LSIS Feed - Orphan Drug Designations from 24.04.2012
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2012-04-24T11:13:31+01:00
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23.04.2012 | BioSpace: Medgenics, Inc. Files for U.S. Orphan Drug Designation for INFRADURE for the Treatment of Hepatitis D
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MISGAV, Israel & SAN FRANCISCO-(BUSINESS WIRE)-Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that it has filed for Orphan Drug Designation with the U.S. Food and Drug Administration (FDA) for INFRADURE ¢ for the treatment of hepatitis D. INFRADURE is based on Medgenics proprietary tissue-based Biopump ¢ platform technology, which (…)
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20.04.2012 | BioSpace: Cytokinetics, Inc. (CYTK) to Announce First Quarter Results on April 26, 2012
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SOUTH SAN FRANCISCO, CA-(Marketwire - April 19, 2012) - Highlighted Links CYTK Website Cytokinetics, Incorporated (NASDAQ: CYTK) announced today that it is scheduled to report first quarter results on Thursday, April 26, 2012 at 4:00 PM Eastern Time. Following the announcement, Cytokinetics' senior management will host a conference call at 4:30 PM Eastern Time to discuss operational and financial results and the company's outlook for the future. The conference call will be simultaneously (…)
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19.04.2012 | BioSpace: Cytokinetics, Inc. (CYTK) Announces Clinical Trial Data Relating to CK-2017357 to Be Presented at the 64th Annual Meeting of the American Academy of Neurology
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SOUTH SAN FRANCISCO, CA-(Marketwire - April 18, 2012) - Highlighted Links CYTK Website Cytokinetics, Incorporated (NASDAQ: CYTK) announced today that one oral presentation and two poster presentations are scheduled to be presented at the 64th Annual Meeting of the American Academy of Neurology, to be held April 21-28, 2012 in New Orleans, LA. In addition, a poster presentation containing preclinical data relating to CK-2017357 is scheduled to be presented at the 2012 Experimental Biology (…)
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10.04.2012 | BioSpace: REGENX Biosciences, LLC Receives FDA Orphan Designation for Treatment of Familial Hypercholesterolemia Using NAV(TM) rAAV8 Vectors
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WASHINGTON, DC-(Marketwire - April 10, 2012) - REGENX BioSciences, LLC. announces that it has received orphan drug product designation from the U.S. Food and Drug Administration (FDA) for its program for the treatment homozygous familial hypercholesterolemia (HoFH) using NAV rAAV8 vectors. Homozygous familial hypercholesterolemia is an ultra-rare, genetic disorder characterized by a defect in the gene coding for the receptor for low-density lipoprotein (LDLR), the major cholesterol-transport (…)
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04.04.2012 | BioSpace: Athersys, Inc. Receives U.S. Patent Covering the Suppression of Graft-versus-Host Disease Associated With Hematopoietic Stem Cell Transplantation With Adult Stem Cells
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CLEVELAND, April 4, 2012 (GLOBE NEWSWIRE) - Athersys, Inc. (Nasdaq:ATHX) announced today that it has been granted U.S. patent 8,147,824 that covers the use of non-embryonic, multipotent stem cells for the reduction in severity or prevention of Graft-versus-Host Disease (GvHD), a serious condition associated with hematopoietic stem cell transplants (HSCTs) used to treat leukemia and related conditions. Athersys recently completed a successful clinical study evaluating the adjunctive (…)
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02.04.2012 | BioSpace: Astellas Pharma Inc. (YPH.BE) and Vical Incorporated (VICL) Advance Toward Phase 3 Trial of TransVax(TM) CMV Vaccine Triggering $10 Million Milestone Payment to Vical
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SAN DIEGO, April 2, 2012 (GLOBE NEWSWIRE) - Vical Incorporated (Nasdaq:VICL - News) today announced that Astellas Pharma Inc. (Tokyo:4503) and Vical have finalized the general design of a pivotal, multinational Phase 3 trial of TransVax(TM), the companies' therapeutic cytomegalovirus (CMV) vaccine for transplant recipients. This progress triggers a $10 million milestone payment to Vical. Based on guidance from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (…)
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30.03.2012 | BioSpace: ImmunoGen, Inc. (IMGN) Announces Initiation of Phase II Evaluation of Its IMGN901 Product Candidate
