|RxNews Recap for Wednesday 03-10-10. Oculus surges on FDA approval. Vanda jumps on upgrade, buyout talk.|
|By BioMedReports.com Staff|
|Wednesday, 10 March 2010 20:17|
Oculus Innovative Sciences, Inc. (Nasdaq: OCLS), as reported here earlier today on BioMedReports, announced that it has received new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for new dermatology indications for Microcyn® Skin and Wound HydroGel. The Rx product, under the supervision of a healthcare professional, Microcyn Skin and Wound HydroGel is intended for management of wounds including itch and pain relief associated with dermal irritation, sores, injuries and ulcers of dermal tissue. Shares soared on the news...reaching as high as $3.20 on the day and finally settling at $2.69, up 88 cents or 48.62%.
Vanda Pharmaceuticals (NASDAQ:VNDA) shares shot up 11.30% or $1.17 to $11.52 after an analyst issued an upgrade along with a report that the company may be a takeover target of Novartis AG (NYSE: NVS). Hapoalim initiated coverage of the stock with an "Outperform" rating and said in a note that the takeover was contingent on the performance of the company's schizophrenia drug, Fanapt. Shares continued to trade higher in the after hours market Wednesday.
News after hours:
Clarient, Inc. (Nasdaq:CLRT), a premier anatomic pathology and molecular testing services resource for pathologists, oncologists and the biopharmaceutical industry, today reported financial results for the fourth quarter and year ended December 31, 2009. Fourth quarter 2009 net revenue was $23.3 million, compared to $21.9 million for the same period in 2008. Net revenue for the full year was $91.6 million, a 24 percent increase over the $73.7 million earned in 2008 and in line with Clarient's revised guidance issued in the third quarter of 2009. Test volume in the 2009 fourth quarter increased to approximately 242,000, a 16 percent increase from the same period in 2008. Test volume for all of 2009 grew by 20 percent to 943,000 from test volume of 786,000 in the prior year. Clarient's customer base of oncology and pathology practices in the U.S. increased by 43 new customers in the fourth quarter, taking Clarient's active customer base to over 1,125 and reflecting a better than 98 percent customer retention rate.
Scientists using advanced genomic analysis technologies from Life Technologies Corporation (NASDAQ: LIFE) have sequenced an individual’s genome and identified the specific causative mutation associated with Charcot-Marie-Tooth Disease (CMT), one of the most common inherited neurological disorders currently affecting 1 in 2,500 individuals in the United States..
Metabolix, Inc. (NASDAQ: MBLX), a bioscience company focused on developing sustainable solutions for plastics, chemicals and energy, today reported financial results for the three months and full year ended December 31, 2009. The Company reported a net loss of $9.8 million or $0.39 per share for the fourth quarter of 2009 as compared to a net loss of $8.9 million or $0.40 per share for the fourth quarter of 2008. For the full year, the Company reported a net loss of $38.0 million or $1.62 per share as compared to a net loss of $36.0 million or $1.58 per share for 2008.
Orthovita, Inc. (NASDAQ: VITA) a specialty spine and orthopedic company with a portfolio of orthobiologic and biosurgery products, reported financial results for the quarter and year ended December 31, 2009. Product sales for the quarter ended December 31, 2009 increased 17% to $24.4 million, compared to $20.8 million for the same period in 2008. Product sales for the year ended December 31, 2009 increased 21% to $92.9 million, compared to $76.9 million for 2008. The 2009 fourth quarter and full year results included U.S. sales of $700,000 and $1.1 million, respectively, of Cortoss™, the Company’s novel synthetic biomaterial that was cleared by the FDA in June 2009 for the treatment of vertebral compression fractures, and AliquotTM, the Company’s Cortoss delivery device.
News from earlier in the day:
Abbott (NYSE:ABT) announced today it has received U.S. Food and Drug Administration approval for the TECNIS® Multifocal 1-Piece intraocular lens (IOL) for cataract patients with and without presbyopia.
Intraocular lenses are implanted in a patient's eye after the removal of the natural lens that has become clouded by a cataract. Conventional monofocal IOLs are designed to focus primarily at one distance and do not correct presbyopia, an age-related change in vision that occurs when the eye's natural lens can no longer adjust its focal length to allow clear vision at different distances.
Affymax, Inc. (Nasdaq: AFFY) today announced that it has received a $5 million development milestone payment from Takeda Pharmaceutical Company as part of the companies’ exclusive global agreement to develop and commercialize Hematide™, Affymax’s investigational drug for the treatment of anemia in chronic renal failure patients. The milestone was achieved with the initiation of Phase 3 clinical testing of Hematide to treat anemia in chronic renal failure patients in Japan.
