|Bayer, J&J's Xarelto Gets FDA Priority Review; Auxilium and Actelion Announce Approval of XIAFLEX®|
|By Staff and Wire Reports|
|Monday, 09 July 2012 19:43|
Bayer (PINK:BAYRY) and Johnson & Johnson's (NYSE:JNJ) anti-blood-clotting pill Xarelto won priority review status from the U.S. FDA for the treatment of deep vein thrombosis and pulmonary embolism.
The priority review also includes the drug's use in the long-term prevention of venous thromboembolism in patients who have already suffered an attack, the German drugmaker and its U.S. partner said on Monday.
Thromboembolism is the clogging up of veins, typically in the leg, which is a major risk for bed-ridden or immobile patients. If such a blood clot dislodges and travels to the lungs, it can cause potentially deadly pulmonary embolism, meaning parts of the lungs get cut off from blood supplies.
An FDA priority review takes six months rather than the usual 10 to 12-months. Bayer also said it would for now withdraw its request for FDA approval of using Xarelto to cut risk of blood clots developing in heart stents. The request was filed on May 9. The move is linked to a separate request, which it had been forced to rework. U.S. regulators last month declined to approve a new use for Xarelto to reduce the risk of heart attacks and strokes in patients with acute coronary syndrome, and Bayer and J&J are now working on a renewed application that will also include the use for stent patients.
Xarelto is one of three new medicines that offer potential advantages over older drugs to prevent strokes and other dangerous conditions caused by blood clots.
Pfizer Inc (NYSE:PFE) and Bristol-Myers Squibb Co's (NYSE:BMY) Eliquis and private German drugmaker Boehringer Ingelheim's Pradaxa are the other drugs.
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced that it will present at the 7th Annual JMP Securities Healthcare Conference on Friday, July 13, 2012, at 11:00 a.m. Eastern Time at The Peninsula Hotel in New York City.
Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) and Actelion Pharmaceuticals Canada Inc. announced Auxilium was granted a Notice of Compliance (approval) by Health Canada for XIAFLEX® (collagenase clostridium histolyticum or CCH), a novel, first-in-class biologic for the treatment of Dupuytren's contracture in adults with a palpable cord in Canada.
Under the terms of the Collaboration Agreement between Actelion and Auxilium, Actelion received exclusive rights to commercialize XIAFLEX for the treatment of Dupuytren's contracture and Peyronie's disease in Canada, Australia, Brazil and Mexico upon receipt of the respective regulatory approvals. Pursuant to the Collaboration Agreement, Auxilium intends to transfer regulatory sponsorship of the dossier to Actelion and Actelion will be primarily responsible for the applicable regulatory and commercialization activities for XIAFLEX in Canada and, upon approval, in the remainder of these countries. Actelion expects to make XIAFLEX available to patients in Canada in the first half of 2013.
Jacques Archambault, General Manager of Actelion Pharmaceuticals Canada commented: "The approval of XIAFLEX in Canada is excellent news for Canadian patients and for Actelion. This milestone is the signal to Actelion's organization to move quickly and diligently to make XIAFLEX available to Canadian patients as soon as possible."
Advanced Cell Technology, Inc. (OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the Data and Safety Monitoring Board (DSMB), an independent group of medical experts closely monitoring the company’s three ongoing clinical trials, has authorized the company to move forward with enrollment and treatment of additional patients in its clinical trial for dry age-related macular degeneration (dry AMD).
Affymax, Inc. (Nasdaq: AFFY) today announced the promotion of Michael Holfinger, Ph.D., to vice president, manufacturing and CMC development.
Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), a biopharmaceutical company developing innovative proprietary drugs for inflammation, eye disease, kidney disease, CNS disease, metabolic disease and male sexual dysfunction and conducting clinical trials on its three lead drugs (Ampion™ , Optina™ & Zertane™), announced the significant results from their further analysis of its Optina™ trial on DME .
Anavex Life Sciences Corp. (OTCBB: AVXL) today announced that new data on ANAVEX 2-73, the company's lead compound for Alzheimer's disease currently in human clinical trials, will be presented in a poster session at the 2012 Alzheimer's Association International Conference (AAIC) in Vancouver, BC, Canada.
AptarGroup, Inc. (NYSE: ATR) today announced it completed the acquisition of the Stelmi Group, in early July, after receiving the necessary regulatory approvals.
AtheroNova Inc. (OTCBB: AHRO), a biotech company focused on the research and development of compounds to regress atherosclerotic plaque, announced that it has received a Notice of Allowance for its patent application for Dissolution of Arterial Plaque.
Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) and Actelion Pharmaceuticals Canada Inc. announced today that Auxilium was granted a Notice of Compliance (approval) by Health Canada for XIAFLEX® (collagenase clostridium histolyticum or CCH), a novel, first-in-class biologic for the treatment of Dupuytren's contracture in adults with a palpable cord in Canada.
BIOLASE, Inc. (NASDAQ: BIOL), the world's leading dental laser manufacturer and distributor, announced today that the Company has voluntarily elected to re-file Exhibit 10.32 to its Annual Report on Form 10-K for the fiscal year ended December 31, 2011 (the "2011 Form 10-K"). Exhibit 10.32 is the settlement agreement ("Agreement") dated February 22, 2012 by and between the Company and Henry Schein (NASDAQ: HSIC).
BioLife Solutions, Inc. (OTCBB: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media for cells and tissues, and contract media manufacturer, today announced that it expects to report record revenue of $1,092,450 for its second quarter ended June 30, 2012, up approximately 76 percent from last year's second quarter, and up 31 percent from the first quarter of this year.
BioLineRx (NASDAQ:BLRX) (TASE:BLRX), a biopharmaceutical development company, announced today that it has received from the European Patent Office a notice of intention to grant a European patent claiming the salt of BL-1020, a first-in-class orally available treatment for schizophrenia.
