|Exact Announces Date for FDA Advisory Committee Meeting; Ambit Provides Regulatory Update Regarding Quizartinib|
|By Staff and Wire Reports|
|Tuesday, 03 December 2013 20:44|
Exact Sciences Corp. (Nasdaq: EXAS) announced U.S. FDA's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is tentatively scheduled to review the premarket approval application (PMA) for the company's Cologuard stool-DNA-based, non-invasive colorectal cancer screening test on March 26, 2014. The date and details of the meeting are subject to confirmation by the FDA in a Federal Register notice.
Exact submitted the final module of its PMA for Cologuard on June 7, 2013. The application includes data from the company's 10,000-patient, 90-site DeeP-C pivotal trial, one of the most extensive colorectal cancer screening studies ever conducted in the United States.
“We look forward to discussing with the panel members the DeeP-C clinical trial results and the value of colorectal cancer screening with Cologuard,” said Kevin T. Conroy, Exact's president and CEO. “The scheduling of this advisory panel meeting marks another milestone in bringing Cologuard to market.”
Ambit Biosciences (Nasdaq: AMBI), a biopharmaceutical company focused on discovery and development of drugs targeting unmet needs in oncology, autoimmune and inflammatory disease, announced a regulatory update after receiving feedback from the U.S. FDA on the development of quizartinib (AC220), the Company's lead drug candidate, for the treatment of relapsed/refractory acute myeloid leukemia (AML).
Based on feedback from the FDA, the Company continues to move forward with its baseline plan to conduct a randomized, controlled Phase 3 clinical trial in relapsed/refractory FLT3-ITD positive AML patients with an overall survival endpoint as the basis for the potential initial approval of quizartinib. The Company is continuing to work with the FDA to refine the appropriate starting dose for the Phase 3 trial.
The Company has been in dialogue with the FDA related to acceptance of a novel surrogate endpoint that could support accelerated approval based upon the results of the Company's Phase 2 and Phase 2b trials. The FDA informed the Company it does not agree that complete remission with incomplete hematologic recovery (CRi) represents a surrogate endpoint reasonably likely to predict clinical benefit.
Based on the FDA's current position, the Company does not plan at this time to submit a NDA for accelerated approval of quizartinib based on the Phase 2 and 2b clinical trial data.
ActiveCare, Inc. (OTCBB:ACAR), a leader in diabetes management and wellness services, announced today that it has retained DelMorgan & Co., an internationally recognized investment banking firm, as its financial advisor to advise ActiveCare on its strategic alternatives, including growth capital investments, possible acquisitions or divestitures, joint ventures or other strategic alliances, and other initiatives to deliver shareholder value.
Ambit Biosciences (Nasdaq: AMBI), a biopharmaceutical company focused on discovery and development of drugs targeting unmet needs in oncology, autoimmune and inflammatory disease, today announced a regulatory update after receiving feedback from the U.S. Food and Drug Administration (FDA) on the development of quizartinib (AC220), the Company's lead drug candidate, for the treatment of relapsed/refractory acute myeloid leukemia (AML).
Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to neurodegeneration and apoptosis, today announced that it has entered into an exclusive option agreement with the University of Miami to license the Bascom Palmer Eye Institute's method of use intellectual property surrounding the use of MANF and CDNF for the treatment of retinal diseases.
Baxano Surgical, Inc. (Nasdaq:BAXS), a medical device company focused on designing, developing and marketing minimally invasive products to treat degenerative conditions of the spine affecting the lumbar region, today announced the execution of a comprehensive financing that includes securing a credit facility of up to $15.0 million with Hercules Technology Growth Capital, Inc. (NYSE:HTGC) and entering into a stock purchase agreement for up to $7.0 million with Lincoln Park Capital Fund, LLC.
CAS Medical Systems, Inc. (Nasdaq:CASM), a leader in medical devices for non-invasive patient monitoring, today announced that the worldwide installed base of its FORE-SIGHT Cerebral Oximeters surpassed 900 in November.
Celldex Therapeutics, Inc. (Nasdaq:CLDX) today announced that it is offering 6.5 million shares of its common stock in a proposed underwritten public offering.
ChemoCentryx, Inc., (Nasdaq:CCXI), today announced positive top-line data from the first two steps of a Phase II trial with CCX168, an inhibitor targeting the chemoattractant receptor known as C5aR, in anti-neutrophil cytoplasmic antibody (ANCA)-associated renal vasculitis (AARV). AARV is a serious autoimmune disease causing inflammation of the smaller blood vessels.
Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care (POC) diagnostic tests for infectious diseases, announces that Lawrence A. Siebert, Chief Executive Officer, will present at the LD Micro VI: The Main Event Conference to be held December 3 – 5, 2013 in Los Angeles, CA.
Cleveland BioLabs, Inc. (Nasdaq:CBLI) today announced that the Company is scheduled to present at the Oppenheimer & Co. 24th Annual Healthcare Conference, December 10-11, in New York, NY.
Emergent Health Corp. (Pink Sheets:EMGE) is pleased to announce today there exists an agreement of sale executed on November 12, 2013 by its controlling shareholder for the Company control to be passed on to another controlling shareholder group, Clover Capital and Parcae Capital Corp.
