Date Set for Arbitration Trial between CEL-SCI and inVentiv; DARA Granted Waiver of Product and Establishment Fees Print E-mail
By David Fowler   
Tuesday, 06 January 2015 20:23
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 6, 2015.
CEL-SCI Corporation (NYSE MKT:CVM) announced the trial in its ongoing arbitration against inVentiv Clinical LLC (f/k/a PharmaNet LLC and PharmaNet GmbH (f/k/a PharmaNet AG)) a clinical research organization is currently scheduled for May 4 2015.

CEL-SCI initiated an arbitration claim against inVentiv in October 2013. CEL-SCI initially retained inVentiv to conduct the Phase III clinical trial of CEL-SCI's investigational drug Multikine* (Leukocyte Interleukin Injection). CEL-SCI terminated inVentiv in or about April 2013 and replaced inVentiv with new clinical research organizations. CEL-SCI's arbitration claim is initiated under the Commercial Rules of the American Arbitration Association alleging (i) breach of contract (ii) fraud in the inducement and (iii) common law fraud and seeks at least $50 million in damages.

About Multikine -- Multikine* (Leukocyte Interleukin Injection) is an investigational immunotherapeutic agent that is being tested in an open-label randomized controlled global pivotal Phase III clinical trial as a potential first-line treatment for advanced primary head and neck cancer. If approved for use following completion of CEL-SCI's clinical development program for head and neck cancer Multikine would be a different type of therapy in the fight against cancer; one that appears to have the potential to work with the body's natural immune system in the fight against tumors. CEL-SCI is aiming to complete enrollment of subjects to the Phase III head and neck cancer study by the end of 2015. The trial is expected to expand into a total of approximately 100 clinical centers in about 20 countries.

In October 2013 CEL-SCI announced that it had signed a CRADA (Cooperative Research and Development Agreement) with the US Naval Medical Center San Diego to develop Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts. CEL-SCI also announced that it entered into two new co-development agreements with Ergomed to further clinically develop Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.

About CEL-SCI Corporation -- CEL-SCI’s work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. Its lead investigational therapy Multikine (Leukocyte Interleukin Injection) is currently being studied in a pivotal Phase III clinical trial against head and neck cancer. If the study endpoint which is a 10% improvement in overall survival of the subjects treated with Multikine treatment regimen as compared to subjects treated with current standard of care only is satisfied the study results will be used to support applications which will be submitted to regulatory agencies in order to receive from these agencies commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine which are being investigated include cervical dysplasia in HIV/HPV co-infected women and the treatment of peri-anal warts in HIV/HPV co-infected men and women. A Phase I trial of the former indication has been completed at the University of Maryland. The latter indication is now in a Phase I trial in conjunction with the U.S. Navy under a CRADA (Cooperative Research and Development Agreement).


 
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DARA BioSciences, Inc. (NASDAQ: DARA)
, an oncology supportive care pharmaceutical company dedicated to providing healthcare professionals a synergistic portfolio of medicines to help cancer patients adhere to their therapy and manage side effects arising from their cancer treatment, announced it has been granted a "barrier-to-innovation" waiver for certain product and establishment fees.

The Food and Drug Administration (FDA) has granted DARA's request for a barrier-to-innovation waiver of the Fiscal Year 2012 product and establishment fees, Fiscal Year 2013 product fee, and Fiscal Year 2014 product and establishment fees for NDA, 21-807, Soltamox oral solution totaling approximately $1.1 million.

A waiver or reduction in PDUFA fees may be appropriate when (1) the product for which the waiver is being requested is innovative or the entity requesting the waiver is otherwise pursuing innovative drug products or technology, and (2) the fee would be a significant barrier to the entity's ability to develop, manufacture, or market innovative products or technology. Specifically, the FDA acknowledged DARA's development work surrounding its KRN5500 asset during the years relating to the waiver, and determined that the imposition of the fees during those years created a significant financial barrier to the Company. DARA has requested a similar waiver for 2015.

The FDA's Office of Financial Management (OFM) has been directed to refund the fees related to fiscal year 2012 already remitted by DARA in the amount of approximately $619 thousand, which should be processed and refunded within 30 days from the waiver being granted. The fees related to fiscal years 2013 and 2014 which have not been remitted total approximately $480 thousand.

The FDA plans to publicly disclose information about its actions granting or denying waivers and reductions, which will be consistent with the laws and regulations governing the disclosure of confidential commercial or financial information.



Also Tuesday:



Abiomed, Inc. (Nasdaq:ABMD)
announced today that on Tuesday, January 27, 2015, the Company will release financial results for the third quarter of fiscal 2015.

Agile Therapeutics, Inc. (Nasdaq:AGRX) a women's health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive products, announced today that Al Altomari, President and Chief Executive Officer will present at the Noble Financial Capital Markets' Eleventh Annual Equity Conference on Tuesday, January 20, 2015 at 3:00 PM Eastern Standard Time.

American CareSource Holdings (Nasdaq:ANCI)
, operator of urgent care centers and a national network of ancillary health care providers, announced today that its Virginia subsidiary has completed the purchase of substantially all the assets used in the operation of two urgent care centers located in northern Virginia.

