Myriad Submits Premarket Approval to FDA for BRACAnalysis(R); FDA Extends PDUFA Date for MannKind'S AFREZZA Print E-mail
By Staff and Wire Reports   
Monday, 07 April 2014 21:33
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 7, 2014.

Myriad Genetics (Nasdaq: MYGN) today announced that it has submitted the first module of a premarket approval (PMA) application to the Food and Drug Administration (FDA) for the use of BRACAnalysis(R) testing as a companion diagnostic with olaparib.

Olaparib is an investigational, orally active poly-ADP ribose polymerase (PARP) inhibitor being developed by AstraZeneca. "We believe an FDA-approved BRACAnalysis test will provide additional assurance that patients are receiving the most accurate test results and improve patient care by identifying candidates for treatment with olaparib," said Mark Capone, president of Myriad Genetics Laboratories. "Our PMA application for BRACAnalysis will provide the FDA with scientific data to evaluate the safety and effectiveness of BRACAnalysis as a companion diagnostic."

Consistent with the FDA's modular premarket approval process, Myriad submitted the first of four PMA modules and is working to submit the remaining modules according to a pre-specified plan. The modular approach allows FDA to review each module as it is received and provides Myriad with timely feedback from FDA in order to help resolve issues early in the review process. "Our PMA submission is a milestone for Myriad and BRACAnalysis is one of the first laboratory developed tests submitted for FDA premarket approval," said Capone. "Our ability to navigate the regulatory process is benefitted by our extensive experience in testing 1.2 million patients and our commitment to high quality."

The collaboration between Myriad and AstraZeneca on olaparib began in 2007. Since then, the two companies have shared scientific insight and worked closely together to move cancer research forward. In 2012, Myriad made strides in developing BRACAnalysis as a companion diagnostic by retrospectively genotyping patients in a previously completed Phase 2 study of olaparib.

This is a powerful example of how a companion diagnostic can advance the goals of personalized medicine by stratifying patients in a clinical trial. About Myriad Genetics Myriad Genetics is a leading molecular diagnostic company dedicated to making a difference in patients' lives through the discovery and commercialization of transformative tests to assess a person's risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence.

Myriad's molecular diagnostic tests are based on an understanding of the role genes play in human disease and were developed with a commitment to improving an individual's decision-making process for monitoring and treating disease. Myriad is focused on strategic directives to introduce new products, including companion diagnostics, as well as expanding internationally.


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MannKind Corporation (Nasdaq: MNKD)
announced that the U.S. FDA has extended the Prescription Drug User Fee Act (PDUFA) date for AFREZZA® by three months to July 15, 2014 in order to provide time for a full review of information submitted by MannKind in response to the FDA's requests.


Also Monday:


Apricus Biosciences, Inc. (Nasdaq:APRI)
, a pharmaceutical company focusing on the development and commercialization of novel therapeutics for men's and women's health, today announced that the Company, along with its European commercial partners, is sponsoring a symposium – "A New Paradigm in the Treatment of ED - The Topical Option" – during the European Association of Urology (EAU) Congress. Vitaros® is Apricus' novel topical on-demand treatment for erectile dysfunction ("ED"), approved in Canada and nine countries in Europe.

Argos Therapeutics, Inc. (Nasdaq:ARGS)
announced that it has filed its Annual Report on Form 10-K for the year ended December 31, 2013 with the Securities and Exchange Commission.

Arno Therapeutics, Inc. (OTCQB:ARNI)
, a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, today announced that it has enrolled the first patient in a Phase I/II trial (NCT02049190) evaluating its lead compound onapristone in men with advanced castration-resistant prostate cancer (CRPC) after failure of abiraterone or enzalutamide.

Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY)
announced today that updated data from an NCI sponsored combination study of Bavarian Nordic's active immunotherapy candidate PROSTVAC and ipilimumab will be presented at the American Association for Cancer Research (AACR) Annual Meeting in San Diego on Wednesday, April 9, 2014.

