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Monthly Archives: February 2017

FDA Grants Priority Review to Teva’s Tardive Dyskinesia Drug

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today announced the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review for SD-809 (deutetrabenazine) for the treatment of tardive dyskinesia (TD). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal …

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Kite Pharma’s CAR-T Therapy Meets Primary Endpoint in Pivotal Trial in Patients with Non-Hodgkin Lymphoma

SANTA MONICA, Calif.–(BUSINESS WIRE)–Kite Pharma, Inc., (Nasdaq:KITE) today announced positive data from the primary analysis of ZUMA-1 for its lead CAR-T candidate, axicabtagene ciloleucel (previously referred to as KTE-C19), in patients with chemorefractory aggressive B-cell non-Hodgkin lymphoma (NHL). The study met the primary endpoint of objective response rate (ORR), or …

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Exonics Therapeutics Launches with Funding from CureDuchenne to Advance CRISPR/Cas9 Therapy for DMD

BOSTON, Feb. 27, 2017 (GLOBE NEWSWIRE) — Exonics Therapeutics, Inc., a newly formed biotechnology company focused on developing gene editing technologies like CRISPR/Cas9 to permanently correct a majority of mutations causing Duchenne muscular dystrophy and other neuromuscular diseases, today announced a commitment of $5 million in seed financing from CureDuchenne …

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Advaxis Licenses Antigen Delivery Technology to Sellas for Development of Targeted Cancer Immunotherapy

PRINCETON, N.J., and HAMILTON, Bermuda, Feb. 27, 2017 (GLOBE NEWSWIRE) — Advaxis, Inc. (NASDAQ:ADXS) and SELLAS Life Sciences Group, both late-stage biopharmaceutical companies focused on developing cancer immunotherapies, today announced that Advaxis has granted SELLAS a license to develop a novel cancer immunotherapy agent using Advaxis’ proprietary Lm-based antigen delivery …

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FDA Grants Fast Track Status to OncoSec’s ImmunoPulse IL-12 for the Treatment of Metastatic Melanoma

SAN DIEGO, Feb. 27, 2017 /PRNewswire/ — OncoSec Medical Incorporated (“OncoSec”) (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its ImmunoPulse® IL-12, a potentially first-in-class, Intratumoral anti-cancer gene therapy that expresses interleukin-12 (IL-12) for the treatment …

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Bristol-Myers Squibb and Exelixis Partner for Late-Stage Combination Trial in First-Line Renal Cell Carcinoma

SOUTH SAN FRANCISCO, Calif. & NEW YORK–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq:EXEL) and Bristol-Myers Squibb Company (NYSE:BMY) today announced the companies have entered into a clinical development collaboration to evaluate CABOMETYX™ (cabozantinib), Exelixis’ small molecule inhibitor of receptor tyrosine kinases, with Opdivo (nivolumab), Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, either alone or …

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Sangamo Therapeutics Receives Rare Pediatric Disease Designation from the FDA for its MPS I Candidate

RICHMOND, Calif., Feb. 27, 2017 /PRNewswire/ — Sangamo Therapeutics, Inc. (Nasdaq: SGMO), the leader in therapeutic genome editing, today announced that the U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designation for SB-318, the Company’s in vivo genome editing product candidate for the treatment of Mucopolysaccharidosis Type …

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Merck’s Letermovir Demonstrates Positive Results in Late-Stage CMV Study

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck & Co., Inc. (NYSE:MRK), known as MSD outside the United States and Canada, today announced results of the pivotal Phase 3 clinical study of letermovir, an investigational antiviral medicine for the prevention of clinically-significant cytomegalovirus (CMV) infection in adult (18 years and older) CMV-seropositive recipients of an …

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Tocagen’s Lead Drug Candidate Receives Breakthrough Therapy from the FDA for Treatment of Recurrent High Grade Glioma

SAN DIEGO – Feb. 23, 2017 – Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, today announced the U.S. Food and Drug Administration (FDA) has granted Toca 511 & Toca FC Breakthrough Therapy Designation for the treatment of patients with recurrent high grade glioma (HGG). Toca 511 & Toca FC …

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New Assay May Lead to a Cure for Debilitating Inflammatory Joint Disease

Current treatments for rheumatoid arthritis relieve the inflammation that leads to joint destruction, but the immunologic defect that triggers the inflammation persists to cause relapses, according to research conducted at NYU Langone Medical Center and the University of Pittsburgh. Known as autoantibodies and produced by the immune system’s B cells, …

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