|Theravance Announces Postponement of March 7 PDAC Meeting; Sangamo Presenting New Data at CROI 2013|
|By Staff and Wire Reports|
|Wednesday, 06 March 2013 18:49|
Theravance (NASDAQ: THRX) announced postponement of March 7 PDAC meeting on 8-K by the FDA after notifying GlaxoSmithKline plc (NYSE: GSK) about the Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting due to forecasted adverse weather conditions. The FDA is working to reschedule the meeting in a timely manner.
The new drug application (NDA) 204275, for fluticasone furoate and vilanterol dry powder inhaler (proposed trade name BREO ELLIPTA™), sponsored by GSK, for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease, was scheduled to be discussed at the PADAC meeting. Fluticasone furoate and vilanterol, an investigational once-daily inhaled corticosteroid/long-acting beta2 agonist (LABA) combination treatment, is in development under the LABA collaboration between GSK and Theravance, Inc.
Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced new data from its program to develop a 'functional cure' for HIV/AIDS in two presentations at the 20th Conference on Retroviruses and Opportunistic Infections (CROI), held in Atlanta from March 3 to 6, 2013.
The first presentation described data from the SB-728-T Phase 1 study (SB-728-902, Cohorts 1-3) demonstrating that SB-728-T treatment of HIV-infected subjects leads to durable reconstitution of the immune system driven by increases in total CD4+ central memory T-cells (T[CM]) and CCR5-protected T[CM]. T[CM] are long-lived, self-renewing cells that have the ability to remember and react against foreign antigens including HIV. The data also showed that certain cell surface marker and gene expression profiles may predict which patients will likely respond best to SB-728-T treatment.
"These important data extend our understanding of why SB-728-T treatment improves the immune system as well as the conditions required for optimal engraftment of ZFN-modified T-cells," said Dale Ando, M.D., Sangamo's vice president of therapeutic development and chief medical officer. "They confirm that SB-728-T meets the key immunologic requirements for immune reconstitution in HIV-infected individuals. In addition, analysis of cell surface marker and gene expression profiles of immune system cells in subjects who show superior responses to treatment in terms of increased T-cell counts provides us with important indicators that will aid us in the optimization of our clinical trials."
"The ability of SB-728-T to durably reconstitute the immune system in HIV-infected subjects after a single treatment has never been observed before with any other therapeutic approach," commented Rafick-Pierre Sekaly, Ph.D., Co-Director & Chief Scientific Officer, The Vaccine & Gene Therapy Institute of Florida (VGTI Florida), whose laboratory carried out the analysis. "Improvement in the overall health of the immune system of HIV-infected individuals, as demonstrated by treatment with SB-728-T, is a key step along the path to developing an immunologic approach to controlling and potentially eliminating the virus. We have analyzed the cells that constitute this unprecedented elevation of total CD4+ cell counts, extending our previous observations that the increase is primarily due to durable expansion of the central memory T-cells. Importantly, the level of ZFN-dependent CCR5 gene disruption is sustained in these cells, which is critical for the durable success of this approach."
Abattis Bioceuticals Corp. (OTC PINK: ATTBF) (CNSX: FLU), announces it has signed a letter of intent with Crudessence Kombucha Inc. ("RISE") to acquire the worldwide exclusive license "the License" to produce, distribute, market and sell a Kombucha tea infused or blended with additional nutraceutical and bioceutical formulas developed and owned by Abattis and its subsidiaries.
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that the United States Food and Drug Administration (FDA) has accepted for review the company’s supplemental new drug application (sNDA) for Feraheme® (ferumoxytol) Injection for Intravenous (IV) use, which was submitted to the FDA in December 2012.
Antares Pharma, Inc. (NASDAQ: ATRS) today announced it will release its fourth quarter 2012 financial results before the market opens on Wednesday, March 13, 2013, and host a conference call shortly thereafter at 8:30 a.m. ET (Eastern Time) to discuss the results.
Atossa Genetics, Inc. (NASDAQ: ATOS), The Breast Health Company™, announced today that Steven C. Quay, M.D., Ph.D., FCAP, chairman, CEO & president, and Kyle Guse, CFO and general counsel, will present the Company's business model, growth strategy and products and services at the 25th Annual ROTH Conference at the Ritz-Carlton Laguna Niguel in Dana Point, California, on Tuesday, March 19, 2013, at 3:30 pm Pacific Time.
