http://www.biospace.comBioSpace RSS GeneratorWed, 19 Jun 2013 14:56:19 GMT20http://rss.biospace.com/images/BSPLogo.gifhttp://www.BioSpace.com/news.aspx?SectionId=1Copyright (C) 2011http://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20130614005057&newsLang=enStaying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br>BOCA RATON, Fla.--(BUSINESS WIRE)--TherapeuticsMD, Inc. (NYSE MKT: TXMD), a womens healthcare company focused on developing and commercializing products targeted exclusively for women, today announced that...Thu, 13 Jun 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20130610005456&newsLang=enStaying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br>NEW PROVIDENCE, N.J.--(BUSINESS WIRE)--Edge Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing life-saving hospital products for acute, fatal or debilitating...Mon, 10 Jun 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=299422&full=1Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br><div id"releaseBody"><p>SAN DIEGO, CA--(Marketwired - June 07, 2013) - Regen BioPharma, wholly owned subsidiary of <b>Bio-Matrix Scientific Group, Inc.</b> (OTCQB: <a href"http://www.marketwire.com...Fri, 07 Jun 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=299168&full=1Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br><div class"xn-content"><p><span class"xn-location">ALISO VIEJO, Calif.</span>, <span class"xn-chron">June 5, 2013</span> /PRNewswire/ -- <b>Avanir Pharmaceuticals, Inc.</b> (NASDAQ: AVNR) today announced...Wed, 05 Jun 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=298981&full=1Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br><div id"releaseBody"><p>SAN DIEGO, CA--(Marketwired - June 04, 2013) - <a href"http://www.ljpc.com/">La Jolla Pharmaceutical Company</a> (OTCQB: <a href"http://www.marketwire.com/mw/stock.jsp?Ticker...Tue, 04 Jun 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=298982&full=1Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br><div id"releaseBody"><p>MONTREAL--(Marketwired - June 04, 2013) - Sunshine Biopharma Inc. (OTCQB: <a href"http://www.marketwire.com/mw/stock.jsp?TickerSBFM">SBFM</a>), a pharmaceutical company focused...Tue, 04 Jun 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=298260&full=1Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br>CHARLOTTESVILLE, Virginia and CHARLOTTE, North Carolina, May 29, 2013 /PRNewswire/ --</p><p>Biovista and the CFIDS Association of America announced today the successful completion of the first phase of...Wed, 29 May 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=297797&full=1Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br> <div class"xn-content"><p /><p><span class"xn-location">SEATTLE</span>, <span class"xn-chron">May 23, 2013</span> /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that its Investigational...Thu, 23 May 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20130522005478&newsLang=enStaying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br>MOUNT KISCO, N.Y.--(BUSINESS WIRE)--Perosphere Inc. announced today that it has received U.S. Food and Drug Administration ("FDA") Investigational New Drug ("IND") clearance to initiate clinical investigations...Wed, 22 May 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=297132&full=1Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br> JERUSALEM, May 17, 2013 /PRNewswire/ --</p><p>Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that the United States...Fri, 17 May 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20130506005856&newsLang=enStaying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br>WATERTOWN, Mass.--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc., (NASDAQ: ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease...Mon, 06 May 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=295167&full=1Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br><div class"xn-content"><p><span class"xn-location">GERMANTOWN, Md.