Vanda Announces FDA Advisory Committee Meeting On November 14, 2013; Dynavax Issues Update on HEPLISAV, Will Host Call 10/17/13 Print E-mail
By Staff and Wire Reports   
Wednesday, 16 October 2013 18:18

Below is a look at some of the headlines for companies that made news in the healthcare sector on October 16, 2013. Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) announced the U.S. FDA has notified the company of the scheduling of a Peripheral and Central Nervous System Drugs Advisory Committee meeting on November 14, 2013, for the review of Vanda's New Drug Application (NDA) for tasimelteon, proposed trade name HETLIOZ™, for the treatment of Non-24-Hour Disorder (Non-24) in the totally blind.  Vanda's tasimelteon NDA is currently under Priority Review by the FDA with an action target date under the Prescription Drug User Fee Act (PDUFA-V) of January 31, 2014.  

About Non-24-Hour DisorderNon-24 is a serious, rare, and chronic circadian rhythm disorder characterized by the inability to entrain (synchronize) the master body clock with the 24-hour day-night cycle.  Non-24 affects a majority of totally blind individuals, or between 65,000 and 95,000 people in the U.S.  Non-24 occurs almost entirely in individuals who lack the light sensitivity necessary to entrain the master body clock in the brain with the 24-hour day-night cycle.  Most people have a master body clock that naturally runs longer than 24-hours and light is the primary environmental cue that resets it to 24 hours each day.  Individuals with Non-24.



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Dynavax Technologies Corporation (NASDAQ: DVAX)
announced the design of its next large-scale clinical study of HEPLISAV, its investigational adult hepatitis B vaccine, following discussions with the U.S. FDA. The planned study, HBV-23, is intended to provide a sufficiently-sized safety database for the Agency to complete its review of Dynavax's Biologics License Application (BLA). It will be an 8,000 subject, Phase 3, observer-blinded, randomized, active-controlled, multicenter trial of the safety and immunogenicity of HEPLISAV compared with Engerix-B(R) in adults 18 to 70 years of age.

The primary objectives of HBV-23 will be:  To evaluate the overall safety of HEPLISAV with respect to clinically significant adverse events; and -- To demonstrate the noninferiority of the peak seroprotection rate (SPR) induced by HEPLISAV to Engerix-B in subjects with type 2 diabetes mellitus.

HBV-23 will include 5,500 HEPLISAV subjects and 2,500 Engerix-B subjects, randomized 2:1 and stratified by age and diabetes diagnosis. HEPLISAV subjects will receive two doses at 0 and 1 month, while Engerix-B subjects will receive three doses at 0, 1 and 6 months. All HEPLISAV subjects will be evaluated for safety for one year following the second dose and all potential autoimmune events will be adjudicated by a Safety Evaluation and Adjudication Committee. Immunogenicity assessments will be conducted in a subset of subjects, including those with type 2 diabetes.

"Following extensive discussion with FDA, we've finalized a study design that we believe will provide confidence to the Agency regarding HEPLISAV's safety profile, and importantly, will provide Dynavax with the opportunity to prospectively generate additional immunogenicity data in persons with diabetes, a population for whom there is a clear unmet medical need," commented Eddie Gray, Dynavax Chief Executive Officer.

Dynavax intends to initiate this study in the first quarter of 2014 and conclude subject visits by the end of 2015 and estimates the external costs of the study to be in the range of $50-55 million.

Dynavax's Marketing Authorization Application for HEPLISAV remains on file in Europe. The Company is currently preparing its response to the European Medicines Agency's (EMA) 120-Day List of Questions to be submitted in the fourth quarter of 2013, following which the EMA will provide Dynavax its 180-Day List of Outstanding Issues expected in the first quarter 2014.

The 120-Day response will incorporate the target population for HEPLISAV and size of the safety database, and will address Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP)-related items, including questions arising from a recent EMA GCP inspection. Dynavax will continue to work through the European regulatory review process to determine the appropriate next steps, corrective actions, and possible post-approval commitments. The Company anticipates that some of these matters will need to be resolved following issuance of the 180-Day List of Outstanding Issues, which when received, will enable Dynavax to provide further clarification on HEPLISAV's potential path forward in Europe.  Engerix-B(R) is a registered trademark of GlaxoSmithKline.



Also Wednesday:



Amarin Corporation plc (Nasdaq:AMRN)
, a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee has voted 9 to 2 against approval of Vascepa® (icosapent ethyl) capsules for use as an adjunct to diet and exercise and in combination with a statin in the treatment of adult patients with high triglycerides (TG 200-499 mg/dL) with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent (the ANCHOR indication) based on the information presented at the committee meeting today.

