Label Restrictions Sought On Vanda's Sleep Drug; Rock Creek Announces Clinical Update Print E-mail
By William Kent   
Thursday, 11 June 2015 19:28
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 11, 2015.
Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) fell sharply on Tuesday after a consumer group petitioned regulators to add restrictive labeling to Vanda's sleep disorder drug.
  
The petition, dated Thursday, was reported by The Wall Street Journal and seeks to have Vanda's Hetlioz' labeling restricted to patients who are completely blind.
   
A Closer Look At Hetlioz -- The drug aims to treat non-24 sleep-wake disorder, a condition that almost exclusively affects blind people.  The consumer group is also seeking additional label warnings about risks of cancer and risks to pregnancies, as well as further safety studies.
  
Vanda, which obtained approval for the drug last year, expects 2015 Hetlioz sales of between $40 million and $45 million, or more than 40 percent of its expected total sales.
  
Public Citizen Petition -- Vanda hasn't commented on the Public Citizen petition, but noted in its FDA application that there are an estimated 100,000 Americans who both suffer from the disorder and are completely blind.  The advocacy group said that an initial approval letter last year from the Food and Drug Administration included the blind-only restriction, which is "inexplicably" omitted from current labeling.
  
Vanda shares, which saw a dramatic downward spike earlier, traded recently at $12.79, off $0.14.
  
  
  
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Rock Creek Pharmaceuticals, Inc., (NASDAQ: RCPI), a drug development company focused on chronic inflammatory disease and neurologic disorders, announced today an update on its clinical and regulatory drug development activities.
  
The United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) approved in January 2015 a Clinical Trial Application (CTA) to commence a Phase I study of the Company's lead compound, Anatabine Citrate. The trial consists of three parts, with Part Two being optional. The objectives of Parts One and Two are to evaluate the safety, tolerability, and pharmacokinetic (PK) profiles of various modified and immediate release formulations of anatabine citrate in healthy adult subjects, and to identify an optimal formulation for multiple day dosing in Part Three. Exploratory pharmacodynamic (PD) outcome measures are also being assessed.
  
As previously announced, the Company completed recruitment and commenced human dosing for the study by March 1, 2015. As of June 1, 2015, Part One of the Phase I study is complete, and the Company announces that there were no reports of serious adverse events (AEs) or AEs leading to study withdrawal. Further, there were no safety concerns raised by either the Company's UK contract research organization or its UK based trial medical monitor.
  
The Company now expects to conduct Part Two of the study primarily to evaluate the effects of food on PK parameters. Dosing in Part Two is expected to commence and be completed within the third quarter 2015.
  
Subsequently, the Company expects to conduct Part Three of the study comprised of a double-blind, placebo-controlled, seven-day multiple dose study of the optimal formulation in healthy subjects and is targeting study completion and generating preliminary results in the third quarter 2015. It is anticipated that follow up data management and analysis will be completed during the fourth quarter 2015. As per the trial design, outcome measures will focus primarily on overall safety and tolerability with secondary measures focusing on standard PK parameters and also PD assessment, specifically measuring the impact of the drug on inflammatory processes.
  
New Zealand Study -- As previously announced, the Company completed its New Zealand study of the Company's nutritional supplement variant of Anatabine Citrate. In December 2014, the Company received a New Zealand Ministry of Health Ethics Committee approval to conduct a single-site, single dose, open-label human study, entitled "Determination of the Blood Pharmacodynamic Effects following a Single Dose of Oral Anatabine Citrate in Normal, Healthy Volunteers." The primary outcome measure of the study was a pharmacodynamic assessment of whether a single dose of orally administered anatabine citrate can acutely attenuate expression and/or production of pro-inflammatory mediators in human white blood cells, thus creating an anti-inflammatory effect. Follow up analysis is complete and the Company is expecting to provide a formal report in the third quarter.
  
   
   
  
Also Thursday:
  
  
  
3D Systems (NYSE:DDD) announced today that it has partnered with e-NABLE Community Foundation (ECF) to support e-NABLE, the global network of makers, inventors and designers using 3D printing to make functional, prosthetic hands that are donated to people in need.
  
Achaogen, Inc. (Nasdaq:AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials to treat multi-drug resistant (MDR) gram-negative infections, announced today the appointment of Mr. Greg Stea to its Board of Directors as a Class II director.
  
ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company developing specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, announced that it has initiated a collaboration with the Jeffrey Modell Foundation (JMF), a global nonprofit organization dedicated to patients with Primary Immunodeficiencies (PI). 
  
Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, announced that data from its lead, first-in-class glutaminase inhibitor CB-839 was presented today at the 20th Congress of the European Hematology Association (EHA), in Vienna, Austria.
  