</span>, <span class"xn-chron">May 2, 2013</span> /PRNewswire/ -- RNL BIO, a stem cell biotechnology company dedicated to the commercialization...Thu, 02 May 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20130425006985&newsLang=enStaying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br>TOKYO--(BUSINESS WIRE)--R-Tech Ueno (JASDAQ: 4573): This is to announce that we have submitted IND(Note1) application to US Food and Drug Administration (FDA(Note2)) for clinical trials of recombinant human...Fri, 26 Apr 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20130417006282&newsLang=enSEOUL, Korea--(BUSINESS WIRE)--The Korea-based international pharmaceutical company, SK Biopharmaceuticals, announced today the U.S. Food and Drug Administration (FDA) has authorized the Investigational New Drug (IND) application for SKL15508 to treat cognitive impairment associated with schizophrenia (CIAS). SK Biopharmaceuticals has developed this novel drug since 2007, taking the approach that while...Wed, 17 Apr 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=293430&full=1<div class"xn-content"><p><span class"xn-location">CHARLESTON, S.C.</span>, <span class"xn-chron">April 16, 2013</span> /PRNewswire/ -- Charleston Laboratories, Inc, an emerging specialty pharmaceutical company focused on the research and development of novel pain products that prevent or significantly reduce nausea and vomiting related to opioid analgesics and other pain associated disease states...Tue, 16 Apr 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=293071&full=1JERUSALEM, April 11, 2013 /PRNewswire/ --Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (http://www.oramed.com), adeveloper of oral drug delivery systems, announced today that it has submitted anew Investigational New Drug (IND) application with the U.S. Food and DrugAdministration (FDA) for a sub-study on its oral insulin candidate, ORMD-0801.This filing is in response to FDA feedback from...Thu, 11 Apr 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=293098&full=1<div id"releaseBody"><p>MANCHESTER, NH--(Marketwired - April 11, 2013) - <b> </b>Boston Therapeutics, Inc. (OTCQB: <a href"http://www.marketwire.com/mw/stock.jsp?TickerBTHE">BTHE</a>) ("Boston Therapeutics" or "the Company"), a pharmaceutical company developing and commercializing complex carbohydrate-based drugs to treat diabetes and inflammatory diseases, has requested an Investigational...Thu, 11 Apr 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=292940&full=1HEIDELBERG, Germany, April 10, 2013 /PRNewswire/ --</p><p>IND paves the way for the US element of a global Phase III development program with LT-02 in conjunction with European licensee Dr. Falk Pharma GmbH, whose pivotal study will start in Q4 2013</p><p>Lipid Therapeutics announces today that it has successfully filed its first US IND for its lead product LT-02 and is now in a position to...Wed, 10 Apr 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20130403005672&newsLang=enLYON, France & PHILADELPHIA--(BUSINESS WIRE)--ERYTECH Pharma SA announced today that it has received clearance of its Investigational New Drug (IND) Application from the United States Food and Drug Administration (FDA) to initiate a Phase I clinical trial of its product ERYASP, L-asparaginase loaded erythrocytes, in patients 40 years or older with newly diagnosed Acute Lymphoblastic Leukemia (ALL...Wed, 03 Apr 2013 12:00:00 AM GMThttp://www.globenewswire.com/news-release/2013/04/02/535145/10027030/en/Cleveland-BioLabs-and-Incuron-Announce-Notice-of-Allowance-From-FDA-to-Commence-Clinical-Testing-With-CBL0137.htmlBUFFALO, N.Y., April 2, 2013 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc. (Nasdaq:CBLI) and Incuron, LLC, a joint venture between the Company and Bioprocess Capital Ventures, today announced the receipt of a Notice of Allowance from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application for CBL0137. A multi-center, Phase 1, single agent, dose escalation trial evaluating...Tue, 02 Apr 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=291716&full=1 <div class"xn-content"><p><span class"xn-location">PRINCETON, N.J.</span>, <span class"xn-chron">March 27, 2013</span> /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a clinical stage biopharmaceutical company, announced today that the Food and Drug Administration (FDA) has completed its review and cleared the Investigational New Drug (IND) application for SGX942 for the...Wed, 27 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=290766&full=1<div id"releaseBody"><p>SAN DIEGO, CA--(Marketwire - March 18, 2013) - Regen BioPharma, Inc., a wholly-owned subsidiary of Bio-Matrix Scientific Group Inc. (PINKSHEETS: <a href"http://www.marketwire.com/mw/stock.jsp?TickerBMSN">BMSN</a>), announced today issuance of IND number 15376 for its proposed Phase I/II clinical trial evaluating use of its stem cell product, HemaXellerate, for treatment...Mon, 18 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=290767&full=1<div id"releaseBody"><p>MONROVIA, CA--(Marketwire - March 18, 2013) - <b> Immunotech Laboratories, Inc.