AMRI (NASDAQ: AMRI)
today announced the appointment of Michael A. Luther, Ph.D., as Senior Vice President, Discovery, effective October 28, 2013.

Bioheart, Inc. (OTCQB: BHRT)
, a biotechnology company focused on the discovery, development and commercialization of autologous cell therapies, announced today it has signed a contract with African-Middle East Medical (AFRIMID) to implement Bioheart therapies for the more than 36 million patients in Uganda. Bioheart will begin distributing MyoCell™ (muscle derived stem cells) and AdipoCell™ (adipose derived stem cells) for a variety of indications in Uganda.

Biomerica, Inc. (OTCBB: BMRA), a global provider of advanced diagnostic products for the early detection of medical conditions, announced financial results today for the first fiscal quarter ended August 31, 2013.

MediciNova, Inc., a biopharmaceutical company that is publicly traded on the NASDAQ Global Market (Nasdaq:MNOV) and the Jasdaq Market of the Tokyo Stock Exchange (Code Number: 4875), today announced the appointment of Mr. Yutaka Kobayashi to its Board of Directors.

MediSwipe Inc. (OTCQB: MWIP)
, the leader in Compassionate Care Technology Solutions for the medicinal marijuana industry today announced the Company has signed an exclusive agreement with MCN on behalf of www.MarijuanaDoctors.com, the nation's first online search-and-booking platform to the medicinal cannabis industry for all rights to the Country of Canada.

MiMedx Group, Inc. (NASDAQ: MDXG)
, an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that the Company's meeting with the FDA that was scheduled for today, October 16, 2013, to discuss the recent Untitled Letter has been postponed.

MiMedx Group, Inc. (NASDAQ: MDXG)
, an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that the Company will exceed the $16.0 million high end of its revenue guidance range for the third quarter of 2013, marking the 8th consecutive quarter in which MiMedx has met or exceeded its revenue guidance.

NuVasive, Inc. (NASDAQ: NUVA)
, a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, featured its game-changing products and procedures and celebrated a decade of changing spine surgery at the 28th Annual North American Spine Society (NASS) Annual Meeting in New Orleans, La.

Pacific Edge (NZX:PEB
), a cancer diagnostic company leading in the development and commercialisation of molecular diagnostic tests, has signed an agreement with FedMed, a national preferred provider network in the United States, to make Cxbladder available to an additional 40 million Americans.

Plandaí Biotechnology, Inc. (OTCQB: PLPL)
, a producer of highly bioavailable plant extracts for industries including health, wellness, nutriceutical, and pharmaceutical, today announced that it has been featured in the October 18th edition of Farmer's Weekly (www.farmersweekly.co.za).

PLC Systems Inc. (OTCBB: PLCSF), a company focused on innovative medical device technologies, today announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the initiation of a clinical trial in Japan using RenalGuard Therapy®.

The Pulse Beverage Corporation (OTCQB:PLSB),
makers of the PULSE® brand of functional beverages and Natural Cabana® Lemonade, today announced that Natural Cabana® Lemonade is now available at more than 380 Albertsons grocery stores in the company's Northwest, Southwest, Texas and Rocky Mountain divisions.

Quantum Materials Corp. (OTCQB:QTMM)
this week filed its annual report on Form 10-K for the year ended June 30, 2013 with the Securities and Exchange Commission.

Rosetta Genomics Ltd. (NASDAQ: ROSG)
, a leading developer and provider of microRNA-based molecular diagnostics, announces that the Rosetta Cancer Origin Test™ will be incorporated into Altos Solutions, Inc.'s (Altos) Electronic Medical Records (EMR) system, OncoEMR®.

Sigma-Aldrich Corporation's (NASDAQ: SIAL)
custom manufacturing services business unit, SAFC® Commercial, has broadened production at its Arklow, Ireland, facility to include new PharmaGrade products.

The Medicines Company (NASDAQ: MDCO)
has scheduled its quarterly conference call for Wednesday, October 23 at 8:30 a.m. Eastern Time to discuss third quarter 2013 financial results, operational developments, and outlook for 2013.

Titan Medical Inc. (TSX VENTURE:TMD) (OTCQX:TITXF)
has posted a video (http://www.titanmedicalinc.com/investor-relations/sport-clips/) on its website demonstrating the impressive preciseness and reliability of the robotic instruments of its Single Port Orifice Robotic Technology (SPORT™) Surgical System.

WuXi PharmaTech (NYSE: WX)
, a leading pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the United States, announced today that its genomics clinical laboratory in Shanghai has successfully passed the survey by the Centers for Medicare and Medicaid Services of the U.S. Department of Health and Human Services relating to CLIA (Clinical Laboratory Improvement Amendments) standards, thereby receiving CLIA certification.  WuXi's laboratory is the only CLIA-certified clinical laboratory in China.




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