Teva Issues Results from Final Phase III Study of Armodafinil for Depression; Bayer's Stivarga Approved in Europe Print E-mail
By Staff and Wire Reports   
Friday, 30 August 2013 18:41
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 30, 2013.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced top-line results of its final Phase III clinical study for armodafinil (NUVIGIL®) as adjunct therapy in adults with major depression associated with bipolar I disorder. The study reached statistical significance in several important secondary endpoints, such as responder rate and remission. However, it did not reach its primary endpoint --to determine whether armodafinil treatment (150mg per day) is more effective than placebo as adjunct therapy to mood stabilizers and/or atypical antipsychotics.

This study was the third of three, Phase III studies, all of which demonstrated improvements in patient response. However, based on an evaluation of the totality of results, Teva will not proceed with regulatory filings for armodafinil for the treatment of major depression associated with bipolar I disorder. There is no material impact to the Company.



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Bayer HealthCare (OTC: BAYRY) and Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX)
announced today that the European Commission has approved Stivarga® (regorafenib) tablets for the treatment of adult patients with metastatic colorectal cancer (mCRC).

In September 2012, Stivarga was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.

The approval of Stivarga was based on data from the pivotal Phase III CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial. Full results from the CORRECT study were presented at the 48th Annual Meeting of the American Society of Clinical Oncology in June 2012 and published online on November 22, 2012 in The Lancet.

About Stivarga® (regorafenib) Tablets In the United States, Stivarga is indicated for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. It is also indicated for the treatment of patients with locally advanced, unresectable or metastatic GIST who have been previously treated with imatinib mesylate and sunitinib malate.

Stivarga is an inhibitor of multiple kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, and maintenance of the tumor microenvironment.

Stivarga is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the United States. In 2011, Bayer entered into an agreement with Onyx, under which Onyx receives a royalty on all global net sales of Stivarga in oncology.




Also Friday:




Acme United Corporation (NYSE MKT: ACU)
, a leading worldwide supplier of innovative cutting, measuring and safety products to the school, home, office, hardware and industrial markets, has been invited to present at the 2013 Gateway Conference being held on Tuesday, September 10, 2013 at the Palace Hotel in San Francisco.

Biomerica, Inc. (OTCBB: BMRA), a global provider of advanced diagnostic products for the early detection of medical conditions, today reported net sales for the fiscal year 2013 were $6,472,960 versus net sales of $6,081,131 in fiscal 2012, an increase of 6.4%.

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY)
, announced today that the European Commission has granted marketing authorization for Aubagio® (teriflunomide) 14 mg, a once-daily, oral therapy indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS).

Mauna Kea Technologies (Paris:MKEA) (NYSE Euronext: MKEA, FR0010609263)
, leader in the optical biopsy market and developer of Cellvizio®, today reported its full financial results for the first half of this fiscal year, ended June 30, 2013 and approved by the Board on August 30th.

MediSwipe Inc. (OTCQB: MWIP)
, the leader in Compassionate Care Technology Solutions for the medicinal marijuana industry, today announced that the Company has entered into an agreement with several Colorado based dispensaries to provide Mello Meal™ boxes as secure packaging for edibles and patient medicine on behalf of dispensaries and caregivers, Hemp based beverages including "Chillo and C+Swiss" and begin to provide financial payment solutions for alternatives to cash only transactions for state licensed dispensaries eligible for the recreational market in 2014.

Press Ventures Inc. (OTCQB:PVEN)
, is pleased to announce that the Company has completed an initial $250,000 USD private placement financing from a foreign institutional investor.

The Radiant Creations Group, Inc. (OTCBB: RCGP)
has completed its first product in the REVIVASOL product line and has received initial orders.

SK3 Group, Inc. (PINKSHEETS: SKTO)
has announced that it is moving its headquarters to Irvine, California.

Targeted Medical Pharma, Inc. (OTCQB: TRGM)
today announced that the company will begin a clinical trial on a new medical food indicated for the dietary management of Autism and Autism Spectrum Disorders.

Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM)
, a leading developer of RNA interference (RNAi) therapeutics, announced the publication of two articles in peer-reviewed scientific journals – the Journal of Infectious Diseases and New England Journal of Medicine – that highlight results enabled by Tekmira's lipid nanoparticle (LNP) technology.

TESARO, Inc. (Nasdaq:TSRO)
, an oncology-focused biopharmaceutical company, announced that Lonnie Moulder, CEO of TESARO, and Mary Lynne Hedley, Ph.D., President of TESARO, will participate in several upcoming investor conferences during the month of September

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA)
today announced top-line results of its final Phase III clinical study for armodafinil (NUVIGIL®) as adjunct therapy in adults with major depression associated with bipolar I disorder.

TOMI™ Environmental Solutions, Inc. (OTCQB: TOMZ)
, a global bacteria decontamination and infectious disease control company, by invitation of The Minister of Health of the Kingdom of Saudi Arabia and Sheikh Abdullah Al-Meleihi, the Chairman of the Al Ramez Establishments for Medical Supplies A DIVISION ALRAMEZ GROUP lead a symposium entitled “Insights and Solutions for Emerging Viruses and Infectious Diseases” in Riyadh on August 29, 2013 at the Riyadh Marriott Conference Center. Sheikh Abdullah Al-Meleihi stated, “We are bringing in the TOMI™ team to share their knowledge about these deadly infectious diseases, as well as to learn their approaches and solutions.

Verisante Technology, Inc. (TSX VENTURE:VRS) (OTCQX:VRSEF)
, a leader in cancer detection technology, announced today that the Company has released its financial results for the second quarter ended June 30, 2013.



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