</b> (PINKSHEETS: <a href"http://www.marketwire.com/mw/stock.jsp?TickerIMMB">IMMB</a>) today announced the company has begun discussions with a professional medical consulting group to start the process for Pre-IND (Investigational New Drug) application in the USA.<p>This application...Mon, 18 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=290531&full=1<div id"releaseBody"><p>MONTREAL--(Marketwire - March 14, 2013) - Sunshine Biopharma Inc. (OTCQB: <a href"http://www.marketwire.com/mw/stock.jsp?TickerSBFM">SBFM</a>), a pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, is pleased to report that it has commenced negotiations with several Contract Manufacturing...Thu, 14 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=289296&full=1<div id"releaseBody"><p>SAN DIEGO, CA--(Marketwire - March 04, 2013) - La Jolla Pharmaceutical Company (<a href"http://www.ljpc.com/">www.ljpc.com</a>) (OTCQB: <a href"http://www.marketwire.com/mw/stock.jsp?TickerLJPC">LJPC</a>) ("La Jolla" and "Company"), a leader in the development of therapeutics targeting galectin proteins (<a href"http://www.ljpc.com/technology-galectins.html">www...Mon, 04 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=288678&full=1<div id"releaseBody"><p>MONTREAL--(Marketwire - February 26, 2013) - Sunshine Biopharma Inc. (OTCBB: <a href"http://www.marketwire.com/mw/stock.jsp?TickerSBFM">SBFM</a>), a pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, is pleased to provide an update on the progress of the IND-Enabling studies of Adva...Tue, 26 Feb 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=288545&full=1<div class"xn-content"><p /><p><span class"xn-location">GREENWOOD VILLAGE, Colo.</span>, <span class"xn-chron">Feb. 25, 2013</span> /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) announced today that it's Phase III clinical study of Ampion for the treatment for osteoarthritis of the knee will include a dose-escalation run-instudy as recommended by the FDA. </p><p>(Logo: ...Mon, 25 Feb 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=287690&full=1 <div class"xn-content"><p><span class"xn-location">RALEIGH, N.C.</span>, <span class"xn-chron">Feb. 13, 2013</span> /PRNewswire-iReach/ -- Scioderm announced that the US Food and Drug Administration (FDA) has reviewed and allowed the investigational new drug (IND) application for SD-101 to proceed. SD-101 is a topical treatment being developed for the treatment of Epidermolysis Bullosa (EB). ...Thu, 14 Feb 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=287599&full=1Melbourne, Australia, 13 February 2013: Mesoblast Limited (ASX: MSB; OTC ADR: MBLTY) today announced that United States Food and Drug Administration (FDA) is in agreement for Mesoblast to supply its proprietary Mesenchymal Precursor Cells (MPCs) for clinical trials in the United States under Investigational New Drug (IND) protocols, from Lonza's contract manufacturing facility in Singapore, in addition...Wed, 13 Feb 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=286743&full=1<div id"releaseBody"><p>SAN DIEGO, CA--(Marketwire - February 05, 2013) - Regen BioPharma a wholly-owned subsidiary of Bio-Matrix Scientific Group Inc. (PINKSHEETS: <a href"http://www.marketwire.com/mw/stock.jsp?TickerBMSN">BMSN</a>), announced today filing of an Investigational New Drug (IND) application with the FDA to initiate clinical trials assessing the company's HemaXellerate I<b>&#8...Tue, 05 Feb 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20130131005087&newsLang=enNORCROSS, Ga.--(BUSINESS WIRE)--Galectin Therapeutics (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced today that it submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) on January 30, 2013. The IND application supports a proposed indication of GR-MD-02 for treatment of non-alcoholic...Thu, 31 Jan 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20130129005383&newsLang=enLOS ANGELES--(BUSINESS WIRE)--ImmunoCellular Therapeutics, Ltd. (ImmunoCellular) (NYSE MKT: IMUC) announced that the US Food and Drug Administration (FDA) has allowed the investigational new drug (IND) application for ICT-140, paving the way for conducting a clinical trial. ICT-140 is a dendritic cell vaccine targeting seven antigens that are over-expressed in ovarian