FDA Advisory Committee Recommends Approval of BREO ELLIPTA; Neuralstem Wins FDA Approval to Begin Phase II Stem Cell Trial Print E-mail
By Staff and Wire Reports   
Wednesday, 17 April 2013 18:32
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 17, 2013.

GlaxoSmithKline and Theravance (NASDAQ: THRX)
announced the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US FDA voted the efficacy and safety data provide substantial evidence to support approval of BREO™ ELLIPTA™ as a once-daily inhaled treatment for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) (9 for, 4 against) and also for the reduction of COPD exacerbations in patients with a history of exacerbations (9 for, 4 against)*.

BREO™ ELLIPTA™, is the proposed proprietary name for FF/VI 100/25 mcg, a combination of the inhaled corticosteroid (ICS) fluticasone furoate "FF" and the long acting bronchodilator (LABA) vilanterol "VI" (FF/VI).

The FDA Advisory Committee also voted that the safety of FF/VI 100/25 mcg once daily in COPD has been adequately demonstrated for the proposed indications (10 for, 3 against).

Patrick Vallance, GSK's President of Pharmaceuticals, R&D, said: "We are pleased with the outcome of today's meeting. COPD is a debilitating and progressive disease. Its symptoms are often severe and can have a huge impact on patients' lives. This positive recommendation is a crucial first step towards making BREO ELLIPTA available for appropriate COPD patients across the US. We look forward to a final decision from the FDA later this year."

"After a decade of development in this programme, our collaboration with GSK is one step closer to providing an important therapeutic option to COPD patients," said Rick E Winningham, Chief Executive Officer of Theravance. "We are proud to collaborate with GSK on the development and potential commercialisation of treatments for COPD and other respiratory diseases. The panel's positive recommendation of BREO ELLIPTA represents an important achievement in a transformative year for Theravance."

In July 2012, a New Drug Application (NDA) was submitted to the FDA for the use of BREO™ administered by the ELLIPTA™ inhaler for the long-term once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema, and to reduce exacerbations of COPD in patients with a history of exacerbations.

In June 2012, a regulatory application for FF/VI was submitted in the European Union under the trade name RELVAR™ for the treatment of patients with COPD and asthma. In the United States, BREO ELLIPTA is not proposed for the relief of acute bronchospasm or for the treatment of asthma. GSK and Theravance are reviewing the strategy for a future US filing for asthma.

The FDA Advisory Committee provides non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA. The Prescription Drug User Fee Act (PDUFA) goal date for FF/VI is 12 May 2013.

*One panel member indicated that he intended to vote no, however a vote cannot be changed once read into the official FDA record.



======


Neuralstem, Inc. (NYSE: CUR)
announced it has received approval from the FDA to commence a Phase II trial using NSI-566 spinal cord-derived human neural stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). This Phase II dose escalation and safety trial will expand to two centers, Emory University Hospital in Atlanta, Georgia, where Phase I was recently completed, and ALS Clinic at the University of Michigan Health System, in Ann Arbor, Michigan, subject to approval by the Institutional Review Board at each institution.

The trial is designed to treat up to 15 patients, in five different dosing cohorts. All of the patients will be ambulatory and reside within close geographic proximity to the research center where they will participate. The first 12 patients will receive injections in the cervical region of the spinal cord only, where the stem cells could help preserve breathing function.  The final three patients will receive both cervical and lumbar injections.



Also Wednesday:



Alkermes plc (NASDAQ: ALKS)
today announced positive preliminary topline results from a phase 2 study of ALKS 5461, its novel drug compound for major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression.

Arrhythmia Research Technology, Inc. (NYSE MKT: HRT)
(the "Company") reported today that it was unable to file its annual report on Form 10-K for the fiscal year ended December 31, 2012 within the automatic extension of its due date to April 16, 2013 afforded by its filing of a Form 12b-25 Notification of Late Filing with the Securities and Exchange Commission.

BIOLASE, Inc. (NASDAQ: BIOL)
, the world's leading dental laser manufacturer and distributor, announced today that it recently entered into a royalty agreement with Lambda S.p.A. (Lambda) which resulted in a payment from Lambda for past royalties and established a royalty rate for Lambda to pay on future sales.

BioLineRx (NASDAQ:BLRX) (TASE:BLRX)
, a biopharmaceutical development company, announced today positive Phase IIa results for BL-7040, an orally available drug for treating inflammatory bowel disease (IBD).

Celsus Therapeutics (OTCQB: MRRBY)
, an emerging growth, development-stage biotech company, announced today that the United States Patent and Trademark Office (USPTO) has granted patents with claims covering Composition of Matter and Method of Treatments for clinical drug product candidates MRX-4 for the treatment of allergic rhinitis, MRX-5 for the treatment of inflammatory bowel disease, and MRX-6 for the treatment of dermatitis, and pre-clinical product candidate OPT-1 for the treatment of conjunctivitis.

Cerus Corporation (NASDAQ:CERS)
announced today that its first quarter results will be released on Tuesday, April 30, 2013, after the close of the stock market.

Covidien (NYSE: COV)
, a leading global provider of healthcare products, is launching two new surgical access devices at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), which starts today.

