|FDA Says Pfizer's Chantix Increased CVE Risk Not Significant; Eli Lilly Discusses Solanezumab|
|By Staff and Wire Reports|
|Wednesday, 12 December 2012 20:43|
The FDA is informing the public about the results of a large, combined analysis (called a meta-analysis) of clinical trials that compared patients who received the smoking cessation drug Chantix (varenicline) to patients who received a placebo (an inactive treatment).
FDA required the manufacturer of Pfizer's (NYSE:PFE) Chantix to conduct the meta-analysis to further evaluate the cardiovascular safety of the drug, and believes it is important to let health care professionals and patients know about the results of this study. FDA first notified the public about a possible increased risk of cardiovascular adverse events with Chantix in its June 2011 Drug Safety Communication (DSC)3.
Eli Lilly and Company (NYSE: LLY) provided an update on the next steps planned for solanezumab, its Phase 3 monoclonal antibody being studied as a potential therapy for patients with mild Alzheimer's disease. Following discussions with regulators in the U.S., Europe and Canada, Lilly plans to conduct an additional Phase 3 study of solanezumab in patients with mild Alzheimer's disease. Additional details, including study design and length, are still being determined. Lilly expects to initiate this study no later than Q3 2013.
Based on recent meetings with the U.S. FDA, Lilly does not intend to submit a Biologics License Application (BLA) at this time in the U.S. based solely on the existing analyses of data from the EXPEDITION studies. Lilly will continue to analyze and discuss the data from the two, Phase 3, double-blind, placebo-controlled solanezumab EXPEDITION studies with regulators globally to determine the regulatory paths forward in different regions. It is possible that different courses of action could be taken in different jurisdictions.
Independent analyses of the Phase 3 solanezumab EXPEDITION data were conducted by the Alzheimer's Disease Cooperative Study (ADCS), an academic research consortium, and presented at the annual meeting of the American Neurological Association (ANA) on Oct. 8, 2012, and at the Clinical Trial on Alzheimer's Disease (CTAD) meeting on Oct. 29, 2012.
Accelr8 Technology Corporation (NYSE MKT: AXK) announced today that its common stock has been approved by The NASDAQ Stock Market, LLC for listing on the NASDAQ Capital Market.
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for atrial fibrillation and other cardiovascular diseases, today announced that the paper "Effect of Bucindolol (Gencaro) on Heart Failure Outcomes and Heart Rate Response in Patients with Reduced Ejection Fraction Heart Failure and Atrial Fibrillation” was published in the European Journal of Heart Failure (www.escardio.org/journals/european-journal-heart-failure), a publication of the Heart Failure Association of the European Society of Cardiology.
ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, announced that it will present at the Oppenheimer 23rd Annual Healthcare Conference later today, Wednesday, December 12, 2012, at 3:55 p.m. Eastern Time at The Waldorf=Astoria Hotel in New York City.
AmerisourceBergen Corporation (NYSE: ABC) today will reaffirm its previous fiscal year 2013 guidance at its Investor Day Meeting in New York City. The Company is hosting a webcast of the meeting today beginning at 12:30 pm Eastern Standard Time.
Aradigm Corporation (OTCBB:ARDM) (the “Company”) today announced that it has entered into a definitive agreement for the sale of common stock to two existing shareholders, including accounts managed by First Eagle Investment Management, LLC, in a private placement for aggregate gross proceeds of $6 million.
Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today reported financial results for the three and twelve months ended September 30, 2012.
Biogen Idec (NASDAQ: BIIB) and Eisai Inc. today announced a strategic alliance that will bolster the manufacturing capabilities of both companies’ Research Triangle Park (RTP)-based facilities.
Capital Group Holdings, Inc. (OTCQB: CGHC) announced its consolidated results of operations for the quarter ending September 30th, 2012. While Capital Group's subsidiary acquired Alliance Urgent Care on September 3rd, 2012, the pro forma results include the activities of Alliance Urgent Care (Alliance) for the entire quarter.
CDEX Inc. (OTCQB: CDEX), a leading developer of chemical detection products using patented technologies for use in healthcare, safety and security markets, today announced the company secured an order for 10 units of its ValiMed™ CCT drug validation system from Al-Essa Medical & Scientific Equipment Company in Safat, Kuwait.
Charles River Laboratories International, Inc. (NYSE: CRL) today provided guidance for 2013 and reaffirmed guidance for 2012.