Anavex Life Sciences Corp. (OTCQX:AVXL)
welcomes new data published in the current issue of the International Journal of Neuropsychopharmacology (IJNP) revealing that the sigma-1 receptor, the Company's drug target, interacts positively and directly with the cannabinoid receptor.

AngioDynamics (Nasdaq:ANGO)
, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced today that Joseph M. DeVivo, President and Chief Executive Officer, is scheduled to present at the J.P. Morgan Healthcare Conference on Wednesday, January 14, 2015, at 2:30 p.m. (PT).

Apricus Biosciences, Inc. (Nasdaq:APRI)
, a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced Richard Pascoe, Chief Executive Officer, will present at the Biotech Showcase 2015 Conference on Monday, January 12, 2015 at 3:30 p.m. Pacific Time.

Argos Therapeutics Inc. (Nasdaq:ARGS)
, a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases based on the Arcelis® technology platform, today announced a collaboration with Saint-Gobain's Performance Plastics division, a leader in high-performance components and solutions using engineered polymers.

Argos Therapeutics, Inc. (Nasdaq:ARGS)
, a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform, today announced that Jeff Abbey, president and chief executive officer, will present the Biotech Showcase™ 2015 Conference on Monday, January 12th, 2015 at 2:30 p.m. Pacific Time.

Cellular Biomedicine Group Inc. (Nasdaq:CBMG)
, a biomedicine firm engaged in the development of effective treatments for degenerative and cancerous diseases, today announced the initiation of patient recruitment to support a study of ReJoinTM human adipose derived mesenchymal progenitor cell (haMPC) therapy for Cartilage Damage (CD) resulting from osteoarthritis (OA) or sports injury.

Cerner Corporation (Nasdaq:CERN)
invites you to listen to the live broadcast of the company's presentation at the JP Morgan Healthcare Conference in San Francisco on Jan. 13, at 4:30 p.m. PST.

Chembio Diagnostics, Inc. (Nasdaq:CEMI)
, a leader in point-of-care (POC) diagnostic tests for infectious diseases, today announced that it has entered into an agreement with the Concussion Science Group (CSG) Division of Perseus Science Group LLC, to utilize Chembio's patented DPP® technology to develop a POC diagnostic test for traumatic brain injury (TBI), including sports-related concussion.

ChemoCentryx, Inc., (Nasdaq:CCXI)
, a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, today announced that Thomas J. Schall, Ph.D., President and Chief Executive Officer, will present at the 33rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2015, at 4:00 p.m. Pacific Time.

CombiMatrix Corporation (Nasdaq:CBMX)
, a molecular diagnostics company specializing in DNA-based testing services for pre- and postnatal developmental disorders, today announced that the Superior Court of the State of California, County of Orange (the "Court"), has issued a tentative ruling and proposed statement of decision (the "Proposed Statement of Decision") in the matter of the People of the State of California and Relator Michael Strathmann ("Plaintiff") vs. Acacia Research Corporation,

Coronado Biosciences, Inc. (Nasdaq:CNDO)
, founder of CB Pharma Acquisition Corp., reports on the separation of CB Pharma Acquisition Corp.'s (Nasdaq:CNLMU) securities into ordinary shares, rights and redeemable warrants, from the units.

Cutera, Inc. (Nasdaq:CUTR)
, a leading provider of laser, light and other energy-based aesthetic systems for practitioners worldwide, today announced several changes to the composition and structure of its Board of Directors.

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP)
, a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, today announced that the Company will present at the Biotech ShowcaseTM 2015 conference being held at Parc 55 Wyndham San Francisco – Union Square in San Francisco, California.

Ekso Bionics Holdings, Inc. (OTCQB:EKSO)
, a robotic exoskeleton company, announced today that their robotic technology expertise will be featured on two separate panels at the International Consumer Electronics Show (CES).

Emergent Health Corp. (Pink Sheets:EMGE)
announced today the appointment of Kevin Harrington, Founder of As Seen on TV, Inc. and original shark investor on ABC's hit show Shark Tank, to the Company's Board of Directors.

Richard E. Perlman, Executive Chairman and James K. Price, Chief Executive Officer of ExamWorks Group, Inc. (NYSE:EXAM), will present at the Needham Growth Conference, January 14th at 12:45 p.m.

Fate Therapeutics, Inc. (Nasdaq:FATE)
, a biopharmaceutical company engaged in the development of programmed cellular therapeutics for the treatment of severe, life-threatening diseases, today announced that Christian Weyer, M.D., M.A.S., President and Chief Executive Officer, will present an overview of the Company's programs at the 7th Annual Biotech Showcase conference on Monday, January 12, 2015 at 11:30 am PST in San Francisco, CA.