cancer, as well as cancer stem...Tue, 29 Jan 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=285720&full=1<div id"releaseBody"><p>SAN DIEGO, CA--(Marketwire - January 24, 2013) - Regen BioPharma, a wholly owned subsidiary of Bio-Matrix Scientific Group Inc. (PINKSHEETS: <a href"http://www.marketwire.com/mw/stock.jsp?TickerBMSN">BMSN</a>), announced today publication in a peer reviewed medical journal the scientific basis for its HemaXellerate&#8482; bone marrow failure product. The manuscript is...Fri, 25 Jan 2013 12:00:00 AM GMThttp://www.globenewswire.com/news-release/2013/01/21/517365/0/en/FDA-has-approved-IND-application-for-clinical-trial-with-PledOx-in-the-U-S.htmlStockholm, 2013-01-21 08:30 CET (GLOBE NEWSWIRE) -- PledPharma (STO: PLED) announced today that their PledOx Phase IIb clinical trial, PLIANT, is approved by the U.S. Food and Drug Administration (FDA). The goal of the PLIANT study is that pretreatment with PledOx reduces serious side effects of the chemotherapy FOLFOX in patients treated for advanced colorectal cancer.Tue, 22 Jan 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=285334&full=1<div class"xn-content"><p /><p><span class"xn-location">GREENWOOD VILLAGE, Colo.</span>, <span class"xn-chron">Jan. 22, 2013</span> /PRNewswire/ Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE) announced today that the FDA has accepted the Company's IND for Optina for the treatment of diabetic macular edema (DME). Ampio plans to commence enrollment in a clinical trial in the first quarter of 2013. The...Tue, 22 Jan 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20130110005847&newsLang=enALPHARETTA, Ga.--(BUSINESS WIRE)--Clearside Biomedical, Inc., a privately held ophthalmic company developing and commercializing targeted therapeutics for the treatment of sight threatening diseases, announced today that the standard 30-day review period by the U.S. Food and Drug Administration (FDA) relating to Clearsides Investigational New Drug (IND) Application for CLS1001 (triamcinolone acetonide...Thu, 10 Jan 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=283784&full=1<div class"xn-content"><p><span class"xn-location">PRINCETON, N.J.</span>, <span class"xn-chron">Jan. 4, 2013</span> /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that the Food and Drug Administration (FDA) has completed its review and cleared the Investigational New Drug (IND) application for OrbeShield...Fri, 04 Jan 2013 12:00:00 AM GMThttp://www.globenewswire.com/news-release/2013/01/03/514461/10016949/en/TG-Therapeutics-Inc-Announces-FDA-Clearance-to-Commence-Clinical-Trials-of-Its-Novel-PI3K-Delta-Specific-Inhibitor-TGR-1202-Under-Its-Recently-Filed-U-S-Investigational-New-Drug-IN.htmlNEW YORK, Jan. 3, 2013 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (TGTX) today announced that the U.S. Food and Drug Administration ("FDA") has cleared its Investigational New Drug ("IND") Application for TGR-1202, the Company's novel, highly specific PI3K-Delta inhibitor being developed jointly with Rhizen Pharmaceuticals, S A.Thu, 03 Jan 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=282633&full=1<div class"xn-content"><p><span class"xn-location">NEW YORK</span>, <span class"xn-chron">Dec. 18, 2012</span> /PRNewswire/ -- Transparency Life Sciences, LLC (TLS), the world's first drug development company based on open innovation, today announced that its Investigational New Drug Application (IND) to assess lisinopril as an adjunctive therapy for multiple sclerosis (MS) has been cleared by the...Tue, 18 Dec 2012 12:00:00 AM GMThttp://www.globenewswire.com/news-release/2012/12/17/511946/10015866/en/Amarin-Announces-Completion-of-Dosing-in-a-Fixed-Dose-Combination-Study-With-Vascepa-R-and-a-Leading-Statin.htmlBEDMINSTER, N.J., and DUBLIN, Ireland, Dec. 17, 2012 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that it has completed dosing and pharmacokinetic sampling in a study to test a fixed-dose combination of Vascepa (icosapent ethyl) capsules and a...Mon, 17 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=282542&full=117 December 2012 -- Clinical-stage drug development company Invion Limited (ASX:IVX) today announced that a pre-IND meeting with the Pulmonary, Allergy and Rheumatology Products Division of the US Food and Drug Administrations (FDA) Center for Drug Evaluation and Research (CDER) took place on 14 December 2012. </p><p>Invion requested the meeting with the FDA to...Thu, 13 Dec 