|BIOLASE Wins FDA Clearance for 940nm Diolase 10; Seattle Genetics Starts Two Phase I Trials of SGN-CD19A|
|By Staff and Wire Reports|
|Wednesday, 06 February 2013 20:47|
BIOLASE, Inc. (NASDAQ: BIOL), the world's leading manufacturer and distributor of dental lasers, announced the U.S. FDA has cleared the 940nm Diolase 10 diode soft tissue laser for use in 19 additional medical markets including: ear, nose and throat, oral surgery, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, GI/GU, gynecology, neurosurgery, ophthalmology, pulmonary surgery, cardiac surgery, thoracic surgery, urology, dermatology, aesthetics, and vascular surgery. This FDA clearance includes over 80 different procedures.
BIOLASE's diode lasers are used in dentistry for surgical soft tissue procedures as an alternative to invasive and traumatic conventional devices, such as the high-speed drill, scalpel or electrosurge. The 940nm wavelength is better absorbed by hemoglobin (Hb) and oxyhemoglobin (HbO2) than other diode laser wavelengths(1), so it cuts efficiently at low power and with considerably less heat and discomfort, making it an excellent alternative to conventional surgical devices. BIOLASE's 940nm wavelength is also FDA cleared for tooth whitening and temporary pain relief in a number of BIOLASE products.
Seattle Genetics, Inc. (Nasdaq: SGEN) announced the initiation of two phase I clinical trials of SGN-CD19A, one for patients with B-cell acute lymphoblastic leukemia (ALL) and one for patients with B-cell non-Hodgkin lymphomas. SGN-CD19A utilizes Seattle Genetics' industry-leading antibody-drug conjugate (ADC) technology. The trials are designed to assess the safety and antitumor activity of SGN-CD19A, an ADC targeted to CD19.
“CD19 is expressed in a variety of hematologic malignancies, including non-Hodgkin lymphoma and ALL, and has limited expression on normal tissues making it an ideal ADC target. Our preclinical data indicate that SGN-CD19A internalizes rapidly into tumor cells, resulting in targeted cell killing,” said Jonathan Drachman, M.D., Senior Vice President, Research and Translational Medicine at Seattle Genetics. “Our SGN-CD19A clinical development program comprises two trials that, together, will provide a robust understanding of the activity and tolerability of this ADC in patients with aggressive CD19-positive lymphomas or ALL. In addition to the five ADCs already in ongoing clinical trials, we plan to advance two additional ADC programs into the clinic during 2013, underscoring our leadership in the field.”
The studies are phase I, open-label, dose-escalation clinical trials. The primary endpoints are to estimate the maximum tolerated dose and to evaluate the safety of SGN-CD19A. In addition, the trials will evaluate antitumor activity, pharmacokinetics, progression-free survival and overall survival. One trial will enroll adult and pediatric patients with relapsed or refractory B-cell ALL, as well as patients with Burkitt lymphoma or leukemia or B-cell lymphoblastic lymphoma. The dose escalation portion of the study is designed to evaluate both weekly and every three week schedules and will enroll approximately 80 patients at multiple centers in the United States. A second trial will enroll patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma. The dose escalation portion of the trial will evaluate SGN-CD19A administered every three weeks and will enroll approximately 25 patients at multiple centers in the United States.
Both trials permit additional patients to be enrolled into expansion cohorts following determination of the maximum tolerated dose.
Actinium Pharmaceuticals, Inc. (OTC BB: CTVN) a biopharmaceutical company that develops innovative alpha particle immunotherapeutics, is pleased to announce that Mr. Jack Talley, Actinium's President & CEO will be presenting at the 15th Annual BIO CEO & Investor Conference on Monday, February 11th at 10:15 AM EST.
Biogen Idec Inc. (NASDAQ: BIIB) today announced the company has agreed to purchase Elan’s interest in TYSABRI (natalizumab) and upon closing will gain full strategic, commercial and decision-making rights to TYSABRI.
Cadence Pharmaceuticals, Inc. (NASDAQ: CADX), a biopharmaceutical company focused on acquiring, in-licensing, developing and commercializing proprietary products principally for use in the hospital setting, announced today that the company's President and CEO Ted Schroeder will present the company's corporate overview on Wednesday, February 13, 2013 at 3:30pm Eastern Time (12:30pm Pacific Time) during the Leerink Swann Global Healthcare Conference at the Waldorf Astoria Hotel in New York City.
Cambrex Corporation (NYSE: CBM) reports results for the fourth quarter and full year ended December 31, 2012.
Covidien plc (NYSE: COV) today announced the initial filing by Mallinckrodt plc of a Form 10 Registration Statement with the U.S. Securities and Exchange Commission (SEC) in connection with Covidien’s previously announced plan to spin off its Pharmaceuticals business.
