Bristol-Myers Squibb (NYSE:BMY) said today that it landed an exclusive licensing agreement for PsiOxus Therapeutics‘ ‘armed’ oncolytic virus, NG-348, for the treatment of solid tumors. According to the agreement, Bristol-Myers will pay PsiOxus $50 million upfront and will assume responsibility for global clinical development and commercialization. PsiOxus will be eligible for $886 million in development, regulatory and […]
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Draper, Pfizer ink ‘organ-on-a-chip’ deal
Draper said today that it inked a 3-year collaboration deal with Pfizer (NYSE:PFE) to develop Draper’s microphysiological system technology. The ‘organ-on-a-chip’ system is designed to improve preclinical safety and model diseases more effectively. The Cambridge, Mass.-based company’s miniature organ model enables researchers to measure tissue function and test potential new drug candidates. Draper and Pfizer will collaborate […]
21st Century Cures Act adds Hatch-Waxman rule to drug-device combos
Section 3038 of the 21st Century Cures Act applies Hatch-Waxman rules to certain drug-device combination products, addressing the regulatory pathway for devices that incorporate already approved drugs. The Hatch-Waxman Act, named for Sen. Orrin Hatch (R-Utah) and Rep. Henry Waxman (D-Calif.), was approved in 1984. It was designed to make it easier for generic drugs to enter […]
Study: Laser-activated deep-sea drug kills prostate cancer
Researchers from the Weizmann Institute of Science and Steba Biotech have reportedly developed a light-sensitive drug derived from deep-sea bacteria that has been shown to kill cancer cells in low-risk prostate cancer patients without affecting healthy tissue. The team’s work was published in Lancet Oncology. Vascular-targeted photodynamic therapy, VTP, utilizes a drug called WST11 which was […]
Researchers use gold nanoparticles to deliver hepatitis C vaccine
Researchers at Brigham & Women’s Hospital have developed electrically activated gold nanoparticles that can bore holes into cells’ outer membranes and allow DNA, RNA and proteins to pass through carrying their cargo. The team’s work was published in Advanced Functional Materials. The team tested its technique using a DNA vaccine against hepatitis C in a mice model. […]
Anika Therapeutics wins CE Mark for tennis elbow injection
Anika Therapeutics (NSDQ:ANIK) said today that it won CE Mark approval in the European Union for its Orthovisc-T injection. The Bedford, Mass.-based company’s treatment is indicated to relieve pain and restore function in tendons affected by tennis elbow, or chronic lateral epicondylosis. The sodium hyaluronate injection promotes tendon gliding and repair at the site of the […]
Cerus raises funds for phase III trial of Intercept red blood cell system
Cerus Corporation (NSDQ:CERS) said today that it exercised $10.8 million in additional options from its contract with the Biomedical Advanced Research & Development Authority, a part of the U.S. Dept. of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. The funds will go towards in vitro pathogen inactivation and red blood cell […]
Amgen wins recommendation for single injection Repatha device
Amgen (NSDQ:AMGN) said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion for its Repatha single monthly injection device. The device is already cleared in Europe for dosing every 2 weeks. The hands-free device, with prefilled cartridges, delivers 420 milligrams of Repatha (evolocumab) in a single injection. […]
GSK launches phase III trial for inhaled triple combination therapy
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said today that they launched a phase III trial evaluating the triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in patients with asthma. The companies’ triple combination therapy is made up of 3 drugs – an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta-adrenergic agonist. The treatment is delivered once a day using GSK’s […]
Brainstorm’s NurOwn stem cell treatment for ALS readies for phase III
Brainstorm Cell Therapeutics (NSDQ:BCLI) said today that it’s preparing for a phase III trial of its NurOwn stem cell treatment, after meeting with the FDA about a biologic license application. The company is developing adult stem cell therapies derived from autologous bone marrow cells to treat neurodegenerative diseases, such as ALS. Hackensack, N.J.-based Brainstorm is planning […]