Covidien plc (NYSE: COV) will report first-quarter results on January 25, 2013, before trading begins.
EastBridge Investment Group Corporation (OTCQB: EBIG), a provider of financial consulting services to companies in Asia ("EastBridge") today announced management teams of EastBridge and Cellular BioMedicine Group Corp have attended an investor conference held in New York city on Dec 04, 2012, organized by SeeThruEquity.
Elan Corporation, plc (NYSE: ELN) announces that, at an Extraordinary General Meeting (EGM) held earlier today, the sole ordinary resolution to approve the demerger of the Prothena Business was duly passed.
Gilead Sciences, Inc. (Nasdaq: GILD) and YM BioSciences Inc. (NYSE MKT: YMI, TSX: YM) announced today that the companies have signed a definitive agreement under which Gilead will acquire YM for U.S.$2.95 per share in cash.
GlobalWise Investments, Inc. (OTCBB: GWIV) (OTCQB: GWIV) (www.GlobalWiseInvestments.com) and its wholly owned subsidiary Intellinetics, Inc., a leading-edge technology company focused on the design, implementation and management of cloud-based Enterprise Content Management ("ECM") systems in both the public and private sectors, today provide an update on the successful Sycle.net (http://web.sycle.net/) clinic expansion growth and ongoing annuity stream billing of the eDocs cloud based software into 215 audiology clinics nationwide.
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced changes to its Board of Directors.
Medical Marijuana, Inc. (OTC: MJNA), a leading hemp industry innovator, is pleased to update its shareholders on the status of its portfolio company, PhytoSPHERE Systems, LLC and product applications for it's 2013 harvest.
MediSwipe Inc. (OTCQB: MWIP), a merchant payment solutions and financial security products company for the medical health care industry, today announced that the company has unveiled plans to offer the first digital patient records solution specifically targeting the medical marijuana dispensary marketplace.
Metabolix, Inc. (NASDAQ: MBLX), an innovation-driven bioscience company focused on delivering sustainable solutions for plastics, chemicals and energy, today announced that it has entered into an agreement with Kenmare Srl., a packaging solutions supplier based in Milan, Italy and Lugano, Switzerland.
Northwest Biotherapeutics, Inc. (Nasdaq: NWBO; NWBOW), a biotechnology company developing DCVax® personalized immune therapies for cancer, announced the full exercise of the over-allotment option granted to the underwriters to purchase an additional 450,000 shares of common stock and warrants to purchase 225,000 shares, at a public offering price of $4.00 per share and $0.01 per warrant in connection with its previously announced underwritten public offering of 3,000,000 shares of common stock and warrants to purchase 1,500,000 shares of common stock, bringing total gross proceeds from the offering to $13.8 million.
Novation Holdings (OTCBB:ALZM) today announced that it has acquired Burgoyne Internet Services, LLC, a profitable Internet service provider based in Utah.
OphthaliX Inc.(OTCBB: OPLI) today announced that it has appointed Dr. Gil Ben-Menachem as Chief Executive Officer effective January 1, 2013.
Stevia First Corp. (OTCQB: STVF) ("Stevia First" or the "Company"), an early-stage agribusiness based in California's Central Valley growing region and focused on the industrial scale production of stevia, the all-natural zero-calorie sweetener that is rapidly transforming the food and beverage industry, is pleased to announce its determination to act in concert with USDA-funded researchers by providing plant material, logistical support, and sites for ongoing stevia field trials.
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that it has received approval of an sNDA for RESCULA® (unoprostone isopropyl ophthalmic solution) 0.15% for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension from the U.S. Food and Drug Administration (FDA).
UV Flu Technologies, Inc. (OTCBB: UVFT) (the "Company") is pleased to announce plans for a 2013 rollout for its patented FDA Cleared Viratech 400 and RX Air units.
Venaxis, Inc. (Nasdaq: APPY), formerly AspenBio Pharma, an in vitro diagnostic company, today announced it has changed its corporate name after receiving approval from its shareholders at a Special Meeting of Shareholders held on December 11, 2012.
VisualMED Clinical Solutions Corp. (PINKSHEETS: VMCS) (FRANKFURT: VA6) and Intelaform, Inc. ("Intelaform") announce an expansion of their Maryland transitional care initiative to include the District of Columbia by forming the National Capital Region Hospital Readmission Reduction Consortium ("NCR Consortium").