Below is a list of the companies that made news in the healthcare sector on Tuesday, July 27, 2010.
Antigenics (NASDAQ: AGEN) announced positive results with AG-707, an investigational therapeutic vaccine being developed to treat herpes simplex virus-2 (HSV-2), the virus that causes genital herpes, in infected patients. Developed by Antigenics, the vaccine triggers a cellular immune response, stimulating both CD4 and CD8 T-Cells.
"I believe these data represent the first finding of their kind in genital herpes treatments—showing a vaccine, AG-707, elicits both CD4+ and CD8+ T-cell responses in humans," said David Koelle, M.D., study investigator and professor of Medicine, Laboratory Medicine and Global Health Medicine, University of Washington. "We are very encouraged by these results. Recent data suggest both of these arms of immunity are needed for successful treatment of genital herpes."
Shares of Antigenics jumped more than 15% on the news, closing the day at 91 cents.
Exact Sciences Corp (Nasdaq: EXAS) and OncoMethylome Sciences S.A. (Brussels: ONCOB) today announced that they have entered into a license agreement under which Exact Sciences has obtained exclusive, worldwide rights to up to two OncoMethylome Sciences’ DNA methylation biomarkers for use in stool-based detection of colorectal cancer. Exact Sciences has also gained non-exclusive access to part of OncoMethylome’s platform technology. In return, OncoMethylome will receive milestone payments and royalties on net sales.
DNA methylation regulates gene expression, and multiple scientific studies have shown that methylation markers are clinically relevant markers for colorectal cancer. In cancers and pre-cancers, methylation biomarkers are typically present more frequently than individual DNA mutation biomarkers, and as a result, fewer methylation markers are required to detect most cancers and pre-cancers.
Exact Sciences gained 23 cents or 6.22% on the news.
ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board:ACCP.ob), a biopharmaceutical company specializing in products for cancer and supportive care, today announced its e-marketing partner, iMedicor (OTC Bulletin Board:VMCI.ob) commenced the initial phase of a multi-channel marketing program for MuGard. iMedicor's two-pronged marketing approach involves leveraging its direct sales channel through Direct Medical Solutions (DMS) and its online pharma marketing portal to further support Access' ongoing commercial launch efforts for its lead product. The initial phase of the marketing program for MuGard includes a targeted sampling program to DMS' physician network.
Antares Pharma, Inc. (NYSE Amex:AIS) announced today positive results from its Phase 3 study of Anturol Gel in patients with overactive bladder (OAB). The study met its primary endpoint of a statistically significant reduction in urinary incontinence episodes for both doses studied. An Open Label Extension study, evaluating long term safety remains ongoing and is scheduled to complete by Q4 2010.
Cytori Therapeutics (NASDAQ: CYTX) received expanded European approval (CE Mark) for its Celution® System, a medical device that extracts and separates stem and regenerative cells from a patient’s own fat tissue. The new indications include key medical applications such as breast reconstruction, repair of soft tissue defects, as well as the facilitation of healing certain types of wounds, such as those resulting from Crohn’s disease. This broadens Cytori’s ability to offer the Celution® System to patients and hospitals and further supports the company’s efforts to gain treatment reimbursement.
Hologic, Inc. (Nasdaq:HOLX), a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced that the Company's Selenia Dimensions three-dimensional (3-D) digital mammography tomosynthesis system has been scheduled to be reviewed by the Radiological Devices Panel of the U.S. Food and Drug Administration on September 24, 2010 as part of the Company's pre-market approval ("PMA") application. The PMA application being reviewed was originally filed in 2008 and subsequently updated with additional data, and seeks approval of the use of the system for both screening and diagnostics. In addition, the Company is conducting a number of additional clinical trials for a separate FDA submission expected to be filed at a later date. Hologic's 3-D imaging technology, "Selenia Dimensions," is available commercially in more than a dozen countries, including countries in Europe, the Middle East, South America, Asia and Australia. In North America, commercial Selenia Dimensions systems are installed in Canada and Mexico. In the United States, Selenia Dimensions is currently available as a two dimensional (2-D) only system that is upgradeable to do breast tomosynthesis (3-D) imaging when and if the product is approved by the FDA.
Shares rose 8.75% or $1.21 on the news.
Natus Medical Incorporated (Nasdaq:BABY) today announced that it has received a significant purchase order from the Kingdom of Saudi Arabia for the Company’s newborn care products.
The order, which is valued at over $2.7 million, was received from the Company’s distribution partner working with the Saudi Ministry of Health. The order is for ALGO newborn hearing screeners, Cool-Cap selective head-cooling devices, and Olympic Cerebral Function Monitors (CFM). The order is expected to ship by the end of the year.
Affymax, Inc. (Nasdaq: AFFY) today announced that Paul Cleveland, the company's chief financial officer and executive vice president, Corporate Development, will present at the BMO Capital Markets 10th Annual Focus on Healthcare Conference on Thursday, August 5, 2010 at 9:00 a.m. ET (6:00 a.m. PT).
Antares Pharma, Inc. (NYSE Amex:AIS) announced today positive results from its Phase 3 study of AnturolTM Gel in patients with overactive bladder (OAB).
AVANIR Pharmaceuticals, Inc. (Nasdaq: AVNR) today announced that the Company will present at the Wedbush Securities Life Sciences Best Ideas Management Access Conference on Tuesday, August 3rd at 3:35 p.m. Eastern time (12:35 p.m. Pacific time) at the Le Parker Meridien Hotel in New York.
