|Mayo Clinic Selects Complete Genomics; Chelsea Therapeutics CEO to Review NORTHERA(TM) NDA|
|By Staff and Wire Reports|
|Monday, 13 February 2012 19:48|
Complete Genomics Inc. (NASDAQ:GNOM) announced it has been selected by Mayo Clinic's Center for Individualized Medicine to provide outsourced whole human genome sequencing. Mayo Clinic researchers will now be able to employ Complete Genomics' sequencing service for some of its large-scale whole genome sequencing projects.
The Center for Individualized Medicine operates a comprehensive sequencing laboratory in its own Medical Genome Facility, but it determined that collaboration with Complete Genomics could supplement the services available to its community of medical researchers. Under the terms of the agreement, Mayo Clinic can send genetic material to Complete Genomics for sequencing and analysis. It will continue to operate and invest in its Medical Genome Facility. Financial details of the agreement were not disclosed.
"Mayo Clinic, through the Center for Individualized Medicine, already has several high-impact genome- and epigenome-based studies underway in individualized care for our patients," said Gianrico Farrugia, M.D., director of Mayo Clinic's Center for Individualized Medicine. "Access to quality whole genome sequencing services can only expedite our efforts to improve care for all of our patients with new individualized medicine tools and techniques."
"It is exciting to see a world-renowned healthcare organization like Mayo Clinic take the next step towards bringing high-quality whole genome sequencing data into the clinic. They clearly recognize its potential to personalize treatment options and improve the future quality of patient care," said Leroy Hood, M.D., Ph.D., president of the Institute for Systems Biology and a member of Complete Genomics' Scientific Advisory Board. "This is a big step toward the realization of personalized medicine."
"For well over a century, Mayo Clinic has been an innovator and leader in translating cutting-edge clinical research into world-class patient care and treatment," said Clifford Reid, Ph.D., chairman, president and CEO of Complete Genomics. "We are honored to be partnering with Mayo Clinic researchers to provide sequencing and analysis for their genomic studies and investigations."
Projects will be coordinated with the Center of Individualized Medicine's Medical Genome Facility and will help expedite Mayo Clinic's translational genomics-based programs. Through these initiatives, Mayo Clinic will develop best practices for using genetic information to guide patient care.
Mayo's effort is part of a growing trend in medicine to collect and analyze the genetic information from consenting patients to optimize medical care in a variety of disciplines, including cancer diagnosis and treatment, drug therapy, disease prevention, and many others. This information could also be used by doctors to advise patients about lifestyle changes that could help prevent or delay disease onset.
Chelsea Therapeutics International, Ltd. (NASDAQ:CHTP) announced during a presentation at the 14th Annual BIO CEO and Investor Conference president and CEO, Dr. Simon Pedder, plans to provide an update regarding the company's New Drug Application (NDA) for NORTHERA(TM) (droxidopa), an overview of key issues identified in the FDA briefing document received by the company and anticipated discussion points for the upcoming Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting scheduled for February 23rd.
FDA is currently reviewing Chelsea's application for marketing approval of Northera, an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (Neurogenic OH) in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy. Under the Prescription Drug User Fee Act IV (PDUFA), FDA's goal is to review and act on the NDA by March 28, 2012
"In light of recent communications with FDA, including receipt of a briefing document for our upcoming advisory committee meeting, we wanted to take this opportunity to update our shareholders on several lines of inquiry that have emerged as significant components of the benefit-risk analysis of Northera," commented Dr. Pedder. "A number of these questions relate to previously discussed issues identified for our development program, namely the short duration of our clinical studies, the limited size of our study population given the orphan indication and the challenges in quantifying symptomatic and clinical benefit. FDA has, however, placed increased emphasis on safety data from our long-term extension program and the post-marketing surveillance program in Japan. We look forward to the opportunity to address these questions in depth during the advisory committee meeting and to continuing to work with FDA to address any additional questions they may have regarding Northera and our clinical program."
During his presentation, Dr. Pedder plans to review key clinical portions of the Northera NDA filing, including combined safety and efficacy data from Chelsea's two completed Phase 3 efficacy studies in NOH (Studies 301 and 302), two long-term open-label extension studies, a dedicated thorough QTc study, and a 24-hour ambulatory blood pressure monitoring safety study.
Dr. Pedder also plans to provide an update on key issues identified in the FDA briefing document that Chelsea received in advance of the advisory committee meeting, including:
Clinical Endpoints in Neurogenic OH: The Orthostatic Hypotension Questionnaire Composite Score vs. The Orthostatic Hypotension Symptom Assessment Item #1 (Dizziness)
Neurogenic OH has historically been assessed on the basis of an improvement in standing systolic blood pressure (SBP). However, because the correlation between standing SBP and symptom relief has not been adequately demonstrated in any clinical trial, FDA advised us in 2007 that demonstrating improvement in standing SBP would not provide sufficient evidence of efficacy to support US marketing approval.
