|NW Bio Receives Recommendation To Continue With Phase III GBM Brain Cancer Trial; Furiex Confirms Takeda’s Submission for Trelagliptin Succinate|
|By Staff and Wire Reports|
|Friday, 07 March 2014 23:49|
Northwest Biotherapeutics (NASDAQ: NWBO), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today, in response to shareholder inquiries, that the Data Safety Monitoring Board (DSMB) has made an unblinded review of the safety data for the Company's ongoing international Phase III GBM Trial, and has recommended that the trial continue as planned. The DSMB's review of the efficacy data is still pending.
Dr. Marnix Bosch, Chief Technical Officer of NW Bio noted, "We are pleased with the recommendation of the DSMB to continue the trial as planned. This is an important step in the ongoing progress of our Phase III trial."
Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today confirmed that Takeda Pharmaceutical Company Limited announced that it has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare for trelagliptin succinate (SYR-472), a once weekly dosage treatment for type 2 diabetes.
Under Furiex’s agreement with Takeda, Furiex is eligible to receive royalties and sales-based milestones if trelagliptin succinate is approved and marketed in Japan.
Takeda’s NDA is based on the safety and efficacy results of multiple Phase III clinical studies in patients with type 2 diabetes in Japan. The efficacy of once-weekly trelagliptin succinate was confirmed in all studies, in addition to a good safety and tolerability profile. Trelagliptin succinate controls blood glucose levels effectively with single weekly dosing, and is expected to contribute to improvement in drug adherence of patients.
"We are pleased that Takeda has taken this important step in seeking approval of trelagliptin succinate in Japan," said Fred Eshelman, Pharm.D., chairman of Furiex. “This is a significant achievement for Furiex and Takeda’s type 2 diabetes franchise.”
Added June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex, "We are excited about the potential for trelagliptin succinate to provide type 2 diabetes patients with a convenient, once-weekly treatment option."
AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today announced the U.S. Food and Drug Administration granted 510(k) clearance for its BioFlo DuraMax chronic hemodialysis catheter.
Gil Van Bokkelen, Chairman and Chief Executive Officer of Athersys, Inc. (Nasdaq:ATHX), will present at the second annual Regen Med Investor Day on Wednesday, March 26, 2014 at 1:30 pm (Eastern Time).
Baxano Surgical, Inc. (Nasdaq:BAXS) announced today that it will participate in the Canaccord Genuity Musculoskeletal Conference on March 11, 2014.
Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today reported financial results for the fourth quarter and full year 2013.
On March 5, 2014, a class action lawsuit was filed in the United States District Court for the District of Oregon against Galena Biopharma, Inc. (NASDAQ: GALE).
Hemp, Inc. (OTC:HEMP), through its wholly owned subsidiary, The Industrial Hemp and Medical Marijuana Consulting Company, Inc. (IHMMCC), announced today that its Board of Directors has appointed Gustavo Guadamud to serve as Hemp Ambassador to Webxu, Inc. (OTC:WBXU).
Hyperion Therapeutics (Nasdaq:HPTX) announced today that the company is scheduled to present at the 26th Annual Roth Conference on Tuesday, March 11, 2014 at 10:30 a.m. PT.
Natural Health Trends Corp. (OTCQB:NHTC), a leading direct selling company that markets premium quality personal care, wellness and "quality of life" products under the NHT Global brand, today announced record financial results for the quarter and full year ended December 31, 2013.
Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, today announced the Company's Chief Executive Officer Zami Aberman will deliver a brief presentation and be a panelist at BIO-Europe Spring 2014 on March 10, 2014 at 4pm.
RadNet, Inc. (Nasdaq:RDNT) announced today that it has commenced a tender offer to purchase for cash any and all of the outstanding $200 million aggregate principal amount of 10 3/8% Senior Secured Notes due 2018 (CUSIP# 750492 AD2).
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary drugs for the treatment of inflammatory and gastrointestinal diseases and related conditions, today reported that it has secured direct rights from Temple University to the original RHB-102 patents, a once-daily oral formulation of the anti-emetic drug ondansetron.
Stratus Media Group, Inc., (OTCBB:SMDI) announced today a name change to RestorGenex Corporation (RestorGenex), as well as a 1 for 100 reverse split of its common stock.