Celldex Therapeutics, Inc. (Nasdaq:CLDX)
today reported results of preclinical studies evaluating the anti-tumor activity of CDX-014 against a variety of cell lines.

Celsus Therapeutics Plc (Nasdaq:CLTX)
, an emerging growth, development-stage biotech company, announced today the formation of a new Dermatology Scientific Advisory Board (SAB).

Cerner (Nasdaq:CERN)
announced today it will release its first quarter 2014 earnings results after the market closes on April 24.

Chembio Diagnostics, Inc. (Nasdaq:CEMI)
a leader in point-of-care ("POC") diagnostic tests for infectious diseases, announced today that it notified Alere Inc., formerly Inverness Medical Innovations, Inc. ("Alere"), of termination of its U.S. STAT-PAK® distribution agreement.

Curis, Inc. (Nasdaq:CRIS)
, an oncology focused company developing novel, targeted drug candidates for the treatment of human cancers, and Debiopharm Group™ (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs, including oncology as well as companion diagnostics, today announced the presentation of data for Debio 0932 at the Annual Meeting of the American Association for Cancer Research (AACR) that demonstrated synergy between Debio 0932 and various standard of care (SOC) agents in multiple in vitro and xenograft models of non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC).

Cytomedix, Inc. (OTCQX:CMXI)
, a leading developer of biologically active regenerative therapies, announced today the appointment of Andrew Cohen as Vice President of Marketing. He will have overall marketing responsibilities as the Company moves forward with its commercial plan to launch AutoloGelTM in the wound care market.

Curis, Inc. (Nasdaq:CRIS)
, an oncology-focused company developing novel, targeted drug candidates for the treatment of human cancers, today announced that it reported data from in vitro studies and a translational biomarker analysis for CUDC-907, a dual histone deacytelase (HDAC) and phosphoinositide 3-kinase (PI3K) inhibitor, as well as results from in vitro and in vivo studies for CUDC-427, an antagonist of inhibitor of apoptosis (IAP) proteins, at the American Association for Cancer Research (AACR) 2014 Annual Meeting. CUDC-907 is being investigated in a Phase 1 trial in patients with relapsed/refractory lymphoma or multiple myeloma.

FutureWorld (OTCQB: FWDG)
, a U.S. Diversified Holding Company formed to capitalize on the burgeoning technology markets globally, announces today that HempTech is to acquire interest in Verecis Corporation to further develop CaNNaTRAK® product line for the legal medical marijuana and the industrial hemp markets.

Hemp, Inc. (OTC:HEMP)
announced today that the Financial Industry Regulatory Authority (FINRA) has approved the dividend payment to Hemp, Inc. common shareholders for the spin-off of Hemp, Inc. subsidiary, BioSwan, Inc. assets.

Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX)
, a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced continued progress of the Company's program to develop nucleotide prodrug inhibitors for the treatment of hepatitis C virus (HCV) infection.

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 5 patients reported a partial response as their best response, based on RECIST 1.1 criteria, in the Company's ongoing Phase I/II clinical trial of its investigational antibody-drug conjugate (ADC), IMMU-132, in patients with solid cancers.

Intra-Cellular Therapies, Inc. (Nasdaq:ITCI)
, a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders has presented several posters and a talk at the 4th Biennial Schizophrenia International Research Society (SIRS) conference being held in Florence, Italy.

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 reported the results from 3 Phase I trials with IMMU-130, the Company's investigational anti-CEACAM5 antibody conjugated to the irinotecan-metabolite, SN-38.

Integra LifeSciences Holdings Corporation (Nasdaq:IART)
today announced that Mark Augusti has joined Integra as CVP, President, Orthopedics and Tissue Technologies.

Kelyniam Global Inc.(OTC: KLYG)
, a manufacturer of custom cranial implants, announces preliminary revenue of $1,857,516 for 2013. This represents an increase of 54% vs. sales of $1,206,227 in 2012.  

