FDA Approves Pluristem's Commercial Scale Cell Manufacturing Process; Alcobra Announces FDA Clearance of Metadoxine Extended Release Print E-mail
By Staff and Wire Reports   
Thursday, 06 March 2014 11:49

Below is a look at some of the headlines for companies that made news in the healthcare sector on March 6, 2014.

Pluristem Therapeutics, Inc. (TASE:PLTR), a leading developer of placenta-based cell therapies, today announced that the United States Food and Drug Administration (FDA) has reviewed Pluristem's comparability studies of its PLacental eXpanded (PLX) cell products and granted approval for the Company to manufacture these products in its new commercial-scale cell manufacturing facility.

 

"We believe we have the largest, scalable, most efficient, most consistent and controlled process for manufacturing cell therapies," stated Zami Aberman, Chairman and CEO of Pluristem. "Knowing that the 'Process is the Product' in cell therapy, we have established our leadership position in the industry by focusing on our 3D commercial scale cell manufacturing processes. To be a successful company in the industry, we believe it is imperative to possess and control the manufacturing processes we have developed at Pluristem. We believe this FDA approval, combined with the approval given by the Paul-Ehrlich-Institute (PEI) of Germany announced on January 23, 2014, is an indication that these regulatory bodies see our proprietary 3D manufacturing process as a valid and sustainable commercial scale solution for potential cell therapies."

At its new state-of-the-art GMP manufacturing facility, Pluristem has implemented its proprietary, fully automated 3D cell expansion manufacturing platform that uses its patented high-throughput culturing technologies, 3D bioreactors, and downstream equipment. Pluristem's facility has the ability to efficiently produce approximately150,000 doses of PLX cells annually, with batch-to-batch consistency, which potentially translates into significant economic value.


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Alcobra Ltd. (NASDAQ:ADHD)
, an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug candidate Metadoxine Extended Release (MDX) to treat cognitive dysfunctions, such as Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, announced the US. FDA has cleared the Company's Investigational New Drug (IND) application for MDX. This step will allow for the initiation of US clinical trials.

"The FDA's acceptance of our IND marks an important development milestone for MDX," said Dr. Yaron Daniely, President & Chief Executive Officer of Alcobra. "It allows us to commence our U.S. based Phase 3 study in adult patients with ADHD, and we expect to enroll the first patients shortly. The IND will also pave the way for additional studies for other related indications, including a planned trial in Fragile X Syndrome."

Unlike the most commonly prescribed ADHD medications, MDX is not a stimulant. MDX has a novel mechanism of action that neither targets dopamine nor norepinephrine. MDX has demonstrated significant efficacy and was generally well tolerated in two separate placebo-controlled Phase 2 studies in adults with ADHD. Additionally, MDX has demonstrated significant efficacy following the first dose.




Also Thursday:


 


The Alkaline Water Company Inc.(OTCBB: WTER)
, developers of an innovative state of the art proprietary electrolysis beverage process, packaged and sold in 3 liter and 1 gallon sizes under the trade name Alkaline88, is pleased to announce that it has expanded its product manufacturing capabilities by entering into a manufacturing agreement with Brookshire's Grocery Company (BGC), a Texas-based regional food chain comprised of more than 150 store locations in which Alkaline88's products can already be found.

Alcobra Ltd. (Nasdaq:ADHD)
, an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug candidate Metadoxine Extended Release (MDX) to treat cognitive dysfunctions, such as Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, announced today that the US. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for MDX.

Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS)
, a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to endoplasmic reticulum stress, cell cycle dysregulation, neurodegeneration and apoptosis, today announced that it entered into an exclusive option agreement with the University of Massachusetts to license the University's method of use intellectual property surrounding the use of MANF and CDNF for the treatment of antibiotic-induced ototoxicity.

athenahealth, Inc.(Nasdaq:ATHN)
, a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, today formally announced plans to expand in Austin, Texas.

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 its financial results for the year-ended December 31, 2013 and is providing a corporate update on operations and progress on lead candidate AHRO-001.

BioCorRx Inc. (OTCQB:BICX)
is pleased to announce the launching of a national ad campaign by TVA Media Group, Inc. (TVA).

Burcon NutraScience Corporation (TSX:BU) (Nasdaq:BUR),
a leader in functional, renewable plant proteins, is pleased to announce that it has received written notice from Archer Daniels Midland Company ("ADM") that ADM intends to expand to full-commercial scale production of CLARISOY™ soy protein.

CannaVest Corp. (OTC:CANV)
, the world's leading hemp-based investment company spearheading the development of cannabidiol (CBD)-rich hemp oils and other hemp industry-related products and services, would like to clarify its relationship with both General Hemp, LLC and Kannaway, LLC.

CAS Medical Systems, Inc. (Nasdaq:CASM)
, a leader in medical devices for non-invasive patient monitoring, today reported financial results for the three and 12 months ended December 31, 2013.

Chembio Diagnostics, Inc. (Nasdaq:CEMI)
, a leader in point-of-care diagnostic tests for infectious diseases, today reported financial results for the quarter and year ended December 31, 2013, which include record revenues, and a tenth consecutive year of double-digit organic revenue growth.