Caraco Pharmaceutical Laboratories, Ltd. (NYSE Amex: CPD) recorded net sales of $130.0 million during the first quarter of Fiscal 2011 compared to $48.1 million during the first quarter of Fiscal 2010.
China BCT Pharmacy Group, Inc., (OTC Bulletin Board: CNBI), ("China BCT" or the "Company"), a leading pharmaceutical distributor, retail pharmacy, and manufacturer of pharmaceutical products in Guangxi Province, China, today announced that the Financial Industry Regulatory Authority (FINRA) confirmed the Company's new corporate name, China BCT Pharmacy Group, Inc., effective July 22, 2010.
Compugen Ltd. (NASDAQ: CGEN) today reported its results for the second quarter ending June 30, 2010.
Covidien (NYSE: COV), a leading global provider of healthcare products, today announced the completion of its tender offer through its subsidiary, Covidien DE Corp., to purchase all of the outstanding common shares of Somanetics Corporation.
Dynavax Technologies Corporation (NASDAQ: DVAX) today reported completing enrollment andthe first immunizations of 39 subjects enrolled in its Phase 1 study of the company's Universal Flu vaccine.Safety and immunogenicity data from this study are anticipated in the fourth quarter of this year.
Genzyme Corp. (NASDAQ: GENZ) today said it welcomed the Centers for Medicare and Medicaid Services’ (CMS) decision not to include oral medications without IV equivalents in Medicare’s End Stage Renal Disease (ESRD) patient benefit.
Hologic, Inc. (Hologic or the Company) (Nasdaq: HOLX), a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced that the Company's Selenia Dimensions three-dimensional (3-D) digital mammography tomosynthesis system has been scheduled to be reviewed by the Radiological Devices Panel (Panel) of the U.S. Food and Drug Administration (FDA) on September 24, 2010 as part of the Company's pre-market approval ("PMA") application.
ImageXpres Corporation (PINKSHEETS: IMJX) today announced that its Surg-i-Scan™ "digital" Surgical Safety Checklist system has been approved by Apple Corporation and is now available as an Apple software "app" via the Apple iTunes Online Store.
Luminex Corporation (Nasdaq: LMNX), the worldwide leader in multiplexed solutions, today announced the global launch of MAGPIX®, an analytical instrument that is capable of performing up to 50 tests on a single sample and providing nearly 5,000 data points in under an hour.
MabCure, Inc. (OTC Bulletin Board: MBCI) today announced that a confirmatory study demonstrated the company's proprietary monoclonal antibodies (MAbs) successfully identified ovarian cancer in blood (94 percent accuracy) and with no false positives or cross-reactions with benign ovarian tumors or healthy blood.
Marina Biotech, Inc. (NASDAQ: MRNAD) (formerly known as MDRNA, Inc.) and Dr. Pirjo Laakkonen at the University of Helsinki Biomedicum in Finland today announced the extension of their collaboration to identify novel peptides with preferential homing-like properties which allow the peptides to target specific tissues, including tumors.
OmniComm Systems, Inc. (OTC: OMCM), a global provider of eClinical solutions and services announced its results of operations for the first half of fiscal 2010.
Obagi Medical Products, Inc. (Nasdaq:OMPI), a leader in topical aesthetic and therapeutic skin health systems, today announced that its second quarter 2010 financial results will be released after the market close on Thursday, August 5, and will be followed by an investor conference call on the same day at 4:30 p.m. Eastern time (1:30 p.m. Pacific time).
PPD, Inc. (Nasdaq: PPDI) and Microsoft Corp. (Nasdaq: MSFT) today announced they have entered into an agreement to jointly implement an innovative technology so ution designed to improve efficiency in managing U.S. Food and Drug Administration-mandated Risk Evaluation and Mitigation Strategy (REMS) programs.
Protectus Medical Devices, Inc. (OTCQB: PTMD), which designs, engineers, and manufactures safety needle devices to protect healthcare workers from accidental needlestick injuries, reports that Synergistic Medical Network, LLC is expanding its ongoing pre-launch marketing campaign for the Protectus Safety Syringe, the Company's 510(k) cleared, patented, self-sheathing, hypodermic safety syringe.
Response Biomedical Corporation (TSX: RBM, OTCBB: RPBIF)announced that at the Company’s Special General Shareholders’ Meeting held today in Vancouver, shareholders approved the private placement of an aggregate of 13,333,333 common shares (the "Offered Shares"), at a price of Cdn. $0.60 per Offered Share, to Caduceus Private Investments III, LP, OrbiMed Associates III, LP and Caduceus Asia Partners, LP (the "Purchasers") for gross proceeds of approximately Cdn. $8 million.
Seattle Genetics, Inc. (Nasdaq: SGEN) today reported financial results for the second quarter and six months ended June 30, 2010. The company also highlighted recent product development activities and upcoming milestones.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today reported results for the quarter ended June 30, 2010.
Unigene Laboratories, Inc. (OTCBB: UGNE) will release financial results for the quarter ended June 30, 2010, after the market closes on Monday, August 9, 2010.
XenoPort, Inc. (Nasdaq:XNPT) announced today that it will release its second quarter financial results on August 5, 2010 at approximately 4:30 p.m. Eastern T me. The company will host a conference call at 5:00 p.m. Eastern Time that same day. A replay of the call will be available for one week following the event.
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