BIOLASE, Inc. (NASDAQ: BIOL), the world's leading dental laser manufacturer and distributor, announced today that Chief Executive Officer Federico Pignatelli will continue at a symbolic annual cash salary of $1.00 for the year ending December 31, 2013.
Cantel Medical Corp. (NYSE: CMN), a leading provider of infection prevention and control products, has officially launched RAPICIDE OPA/28, an ortho-phthalaldehyde (OPA) based high-level disinfectant for semi-critical medical devices, to multiple segments of the healthcare market.
eHealth, Inc. (NASDAQ: EHTH) announced today that its Board of Directors has authorized a $30 million increase to its existing $30 million share repurchase program that was previously announced in September 2012.
FONAR Corporation (NASDAQ: FONR), The Inventor of MR Scanning™, reported that yesterday HMCA, a subsidiary of Fonar Corporation, acquired through a majority interest in a newly formed limited liability company, a business managing 12 Stand-Up® MRI centers and 2 other scanning centers located in Florida and New York for purchase price of $34.4 million dollars.
LED Medical Diagnostics Inc. (TSX VENTURE:LMD) (OTCQX:LEDIF) (FRANKFURT:LME), a developer of tissue fluorescence visualization technologies for the medical industry, announced today that it is expanding its investigation of the application of its tissue fluorescence visualization technology to the detection of skin cancer and other dermatologic diseases.
Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive lipid-targeted therapeutics, has signed a collaboration and license agreement to develop cancer diagnostics with Provista Diagnostics, Inc. a leader in molecular cancer diagnostics and a CLIA-accredited reference laboratory.
mPhase Technologies, Inc. (OTCBB: XDSL) announced today that it will be attending and exhibiting at the New Jersey Technology Council (NJTC) Venture Conference being held at the Hyatt Regency Hotel in New Brunswick, N.J. on March 22, 2013.
PDI, Inc. (Nasdaq: PDII), today reported financial and operational results for the fourth quarter and year ended December 31, 2012.
Osiris Therapeutics, Inc. (NASDAQ: OSIR) the leading stem cell company focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets, announced today its results for the fourth quarter and full year ended December 31, 2012.
Response Biomedical Corp. ("Response") (TSX:RBM) (OTCBB:RPBIF) will release its fourth quarter and fiscal year 2012 financial results after the markets close on, March 11, 2013.
RP Management, LLC ("Royalty Pharma") remains committed to acquiring Elan (NYSE: ELN) on the terms set out in the Proposal Announcement of February 25, 2013, but continues to be disappointed that the Board of Elan has not engaged in discussions.
Santarus, Inc. (NASDAQ: SNTS) and VeroScience, LLC today announced publication of a review article and recommendations of an American Association of Clinical Endocrinologists (AACE) expert panel on the role of bromocriptine-QR in the management of type 2 diabetes.
Sionix Corporation (OTCQB: SINX) announced today that it has hired Dr. Rex Crick as its Chief Operating Officer.
In honor of National Colorectal Cancer Awareness Month, Sanofi (EURONEXT: SAN and NYSE: SNY) and the Colon Cancer Coalition/Get Your Rear in Gear have collaborated to raise awareness of colorectal cancer in Cambridge, Massachusetts by asking the Mayor to sign a proclamation decreeing today, March 6 as Colorectal Cancer Awareness Day in Cambridge.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) announced today enrollment of the first patient in the CONCERTO study - the third Phase III placebo-controlled study designed to evaluate the efficacy, safety and tolerability of once-daily oral laquinimod in patients with relapsing-remitting multiple sclerosis (RRMS).
VaporBrands International, Inc. (OTC Pink: VAPR) ("VAPR, VBI"), is excited to have the exclusive VAMP™ brand and is also able to offer other branding opportunities for international distribution.
YaFarm Technologies, Inc. (PINKSHEETS: YFRM) (YaFarm, or the Company) announced today that the Integrative Stem Cell Institute (ISCI) has received significant funding for its venture in Cancun, Mexico.
Zalicus Inc. (Nasdaq Global Market: ZLCS), a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain, today reported financial results for the fourth quarter and year ended December 31, 2012.