|Talon Therapeutics' Marqibo Granted Accelerated Approval by FDA; FDA's ODAC to Review Exelixis NDA for Cabozantinib|
|By Staff and Wire Reports|
|Thursday, 09 August 2012 19:41|
Talon Therapeutics (OTC:TLON) announced Marqibo received accelerated approval from the U.S. Food and Drug Administration for the treatment of adult patients with Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies.
This indication is based on overall response rate. Clinical benefit such as improvement in overall survival has not been verified. Marqibo is administered at a dose of 2.25 mg/m2 intravenously over 1 hour once every 7 days. Marqibo has different dosage recommendations than non-liposomal vincristine sulfate.
After the close of market on August 8, 2012, Exelixis (NASDAQ: EXEL) was notified that the FDA's Oncologic Drugs Advisory Committee will review the Company's new drug application for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer.
The Company was notified that ODAC will review cabozantinib at its meeting tentatively scheduled for November 9, 2012. The Prescription Drug User Fee Act action date is November 29, 2012.
3SBio Inc. (NASDAQ: SSRX) ("3SBio" or "the Company"), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced changes to its board of directors.
Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, announced today that it has agreed to establish a treatment program that will provide HCV-infected individuals with expanded access to Hemopurifier® therapy.
ALR Technologies Inc. (OTCBB: ALRT) (the "Company"), a health information technology company, is pleased to provide shareholders with an update for its FDA-cleared Health-e-Connect System ("the System") for remote monitoring and chronic disease management.
BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® in the U.S. and XIAPEX® in Europe and Eurasia, today announced its financial results for the second quarter ended June 30, 2012 and provided a corporate update.
CytoSorbents Corporation (OTCBB: CTSO), a critical care focused company using blood purification to modulate the immune system, reduce severe inflammation, and prevent or treat organ failure caused by life-threatening illnesses, announced that it has been selected to give a 20 minute presentation on CytoSorb® at the Military Health System Research Symposium.
Cytori Therapeutics (NASDAQ: CYTX) has expanded the Celution® System CE Mark in Europe to include several new indications, including cryptoglandular fistula. Cryptoglandular fistula is the most common cause of perianal infection, abnormal fecal contamination and incontinence.
DHS Holding, Co. (PINKSHEETS: DHSM) President Charlie Barrett announces today that DHS Belize Limited, a wholly owned subsidiary of DHS Holding, Co. is submitting documentation to obtain the gaming license for the Cenote Falls Hotel & Casino in Belize.
First Choice Healthcare Solutions, Inc. (OTCBB: FCHS) ("FCHS"), a company developing and acquiring efficient multi-specialty medical centers, today reported financial results for the three and six months ended June 30, 2012.
GenVec, Inc. (NASDAQ: GNVC) announced financial results for the three months and six months ended June 30, 2012.
MMRGlobal, Inc. (OTCBB: MMRF) (MMR) today announced it will revitalize efforts to monetize the Company's significant patent portfolio related to Personal Health Records (PHRs) and biotech and has retained the law firm of Liner Grode Stein Yankelevitz Sunshine Regenstreif & Taylor LLP (Liner) to lead the effort.
Oncothyreon Inc. (NASDAQ: ONTY) today reported financial results for the second quarter ending June 30, 2012.
PharmAthene, Inc. (NYSE Amex: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced today that the Department of Defense (DoD) has elected to exercise its option to accelerate funding for PharmAthene's rBChE nerve agent medical countermeasure program contingent on the achievement of key milestone activities.
Pivotal Therapeutics Inc. (OTCQX:PVTTF) (CNSX:PVO), a specialty pharmaceutical company with a focus on cardiovascular health, is pleased to announce that data from a scientific study related to the company's product VASCAZEN™ concluded that highly purified Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA) with a 6:1 ratio caused potent endothelium-dependent relaxations of isolated blood vessels, relaxations superior to that of other pure EPA:DHA ratios (1:1) and only 100% EPA or only 100% DHA.
STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of implantable lenses for the eye, today announced that it will participate in the 32nd Annual Canaccord Growth Conference at the Intercontinental Hotel in Boston. STAAR's presentation will be on Wednesday, August 15, 2012 at 10:30 a.m. Eastern Time.
Sun Healthcare Group, Inc. (NASDAQ: SUNH) today announced that, in connection with the previously announced transaction with Genesis HealthCare, LLC, the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, expired on Aug. 8, 2012.
Yongye International, Inc. (NASDAQ: YONG), ("Yongye" or the "Company") a leading developer, manufacturer, and distributor of crop nutrient products in the People's Republic of China ("PRC"), today announced its financial results for the quarter ended June 30, 2012.