AspenBio Pharma, Inc. (NASDAQ:APPY), an emerging bio-science company dedicated to the development of novel diagnostics and drugs for humans and animals, announced that it has entered into a strategic manufacturing relationship with BBInternational ("BBI") to complete commercial development and manufacture of the AppyScore™ consumable test cassette.
BBI is a leading OEM provider of lateral flow tests and provides reagents, development services, and contract manufacturing for rapid diagnostic tests for the point-of-care markets.
"BBI has provided us with valuable expertise in advancing our ELISA test to a state of the art quantitative lateral flow format," said Daryl J. Faulkner, Chief Executive Officer of AspenBio Pharma. "Combined with our recently announced alliance with LRE, we now have the major pieces in place for high-volume production of our AppyScore Test and can expand our options for commercialization of this important diagnostic tool."
CEL-SCI Corporation (NYSE Amex: CVM) announced today that it has received a $125,000 payment from Byron Biopharma under its licensing agreement where CEL-SCI granted Byron an exclusive license to market and distribute the Company's cancer drug Multikine® in the Republic of South Africa. CEL-SCI already has existing licensing agreements for Multikine with Teva Pharmaceuticals of Israel and Orient Europharma of Taiwan in other countries. CEL-SCI plans to keep the European and US marketing rights for the Multikine head and neck cancer indication in-house.
China Medicine Corporation (OTC Bulletin Board:CHME.OB) a leading distributor and a developer of Western pharmaceuticals, traditional Chinese medicines, and other nutriceuticals, announced today that the the Company has received comments from Nasdaq's Listing Qualifications Department in response to its application for listing its common stock on the NASDAQ Global Market. China Medicine submitted the application earlier this year, following the board of directors' approval of the Company's uplisting.
Cumberland Pharmaceuticals Inc. (Nasdaq:CPIX), a specialty pharmaceutical company focused on the hospital acute care and gastroenterology markets, today announced full year 2009 financial results.
"The approval and launch of Caldolor and our initial public offering made 2009 a pivotal year for Cumberland," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "We are pleased to report that we achieved our objectives of remaining profitable and cash flow positive during the Caldolor launch, and that our balance sheet is now the strongest in the history of the Company."
Cytokinetics, Incorporated (NASDAQ:CYTK) announced today that its fast skeletal muscle troponin activator, CK-2017357, has been granted orphan-drug designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of amyotrophic lateral sclerosis (ALS), also commonly known as Lou Gehrig's Disease. CK-2017357 is the lead drug candidate that has emerged from the company's skeletal sarcomere activator program. Cytokinetics plans to initiate a Phase II Evidence of Effect clinical trial for CK-2017357 in ALS patients in the first half of 2010.
QLT Inc. (Nasdaq:QLTI) (TSX:QLT) today announced results from Phase II clinical trials and a device study for the punctal plug delivery system (PPDS). These studies are part of a development program that is being conducted by QLT's wholly-owned subsidiary, QLT Plug Delivery, Inc. QLT also announced its plans to expand the program to evaluate a second drug for a new target indication. The company today also reported financial results for the fourth quarter ended December 31, 2009 and full year 2009 as well as issued its guidance for 2010.
RTI Biologics Inc. (RTI) (Nasdaq: RTIX), the Florida-based processor of orthopedic, dental, surgical specialties and other biologic implants, is launching two new biologic implants for use in sports medicine surgeries at the American Academy of Orthopaedic Surgeons (AAOS) annual meeting in New Orleans this week. BTB Select®, an innovative allograft that provides precision sized tendons for ACL reconstruction, and BioCAP Select™, a composite allograft plug for customized bone void filling, will be introduced at the RTI Biologics exhibit during the AAOS meeting.
Uroplasty, Inc. (NYSE:Amex: UPI), a medical device company that develops, manufactures and markets innovative proprietary products to treat voiding dysfunctions, today announced the introduction of a newly designed endoscopic injection needle that can be used in conjunction with the system used to inject Macroplastique®. Macroplastique is a soft-tissue urethral bulking agent used to treat adult female stress urinary incontinence primarily due to intrinsic sphincter deficiency. This permanent, nonresorbable material is injected into the tissues surrounding the urethra to help improve urethral closure to enhance bladder control.
Watson Pharmaceuticals, Inc. (NYSE:WPI), today announced that it has reached a settlement agreement with Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals North America resolving outstanding patent litigation related to Watson's generic equivalent version of Actos® (Pioglitazone Hydrochloride) 15mg, 30mg and 45mg tablets. Under terms of the agreement, Takeda granted Watson a non-exclusive royalty free license to its U.S. patents covering Actos®. Under the terms of the agreement, Watson is permitted to launch its generic equivalent version of Actos® on August 17, 2012, or earlier under certain circumstances.
3SBio Inc. (Nasdaq: SSRX), a leading biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China, today announced changes to its board of directors (the "Board").
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