Vanda Announces FDA Acceptance for Review of NDA for Maintenance Treatment of Schizophrenia; XenoPort Announces Positive Phase 2 Study Results for XP23829 Print
By William Kent   
Tuesday, 15 September 2015 19:03
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 15, 2015.  
Vanda Pharmaceuticals Inc., (NASDAQ: VNDA), announced the U.S. FDA has accepted for review Vanda's filing of a supplemental New Drug Application (sNDA) for Fanapt® seeking approval as a maintenance treatment of schizophrenia in adults.
   
Vanda is seeking approval based on the results of the REPRIEVE clinical study, which evaluated the long-term maintenance of efficacy and safety of Fanapt®.
   
The FDA has set a user fee goal date under the Prescription Drug User Fee Act of May 27, 2016, which is the target date for the FDA to complete its review of the sNDA.
   
   
   
  
   
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XenoPort, Inc. (NASDAQ: XNPT) announced positive preliminary top-line results from its Phase 2 clinical trial of XP23829 as a potential treatment for moderate-to-severe chronic plaque-type psoriasis. XP23829 met its primary endpoint in both 800 mg once daily and 400 mg twice daily doses, demonstrating statistically significant improvements in percent change from baseline to week 12 in Psoriasis Area and Severity Index (PASI) score. XP23829 is a patented prodrug of monomethyl fumarate (MMF) in a novel oral formulation that was designed to potentially offer physicians and patients an effective, better tolerated and multiple sclerosis experts, speak with regulatory authorities regarding next steps and explore potential partnerships that could accelerate the development of XP23829 globally. We recently completed non-clinical development studies and manufacturing activities necessary to support Phase 3 development and we believe we will be ready to potentially initiate Phase 3 studies in 2016."
  
   
  
  
   
Also Tuesday:
  
  
  
3D Systems (NYSE:DDD) announced today that it will be hosting a customer webinar on how 3D design software and 3D printing from 3DS can deliver affordable, custom prosthetics and prosthetic fairings that are personalized and individualized.
   
Amedica Corporation (Nasdaq:AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, today announced its expected participation in the following investor conference:  2015 Ladenburg Thalmann Healthcare Conference, Tuesday, September 29, 2015, 11:30 AM Eastern Time, New York, NY, Dr. Sonny Bal, Chairman and
CEO, will conduct a formal presentation and the relationship to different CFS case definitions and CFS disease severity.
   
INC Research Holdings, Inc. (Nasdaq:INCR), a leading global Phase I to Phase IV contract research organization, today announced the time of its presentation at the Morgan Stanley Global Healthcare Conference in New York has changed. The presentation is now scheduled for 12:15 PM EDT on Friday, Sept. 18.
   
Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that Integra filed a lawsuit in the U.S. District Court for the District of Delaware against HyperBranch Medical Technology, Inc. The lawsuit alleges that HyperBranch's Adherus Autospray Dural Sealant, Adherus Dural Sealant, and Adherus Spinal Sealant infringe patents that Integra licenses from Incept LLC.
     
Marathon Pharmaceuticals, LLC, a biopharmaceutical company focused on developing treatments for rare neurological and movement disorders, today announced that Dr. Jordan Dubow has joined the company as chief medical officer and vice president of clinical and medical affairs. In his new role, Dr. Dubow will oversee clinical development, medical affairs activities and drug safety for Marathon’s rare disease treatments.
    
MRI Interventions, Inc. (OTCQB:MRIC) today announced that its ClearPoint Neuro Navigation System will be on exhibit at the Congress of Neurological Surgeons (CNS) 2015 Annual Meeting September 26 - 30, 2015, in New Orleans, LA and will also be featured in the Innovations Showcase.
   
Natus Medical Incorporated (NASDAQ:BABY) today announced that Jonathan Kennedy, Senior Vice President and Chief Financial Officer, will present at the Morgan Stanley Global Healthcare Conference in New York City.
   
Novavax, Inc., (Nasdaq:NVAX) a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced its RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) was shown to be highly immunogenic in a guinea pig model of maternal immunization. The preclinical study was published in the journal Vaccine.
    
Octapharma USA today announced the U.S. Food and + 'src="//sedoparking.com/frmpark/' Drug Administration (FDA) has approved NUWIQ®, Antihemophilic Factor (Recombinant), an intravenous therapy for adults and children living with Hemophilia A. The NUWIQ® approval includes on-demand treatment and control of bleeding episodes; routine prophylaxis to reduce the frequency of bleeding episodes; and perioperative management of bleeding.
    
Optivia Biotechnology Inc., a leading global provider of high-quality transporter assay services and innovative transporter research solutions, announces the launch of its Opti-Target™ Transporter Screening Panel. The new panel will assist in the discovery and development of new classes of transporter-targeted therapeutics; including CNS disorders, oncology, and metabolic diseases. It also aids researchers in adopting a transporter-conscious strategy to improve drug response and safety.
   
