- Verastem, Inc. (VSTM), focused on discovering and developing drugs to treat cancer, today reported financial results for the year ended December 31, 2015, and also provided an overview of certain corporate developments.
“We are developing treatments that reduce cancer stem cells and modulate the local tumor microenvironment to allow both cancer treatments and the immune system to do their job more efficiently,” said Robert Forrester, President and Chief Executive Officer of Verastem. “Our recently announced collaborations with Pfizer and Merck KGaA, and with Merck & Co. and Washington University in St. Louis, to evaluate the combination of our FAK inhibitors with immune-oncology agents speak to the understanding among the clinical community that innovative combination therapies have the potential to complement and enhance existing therapies. We begin 2016 with a strong balance sheet and expect significant progress from our ongoing programs targeting high unmet need cancers including non-small cell lung, ovarian, lymphoma, mesothelioma and pancreatic cancer. We are also planning for several trial initiations this year and we look forward to keeping you updated on our progress.”
VICTORIA, British Columbia-- Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the “Company”) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for voclosporin, the Company’s next generation calcineurin inhibitor, for the treatment of Lupus Nephritis (LN).
The Fast Track program was created by the FDA to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address significant unmet medical needs. Compounds that receive this FDA designation benefit from more frequent meetings and communications with the FDA to review the drug’s development plan including the design of clinical trials and the use of biomarkers to support approval. Additionally, Fast Track designation allows the Company to submit parts of the New Drug Application (NDA) on a rolling basis for review as data becomes available.