Endologix, Inc. (Nasdaq:ELGX) today announced that it intends, subject to market and other conditions, to offer $75 million aggregate principal amount of convertible senior notes due 2018 (the "Convertible Notes") in an offering registered under the Securities Act of 1933, as amended.
Enzymotec Ltd. (Nasdaq:ENZY), a developer, manufacturer and marketer of innovative bio-active lipid ingredients, announced today the acceptance for future publication of its clinical study results evaluating the health benefits of K-REAL™, krill oil, compared with fish oil.
Health Enhancement Products, Inc. (OTCQB: HEPI), which investigates and licenses algae-derived, high-value bioactive molecules that benefit human and animal health, has expanded and upgraded its corporate website and that of its wellness testing subsidiary, WellMetris LLC.
Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that the Company will present at the Oppenheimer 24th Annual Healthcare Conference on Tuesday, December 10th at 10:20 a.m. Eastern Time at Crowne Plaza Times Square Hotel in New York City.
Landauer, Inc. (NYSE: LDR), a recognized leader in personal and environmental radiation measurement and monitoring, outsourced medical physics services and high quality medical consumable accessories, announced today that its Board of Directors declared, at its meeting on December 3, 2013, a regular quarterly cash dividend of $0.55 per share for the first quarter of fiscal 2014.
Lightlake Therapeutics Inc. (OTC BB: LLTP), a biopharmaceutical company developing addiction treatments based on its expertise in opioid antagonists, has announced that the initial findings of its clinical trial with the National Institute on Drug Abuse, part of the National Institutes of Health, supports Lightlake's intranasal delivery of naloxone as a promising innovative treatment for opioid overdose.
Medical Marijuana, Inc. (OTC Pink:MJNA) is pleased to inform shareholders and the general public that HempMedsPX™ — a corporate portfolio company of Medical Marijuana, Inc. and the exclusive master distributor and contracted marketing company for CannaVest Corp. and Medical Marijuana, Inc. — represented CBD Simple by PhytoSPHERE Systems — a CannaVest Corp. brand — at the 2013 High Times Cannabis Cup competition in Amsterdam and accepted the Cannabis Cup award for Highest CBD Concentrate.
MRI Interventions, Inc. (OTCQB:MRIC) today announced the presentation of clinical data demonstrating the precision of MRI-guided delivery of the investigational gene therapy Toca 511 to high grade gliomas using the company's ClearPoint® Neuro Intervention System as the delivery platform.
NeoStem, Inc. (Nasdaq:NBS), and its subsidiary, Progenitor Cell Therapy, LLC, announced the expansion of PCT's relationship with ImmunoCellular Therapeutics, Ltd. (NYSE MKT:IMUC), a clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers, for current good manufacturing practices (cGMP) and development services for ImmunoCellular's dendritic cell-based vaccines. PCT currently manufactures ICT-121, a dendritic cell vaccine targeting CD133 cells, in a Phase 1 clinical trial for recurrent glioblastoma multiforme (GBM) pursuant to a Services Agreement between the companies.
Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB) announces that it acquired securities of its subsidiary Acasti Pharma Inc. in connection with the closing of Acasti's US$23 million public offering of units, which closed today and pursuant to which 18.4 million Units were issued.
OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED) and Celgene Corporation (Nasdaq:CELG) today announced an agreement to jointly develop and commercialize up to six anti-cancer stem cell (CSC) product candidates from OncoMed's biologics pipeline, including demcizumab (OMP-21M18, Anti-DLL4).
Orgenesis, Inc. (OTCQB: ORGS), a development-stage company with a novel regenerative medicine technology that converts a diabetes patient's liver cells into functioning insulin-producing cells, has been invited to present at the 2013 World Stem Cell Summit on Wednesday, December 4, 2013 at the Manchester Grand Hyatt in San Diego.
Pacific Biosciences of California, Inc. (Nasdaq:PACB), provider of the PacBio® RS II DNA Sequencing System, today announced it is collaborating with the Wellcome Trust Sanger Institute and Public Health England to complete the sequences of 3,000 bacterial genome strains from PHE's National Collection of Type Cultures (NCTC).
Portola Pharmaceuticals, Inc. (Nasdaq:PTLA) today announced two upcoming data presentations at the 55th American Society of Hematology (ASH) Annual Meeting and Exposition, which is being held in New Orleans from December 7-10. The Company also will webcast an investor briefing during the ASH Annual Meeting.
Premier, Inc. (Nasdaq:PINC) has added seven new members to its Bundled Payment Collaborative, which now includes 17 healthcare provider systems with more than 45 hospitals across the nation.
Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today that Dr. David Aviezer, the Company's President and Chief Executive Officer, will present at Oppenheimer's 24th Annual Healthcare Conference on Wednesday, December 11, 2013 at 10:05 AM ET.
Vanda Pharmaceuticals Inc. (NASDAQ: VNDA), a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders, today announced that it will deliver a corporate presentation at the 25th Annual Piper Jaffray Healthcare Conference in New York City on Wednesday, December 4, 2013 at 11:30 a.m. Eastern Time.
Zogenix, Inc. (Nasdaq:ZGNX) and Battelle today announced that they have entered into a new long-term collaborative agreement regarding co-marketing of Zogenix's DosePro®