Foundation HealthCare (OTCQB:FDNH)
, which owns and operates surgically focused hospitals and related ancillary services, announced today that Mr. Stanton Nelson, CEO, will present a business overview and update at the OneMedForum investor conference on Tuesday, January 13, 2015 at 3:15 pm PST (6:15 pm EST).

iKang Healthcare Group, Inc. (Nasdaq:KANG)
, the largest provider in China's fast growing private preventive healthcare services market in terms of revenue in 2013, today announced that it will attend the 33rd Annual J.P.Morgan Healthcare Conference to be held on January 12th to 15th at the Westin St. Francis Hotel in San Francisco.

ICU Medical, Inc. (Nasdaq:ICUI)
, a leader in the development, manufacture and sale of innovative medical devices used in infusion therapy, oncology and critical care applications, today announced that Company management will be presenting at the 33rd Annual J.P. Morgan Healthcare Conference to be held on January 12-15, 2015, at the Westin St. Francis Hotel in San Francisco, CA.

Immunomedics, Inc., (Nasdaq:IMMU)
today announced the appointment of Francois E. Wilhelm, M.D., Ph.D., as Chief Medical Officer of the Company.

Kite Pharma, Inc., (Nasdaq:KITE),
a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced that the European Commission (EC), acting on the positive recommendation from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), has designated KTE-C19 as an orphan medicinal product for the treatment of diffuse large B cell lymphoma (DLBCL).

Landec Corporation (Nasdaq:LNDC)
, a leading developer and marketer of innovative and proprietary products for healthy living applications in the food and biomedical markets, reported results for the second quarter of fiscal 2015 and first six months ended November 30, 2014.

Marrone Bio Innovations, Inc. (Nasdaq:MBII)
, a leading global provider of bio-based pest management and plant health products, announced today that the Regional Euro-Asian Biological Invasions Centre (REABIC) has published research from a study of Zequanox®, a naturally derived biopesticide for controlling zebra mussel infestations in the journal Management of Biological Invasions.

Mesa Laboratories, Inc. (Nasdaq:MLAB)
today announced that its Board of Directors has declared a regular quarterly dividend of $0.16 per share of common stock.

Nuvilex, Inc. (OTCQB:NVLX)
today announced that its Chief Executive Officer (CEO), Kenneth L Waggoner, JD, and its Chief Operating Officer, Gerald W. Crabtree, Ph.D., will be attending the 2015 Gastrointestinal Cancers Symposium, "Bridging Cancer Biology to Clinical GI Oncology," to be held in the Moscone West Convention Center in San Francisco, California, January 15-17, 2015.

Otonomy, Inc. (Nasdaq:OTIC),
a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that David A. Weber, Ph.D., president and chief executive officer, will present at the 33rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2015 at 3:00 p.m. PT at the Westin St. Francis Hotel in San Francisco.

Oxford Immunotec Global PLC (Nasdaq:OXFD)
, a global, commercial-stage diagnostics company focused on developing and commercializing proprietary tests for the management of immune-regulated conditions, today announced that the company's T-SPOT®.

Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK)
today announced Actavis will be making a $4 million milestone payment to Paratek under the terms of the parties' collaboration for the development of sarecycline (WC3035).

Portola Pharmaceuticals (Nasdaq:PTLA)
today announced that it will host an investor webcast on Monday, January 12, at 12:00 p.m. Pacific Time (3:00 p.m. Eastern Time), which will coincide with the 33rd Annual J.P. Morgan Healthcare Conference in San Francisco.

PositiveID Corporation (OTCQB:PSID),
a developer of biological detection and diagnostics solutions, announced today that Chairman and CEO William J. Caragol released a letter to stockholders.

Premier, Inc. (Nasdaq:PINC)
, a leading healthcare improvement company, announced today that its President and CEO, Susan DeVore, will present at the 33rd Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, January 12, 2015, at 3:30 p.m. PT.

Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN)
, a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced the online publication of preclinical results for RX-3117 in the peer reviewed medical journal, Anticancer Research, in an article titled, "A Novel Cytidine Analog, RX-3117, Shows Potent Efficacy in Xenograft Models,

Signal Genetics, Inc. (Nasdaq:SGNL)
, a commercial stage, molecular diagnostic company focused on providing innovative diagnostic services that help physicians make better-informed decisions concerning the care of their patients suffering from cancer, today announced the appointment of Sudipto Sur as Chief Information Officer.

Stereotaxis, Inc. (Nasdaq:STXS)
, a leading provider of innovative technologies for the treatment of cardiac arrhythmias, announced today that more than 75,000 patient cases have been completed with its remote magnetic navigation technology.

Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE)
, a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, announced the initiation of a new development program for the human monoclonal anti-FGF23 antibody KRN23 (UX023) in tumor-induced osteomalacia (TIO).

Vascular Solutions, Inc. (Nasdaq:VASC)
today announced that more than 75,000 ClosureFAST catheters have been successfully reprocessed by its partner, Northeast Scientific, Inc. (NES), since Vascular Solutions launched the reprocessing service in collaboration with NES for the popular vein ablation catheters in January 2012.

VBI Vaccines (Nasdaq:VBIV)
will present at the Noble Financial Capital Markets Eleventh Annual Equity Conference on Tuesday, January 20th at 2:30 PM ET.



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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