2012 12:00:00 AM GMThttp://www.globenewswire.com/news-release/2012/12/13/511339/10015601/en/Results-From-Gentium-s-Treatment-IND-for-Defibrotide-Presented-at-the-American-Society-of-Hematology-Annual-Meeting.htmlVILLA GUARDIA (COMO), Italy, Dec. 13, 2012 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") today announced that additional data from ongoing trials of Defibrotide were presented this week at the 54th Annual Meeting and Exposition of the American Society of Hematology (ASH) held at the Georgia World Congress Center in Atlanta, Georgia.Thu, 13 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=281758&full=1<div id"releaseBody"><p>MONTREAL--(Marketwire - December 10, 2012) - Sunshine Biopharma Inc. (OTCQB: <a href"http://www.marketwire.com/mw/stock.jsp?TickerSBFM">SBFM</a>), a pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, today announced that it has completed a new IND-Enabling study in which Adva-27a, the...Mon, 10 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=281359&full=1<div id"releaseBody"><p>SAN DIEGO, CA--(Marketwire - December 05, 2012) - <a href"http://www.ljpc.com/">La Jolla Pharmaceutical Company</a> (OTCQB: <a href"http://www.marketwire.com/mw/stock.jsp?TickerLJPC">LJPC</a>) ("La Jolla" and "Company"), a leader in the development of therapeutics that target <a href"http://www.ljpc.com/technology-galectins.html">galectin-3</a>, announced today that...Wed, 05 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=281251&full=1<div id"releaseBody"><p>MONTREAL--(Marketwire - December 04, 2012) - Sunshine Biopharma Inc. (OTCBB: <a href"http://www.marketwire.com/mw/stock.jsp?TickerSBFM">SBFM</a>), a pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, today announced that it has completed six IND-Enabling studies for Adva-27a, the Company...Tue, 04 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=281137&full=1<div id"releaseBody"><p>MECHELEN, BELGIUM--(Marketwire - December 03, 2012) - Galapagos NV (EURONEXT BRUSSELS: GLPG)announcedtoday that it has opened its Investigational New Drug application forGLPG0634with the US Food and Drug Administration.<p>Galapagos intends to conduct a Phase 1 drug interaction study in theUnitedStates, which is expected to be completed in the...Mon, 03 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=280628&full=1 <div class"xn-content"><p><span class"xn-location">LEXINGTON, Mass.</span>, <span class"xn-chron">Nov. 27, 2012</span> /PRNewswire/ -- Avaxia Biologics, Inc., a privately-held biotechnology company developing oral antibody drugs that act locally within the digestive tract, announced today that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for...Tue, 27 Nov 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=279638&full=1<div class"xn-content"><p><span class"xn-location">IRVINE, Calif.</span>, <span class"xn-chron">Nov. 13, 2012</span> /PRNewswire/ --AtheroNova Inc. (OTCBB: AHRO), a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and to improve lipid profiles in humans, today announced that its Russian licensing partner OOO CardioNova has formally submitted...Tue, 13 Nov 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=278695&full=1<div class"xn-content"><p><span class"xn-location">BUFFALO, N.Y.</span> and <span class"xn-location">SEOUL, South Korea</span>, <span class"xn-chron">Nov. 6, 2012</span> /PRNewswire/ -- Kinex Pharmaceuticals and Hanmi Pharmaceutical announced today that the Korean FDA (KFDA) has accepted Hanmi's Investigational New Drug (IND) application for KX-01, Kinex's dual src/pretubulin inhibitor, in the...Wed, 07 Nov 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=277494&full=1<div id"releaseBody"><p>ANN ARBOR, MI--(Marketwire - October 26, 2012) - TSRL, Inc. is a privately-owned specialty pharmaceutical company focused on the discovery and development of orally available antiviral and anticancer therapeutics based on its proprietary prodrug technology. <p>The company announced today that it reached agreement with the FDA on its preclinical and clinical development...Fri, 26 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=277096&full=1<div id"releaseBody"><p>NEW YORK, NY--(Marketwire - October 24, 2012) - <b> </b>Tonix Pharmaceuticals Holding Corp. (OTCQB: <a href"http://www.marketwire.com/mw/stock.jsp?TickerTNXP">TNXP</a>) ("TONIX" or the "Company"), a specialty pharmaceutical company developing novel treatments for challenging disorders of the central nervous system, including fibromyalgia ("FM") and post-traumatic stress...Wed, 24 Oct 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20121011006309&newsLang=enWALTHAM, Mass.