Pfizer Announces FDA Acceptance for Review of Application to Expand Labeling for XELJANZ® Print E-mail
By Staff and Wire Reports   
Friday, 21 June 2013 18:22

Below is a look at some of the headlines for companies that made news in the healthcare sector on June 21, 2013.

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA)for the XELJANZ® (tofacitinib citrate) rheumatoid arthritis (RA) indication seeking expansion of the label to include inhibition of progression of structural damage. The FDA will review the sNDA and is expected to provide a decision by February 2014, based on the anticipated Prescription Drug User Fee Act (PDUFA) action date for the sNDA.

XELJANZ 5 mg twice daily (BID) was approved by the FDA in November 2012 for the treatment of adults with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate (MTX), and is the first approved RA treatment in a new class of medicines known as Janus kinase (JAK) inhibitors. In the United States, XELJANZ may be used as monotherapy or in combination with MTX or other non-biologic disease-modifying antirheumatic drugs (DMARDs). XELJANZ should not be used in combination with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine.

The sNDA is supported by the results of ORAL Start (A3921069), a 24-month Phase 3 randomized, double-blind, controlled trial in MTX-naïve patients with moderately to severely active RA who were randomized to receive XELJANZ 5 or 10 mg BID or MTX. A pre-planned interim 12-month analysis showed that XELJANZ 5 and 10 mg BID as monotherapy were superior to MTX, with statistically significantly greater inhibition of structural damage, as measured by mean change from baseline in the van der Heijde modified Total Sharp Score (mTSS), and statistically significantly greater improvement in signs and symptoms of RA, as measured by ACR70 response rates. Both primary endpoints assessed XELJANZ versus MTX at six months. No new safety signals emerged in the ORAL Start study, and the safety profile of XELJANZ was consistent with that seen previously in the clinical development program.

ORAL Start data were first presented at the American College of Rheumatology Annual Meeting in November 2012. The results of ORAL Start were not included in the New Drug Application to the FDA for XELJANZ as the study was ongoing at the time of the original regulatory submission.

Also Friday:

Amarantus BioScience Holdings, Inc. (OTCQB: AMBS), a biotechnology company discovering and developing treatments and diagnostics for diseases associated with neurodegeneration and apoptosis, today announced that it plans to evaluate its LymPro Test® as a potential diagnostic and prognostic for Chronic Traumatic Encephalopathy (CTE).

Amarin Corporation plc (Nasdaq: AMRN)
, a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today the results from a Phase 1 clinical trial that compared bioavailability of components from a fixed-dose combination of its flagship product, Vascepa® (icosapent ethyl), plus rosuvastatin, to concomitant administration of the two agents independently, and to rosuvastatin alone.

athenahealth, Inc. (Nasdaq:ATHN)
, a leading provider of cloud-based services for electronic health record (EHR), practice management and care coordination, today announced that it has been named one of the Best Places to Work in Massachusetts by The Boston Business Journal.

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)
announced today that on June 20, 2013, it received a letter from NASDAQ informing BioSante that, since the merger with ANIP Acquisition Company d/b/a ANI Pharmaceuticals, Inc. (ANI) constituted a business combination resulting in a change of control under Listing Rule 5110(a), BioSante was required to meet the initial listing criteria for the NASDAQ Global Market.

Cardium Therapeutics (NYSE MKT: CXM)
held its reconvened Annual Meeting of Stockholders earlier today and has temporarily adjourned the meeting to Tuesday, July 2, 2013, at 1:00 p.m. Pacific, at the same location.

China Green Agriculture, Inc. (NYSE: CGA)
, a company that mainly produces and distributes humic acid-based compound fertilizers, other varieties of compound fertilizers and agricultural products through its wholly-owned subsidiaries in China, today announced that one of the Company's wholly-owned subsidiaries organized under the laws of the PRC, Beijing Gufeng Chemical Products Co., Ltd. ("Gufeng"), was engaged by the Ministry of Agriculture ("Ministry") as a corporate participant in the Ministry-administered fertilizer promotion program.

Coronado Biosciences, Inc. (Nasdaq:CNDO)
, a biopharmaceutical company focused on the development of novel immunotherapy biologic agents for the treatment of autoimmune diseases and cancer, announced today that Dr. Harlan F. Weisman, Coronado's Chairman and CEO, will participate in the upcoming investor conferences.

iCAD, Inc. (Nasdaq: ICAD)
, a leading provider of advanced imaging and radiation therapy technologies for the detection and treatment of cancer, today announced that the Company will join the Russell Microcap® Index when Russell Investments reconstitutes its comprehensive set of U.S. and global equity indexes on June 28, 2013, according to a preliminary list of additions posted June 14, 2013 on www.russell.com/indexes.

Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today announced that it will present positive Phase 1 trial results on IMO-8400, a selective inhibitor of Toll-like receptors (TLRs) 7, 8 and 9 and a lead candidate for the treatment of autoimmune diseases, at the 13th Annual Meeting of the Federation of Clinical Immunology Societies (FOCIS), June 27-30, 2013, in Boston, MA.

InSite Vision Incorporated (OTCBB: INSV) today announced that the company has regained North American development rights to azithromycin ophthalmic solution 2%, trademarked as AzaSite Xtra™, from Inspire Pharmaceuticals Inc., a subsidiary of Merck & Co., Inc., known as MSD outside the United States and Canada. AzaSite Xtra, formulated in InSite’s DuraSite® topical drug delivery system, is a product candidate intended for the topical treatment of ocular infections.

Merge Healthcare Incorporated (Nasdaq:MRGE), a leading provider of clinical systems and innovations that seek to transform healthcare, today announced the eClinical OS™ Marketplace, extending its clinical trial platform to connect customers with premier industry service providers.

Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP)
(http://www.oramed.com), a developer of oral drug delivery systems, announced today that it will be presenting its abstract titled, "Dose response to oral insulin capsules in fasting, healthy subjects," at the 73rd Scientific Sessions of the American Diabetes Association, on June 21st through 25th, 2013, in Chicago, Illinois, USA.

Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that it has withdrawn the previously announced proposed underwritten public offering of its common stock due to market conditions.

PuraMed BioScience®, Inc., (OTCBB:PMBS), a researcher, developer, and marketer of over-the-counter (OTC) medicinal and healthcare products, announced the science behind LipiGesic® M, its homeopathic, over-the-counter migraine medication.

Santarus, Inc. (NASDAQ: SNTS) and VeroScience, LLC today announced that clinical data on CYCLOSET® (bromocriptine mesylate) will be featured in two poster presentations at the 73rd Scientific Sessions of the American Diabetes Association being held at McCormick Place in Chicago, Ill. from June 21 – 25, 2013.

Seattle Genetics, Inc. (Nasdaq: SGEN)
today highlighted multiple ADCETRIS (brentuximab vedotin) data presentations at the 12th International Conference on Malignant Lymphoma (ICML) being held June 19-22, 2013 in Lugano, Switzerland.

Soligenix, Inc. (OTCQB: SNGX)
, a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there remains an unmet medical need, announced today the pricing of a registered public offering of shares of common stock and warrants to purchase common stock.

Teva Women’s Health, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved the emergency contraceptive Plan B One-Step® (levonorgestrel) tablet 1.5 mg for over-the-counter sale to all consumers in the United States.




"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'.

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