Edwards Lifesciences Corporation (NYSE: EW)
, the global leader in the science of heart valves and hemodynamic monitoring, today announced the successful completion of the first three human implants of its FORTIS mitral transcatheter heart valve, which were performed in February and March by the Heart Team at St. Thomas' Hospital in London.

Fate Therapeutics, Inc. (Nasdaq:FATE)
, a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, announced today the publication of an article in the journal Stem Cell Reports by Fate scientists demonstrating high-throughput derivation of human induced pluripotent stem cells (hiPSCs) that exhibit characteristics necessary for therapeutic application.

Global Links Corp. (OTC:GLCO)
today announced the launch of a new online marketing campaign by its Hemp Life Today division aimed toward increasing product revenue from its website, HempLifeToday.com.

Harris & Harris Group, Inc. (Nasdaq:TINY)
, an investor in transformative companies enabled by disruptive science, notes the announcement by its portfolio company, Metabolon, Inc., that it has signed an agreement with newly-launched Human Longevity Inc. (HLI), whereby Metabolon will provide biochemical profiling services to assist HLI in its mission to address diseases of aging by building the world's largest and most complete human genotype, microbiome and phenotype database.

IDS Industries, Inc. (OTCQB: IDST)
announced today that its division, Charge! Energy Storage, (Charge!) has launched a pilot test of its technology for energy storage and power backup for the cultivation of marijuana.

MacroGenics, Inc. (Nasdaq:MGNX)
today announced that its Board of Directors is increasing its size from seven to eight members and that Matthew Fust has been appointed to fill the vacancy.

Medical Marijuana Inc.'s (OTC Pink:MJNA)
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. – is continuing the Company's initiative to increase the public's awareness of their cannabidiol (CBD)-rich industrial hemp oil products at Natural Products Expo West March 7-9, 2014.

NeoStem, Inc. (Nasdaq:NBS)
, a leader in the emerging cellular therapy industry, announced today that it has entered into a sponsored research collaboration with Massachusetts Eye and Ear/Schepens Eye Research Institute, an affiliate of Harvard Medical School.

Goldman Small Cap Research, a stock market research firm focused on the small cap and micro cap sectors, recently published a new research update on Nuvilex Inc. (OTCQB: NVLX).

OncoMed Pharmaceuticals Inc. (Nasdaq:OMED)
, a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that it will provide an extensive update on its anti-cancer stem cell pipeline at the upcoming American Association of Cancer Research (AACR) meeting to be held April 5-9, 2014 in at the San Diego Convention Center in San Diego, CA.

Pain Therapeutics, Inc. (Nasdaq:PTIE)
today announced that Remi Barbier, Chairman, President & CEO, will present at ROTH Capital Partners' 26th Annual ROTH Conference on Monday, March 10 at 12:30 p.m. Pacific Time at the Ritz-Carlton, Laguna Niguel in Dana Point, California.

Plandaí Biotechnology (OTCQB: PLPL)
is one of a handful of publicly traded companies that are eagerly anticipating the legalization of medical marijuana nationwide.

Prosensa Holding N.V. (NASDAQ: RNA)
announced today announced presentations at upcoming investor conferences. Celia Economides, Senior Director, Investor Relations & Corporate Communications, will present a corporate overview at the ROTH Conference 2014 in Dana Point, California on Tuesday, March 11, at 10:30am (Pacific Time) and at the Barclays Healthcare Conference in Miami, Florida on Wednesday, March 12, at 1:30pm (Eastern Time).

RadNet, Inc. (Nasdaq:RDNT)
, a national leader in providing high-quality, cost-effective, fixed-site outpatient diagnostic imaging services through a network of 250 owned and/or operated outpatient imaging centers, previously announced that it intends to pursue a refinancing of its 10 3/8% Senior Unsecured Notes due 2018.

Repligen Corporation (Nasdaq:RGEN)
today reported financial results for the full year and fourth quarter ended December 31, 2013.

Stemline Therapeutics, Inc. (Nasdaq:STML)
announced today that Ivan Bergstein, M.D., Stemline's CEO, will present at the 26th Annual ROTH Conference on Tuesday, March 11, 2014 at 2:30 PM PT.

Stratus Media Group, Inc., (OTCBB:SMDI)
announced today the acquisition, through merger, of two biotechnology companies, Paloma Pharmaceuticals, Inc. and VasculoMedics, Inc.

Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS)
today reported financial results for the fourth quarter and year ended December 31, 2013.

Swisher Hygiene Inc. (Nasdaq:SWSH) (TSX:SWI)
, a leading provider of essential hygiene and sanitizing solutions, announced today that current Director Steven R. Berrard has notified the Board of Directors that he will not stand for reelection at Swisher's 2014 Annual Meeting of Stockholders.

TESARO, Inc. (Nasdaq:TSRO)
announced today that Lonnie Moulder, CEO of TESARO, will present at the Barclays Global Healthcare Conference in Miami on Thursday, March 13, 2014 at 8:30 a.m. Eastern time.




"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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