--(BUSINESS WIRE)--Avedro, Inc. and Hersh Vision Group announced today that Dr. Peter Hersh has treated the first patient in a physician sponsored Investigational New Drug (IND) study for the Safety and Efficacy of the Keraflex Microwave System. Recruiting for additional eligible patients with keratoconus has now begun. Dr. Hersh remarked, Keraflex, combined with corneal collagen cross...Fri, 12 Oct 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20121011005215&newsLang=enLOS ANGELES--(BUSINESS WIRE)--Genesis Biopharma, Inc. (OTC/BB: GNBP), a biotechnology company developing targeted cellular immunotherapies for the treatment of cancer, today announced receipt of meeting minutes from the U.S. Food and Drug Administration (FDA) regarding a pre-Investigational New Drug (IND) application submission meeting for Contego held on August 23, 2012. Thu, 11 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=275501&full=1<div id"releaseBody"><p>MONTREAL--(Marketwire - October 09, 2012) - Sunshine Biopharma Inc. (OTCBB: <a href"http://www.marketwire.com/mw/stock.jsp?TickerSBFM">SBFM</a>), a pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, today announced that it has received the Scale-Up Manufacturing Protocol from the Contract...Tue, 09 Oct 2012 12:00:00 AM GMThttp://www.globenewswire.com/newsroom/news.html?d=10006989WALTHAM, Mass., Oct. 2, 2012 (GLOBE NEWSWIRE) -- TESARO, Inc. (Nasdaq:TSRO) announced today that the Investigational New Drug (IND) application for TSR-011, an orally available ALK inhibitor (targeted anti-cancer agent) has become effective. The Company plans to dose the first patient in a Phase 1/2 clinical study within the next few months. Wed, 03 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=274876&full=1 <div class"xn-content"><p><span class"xn-location">SEATTLE</span>, <span class"xn-chron">Oct. 2, 2012</span> /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that the Company's OMS824 Investigational New Drug Application (IND) has been cleared by the U.S. Food and Drug Administration (FDA). With this clearance, Omeros may commence enrollment in its Phase 1 clinical trial evaluating...Tue, 02 Oct 2012 12:00:00 AM GMThttp://www.globenewswire.com/newsroom/news.html?d=10004913NEW YORK, Sept. 12, 2012 (GLOBE NEWSWIRE) -- Synergy Pharmaceuticals, Inc. (Nasdaq:SGYP), a developer of new drugs to treat gastrointestinal (GI) disorders and diseases, announced today that an Investigational New Drug (IND) application was submitted on September 7, 2012 for clinical evaluation of SP-333 to treat inflammatory bowel disease (IBD). SP-333 is a second-generation guanylate cyclase-C ...Wed, 12 Sep 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=272396&full=1September 07, 2012 -- Cold Genesys, Inc. has reactivated an IND and is pursuing a special protocol assessment (SPA) with the FDA on a pivotal integrated phase II/III clinical trial for patients with Non-Muscle Invasive Bladder Cancer (NMIBC) who have previously failed BCG. Result of SPA decision will be announced in the week of September 10th 2012.</p><p>Those interested in the development of this...Fri, 07 Sep 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=272204&full=1<div class"xn-content"><p /><p><span class"xn-location">SEATTLE</span>, <span class"xn-chron">Sept. 6, 2012</span> /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that it has filed an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) to initiate clinical trials evaluating OMS824, the Company's lead compound from its phosphodiesterase ...Thu, 06 Sep 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=272180&full=1 <div class"xn-content"><p /><p><span class"xn-location">PRINCETON, N.J.</span>, <span class"xn-chron">Sept. 6, 2012</span> /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that the Food and Drug Administration (FDA) has completed its review and cleared the Investigational New Drug (IND) application for SGX...Thu, 06 Sep 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=271901&full=1BRISBANE, 31 AUGUST 2012: Australian drug development company Invion Limited (ASX:CBZ) is pleased to advise that it has received a response from the US Food and Drug Administration (FDA) confirming the timing of its pre Investigational New Drug (pre-IND) meeting for initiating clinical trials of XToll as a treatment for systemic lupus (SLE). The meeting is scheduled to be held at the FDA offices in...Wed, 05 Sep 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=271404&full=1SAN DIEGO</span>, <span class"xn-chron">Aug 29, 2012</span> /PRNewswire/ -- Proacta Incorporated announced today that the US Food and Drug Administration has allowed its Investigational New Drug (IND) Application for PR610, a hypoxia-activated, irreversible multi-kinase inhibitor (MKI) for the treatment of cancer.