Pharmaceutical Product Development, LLC (PPD) today announced the company earned recognition for excellence in multimedia and digital communications that promote the people and technology vital to advancing the development of life-changing medicines. PPD earned five honors in the annual Telly Awards and three in the Digital Health Awards.
   
Perseon Corporation (Nasdaq:PRSN) today announced that data supporting the use of the company's cutting edge microwave ablation technology, MicroThermX, was presented at the 38th Congress of Italian Society of Oncological Surgery (SICO) in Naples, Italy from September 9 – 12, 2015. 
   
Pfenex Inc. (NYSE MKT: PFNX), a clinical-stage biosimilars company, announced today that Dennis M. Fenton, Ph.D., has been appointed to the company's board of directors, deepening the manufacturing and product development expertise of the biosimilar company. Dr. Fenton, an industry pioneer, has over three decades of experience in the biotechnology industry.
    
Pfizer Inc. invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10 a.m. EDT on Tuesday, October 27, 2015. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s Third Quarter 2015 Performance Report, to be issued that morning.
   
RXi Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company focused on discovering and developing innovative therapies primarily in the areas of dermatology and ophthalmology, today announced that Dr. Geert Cauwenbergh, RXi's President and CEO, will be participating in the upcoming 15th Annual Biotech in Europe Forum for Global Partnering and Investment Conference, with an oral presentation and panel discussion. This Forum is recognized as the leading international stage for those interested in investing and partnering in the biotech and life sciences industry.
    
SANUWAVE Health, Inc. (OTCQB:SNWV), a shockwave technology company, announced today that Kevin A. Richardson II, SANUWAVE's Chairman of the board and Chief Executive Officer, will present at the Singular Research 10th Annual Best of the Uncovereds Investor Conference, being held Thursday, September 17, 2015 at the Luxe Hotel in Los Angeles, CA.
   
Sigma-Aldrich Corporation (NASDAQ: SIAL) today announced that the Cerilliant® brand within its Applied Diagnostics and Testing business segment now offers the first-ever reference solutions for qualitative evaluation of drug interferences in a testing laboratory's analytical methods. These seven multi-component solution mixes contain more than 50 of the most routinely monitored over-the-counter (OTC) and prescription drugs. Cerilliant offers the seven mixes separately or as a kit for added convenience.
     
SWK Holdings Corporation (OTCQB:SWKH), a life science focused specialty finance company, announced that the previously disclosed 1-for-100 reverse stock split of its common stock, immediately followed by a 10-for-1 forward stock split of its common stock was executed effective as of 5:00 p.m. on September 15, 2015. 
   
Stereotaxis, Inc. (NASDAQ:STXS), a global leader in innovative technologies for the treatment of cardiac arrhythmias, announced today that the NASDAQ Capital Market has established September 15, 2015 as the "ex-warrants" date for its previously-announced warrants offering.
   
T2 Biosystems, Inc. (Nasdaq:TTOO), a company developing innovative diagnostic products to improve patient health, today announced that new data on the company's T2Candida® Panel will be presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the International Society of Chemotherapy (ICC) joint meeting in San Diego, September 17-21, 2015.
    
TapImmune, Inc. (OTCMKTS: TPIV), congratulates Mayo Clinic for being awarded a grant of $13.3 million from the U.S. Department of Defense. This grant, commencing September 15, 2015, will cover the costs for a 280 patient Phase II Clinical Trial of Folate Receptor Alpha Vaccine in patients with Triple Negative Breast Cancer.
    
Technavio has published a new report on the global anti-aging products market, which is expected to grow at a CAGR of nearly 8% from 2015-2019.
   
TriVascular Technologies, Inc. (NASDAQ:TRIV) announced today that the first European patients have been treated successfully with the Ovation iX Abdominal Stent Graft System in Germany and England. Building off of the clinically proven Ovation® platform, the Ovation iX System provides physicians with options for greater procedural consistency and ease of use.
    
Veritas Genetics, a pioneer in improving the accessibility of genetic testing, is establishing an R&D center in the Hangzhou Economic & Technological Development Area (HEDA), Hangzhou, China, and expanding its China-based leadership team. The R&D center will be dedicated to developing products that address the unique genetic needs of Asian populations. 
    
Vical Incorporated (Nasdaq:VICL), a biotechnology company developing vaccines and therapeutics for prevention and treatment of infectious diseases, today announced that the Company will present a poster summarizing results from preclinical studies of its antifungal compound, VL-2397 (formerly known as ASP2397), at the upcoming Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and the International Congress of Chemotherapy joint meeting in San Diego, California.



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