Below is a list of the companies that made news in the healthcare sector on Monday, July 26, 2010.
Onyx Pharmaceuticals, Inc. (Nasdaq:ONXX) today announced positive top-line results from the Phase 2b 003-A1 study of single-agent carfilzomib, a selective, next generation proteasome inhibitor, in patients with relapsed and refractory multiple myeloma. In an independent review of the data, carfilzomib achieved an overall response rate (partial response or greater) of 24 percent and a median duration of response of 7.4 months in patients who entered the study after receiving a median of five prior lines of therapy (corresponding to a median of 13 anti-myeloma agents) and whose disease was refractory to their last therapeutic regimen. The clinical benefit rate (minimal response or greater) in the study population was 36 percent. Carfilzomib was well-tolerated and there were no new or unexpected toxicities observed. Full results of the trial will be presented at an upcoming scientific meeting. Based on these results, Onyx is continuing discussions with the U.S. Food and Drug Administration (FDA) regarding next steps in filing a new drug application (NDA) for carfilzomib, which the company expects to submit by year-end 2010 for potential accelerated approval in the U.S.
The company reported that patients in the trial had been treated with other drugs including thalidomide and J&J's drug Velcade. Those therapies showed patients had experienced little tumor shrinkage, or had their tumors progress during treatment or within 60 days of the end of their most recent round of treatment.
Shares of Onyx gained $4.54 or 21% to close the day at $26.04.
Abviva, Inc. (Pink Sheets:ABVV.pk), a biomedical company engaged in the development and commercialization of breast cancer-related applications of Mammastatin, announced that the Canadian Patent Office issued notice that it will be issuing patent application Number 2.267.095 within 12 weeks.
The Mammastatin technology continues to increase its protection as evidenced by the granting of patents around its core technology. In recent months, the Japanese Patent Office issued two patents on the Mammastatin technology, and the Canadian patent will help protect the technology when it begins international expansion.
Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board:ADLS.ob), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced that the Company has entered into a sponsored research and option agreement with The University of British Columbia (UBC) to develop several antimicrobial peptides.
Affymetrix, Inc. (NASDAQ:AFFX) today announced that it has released an unparalleled data set based on extensive validation of novel SNPs from the 1000 Genomes Project. This data will give researchers access to more rare mutations for genome-wide association studies and will enable the rapid design of custom arrays for a variety of applications, including the validation of sequencing results.
Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) today announced that it has entered into an agreement to sell, subject to customary closing conditions, $4.06 million of securities to an accredited investor in a private offering.
Gen-Probe Incorporated (Nasdaq:GPRO) announced after the bell Monday that the U.S. Food and Drug Administration (FDA) has cleared for marketing Prodesse's ProFAST + assay, making it the only FDA-cleared molecular diagnostic test to simultaneously detect and differentiate three common influenza A virus subtypes – seasonal A/H1, seasonal A/H3, and 2009 H1N1.
"FDA clearance of our ProFAST+ assay is important for public health, as the test enables physicians to accurately differentiate among influenza A subtypes that have different antiviral susceptibilities," said Carl Hull, Gen-Probe's president and CEO. "In addition, the ProFAST+ clearance kicks off what we believe will be an important new revenue growth cycle for Gen-Probe, as its 510(k) was the first of four U.S. regulatory applications that we expect to submit before year-end."
Hop-on, Inc. (Pinksheets:HPNN) announced today that it signed a Letter of Intent to acquire USAcig. USAcig is the premier US-based Electronic Cigarette Manufacturer. Jay Pignatello, President of Hop-on, stated, "Hop-on is diversifying its business model to acquire fully operational businesses to bring revenue to its bottom line."
XenaCare Holdings, Inc. (OTC.BB:XCHO), a company specializing in the branding, marketing and retail distribution of consumer healthcare products, announced today its upcoming Cobroxin advertising campaign to begin on July 28, 2010. The campaign is designed to support the rapidly growing network of retailers carrying Cobroxin, an over-the-counter (OTC) pain reliever clinically proven to treat moderate to severe (Stage 2) chronic pain. Shares were up more than 62% on the news.
XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced receipt of a $750,000 milestone payment under its collaboration with AVEO Pharmaceuticals, Inc. (Nasdaq:AVEO). The milestone payment resulted from AVEO's recent initiation of a Phase 2 clinical trial to evaluate its AV-299 antibody for the treatment of non-small cell lung cancer. AV-299 is a humanized antibody to hepatocyte growth factor (HGF).
Abviva, Inc. (Pink Sheets: ABVV), a biomedical company engaged in the development and commercialization of breast cancer-related applications of Mammastatin, announced that the Canadian Patent Office issued notice that it will be issuing patent application Number 2.267.095 within 12 weeks.
Alcon, Inc. (NYSE:ACL) reported that global sales rose 12.5 percent to $1.89 billion for the second quarter of 2010, or 11.3 percent excluding the impact of foreign exchange fluctuations and acquisitions.
BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI), a leading developer of adult stem cell technologies and therapeutics, today announced that it h s retained MD Becker Partners LLC, a boutique management and strategy consulting firm focusing on both public and private companies in the life sciences industry.
Biomagnetics Diagnostics Corp., (PINK SHEETS:BMGP) a developer of revolutionary diagnostic systems and other innovative technologies, today provided pdates on corporate activities.
Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a multinational manufacturer and distributor of life science research and clinical diagnostic products, today announced that it has submitted a Premarket Approval application to the U.S. Food and Drug Administration for its fourth-generation HIV assay, the GS HIV Combo Ag/Ab EIA (enzyme immunoassay).