BSD Medical Corporation (NASDAQ:BSDM) (Company or BSD) (www.BSDMedical.com), a leading provider of medical systems that utilize heat therapy to treat cancer, announced today that the Company has sold a MicroThermX® Microwave Ablation System (MicroThermX®) to the University of Miami Hospital and Clinics (UMHC) to include the Sylvester Comprehensive Cancer Center (Sylvester) and the University of Miami Hospital.
Cellceutix Corporation (OTCBB: CTIX) (the "Company"), a biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, reports today that a Site Initiation Visit ("SIV") has been scheduled in July at the host hospitals, Harvard Cancer Center's Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center, for the Company's clinical trials of Kevetrin™, a novel anti- cancer drug for treating cancers.
Cord Blood America, Inc. (OTCBB: CBAI) ("CBAI" or the "Company") today announced it has signed a new Securities Purchase Agreement and related documents with Tonaquint, Inc. ("Tonaquint"), including a Secured Convertible Promissory Note in the amount of $1,252,000.
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company specializing in oncology, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a notice of allowance for a patent application with claims covering a pharmaceutical composition of tamibarotene in capsule form.
Emergent BioSolutions Inc. (NYSE: EBS) announced today that it will report financial results for the second quarter 2012 on Thursday, August 2, 2012, after market close.
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that Greg S. Lea, SVP and Chief Financial Officer, is scheduled to present at the 7th Annual JMP Securities Healthcare Conference on Friday, July 13, 2012 at 1:30 pm Eastern Time, at the Peninsula Hotel, New York, NY.
Five Star Quality Care, Inc. (NYSE: FVE) today announced that it has entered into an agreement to sell its pharmacy business to Omnicare Inc. for $30.7 million.
Forest Laboratories, Inc. (NYSE: FRX) today announced that it has filed definitive proxy materials with the Securities and Exchange Commission (SEC) in connection with its 2012 Annual Meeting of Shareholders, which will be held on August 15, 2012.
Given Imaging Ltd. (NASDAQ: GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced that the Intellectual Property Tribunal of the Korean Intellectual Property Office (KIPO) ruled last week that Given Imaging's two Korean patents asserted against Intromedic Co. Ltd. in Seoul's Central District Court are valid.
InterMune, Inc. (NASDAQ: ITMN) today announced that Jonathan A. Leff, M.D., Executive Vice President, Research and Development of InterMune, will present at the JMP Securities 7th Annual Healthcare Conference in New York on Thursday, July 12 at 12:30 p.m. EDT.
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today that John Higgins, President and Chief Executive Officer of Ligand, will present at the JMP Securities 7th Annual Healthcare Conference on Thursday, July 12, 2012 at 10:00 a.m. Eastern (7:00 a.m. Pacific Time).
MELA Sciences, Inc. (NASDAQ: MELA), the medical device company that has developed MelaFind®, today announced positive results of its study of MelaFind with German dermatologists.
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on the development and commercialization of precision diagnostics and radiopharmaceutical agents, today announced that Dr. Mark Pykett, Navidea’s President and Chief Executive Officer, will participate at the JMP Securities Healthcare Conference on July 12-13, 2012 at the Peninsula Hotel in New York City.
NHS Health Solutions, Inc.'s (PINKSHEETS: NHSH) subsidiary Mineseeker Operations Overseas Limited ("Mineseeker"), has entered in to a Memorandum of Understanding with Columbian based Fastcol Inc. ("Fastcol") to bring its landmine survey technology to South and Central America.
Organovo Holdings, Inc. (OTCQB: ONVO), a biotechnology company focused on delivering breakthrough three-dimensional (3D) bioprinting technology, today announced that James T. Glover has been appointed to the Company's Board of Directors.
Senomyx, Inc. (NASDAQ: SNMX), a company using proprietary taste science technologies to discover novel flavor ingredients for the food, beverage, and ingredient supply industries, announced today that the Company’s flavor modifiers for sucrose (S6973) and sucralose (S2383), and its bitter blockers (S6821 and S7958) have received positive determinations regarding safety from the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that the NASDAQ ticker symbol for Shire's American Depositary Shares ("ADSs") will change from "SHPGY" to "SHPG" on and from the opening of NASDAQ trading on July 11, 2012.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, announced today that an overview of the Company's business strategy will be given at the 2012 JMP Securities Healthcare Conference being held at The Peninsula Hotel in New York City.
SpectraScience, Inc. (PINKSHEETS: SCIE) (OTCQB: SCIE), a San Diego-based medical device company, today announced that it expects revenue of approximately $310,000 for the second quarter ended June 30, 2012.
SurModics IVD Inc., a wholly owned subsidiary of SurModics, Inc. (Nasdaq: SRDX) and a market leader for in vitro diagnostic assay components, is pleased to announce it will launch BioFX® TMB Extended Range HRP Microwell Substrate (TMBX) at the American Association for Clinical Chemistry show in Los Angeles, CA from July 17-19, 2012.
Tonix Pharmaceuticals Holding Corp. (OTCBB: TNXP) (“TONIX” or the “Company”), a specialty pharmaceutical company developing non-addictive treatments for chronic pain syndromes, including fibromyalgia (“FM”), today reported positive data from an animal pharmacokinetic (“PK”) study of its novel sublingual (“SL”) formulation of TNX-102, the Company’s very low dose cyclobenzaprine.
Verastem, Inc., (NASDAQ: VSTM) a biopharmaceutical company focused on discovering and developing drugs to treat breast and other cancers by targeting cancer stem cells, announced that the Company will present at the JMP Securities Healthcare Conference 2012 on July 13, 2012, in New York City.