Edwards Lifesciences Corporation (NYSE: EW)
, the global leader in the science of heart valves and hemodynamic monitoring, plans to announce its operating results for the quarter ended March 31, 2013 after the market closes on Tuesday, April 23, 2013 and will host a conference call at 5:00 p.m. ET that day to discuss its results.

Eli Lilly and Company (NYSE: LLY)
today announced it has acquired two investigational positron emission tomography (PET) tracers from Siemens Medical Solutions USA, Inc.

ERBA Diagnostics, Inc. (NYSE MKT: ERB)
, a fully integrated in vitro diagnostics company, announced today that it is delaying the filing of its Annual Report on Form 10-K for the year ended December 31, 2012 with the Securities and Exchange Commission (the “SEC”).

Genomic Health, Inc. (Nasdaq: GHDX)
today announced that the Journal of Clinical Oncology(JCO) published positive results from the large CALGB 9581 clinical validation study of the Oncotype DX®colon cancer test in stage II colon cancer patients.

Harbor Island Development Corp. (OTCQB: HIDC)
, (the “Company”), through its wholly owned subsidiary BrandSeed Media Services LLC. (“BrandSeed”), a multi-channel direct marketing service provider, today announced that the Company signed an exclusive print marketing agreement with American Enhancement Products, Inc. (“AEP”), a global consumer products company.

InterMune, Inc. (NASDAQ: ITMN)
today announced that it will release its first quarter 2013 financial results at the close of the U.S. markets on Wednesday, April 24, 2013.

KaloBios Pharmaceuticals (Nasdaq: KBIO)
today announced that David Pritchard, President and Chief Executive Officer, will speak at the BIO 2013 International Convention in Chicago, IL on Tuesday, April 23 as part of a panel entitled, "New Defenses Against Old Enemies: Vaccines and Biotherapies for Bacterial Infection."

Mast Therapeutics, Inc. (NYSE MKT: MSTX)
today announced that two posters for its lead product candidate, MST-188, were presented at the 7th Annual Sickle Cell Disease Research & Educational Symposium, currently underway in Miami.  

Medicago Inc. (TSX: MDG; OTCQX: MDCGF)
, a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs) and The Infectious Disease Research Institute (IDRI), a Seattle-based non-profit research organization that is a leading developer of adjuvants used in vaccines combating infectious disease, today reported positive interim results from a Phase I clinical trial for an H5N1 Avian Influenza VLP vaccine candidate ("H5N1 vaccine").

Mesa Laboratories, Inc. (NASDAQ: MLAB)
(we, us, our, "Mesa" or the "Company") today announced that its Board of Directors has declared a regular quarterly dividend of $0.14 per share of common stock.

NeuroMetrix, Inc. (Nasdaq: NURO)
, today said it plans to issue its 2013 first quarter financial results before the opening of the market on April 25, 2013.

Omeros Corporation (NASDAQ: OMER)
today announced that it has filed an Application for Orphan Drug Designation with the U.S. Food and Drug Administration (FDA) for OMS721, the lead human monoclonal antibody in Omeros' mannan-binding lectin-associated serine protease-2 (MASP‑2) program, for use in the treatment of atypical hemolytic uremic syndrome (aHUS).

OncoSec Medical Inc. (OTCQB: ONCS)
, a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumor cancers, announced that Punit Dhillon, President and CEO, will present a company overview at the 2013 BIO International Convention.

PharmAthene, Inc. (NYSE MKT: PIP)
, a biodefense company developing medical countermeasures against biological and chemical threats, announced today that the U.S. Army Medical Research Institute for Chemical Defense has completed initial in vitro testing of the Company's recombinant butyrylcholinesterase (rBChE) bioscavenger demonstrating that it successfully targets and binds to a broad spectrum of nerve agents, including sarin and tabun, which are believed to be part of the Syrian chemical weapons inventory.

Quest Diagnostics (NYSE: DGX)
, the world's leading provider of diagnostic information services, announced today that it has entered into a definitive agreement to acquire lab-related clinical outreach service operations of Dignity Health, a hospital system based in California.

Santarus, Inc. (NASDAQ: SNTS)
and Pharming Group NV (NYSE Euronext: PHARM) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to obtain marketing approval for RUCONEST® (recombinant human C1 esterase inhibitor) 50 U/kg, an investigational drug for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE).

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA)
today presented data from a sub-analysis of a Phase III clinical trial of Milprosa™ (progesterone) vaginal ring, an investigational, once-weekly therapy for luteal phase support in women undergoing in vitro fertilization (IVF).

Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA)
, announced today that it has named Paolo Baroldi, M.D., Ph.D. as its Senior Vice President and Chief Medical Officer.

Ventripoint Diagnostics (TSX VENTURE:VPT) (OTCQX:VPTDF)
is announcing the granting of a CE Mark by the European Notified Body, Intertek Semko AB, for its NRV™ application for the analysis of 2-D ultrasound images for patients with non-specific heart disease.

Yasheng Group (OTCQB: HERB)
, a diversified China-based agricultural conglomerate with US headquarters in California, today announced that it has successfully completed the first shipment of its new Angel Star infant and toddler formulas from the United States to China.



"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'.

Add this page to your favorite Social Bookmarking websites
Digg! Reddit! Del.icio.us! Mixx! Google! Live! Facebook! Technorati! StumbleUpon! MySpace! Yahoo!

blog comments powered by Disqus
 

Newsletter