Cellceutix Corporation (OTCBB: CTIX) is p eased to announce that it has selected Destum Partners to assist in finding a development partner for its psoriasis compound, KM-133.Cellceutix management has carefully evaluated which direction to take in the development of KM-133 and has concluded that this is the best way to create shareholder value.
Cytokinetics, Incorporated (NASDAQ:CYTK) announced today that the National Institute of Neurological Disorders and Stroke (NINDS) has awarded the company a grant in the amount of $2.9 million to support research and development of CK-2017357, a fast skeletal muscle troponin activator, directed to the potential treatment for myasthenia gravis.
Delcath Systems, Inc. (Nasdaq: DCTH) announced today that it will host a conference call to discuss its second quarter results and recent corporate developments on Thursday, July 29, 2010 at 4:30pm, ET. Eamonn Hobbs, President and Chief Executive Officer, and David McDonald, Chief Financial Officer, will host the call.
DK Sinopharma, Inc. (OTC Bulletin Board: DKSP) one of China’s leading manufacturers and distributors of prescription and over-the-counter pharmaceuticals and traditional Chinese medicines, is pleased to announce the launch of its new corporate website.
GenVec, Inc. (Nasdaq: GNVC) announced that research regarding GenVec's efforts to create novel vectors for vaccines is appearing in Vol. 28, issue 35, pages 5691-5702 of Vaccine.
Emerging Healthcare Solutions, Inc. (Pink Sheets:EHSI), Agriculture Under Secretary for Rural Development Dallas Tonsager announced late last week that the USDA will facilitate a virtual public discussion in the field of telemedicine.
Ferro Corporation (NYSE: FOE) today announced net sales of $543 million for the three months ended June 30, 2010, an increase of 36 percent from net sales of $399 million in the second quarter of 2009.
Geron Corporation (NASDAQ:GERN) will announce its financial results for the 2010 second quarter on Thursday, July 29, 2010, after the closing of the equity market.
Gilead Sciences, Inc. (Nasdaq:GILD) today announced its intention to offer, subject to market and other conditions, approximately $1.1 billion principal amount of convertible senior notes due 2014 and approximately $1.1 billion principal amount of convertible senior notes due 2016 to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended.
GTx, Inc. (NASDAQ: GTXI) today announced that it will host a conference call and webcast to discuss the Company's second quarter 2010 results on Monday, August 9 t 9:00 a.m. Eastern.
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today that President and Chief Executive Officer John L. Higgins will present at the BMO Capital Markets 10th Annual Focus on Healthcare Conference on Thursday, August 5, 2010, at 3:30 p.m. Eastern time (12:30 p.m. Pacific).
MannKind Corporation (Nasdaq:MNKD) will release its 2010 second quarter financial results on Monday, August 2, 2010.
Medical Marijuana Inc (PINKSHEETS: MJNA) announces that vendor space for the Health, Wellness and Cannabis Expo, to be held at the Silverdome in Michigan October 29-31 is now available.
NexMed, Inc. (Nasdaq: NEXM), backed by a revenue generating CRO business and seeking to leverage its proprietary, multi-route NexACT drug delivery technology and internal pipeline through out-licensing arrangements and partnerships, announced today that Mohamed Hachicha, Ph.D., has been appointed to the position of Vice President, Research and Development for NexMed USA, effective immediately.
Oncothyreon Inc. (Nasdaq: ONTY) will conduct a conference call to discuss its second quarter 2010 financial results on Thursday, August 5, 2010 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time).
Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, reported today that the U.S. Food and Drug Administration approved Orthovita's PMA supplement for a new collagen processing facility in Malvern, Pennsylvania.
Perrigo Company (Nasdaq: PRGO; TASE) today announced that it has received final approval from the U.S. Food and Drug Administration to manufacture and market over-the-counter (OTC) Cetirizine Cherry Syrup, 1mg/ml.
PetroAlgae Inc. (OTCBB: PALG), a leading renewable energy company that licenses its commercial micro-crop technology globally, today announced that it has signed through its operating subsidiary PA LLC, a Non-Binding Commercial Offtake Agreement (the "Agreement") with Eco-Frontier, a leading cleantech management firm and Asian renewable energy developer based in Seoul, Korea.
QRxPharma (ASX: QRX and Pink Sheets: QRXPY) reported today positive outcomes of its European Scientific Advice meetings on the development and registration of MoxDuo IR, an immediate release Dual-Opioid pain therapy.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Company will report second quarter 2010 financial results following the close of the U.S. financial markets on Monday, August 9, 2010.
Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, today announced that it will release second quarter 2010 financial results after market close on Monday, August 2, 2010.
SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN) today announced that it plans to report second quarter 2010 financial results on Monday, August 9, 2010.
SuperGen, Inc. (Nasdaq: SUPG), a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, today announced that it will release its 2010 second quarter financial results on Monday, August 2, 2010.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that it will release its second-quarter 2010 financial results after the market closes on Monday, August 9, 2010.
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, will highlight its innovative offering of products and services for clinical research and specialty diagnostics during the American Association for Clinical Chemistry (AACC) Annual Meeting and Clinical Lab Expo held in Anaheim, California, July 25 - 29, 2010.
VirtualScopics, Inc. (Nasdaq: VSCP), a leading provider of quantitative imaging for clinical trials, announced today that before the market opens on Thursday, August 12, 2010 it will release its second quarter 2010 financial results.
XenoPort, Inc. (Nasdaq:XNPT) announced today that it will provide access via the World Wide Web to its presentation at the Wedbush Life Sciences Best Ideas Conference 2010.
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