</p><p>The IND allowance permits Proacta to initiate human clinical trials of this novel...Wed, 29 Aug 2012 12:00:00 AM GMThttp://www.chinabiotoday.com/articles/20120817BURLINGAME, Calif.</span>, <span class"xn-chron">Aug. 15, 2012</span> /PRNewswire/ -- Apexigen, Inc., an emerging biopharmaceutical company focused on the discovery and development of monoclonal antibody therapeutics, announced today that its partner, 3SBio [SSRX] of <span class"xn-location">Shenyang, China</span>, filed an Investigational New Drug (IND) application for APX001, also known as SSS...Thu, 16 Aug 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=270227&full=1UPPSALA, August 15, 2012 -- Isconova AB's U.S. partner Genocea Biosciences has received approval from the Food and Drug Administration (FDA) to initiate a Phase I/IIa study. The study relates to a therapeutic vaccine candidate (GEN 003) to treat Herpes Simplex Virus-2 (HSV-2). The vaccine candidate includes two novel protein antigens combined with Isconovas proprietary adjuvant Matrix-M. ...Wed, 15 Aug 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=269476&full=1Barcelona, Spain, August 8, 2012 - Ferrer, a privately-held Spanish pharmaceutical company with full vertical integration from R&D to commercialisation, announces today that it has filed an IND for its topical antifungal agent Arasertaconazole nitrate.</p><p>The agent has recently demonstrated rapid symptomatic relief and significant clinical and mycological benefits after a single administration...Tue, 07 Aug 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=268591&full=1 <div class"xn-content"><p /><p><span class"xn-location">GREENWOOD VILLAGE, Colo.</span>, <span class"xn-chron">Aug. 1, 2012</span> /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), a clinical stage biopharmaceutical company developing drugs for the treatment of inflammation, eye disease, kidney disease, CNS disease, metabolic disease and male sexual dysfunction today announced that a...Wed, 01 Aug 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20120723005025&newsLang=enCINCINNATI--(BUSINESS WIRE)--Camargo Pharmaceutical Services successfully completed five Food and Drug Administration (FDA) pre-IND meetings for 505(b)(2) products in the month of June, including successful meetings with two of Indias top 10 largest pharmaceutical companies.Tue, 24 Jul 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20120719005648&newsLang=enWATERTOWN, Mass.--(BUSINESS WIRE)--pSivida Corp. (NASDAQ: PSDV)(ASX: PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to treat posterior uveitis with pSividas injectable sustained-release micro-insert. pSivida is...Thu, 19 Jul 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.b30484b92e958b11adda3242e6908a0c/index.jsp?ndmViewId=news_view&newsId=20120710005600&newsLang=enBOCA RATON, Fla.--(BUSINESS WIRE)--TherapeuticsMD, Inc. [OTCQB: TXMD], parent company of vitaMedMD, LLC (vitaMedMD), a specialty pharmaceutical company (TherapeuticsMD or the Company), announced today its plans to file up to three Investigational New Drug applications (INDs) with the U.S. Food and Drug Administration (FDA) this year and if accepted, will initiate Phase III clinical trials...Tue, 10 Jul 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20120709005234&newsLang=enLOS ANGELES--(BUSINESS WIRE)--Capricor, Inc., a privately held biotechnology company focused on regenerative medicine, today announced that the U.S. Food and Drug Administration has approved initiation of its Investigational New Drug (IND) application for the ALLSTAR study, which will use allogeneic cardiac-derived stem cells (CDCs) to treat patients following large myocardial infarctions (MI).Mon, 09 Jul 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=264744&full=1 <div class"xn-content"><p><span class"xn-location">GREENWOOD VILLAGE, Colo.