|Navidea Submits Lymphoseek Marketing Application in Europe; Hemispherx Chronic Fatigue Drug Scrutinized Ahead of Panel Review|
|By Staff and Wire Reports|
|Tuesday, 18 December 2012 20:33|
Navidea Biopharmaceuticals, Inc. (NYSE: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced it has submitted a Marketing Authorization Application (MAA) for its investigational radiopharmaceutical Lymphoseek® (technetium Tc 99m tilmanocept) injection, a novel intraoperative lymphatic mapping (ILM) agent, to the European Medicines Agency (EMA).
“The submission of the Lymphoseek MAA marks a significant milestone for Navidea as we continue our global development and commercialization efforts for Lymphoseek. It is also important to note that, as part of the normal MAA filing process, the EMA required good manufacturing practices (GMP) pre-submission inspections at the Lymphoseek contract manufacturing facilities. These inspections were recently successfully completed by independent auditors from the European Union (EU), thereby enabling our MAA filing,” commented Dr. Mark Pykett, President and CEO of Navidea. “We are encouraged by these positive pre-submission manufacturing audits which we believe bode well for Lymphoseek's ultimate commercialization. We are prepared to support the ongoing EMA approval process and to continue our pre-commercialization activities as we confidently anticipate U.S. approval of Lymphoseek in the coming months.”
Navidea is seeking marketing approval for Lymphoseek in the EU for use in ILM, a surgical oncology procedure in which lymph nodes draining the area around a tumor are identified and biopsied to determine if cancer has spread to the lymph nodes. The Lymphoseek MAA has proposed the use of the agent in general lymphatic mapping not restricted to any particular solid tumor type.
Shares of drug developer Hemispherx BioPharma (NYSEAMEX:HEB) are falling Tuesday after a government report questioned whether the company’s treatment for chronic fatigue syndrome works. The stock fell by almost half after previously rising more than 200% this year.
Philadelphia-based Hemispherx is trying to win US approval for its drug Ampligen. In a report, government reviewers not only question whether the drug is effective, but they also point out that the company was warned earlier this year that its drug research data may not support approval.
“It would be unusual for this type of data to provide adequate evidence of efficacy. However, the adequacy of the data will ultimately be a review issue,” Food and Drug Administration officials told company representatives in June. That’s according to this report released today.
Hemispherx faces a panel of expert advisers to the FDA on Thursday. The advisers will hear arguments from the company on why the experimental drug Ampligen should be approved for sale in the US. The FDA will consider the advisers’ recommendations as it decides whether to approve the medicine. The agency is expected to decide by February 2.
In a review of the drug posted online, staff for the FDA questioned a pair of studies of patients conducted to show Ampligen’s effectiveness. “Signals of efficacy are inconsistent between the two trials,” staff reviewers wrote.
Throughout the report, the descriptions for the study were more blunt. A methodology used in one trial was “ill-defined and invalid.” “Limited conclusions” about safety and effectiveness can be drawn from data, FDA staffers said. (See the meeting briefing documents here.)
FDA staff reviewers raised a number of issues related to the research of the drug, including study design and execution, patient selection for the trials, and analysis of the data. What’s more, the company is relying on research conducted before the FDA first rejected the drug in 2009. There are also questions about the safety of the drug, including potential liver damage. As these FDA staff reviews go, the report was scathing.
Hemispherx officials declined to comment, citing the upcoming FDA panel. “It is not appropriate for companies to speak to the press prior to an advisory committee,” a spokeswoman says.
Agilent Technologies Inc. (NYSE: A) today announced that Dr. Robert Gerszten, a recognized leader in cardiovascular research and biomarker discovery, has received an Agilent Thought Leader Award.
The Board of Directors of Astro-Med, Inc. (NASDAQ: ALOT) on December 17, 2012 declared a special cash dividend of $0.07 per share, payable on December 31, 2012 to shareholders of record as of December 27, 2012.
AtheroNova Inc. (OTCBB: AHRO), a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, today announced that Mark K. Wedel, MD, JD has joined the Company as Senior Vice President of Clinical Affairs and Chief Medical Officer.
Bioanalytical Systems, Inc. (NASDAQ:BASI) will release financial results for the fourth quarter and fiscal year 2012 ended September 30, 2012 at approximately 8:30 a.m. EST on Thursday, December 27, 2012.
Bio-Reference Laboratories, Inc. (NASDAQ: BRLI), a national clinical testing laboratory, has announced its donation of $100,000 to the Hurricane Sandy New Jersey Relief Fund.
BioTime, Inc. (NYSE MKT: BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, and its subsidiaries OrthoCyte Corporation and LifeMap Sciences reported today a means of manufacturing seven distinct types of cartilage, bone, and tendon cells from human embryonic stem cells.
Endeavor Power Corporation (OTCQB: EDVP) would like to bring its shareholders up to date on the Company’s completion of the merger between its wholly owned subsidiary, Endeavor Holdings, Ltd. and Parallax Diagnostics, Inc. a bio-medical company in the point of care diagnostics business.