Lion Biotechnologies, Inc. (OTCBB:LBIO),
a biotechnology company that is developing novel cancer immunotherapies based on tumor infiltrating lymphocytes (TILs), today announced that Steven A. Rosenberg, M.D., Ph.D., Chief of Surgery at the National Cancer Institute (NCI), has presented data showing impressive evidence of clinical efficacy from a Phase 2 melanoma clinical trial in a plenary session at the 105th Annual Meeting of the American Association for Cancer Research.

MedAssets, Inc. (Nasdaq:MDAS)
today announced that it plans to release its financial results for the first quarter ended March 31, 2014 after 4:00 p.m. ET on Wednesday, April 30, 2014.

Merit Medical Systems, Inc. (Nasdaq:MMSI)
, a leading manufacturer and marketer of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy, announced today that the Company will release its financial results for the first quarter ended March 31, 2014, after the close of the stock market on Thursday, April 24th, 2014.

Myriad Genetics, Inc. (Nasdaq:MYGN)
today announced that it has submitted the first module of a premarket approval (PMA) application to the Food and Drug Administration (FDA) for the use of BRACAnalysis® testing as a companion diagnostic with olaparib.

Novavax, Inc. (Nasdaq:NVAX)
, a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced the appointment of Cynthia N. Oliver, Ph.D. to the position of Senior Vice President, Process Development Operations, effective April 8, 2014.

Onconova Therapeutics, Inc. (Nasdaq:ONTX)
, a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced the presentation of seven abstracts at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA, being held April 5-9, 2014.

OXiGENE, Inc. (Nasdaq:OXGN)
, a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, today announced results from three preclinical studies related to its ongoing research and development programs.

Premier, Inc. (Nasdaq:PINC)
today announced it has acquired MEMdata, LLC, an equipment planning, sourcing and analytics business focused on capital equipment needs for existing medical facilities, as well as those under construction.

SmallCapVoice.com, Inc. announced today that a new audio interview with PositiveID Corporation  (OTCQB:PSID), a developer of biological detection and diagnostics solutions, is now available.

RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL)
, an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary drugs for the treatment of inflammatory and gastrointestinal diseases and related conditions, today announced that it had concluded a positive European scientific advice meeting with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) regarding RHB-102, a proprietary, extended-release (once-daily) oral pill formulation of the anti-emetic oncology support drug ondansetron for the prevention of chemotherapy and radiotherapy-induced nausea and vomiting ("CINV" and "RINV" respectively).

The Spectranetics Corporation (Nasdaq:SPNC)
today announced preliminary results for the three months ended March 31, 2014.

Stemline Therapeutics, Inc. (Nasdaq:STML)
announced today that Ivan Bergstein, M.D., Stemline's CEO, will present at the 13th Annual Needham Healthcare Conference on Tuesday, April 8, 2014 at 12:10 PM ET.

Strategic Rare Earth Metals, Inc. (OTC Markets:SREH)
announced today that the Company is working with a Attorney in the Cannabis Industry in opening Medical Marijuana Dispensary Stores in California.

TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG)
announced today that it has executed a definitive agreement to acquire by merger 100% of Shape Pharmaceuticals, a privately-held biotechnology company developing suberohydroxamic acid phenyl ester (SHAPE), a novel, tissue-targeted HDAC inhibitor in a topical gel formulation to treat stage IA-IIA Cutaneous T-Cell Lymphoma (CTCL), adding a second clinical-stage oncology compound to the TetraLogic portfolio.

TG Therapeutics, Inc. (Nasdaq:TGTX)
today announced that preclinical data for TGR-1202, the Company's novel PI3k delta inhibitor will be highlighted at the 105th American Association for Cancer Research (AACR) Annual Meeting taking place April 5-9, 2014 in San Diego, California.

Xenetic Biosciences, Inc. (OTCBB:XBIO)
, a biopharmaceutical company focused on developing next-generation biologic drugs and novel oncology therapeutics, today announced the positive results from its Phase I clinical trial of PulmoXenTM for the treatment of cystic fibrosis.



"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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