</span>, <span class"xn-chron">June 21, 2012</span> /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), a clinical stage biopharmaceutical company, with repurposed drugs and new molecular entities (NMEs) that treat inflammatory diseases, including osteoarthritis, diabetic macular edema (DME) and sexual dysfunction...Thu, 21 Jun 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=263411&full=1<div class"xn-content"><p><span class"xn-location">ALISO VIEJO, Calif.</span>, <span class"xn-chron">June 11, 2012</span> /PRNewswire/ --<b> Avanir Pharmaceuticals, Inc. </b>(NASDAQ: AVNR) today announced that the U.S. Food and Drug Administration (FDA) accepted the company's Investigational New Drug (IND) application for the study of AVP-923, an investigational drug for the treatment of agitation...Mon, 11 Jun 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20120606005571&newsLang=enPASADENA, Calif.--(BUSINESS WIRE)--Arrowhead Research Corporation (NASDAQ: ARWR), a targeted therapeutics company, today announced that its hepatitis B virus (HBV) program has completed all internal preclinical requirements and has named a clinical candidate. As such, the Company has initiated the final IND-enabling steps, including GMP manufacturing, GLP toxicology, and preparation of a pre-IND data...Wed, 06 Jun 2012 12:00:00 AM GMThttp://www.globenewswire.com/newsroom/news.html?d=258005SOUTH SAN FRANCISCO, Calif., June 4, 2012 (GLOBE NEWSWIRE) -- Five Prime Therapeutics, Inc. (FivePrime), a leader in the discovery and development of innovative biologics, announced today that Human Genome Sciences (HGS) has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration to initiate a Phase 1b human clinical trial of HGS1036/FP-1039 in combination...Mon, 04 Jun 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20120531005093&newsLang=enWORCESTER, Mass.--(BUSINESS WIRE)--RXi Pharmaceuticals Corporation (OTCBB: RXII.OB) today announced that it has received clearance for its investigational new drug application (IND) from the U.S. Food and Drug Administration (FDA) to initiate clinical trials with RXI-109, a self-delivering RNAi compound that selectively targets Connective Tissue Growth Factor (CTGF). The Phase 1 trial will investigate...Thu, 31 May 2012 12:00:00 AM GMThttp://www.globenewswire.com/newsroom/news.html?d=257537SAN DIEGO, May 30, 2012 (GLOBE NEWSWIRE) -- Zogenix Inc. (Nasdaq:ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, today announced that it has submitted an investigational new drug (IND) application to the U.S. Food & Drug Administration (FDA) for Relday, which is a combination of Zogenix's DosePro needle-free...Wed, 30 May 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=262115&full=1TORONTO, CANADA--(Marketwire - May 29, 2012) - Soricimed Biopharma Inc., a private company developing novel cancer therapeutics and diagnostics, is pleased to announce that the Investigational New Drug (IND) Application for SOR-C13 as an anti-cancer agent has been cleared by the U.S. Food and Drug Administration (FDA). Soricimed has also received clearance for a Clinical Trial Application for SOR...Wed, 30 May 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20120524005898&newsLang=enANN ARBOR, Mich.--(BUSINESS WIRE)--RetroSense Therapeutics, a gene therapy company dedicated to vision restoration, announced completion of a pre-IND meeting with the Center for Biological Evaluation and Research (CBER) division of the FDA that took place on May 22nd 2012 regarding RetroSenses lead biologic, RST-001 for vision restoration in retinal degenerative conditions. Thu, 24 May 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=261017&full=1<div id"releaseBody"><p>BEVERLY, MA--(Marketwire - May 21, 2012) - Cellceutix Corporation (OTCBB: <a href"http://www.marketwire.com/mw/stock.jsp?TickerCTIX">CTIX</a>) (the "Company"), a biopharmaceutical company developing a novel drug to treat cancers and cancers which have proven resistant to today's cancer therapies (drug-resistant cancers), is pleased to announce that its amended Investigational...Mon, 21 May 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=260836&full=1<div class"xn-content"><p><span class"xn-location">SAN DIEGO</span> and <span class"xn-location">JERUSALEM</span>, <span class"xn-chron">May 17, 2012</span> /PRNewswire/ -- Ambit Biosciences and Teva Pharmaceutical Industries Limited (NASDAQ: TEVA) ("Teva") today announced the clearance of an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) for CEP-...Thu, 17 May 2012 12:00:00 AM GMT