|Glaxo, Theravance Confirms FDA Panel Recommends Approval for UMEC/VI Dose for COPD; Alexion Reports Data from Study on Eculizumab|
|By Staff and Wire Reports|
|Tuesday, 10 September 2013 17:27|
GlaxoSmithKline plc (NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) announced the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US Food and Drug Administration (FDA) voted 11 yes to 2 no that the efficacy and safety data provide substantial evidence to support approval of umeclidinium/vilanterol (UMEC/VI, 62.5/25mcg dose) for the long-term, once-daily, maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
ANORO(TM) ELLIPTA(TM) is the proposed proprietary name for UMEC/VI, a combination of two investigational bronchodilator molecules -- GSK573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA), administered using the ELLIPTA(TM) inhaler.
The FDA Advisory Committee also voted that the safety of the investigational medicine has been adequately demonstrated at the 62.5/25mcg dose for the proposed indication (10 yes, 3 no), and the efficacy data provided substantial evidence of a clinically meaningful benefit for UMEC/VI 62.5/25mcg once daily for the long-term, maintenance treatment of airflow obstruction in COPD (13 yes, 0 no).
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) announced researchers have presented preliminary data from a single-arm Phase 2 study of eculizumab (Soliris®) as an investigational therapy to prevent acute antibody-mediated rejection (AMR) in sensitized deceased-donor kidney transplant recipients. The composite primary endpoint was the nine-week occurrence of post-transplantation treatment failure, which occurred in 10.6% of the 47 patients reported today, including a 6.4% rate of AMR1 compared to an expected 30% rate of AMR2 in this highly sensitized population of kidney transplant recipients. The data were presented today in an oral presentation at the 2013 annual congress of the European Society for Organ Transplantation (ESOT) in Vienna, Austria.
Acute AMR can lead to severe kidney allograft damage resulting in rapid loss of function and possible loss of the transplanted kidney, which makes AMR a significant clinical barrier to transplantation in sensitized patients. 3 Research suggests that uncontrolled activation of complement, triggered by the binding of donor-specific antibodies (DSAs) to their target proteins (antigens) of the donor kidney, may be the primary reason for acute AMR in kidney transplant recipients who are sensitized, or have DSAs, to their donors. 3,4 Prophylaxis with a terminal complement inhibitor, such as eculizumab, is thus considered a potential strategy to prevent acute AMR. There are no approved treatments for the prevention of acute AMR.
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) announced researchers have presented preliminary data from a single-arm Phase 2 study of eculizumab (Soliris®) as an investigational therapy to prevent acute antibody-mediated rejection (AMR) in sensitized deceased-donor kidney transplant recipients.
BIOLASE, Inc. (NASDAQ: BIOL), the world's leading manufacturer and distributor of dental lasers, and a pioneer in laser surgery in other medical specialties, today announced that effective September 6, 2013 it amended the terms of its two revolving credit facility agreements with Comerica Bank.
Champions Oncology (OTC:CSBR), a company engaged in the development of advanced technology solutions and services to personalize the development and use of oncology drugs, announced today that it has received a clinical laboratory permit from the New York State Department of Health to provide its innovative Champions TumorGraft test to patients in New York.
Conatus Pharmaceuticals (Nasdaq: CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced initiation of dosing in the Phase 2 clinical trial of emricasan in patients with severe alcoholic hepatitis.
Corgenix Medical Corporation (OTCQB: CONX.OB), a worldwide developer and marketer of diagnostic test kits, today announced signing of a new AtherOx® License and Cooperation Agreement with Eiji Matsuura, Ph.D., an individual of Okayama, Japan.
Exelixis, Inc. (NASDAQ:EXEL) today announced that it has initiated CELESTIAL, a phase 3 pivotal trial comparing cabozantinib with placebo in patients with advanced hepatocellular carcinoma (HCC) who have previously been treated with sorafenib.
Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today announced that the Company will be presenting at the Stifel Nicolaus 2013 Healthcare Conference.
Kraig Biocraft Laboratories, Inc. (OTCQB:KBLB), the leading developer of advanced spider silk based fibers, today announced that the Company's initial testing of its recombinant spider silk, Big Red, indicate that the Company's new recombinant fiber is stronger than Monster Silk®.
Marrone Bio Innovations, Inc. (Nasdaq:MBII), a leading global provider of bio-based pest management and plant health products, announced today plans to move its headquarters to a larger location in Davis, California.
NanoViricides, Inc. (OTC BB: NNVCD) announced today that it has now met all the listing standards of certain major national stock exchanges after executing a one for three and one-half (1:3.5) reverse split of the Company's issued and outstanding common stock on September 9th that will be reflected at the open of the OTC Bulletin Board on September 10, 2013.
Neuralstem, Inc. (NYSE MKT: CUR) announced that the first patient was treated in its Phase II trial using NSI-566 spinal cord-derived neural stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) at Emory University Hospital in Atlanta, Georgia.
Omeros Corporation (NASDAQ: OMER) today announced that it recently submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market OMS302 for use in patients undergoing intraocular lens replacement (ILR) surgery in the European Union (EU).
Oxygen Biotherapeutics, Inc., (NASDAQ: OXBT) a developer of oxygen-carrying therapeutics, today announced that the United States Patent and Trademark Office has issued the Company patent#8,513,309, titled, “Perfluorocarbons for use in Treating Pruritus.”
Stellar Biotechnologies, Inc. (OTCQB: SBOTF) (TSX VENTURE: KLH), announced today that, further to its news release of August 22, 2013, it has completed the initial closing of its private placement, which included brokered and non-brokered portions, raising initial gross proceeds of US$10M (the "Initial Closing").
Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of biologics focused on the prevention and treatment of serious infectious diseases, announced today that Jeffrey Riley, CEO, will present at the First Global Life Sciences Conference to be held on September 16-17, 2013 in Warsaw, Poland.
Verisante Technology, Inc. (TSX VENTURE:VRS) (OTCQX:VRSEF), a leader in cancer detection technology, announced today that the Company has completed the second phase prototype of a rapid Multispectral Imaging ("MSI") System for skin cancer detection.
Walgreen Co. (NYSE: WAG) (NASDAQ: WAG) and Kerr Drug, a privately held regional pharmacy chain in North Carolina, announced today that they have entered into a definitive agreement under which Walgreens would acquire certain assets of Kerr Drug’s retail drugstores and specialty pharmacy business.