Digirad Corporation (NASDAQ: DRAD), a leading provider of diagnostic imaging products, and personnel and equipment leasing services, today announced that it received U.S. FDA 510(k) market clearance to further expand the clinical flexibility of the ergo™ Imaging System for applications throughout the hospital, including the areas of nuclear medicine, surgery and women's health.
EasyMed Services, Inc. (CNSX:EZM) (OTCBB:EMYSF) today announced that following up on an investor event presentation hosted by the Company in Toronto on January 24, the presentation provided at the event has been made available on the Company's website.
eHealth, Inc. (NASDAQ: EHTH) (eHealthInsurance.com), America's first and largest private online health insurance exchange, released tips to help American consumers -- insured and uninsured alike -- understand their coverage options and responsibilities this year.
EasyMed Services, Inc. (CNSX:EZM) (PINKSHEETS:EMYSF) (MUN:EY6) is pleased to announce that it has entered into a commercial agreement with Geneva-based GKAN Holdings SA ("GKAN") to target new customers.
InspireMD, Inc. (OTC: NSPRD) announced financial results for the period ended Dec. 31, 2012, the second quarter of its 2013 fiscal year.
Medifocus, Inc. (OTCQX: MDFZF), (TSX VENTURE: MFS) (Medifocus or the Company), a commercial stage, revenue producing biotechnology company focused on the use of focused microwave for the development and commercialization of minimally invasive systems for the treatment of cancerous and benign tumors, is pleased to announce the launch of its new website, available at www.medifocusinc.com.
MyMedicalRecords, Inc. ("MMR"), a wholly owned subsidiary of MMRGlobal, Inc. (OTCQB: MMRF), today announced the filing of a complaint for patent infringement against Walgreen Co.
MWI Veterinary Supply, Inc. (NASDAQ: MWIV) (the "Company") announced financial results today for its first quarter ended December 31, 2012.
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that Tim Coughlin, Chief Financial Officer of Neurocrine Biosciences, will be presenting at the Leerink Swann Global Healthcare Conference 2013 in New York City.
NewLink Genetics Corporation (NASDAQ: NLNK), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that the underwriters of its recently announced public offering of 4,000,000 shares of common stock have exercised in full their option to purchase an additional 600,000 shares.
Pfizer Inc. (NYSE: PFE) today announced that its former animal health business unit, now a standalone company named ZoetisTM, began trading on the New York Stock Exchange under the ticker symbol “ZTS.”
Rockwell Medical (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, announced successful topline results from the PRIME clinical study of Soluble Ferric Pyrophosphate (SFP), its investigational iron-delivery drug currently in Phase 3 clinical studies for the treatment of iron deficiency in hemodialysis patients.
Sangamo BioSciences, Inc. (Nasdaq: SGMO) today reported fourth quarter and full year 2012 financial results and accomplishments.
Star Nutrition, Inc. (PINKSHEETS: STAU), a California-based diversified health and wellness industry firm, announces that they will be exhibiting at ISPO Munich where they will display their latest Incrediwear products, including the new Shredder line created with snowboarding pioneer Terje Haakonsen.
Stellar Biotechnologies, Inc. (OTCQB: SBOTF) (TSX VENTURE: KLH) today announced that the Company has submitted a provisional application for a patent to the U.S. Patent and Trademark Office for new innovations related to Stellar's Keyhole Limpet Hemocyanin ("KLH")-based combinatorial adjuvant technology.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today enrollment of the first patient in the MODERATO study – a Phase IV clinical study designed to evaluate the effect of AZILECT® (rasagiline tablets) on cognitive function in adults with mild cognitive impairment (MCI) in Parkinson's disease (PD-MCI).
Unilife Corporation (NASDAQ: UNIS; ASX: UNS) announced today that it intends to release its financial results for the fiscal 2013 second quarter ended December 31, 2012 after market trading ends on Monday, February 11, 2013.
VentriPoint Diagnostics (TSX VENTURE:VPT) (OTCQX:VPTDF) announced today that it has submitted to the U.S. Food and Drug Administration (FDA), for 510(k) clearance, the first 2D-ultrasound right-heart analysis system in patients with Pulmonary Arterial Hypertension (PAH).
Verenium Corporation (Nasdaq: VRNM), a leading industrial biotechnology company focused on the development and commercialization of high-performance enzymes, today announced the commercial launch of Pyrolase® HT cellulase, a next-generation cellulase enzyme for use as a biocatalyst to break down the guar-based gel used in hydraulic fracturing.
VIASPACE, Inc. (OTCQB: VSPC) today announced that Chairman, Dr. Kevin Schewe and CEO, Dr. Carl Kukkonen, together attended the 16th Annual Energy, Utility and Environment Conference (EUEC) held in Phoenix, Arizona from Monday, January 28 through Wednesday, January 30, 2013.