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WALTHAM, MA, March 30, 2012 ImmunoGen, Inc. (Nasdaq: IMGN) today announced that it has initiated Phase II testing of its IMGN901 product candidate for first-line treatment of SCLC. The Phase II assessment begun today, also known as the NORTH trial, is designed to evaluate whether the addition of IMGN901 to standard first-line care for SCLC meaningfully impacts duration of progression-free survival (PFS). With SCLC, the efficacy of first-line treatment is considered to be particularly important (…)
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28.03.2012 | BioSpace: Cytokinetics, Inc. (CYTK) to Present at the Eleventh Annual Needham Life Sciences Conference
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SOUTH SAN FRANCISCO, CA-(Marketwire - March 27, 2012) - Highlighted Links CYTK Website Cytokinetics, Incorporated (NASDAQ: CYTK) announced today that Robert I. Blum, President and Chief Executive Officer, is scheduled to present at the Eleventh Annual Needham Life Sciences Conference on Tuesday, April 3, 2012 at 2:00 PM Eastern Daylight Time at The New York Palace Hotel in New York, New York. Interested parties may access the live audio webcast of this presentation by visiting the Investor (…)
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26.03.2012 | BioSpace: Pharming Group (PHGUF.PK) and Hyup Jin Corporation Announce Commercialisation Agreement for RUCONEST in Korea
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LEIDEN, NETHERLANDS-(Marketwire - March 26, 2012) - Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) announced today that it has entered into an agreement with Hyupjin Corporation, a Seoul based Korean specialty pharma company, to commercialise RUCONEST (recombinant human C1 inhibitor) for the treatment of acute attacks of Hereditary Angioedema (HAE) in the Republic of Korea. Under the agreement, Hyupjin will drive the regulatory approval in Korea and (…)
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26.03.2012 | BioSpace: Corcept Therapeutics Inc. (CORT) Announces Exercise of Warrants and Private Placement of New Warrants
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MENLO PARK, CA-(Marketwire - March 26, 2012) - Corcept Therapeutics Incorporated ("Corcept") (NASDAQ: CORT), a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic and psychiatric disorders, today announced that investors exercised warrants to purchase approximately 4.2 million shares of Corcept common stock. The investors had purchased these warrants from the company in a private placement of securities that closed (…)
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22.03.2012 | BioSpace: Corcept Therapeutics Inc. (CORT)'s Korlym(TM) (mifepristone), the First Approved Medication for Patients With Endogenous Cushing's Syndrome, to be Available by April 11
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MENLO PARK, CA-(Marketwire - March 22, 2012) - Corcept Therapeutics Incorporated (NASDAQ: CORT) announced today that it would be ready to ship Korlym to patients by April 11th, three weeks ahead of the company's previously announced launch date. "Cushing's syndrome is a life altering and life threatening disease," said Joseph K. Belanoff, M.D., the company's Chief Executive Officer. "We have worked hard to bring this first-in-class treatment to patients as quickly as possible." On February (…)
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19.03.2012 | BioSpace: Provectus Pharmaceuticals Inc. Announces Top Line Phase 2 Data For PH-10 in Its First Randomized Controlled Psoriasis Study
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KNOXVILLE, Tenn.-(BUSINESS WIRE)-Provectus Pharmaceuticals, Inc. (OTCBB:PVCT,http:/www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announced top-line data for the company's randomized controlled trial (RCT) of PH-10 for mild-to-moderate plaque psoriasis. The Phase 2 trial (protocol PH-10-PS-23) compared safety and efficacy of three dose levels of PH-10 (0.002% Rose Bengal, 0.005% Rose Bengal and 0.01% Rose Bengal) against vehicle. Ninety-nine subjects (…)
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19.03.2012 | BioSpace: QLT Inc. (QLTI) Receives Orphan Drug Designation for Visudyne for Treatment of Central Serous Chorioretinopathy
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VANCOUVER, British Columbia, March 19, 2012 (GLOBE NEWSWIRE) - QLT Inc. (Nasdaq:QLTI) (TSX:QLT) ("QLT" or the "Company") today announced that its commercial product, Visudyne (verteporfin for injection), was granted orphan drug designation for the potential treatment of chronic or recurrent central serous chorioretinopathy (CSC) from the U.S. Food and Drug Administration (FDA).
