|Seattle Genetics Confirms FDA Orphan Drug Status for ADCETRIS; Valeant Offers Results of Efinaconazole|
|By Staff and Wire Reports|
|Monday, 26 November 2012 19:54|
Seattle Genetics, Inc. (Nasdaq: SGEN) announced ADCETRIS (brentuximab vedotin) has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of mycosis fungoides (MF).
MF is the most common type of cutaneous T-cell lymphoma (CTCL). Seattle Genetics and its ADCETRIS collaborator, Millennium: The Takeda Oncology Company, are conducting the ALCANZA trial, a phase III clinical trial of ADCETRIS for patients with CD30-positive relapsed CTCL, including MF. ADCETRIS is not approved for the treatment of CTCL.
Valeant Pharmaceuticals International, Inc. (NYSE: VRX) announced the Journal of the American Academy of Dermatology has published the positive results from our two pivotal, international, multicenter, randomized, double-blind, vehicle-controlled studies that were conducted in 1,655 subjects with onychomycosis. Onychomycosis is a common nail infection caused predominantly by dermatophyte fungi, resulting in nail destruction and deformity. The only approved topical treatments are lacquers with very limited efficacy. Oral treatments, while more efficacious, are limited by drug interactions and numerous safety concerns including the potential for acute liver injury. Valeant investigated the safety and efficacy of efinaconazole 10% topical solution (efinaconazole), the first triazole antifungal agent developed for distal lateral subungual onychomycosis (DLSO).
The study's primary endpoint was stringently defined as the complete cure rate at Week 52, which means that the target nail showed no clinical involvement and no evidence of fungus present by both KOH testing and a negative fungal culture. In Study 1, 17.8% of subjects treated with efinaconazole were completely cured, as compared to only 3.3% of subjects treated with vehicle and in Study 2, 15.2% of subjects treated with efinaconazole were completely cured, as compared to only 5.5% of subjects treated with vehicle. Using the secondary endpoint of complete or almost complete cure, defined as < 5% clinical involvement and 100% mycologic cure, the success rates for efinaconazole increased to 26.4% and 23.4%, respectively. The adverse events that were reported were generally mild and transient and were similar between subjects treated with efinaconazole solution 10% and vehicle.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that the United States Patent and Trademark Office (USPTO) has issued Notices of Allowance for three patent applications from the company’s exclusively held Tuschl II patent estate.
Amarantus BioSciences, Inc. (OTCQB: AMBS), a biotechnology company developing new treatments and diagnostics for Parkinson's disease and Traumatic Brain Injury centred on its proprietary anti-apoptosis therapeutic protein MANF, announced today, with the assistance of its Manhattan-based corporate counsel at JS Barkats, PLLC, it has initiated legal action to effect the expeditious cessation of trading and delisting of Amarantus common stock from the Berlin-Bremen Stock Exchange (the "BBSE"), and/or any other unofficially regulated markets controlled by the BBSE.
AVEO Oncology (NASDAQ: AVEO) today announced that David Johnston, chief financial officer, is scheduled to present at the Deutsche Bank 2012 dbAccess BioFEST Conference on Monday, December 3, 2012 at 4:35 p.m. (ET) in Boston.
BioRestorative Therapies, Inc. (OTC BB: BRTX), a life sciences company focused on stem cell based cellular therapies for various personal medical applications, announced today that it has launched a new website, available at www.biorestorative.com.
Energy crop company Ceres, Inc. (Nasdaq: CERE) today announced that its Brazilian subsidiary Ceres Sementes do Brasil Ltda., has signed a sweet sorghum market development agreement with Syngenta (NYSE: SYT).
Galectin Therapeutics (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that it has received a notice of allowance from the U.S. Patent and Trademark Office for a divisional patent of Patent Number 8,236,780 “Galactose-prolonged polysaccharides in a formulation for antifibrotic therapies”.
GenMark Diagnostics, Inc. (NASDAQ: GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, will present at the Canaccord Genuity Medical Technology & Diagnostics Forum to be held at the Le Parker Meridien in New York, NY on December 4, 2012.
Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), a biotechnology company developing Toll-like receptor targeted product candidates for the treatment of autoimmune diseases and as vaccine adjuvants, today announced that its management will present a company overview at the 24th Annual Piper Jaffray Healthcare Conference in New York, NY.
ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops anticancer therapeutics using its Targeted Antibody Payload (TAP) technology and antibody expertise, today announced the appointment of Charles Morris, MB, ChB, MRCP as Executive Vice President and Chief Development Officer, effective today.