As a result, Chelsea assessed Northera's therapeutic effect using the orthostatic hypotension questionnaire (OHQ), the only validated patient reported outcome measure specifically designed to rate the severity of symptoms resulting from low blood pressure and the degree those symptoms interfere with a patient's ability to perform activities of daily living. Chelsea believes that demonstrating improvement on this questionnaire would permit a claim of symptomatic and functional improvement in patients with Neurogenic OH.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that Jane Wasman, J.D. has been named Chief, Strategic Development. In this new role, Ms. Wasman will oversee the development and execution of the Company’s long-range strategic plans and objectives.
Advanced Cell Technology, Inc. (OTCBB: ACTC), a leader in the field of regenerative medicine, announced today the dosing of third patient in its Phase 1/2 trial for Stargardt’s macular dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).
AeroGrow International, Inc. (PINKSHEETS: AERO) ("AeroGrow" or the "Company"), makers of the AeroGarden® line of indoor gardening products, announced results for the quarter ended December 31, 2011. The December quarter is the third quarter of AeroGrow's fiscal year.
Agilent Technologies Inc. (NYSE:A) today announced its microarrays were used in a landmark research study on prenatal samples.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today announced that it has commenced an underwritten public offering of 7,000,000 shares of its common stock. All of these shares are being sold by Alnylam.
AmerisourceBergen Corporation (NYSE: ABC) today announced that Michael D. DiCandilo, the Company's Executive Vice President and Chief Financial Officer, has left the Company to pursue other interests, effective immediately.
Angeion Corporation (NASDAQ: ANGN) announced today that Todd M. Austin has been named to the newly created position of Executive Vice President – Global Marketing and Corporate Strategy effective immediately.
AxoGen, Inc. (OTCBB: AXGN), an emerging regenerative medicine company focused on the commercialization of proprietary products and technologies for peripheral nerve reconstruction and regeneration, today announced Jill Schiaparelli will be joining as its Senior Vice President of Business Strategy and Marketing.
Baxter International Inc. (NYSE: BAX) announced today that it will host its 2012 Investor Conference on Tuesday, October 9, 2012 at the Ritz-Carlton Hotel in Chicago, IL.
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that Stephen M. Simes, BioSante’s president & CEO will present a corporate update at the BIO CEO & Investor Conference on Tuesday, February 14, 2012 at 10:30 am EST in New York City.
BSD Medical Corporation (NASDAQ:BSDM) (Company or BSD) (www.BSDMedical.com), a leading provider of medical systems that utilize heat therapy to treat cancer, announced the addition of Thomas J. Sobba as U.S. National Sales Manager for the MicroThermX® Microwave Ablation System (MicroThermX®) line of products.
Bristol-Myers Squibb Company (NYSE: BMY) announced today the successful completion of the tender offer by Bristol-Myers Squibb Company (“Bristol-Myers”) for all of the outstanding shares of common stock of Inhibitex, Inc. (NASDAQ: INHX) (“Inhibitex”) at a purchase price of $26.00 per share.
Catalyst Health Solutions, Inc., (NASDAQ: CHSI) today announced that AARP has selected Catalyst Rx as its new member benefit provider, responsible for providing millions of AARP members with access to discounts on their prescriptions.
Charles River Laboratories International, Inc. (NYSE: CRL) today reported its results for the fourth-quarter and full-year 2011. For the quarter, net sales from continuing operations were $291.0 million, an increase of 3.3% from $281.7 million in the fourth quarter of 2010.
Columbia Laboratories, Inc. (Nasdaq: CBRX), and Watson Pharmaceuticals, Inc. (NYSE: WPI), today announced that Columbia has transferred the new drug application for progesterone vaginal gel 8% for use in the reduction of risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy (NDA 22-139) to Watson.
Fresh Start Private Management Inc. (OTCBB: CEYY), a leader in alcohol treatment and rehabilitation, is pleased to announce that it has completed the sale of a licensing agreement with Glacier Holdings, LLC, (Glacier) for the rights to Florida.
GTx, Inc. (NASDAQ: GTXI) today announced that it will host a conference call and webcast to provide a corporate update and discuss the Company's fourth quarter and full year 2011 financial results on Wednesday, February 22 at 9:00 a.m. Eastern.