Cellectar Biosciences, Inc. (Nasdaq:CLRB), a clinical stage biopharmaceutical company developing innovative agents for the detection and treatment of cancer, announced today that, after review of the company's investigational new drug (IND) application, the U.S. Food and Drug Administration (FDA) has determined that Cellectar's tumor margin illumination agent, CLR1502, will be evaluated as a combination product and assigned to the Center for Devices and Radiological Health (CDRH).
  
Celyad SA (Euronext Brussels and Paris: CYAD), today announced the completion of the 30-day safety follow-up of the first patient enrolled in the Company's Phase I clinical trial evaluating the safety and feasibility of its NKG2D CAR T-cell therapy, in cancer patients suffering from acute myeloid leukemia (AML) or multiple myeloma (MM).
  
Enzymotec Ltd. (Nasdaq:ENZY), today announced that it will hold an Annual General Meeting of Shareholders on Wednesday, July 29, 2015. 
  
FutureWorld Corp. (OTC: FWDG), a cannabis technology accelerator and a leading provider of advanced technologies and solutions to the global cannabis industry, announced today that it has completed its process with FINRA on the dividend of FutureLand Corp (FUTL). 
  
INC Research Holdings, Inc. (Nasdaq:INCR), a leading global Phase I to IV contract research organization, will demonstrate its focus on clinical innovation and continued commitment to clinical research sites with an extensive presence at the DIA 2015 51st Annual Meeting June 14-18 at the Walter E. Washington Convention Center in Washington, D.C. 
  
Lion Biotechnologies, Inc. (Nasdaq:LBIO), a biotechnology company that is developing novel cancer immunotherapies based on tumor-infiltrating lymphocytes (TIL), today announced that the FDA has granted orphan status to the company's lead product candidate, LN-144, for the treatment of stage 2b to stage 4 malignant melanoma.
  
Medgenics, Inc. (NYSE MKT:MDGN), the developer of a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides in patients using ex vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, today announced that its wholly owned subsidiary, Medgenics Medical Israel Ltd. (MMI), was awarded a government grant of up to NIS 13.3 million (approximately USD 3.4 million) from the Office of the Chief Scientist (OCS) at the Ministry of Economy of Israel.
  
MJ Holdings, Inc. (OTCQB:MJNE) today announced the launch of FindaMarijuanaDoctor.com. 
MediWound Ltd. (Nasdaq:MDWD), a fully-integrated, biopharmaceutical company developing, manufacturing and commercializing innovative therapies to address unmet needs in severe burn and wound management, announces that the Company has been awarded an approximate $1 million grant by the Israeli Office of the Chief Scientist (OCS) in the Ministry of Economy for 2015.
  
Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, has opened a new Philadelphia office.
  
OpGen, Inc. (Nasdaq:OPGN), today announced that financial results for the company's first quarter ended March 31, 2015 will be released Wednesday, June 17, 2015 following the close of market.   The management team will host a conference call discussing the company's financial results and recent developments on Wednesday, June 17, 2015 at 4:30 p.m. E.T. 
  
Oxford Immunotec Global PLC (Nasdaq:OXFD), a global, commercial-stage diagnostics company focused on developing and commercializing proprietary tests for the management of immune-regulated conditions, today announced the first patient has been enrolled in the REACT study. 
  
Summit Therapeutics plc (AIM:SUMM) (Nasdaq:SMMT), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy ('DMD') and C. difficile infection ('CDI'), today reports its financial results for the three months ended 30 April 2015.
  
T2 Biosystems, Inc. (Nasdaq:TTOO), a company developing innovative diagnostic products to improve patient health, today announced that members of its management team are scheduled to participate in several discussion panels at the 2015 BIO International Convention, the world's largest annual gathering of the biotechnology industry.
  
TG Therapeutics, Inc. (Nasdaq:TGTX), today announced that clinical data for TG-1101 (ublituximab), the Company's novel glycoengineered anti-CD20 monoclonal antibody, and TGR-1202, the Company's once-daily PI3K delta inhibitor, will be presented at the 20th Congress of the European Hematology Association (EHA), being held from June 11 - June 14, 2015 in Vienna, Austria as well as at the 13th International Congress on Malignant Lymphoma (ICML), being held from June 17 - June 20, 2015 in Lugano, Switzerland.
  
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP), a clinical-stage company developing next-generation medicines for fibromyalgia, post-traumatic stress disorder, and episodic tension-type headache, today presented additional data from its Phase 2b BESTFIT clinical study further supporting TNX-102 SL (cyclobenzaprine HCl sublingual tablets) as a promising treatment candidate for patients with fibromyalgia.
  
uniQure N.V. (Nasdaq:QURE), a leader in human gene therapy, today announced financial results for the first quarter ending March 31, 2015, and provided an update on multiple gene therapy programs.
  
Zafgen, Inc. (Nasdaq:ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced that Thomas Hughes, Ph.D., Chief Executive Officer, is scheduled to present a company overview at the 2015 BIO International Convention. 



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