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) will be presenting at the 2012 dbAccess Biofest on December 3, 2012 at 1:40 p.m. ET in Boston.
Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) announced today that testing of multiple synthetic vaccine constructs for cytomegalovirus (CMV) induced robust T cells in mice, demonstrating the potential for a SynCon® DNA vaccine to treat this virus that causes infant death and congenital abnormalities, is associated with cerebral palsy and brain tumors, and is the most common viral infection in organ transplant recipients.
MMRGlobal, Inc. (OTCBB: MMRF) ("MMR") today announced that its fifth online medical records patent, U.S. Patent No. 8,321,240, is being issued from the United States Patent and Trademark Office on Tuesday, November 27th.
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that data from its Lymphoseek® (technetium Tc 99m tilmanocept) studies in breast cancer and melanoma are being presented during the Radiological Society of North America Conference (RSNA) in Chicago and the CTRC-AACR San Antonio Breast Cancer Symposium in San Antonio, Texas. Details of the poster presentations are listed below.
Pfizer Inc. (NYSE: PFE) today announced that Wyeth LLC, its wholly-owned subsidiary, has notified The Bank of New York Mellon, as trustee under the applicable indenture, of its election to fully redeem all of its outstanding 5.500% Notes due March 15, 2013 (after giving effect to a December 4, 2003 upward interest rate adjustment of 0.25%) (CUSIP No. 983024AA8) (the “Notes”). The aggregate principal amount of Notes currently outstanding is $1.5 billion.
Piper Jaffray (NYSE: PJC) today announced that Jeff Ammerman joined as a principal in the healthcare investment banking group.
Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" or the "Company") and Constant Systems Ltd ("CS") today announced they have entered into a two-way, strategic marketing, selling, and distribution agreement (the "Agreement").
Rainbow Coral Corp. (OTCBB: RBCC) joint venture target Amarantus BioSciences (OTCBB: AMBS) recently announced the company will seek orphan drug designation from the FDA for MANF, the therapeutic protein developed to treat Parkinson’s disease and traumatic brain injuries.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals, has been named an Ernst & Young National Entrepreneur Of The Year 2012 Life Science Finalist. Ernst & Young’s Entrepreneur Of The Year is the country’s most prestigious business award for entrepreneurs.
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) (SPI) and Abbott (NYSE: ABT) today announced the availability of AMITIZA® (lubiprostone) in Japan, a prescription medicine for the treatment of chronic constipation not caused by organic diseases. AMITIZA was approved by the Ministry of Health, Labor and Welfare (MHLW) in Japan in June.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) announced today that interim results of the Phase 2b portion of the GALAXY program will be presented on November 28, 2012 at 12:15 p.m. (JST) during the “Highlights of Oral Presentations” session at the Fifth Asia Pacific Lung Cancer Conference (APLCC 2012) in Fukuoka City, Japan.
Tikcro Technologies Ltd. (OTC PK: TIKRF) today announced that its Annual General Meeting of Shareholders will be held on December 26, 2012 at 3:00 p.m. Israel time, at the law offices of Goldfarb Seligman & Co., Electra Tower, 98 Yigal Allon Street, Tel Aviv, Israel.
UnitedHealth Group (NYSE: UNH) will host its annual Investor Conference with analysts and institutional investors in New York City on Tuesday, November 27, 2012, beginning at 8:00 a.m. EST.
WPCS International Incorporated (NASDAQ: WPCS), a leader in design-build engineering services for communications infrastructure, has announced that it has received approximately $5.6 million in new contracts.
XTL Biopharmaceuticals Ltd. (TASE: XTL) (OTC: XTLBY) (the "Company"), a biopharmaceutical development company, announced on November 21st that it has acquired 4,620,356 shares, of Proteologics Ltd. (TASE: PRTL) (hereinafter: "the Shares" and "Proteologics", respectively), from Teva Pharmaceutical Industries Ltd. (NYSE: TEVA, TASE: TEVA) (hereinafter: "Teva") in consideration for an amount of approximately NIS 6.5 million, which represents an amount of NIS 1.405 per Share (approximately 22% premium).
Zurvita Holdings, Inc. (OTCQB: ZRVT) ("Zurvita" or the "Company"), a dynamic direct-to-consumer network marketing company, announced today that it continues its record monthly revenue growth and reached over $2,086,000 in revenues for the month ended September 30, 2012 and $2,260,000 for the month ended October 31, 2012.