InSite Vision Incorporated (OTCBB:INSV) announced today that it will report financial results for the fourth quarter and year ended December 31, 2011 on Tuesday, February 28, 2012.
Insulet Corporation (NASDAQ: PODD), the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, today announced the Company will participate in the Leerink Swann Global Healthcare Conference 2012 at the Waldorf Astoria in New York City.
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) (the “Company”) today announced that the underwriters of its previously announced public offering of Class A common stock have exercised their option to purchase an additional 787,500 shares at a public offering price of $15.09 per share.
MedPro Safety Products, Inc. (OTCBB: MPSP), a leading developer of transformational technologies that enable safer medication delivery and blood collection, announced the results of a survey of 497 pharmacy professionals conducted at the American Society of Health System Pharmacists Mid-Year Clinical Meeting in December 2011.
Medtronic, Inc. (NYSE: MDT) announced today the start of two clinical initiatives evaluating the broader, real-world clinical use of the company’s Symplicity™ renal denervation system across multiple conditions.
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved ZIOPTANTM (tafluprost ophthalmic solution) 0.0015%, the first preservative-free prostaglandin analog ophthalmic solution. ZIOPTAN (pronounced zye-OP-tan) is approved for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension.
mPhase Technologies, Inc. (OTCBB: XDSL) announced today that it is in continuing negotiations with a Private Equity group to invest capital in the Company that would exceed its current capitalized value in the public equity markets.
NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that its President, Dr. Anil Diwan, will present an overview of the company at the 14th Annual BIO CEO and Investor Conference.
NHS Health Solutions, Inc. (PINKSHEETS: NHSH) is pleased to announce that its wholly owned subsidiary Mineseeker Operations Overseas Limited ("Mineseeker" or "Company"), a British Virgin Islands corporation, has formally engaged with a South African company to deploy Mineseeker technology, MIR™, across the Southern African Development Community (SADC).
Florida-based nutraceutical company, Oragenics, Inc. (OTCBB: ORNI), announced today that Chief Executive Officer, John N. Bonfiglio, Ph.D., will be presenting at the BIO CEO & Investor Conference held in New York at the Waldorf Astoria Hotel on February 13th and 14th.
OncoSec Medical Incorporated (OTCBB: ONCS), which is developing its advanced-stage OncoSec Medical System (OMS) ElectroOncology therapies to treat solid tumor cancers, today announced that physicians at the University of Washington and Seattle Cancer Care Alliance in conjunction with the Fred Hutchinson Cancer Center, have treated several patients in an open-label Phase II clinical trial evaluating OncoSec's OMS ElectroImmunotherapy for the treatment of Merkel cell carcinoma (MCC).
Pacific Biosciences of California, Inc. (NASDAQ: PACB), provider of Single Molecule Real Time (SMRT®) sequencing products, today announced it has released a major upgrade to its PacBio® RS system, referred to as “C2”, including new chemistry, enhanced SMRT Cells and upgraded software, which together provide customers with significant performance increases for DNA sequencing.
Remedent, Inc. (OTCBB: REMI), an international company specializing in research, development, and the manufacturing of oral care and cosmetic products, announced today the closing of a strategic financing with IDG-Accel China Growth Fund III L.P. ("IDG-Accel Fund"), IDG-Accel China III Investors L.P. ("IDG-Accel Investors Fund"), Crown Link Group Limited ("Crown Link") (IDG-Accel Fund, IDG-Accel Investors Fund and Crown Link collectively referred to as the "IDG-Accel Investors") and GlamSmile Dental Technologies Ltd. ("GlamSmile Asia"), an entity in which Remedent owns approximately 29%.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Company will report fourth quarter and full year 2011 financial results following the close of the U.S. financial markets on Monday, February 27, 2012.
Seattle Genetics, Inc. (NASDAQ:SGEN) today reported financial results for the fourth quarter and year ended December 31, 2011.
Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, today announced that its board of directors has voted to distribute an ongoing quarterly cash dividend of $0.05 per share to its shareholders beginning with the current fiscal year.
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Vertex will webcast its presentation at the Leerink Swann 2012 Global Healthcare Conference on Thursday, February 16, 2012 at 2:00 p.m. EST, at Citi’s 2012 Global Health Care Conference on Tuesday, February 28, 2012 at 2:00 p.m. EST and at the 2012 RBC Global Healthcare Conference on Wednesday, February 29, 2012 at 10:00 a.m. EST.
ZYTO Corp (OTCBB: ZYTC) (www.ZYTO.com), today ZYTO Corp, a Utah-based company specializing in biocommunication applications, announced plans for its 7th Annual Conference to be held May 4-5, 2012 in Salt Lake City, Utah.