GE Healthcare Life Sciences, a business unit of GE Healthcare (NYSE: GE) and Cellular Dynamics International (CDI), a leading commercial producer of human induced pluripotent stem (iPS) cell lines and tissue cells, announced today that GE Healthcare has licensed CDI to develop, manufacture and sell cellular assays and models derived from induced pluripotent stem (iPS) cells for use in drug discovery and toxicity screening.
GeoVax Labs, Inc.(OTCQB: GOVX), an Atlanta-based biopharmaceutical firm developing vaccines to prevent and treat HIV/AIDS, is pleased to announce full enrollment in a 48 patient Phase 1 trial testing the safety and immunogenicity of its 2nd generation adjuvanted DNA/MVA vaccine for the prevention of HIV infection.
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced the closing of its previously announced underwritten registered public offering of common stock.
Ingen Technologies, Inc. (PINKSHEETS: IGNT), an emerging medical device manufacturer with patented proprietary medical technology for the growing $55 Billion US home healthcare industry, is pleased to announce new purchase orders from major medical suppliers.
Life Technologies Corporation (NASDAQ: LIFE) today announced it will present at JP Morgan 2013 Healthcare Conference on Tuesday, Jan. 8 at 1:30 p.m. PT.
Medicago Inc. (TSX: MDG; OCTQX: MDCGF), a biopharmaceutical company specializing in the development of highly effective and competitive vaccines using proprietary manufacturing technologies and virus-like particles (VLPs), and Folia Biotech, a private biotechnology firm that focuses on vaccine enhancement using plant virus recombinant protein (papaya mosaic virus) as an adjuvant, announce the receipt of $415,000 in financial support from the Quebec government and the municipality of Quebec City to fund a feasibility study for a unique biopharmaceutical production project, known as BioProduction21, part of the Quebec Region's Life Science ACCORD Cluster.
MediSwipe Inc. (OTCQB: MWIP), a patient security solutions and financial products company for the health care industry, announced today that it has provided over $750,000 in elective medical consumer financing for the month of November 2012.
Metabolix, Inc. (NASDAQ: MBLX), an innovation-driven bioscience company focused on delivering sustainable solutions for plastics, chemicals and energy, today announced that I6001, a biobased polymeric modifier for PVC (polyvinyl chloride) formulations based on Metabolix PHA resin, is now available for shipment to customers.
Milestone Scientific Inc. (OTCQB: MLSS), the recognized leader in advanced, computer-controlled injection technologies, today announced that Christie Dental has rolled out Milestone's STA Single Tooth Anesthesia System® across nearly all its dental practices in the Central Florida Region and expects to complete the deployment across the entire organization by the first quarter of 2013.
MMRGlobal, Inc. (OTCQB: MMRF) today announced it has filed a Form 8-K regarding the signing of another royalty-based licensing agreement. On December 17, 2012, MyMedicalRecords, Inc. ("MMR") signed a Non-Exclusive Patent License Agreement with Healthcare Holdings Group, Inc. ("HCH"), the parent of Access My Records, Inc., to license the U.S. rights for the health IT patents owned by MyMedicalRecords, Inc.
Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that it has initiated a Phase IIb clinical trial (Kinect 2 Study) of its proprietary Vesicular Mono-Amine Transporter 2 compound, NBI-98854.
OPKO Health, Inc. (NYSE: OPK) announced that is has completed the acquisition of Prost-Data, Inc., doing business as OURLab, a Nashville-based CLIA laboratory with 18 phlebotomy sites throughout the U.S. and an experienced national sales force calling primarily on urologists.
Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today provided a clinical trial update of the Light Study as well as results of recent market research at its Analyst Day meeting in New York City.
Organovo Holdings, Inc. (OTCQX: ONVO) ("Organovo"), a creator and manufacturer of functional, three-dimensional human tissues for medical research and therapeutic applications, is working together with researchers at Autodesk, Inc., the leader in cloud-based design and engineering software, to create the first 3D design software for bioprinting.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that it has entered into a new five-year, $3.0 billion unsecured revolving credit facility, which replaces its existing $2.5 billion credit facility.
SafeCode Drug Technologies Corp . (OTCBB: SAFC), a developer of a voice recognition drug administration safety application announced today that the company has approved a share Buyback Program which was authorized by the Board Of Directors.
Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today the acquisition of a novel drug technology, known as SGX94, representing a unique approach to modulation of the innate immune system.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that its finance subsidiary Teva Pharmaceutical Finance IV, LLC has called for redemption its $1 billion outstanding principal amount of 1.700% senior notes due 2014 (CUSIP No. 88166H AA5).
University General Health System, Inc. (University General) (OTCQB: UGHS), a diversified, integrated multi-specialty health care delivery system, today announced the closing of its purchase of South Hampton Community Hospital, a 122,000 square-foot (approx.) hospital in Dallas, and an adjacent 23,000 square-foot (approx.) medical office building.
Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) today announced positive results from the SET (Safety and Efficacy of Tasimelteon) Phase III study, evaluating tasimelteon, a circadian regulator for the treatment of Non-24-Hour Disorder (Non-24).
VentriPoint Diagnostics (TSX VENTURE:VPT) (OTCQX:VPTDF) exhibited at the Annual Meeting of EUROECHO & other Imaging Modalities 2012 from December 5th to 8thin Athens, Greece.