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16.03.2012 | BioSpace: Threshold Pharmaceuticals, Inc. (THLD)' TH-302 Receives Orphan Drug Designation in the European Union for the Treatment of Soft Tissue Sarcoma
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SOUTH SAN FRANCISCO, CA-(Marketwire - March 16, 2012) - Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today announced the European Commission has granted Orphan Drug Designation for TH-302, a hypoxia-targeted drug, for the treatment of soft tissue sarcoma. "Receiving orphan designation for TH-302 in soft tissue sarcoma in the European Union (EU) is an important achievement for Threshold," said Barry Selick, Ph.D., CEO of Threshold. "Soft tissue sarcoma is an aggressive form of cancer for (…)
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15.03.2012 | BioSpace: SuppreMol Releases Positive Interim Phase Ib/IIa Results on SM101 in Primary Immune Thrombocytopenia (ITP) Trials
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Munich, Germany, 14th February, 2012. SuppreMol GmbH, an autoimmune diseases specialist, today announced interim results of the Phase Ib/IIa clinical trial of SM101 to treat Primary Immune Thrombocytopenia (ITP). SM101 was safe and very well tolerated with encouraging efficacy data. The Phase Ib section of this randomized, double-blind, placebo-controlled, dose escalating, multi-centric trial enrolled 36 patients that received up to 12 mg/kg intravenous doses of SM101 as weekly administrations (…)
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15.03.2012 | BioSpace: Celsion Corporation (CLN) Reports Year End 2011 Financial Results and Provides Business Update
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LAWRENCEVILLE, NJ-(Marketwire - March 15, 2012) - Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced financial results for the year ended December 31, 2011 and addressed the progress of its clinical trials of ThermoDox, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin for the treatment of hepatocellular carcinoma (HCC), commonly referred to as primary liver cancer. ThermoDox is currently being evaluated under a (…)
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14.03.2012 | BioSpace: Recipharm AB Contracted by ViroPharma Incorporated (VPHM) to Complete Full Commercial Manufacture of DuoCort's Plenadren
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March 14, 2012 - Recipharm and ViroPharma today signed a commercial contract to initiate supply of Plenadren for named patient use. In addition, ViroPharma are investing in capital equipment at the Recipharm manufacturing site - enabling large scale manufacturing for the product. March 14th 2012: - Recipharm, the international contract pharmaceutical development and manufacturing organization, today announced that it has been contracted by ViroPharma to complete commercial scale-up (…)
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08.03.2012 | BioSpace: Promedior Receives U.S. Orphan Drug Designation for PRM-151 for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)
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MALVERN, Penn.-(BUSINESS WIRE)-Promedior, Inc., a clinical stage biotechnology company developing novel biologic therapeutics for the treatment of fibroproliferative diseases, today announced that the United States Food and Drug Administration (FDA) Office of Orphan Products Development has granted an Orphan Drug designation to Promedior s lead drug candidate, PRM-151, for the treatment of idiopathic pulmonary fibrosis (IPF). There are currently no FDA approved treatments for IPF, a (…)
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05.03.2012 | BioSpace: Corcept Therapeutics Inc. (CORT) Announces Fourth Quarter Results and Corporate and Development Update
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MENLO PARK, CA-(Marketwire - March 05, 2012) - Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic and psychiatric disorders, today updated its corporate progress and reported financial results for the fourth quarter and the year ended December 31, 2011. "We are proud of Corcept's transformation over the last 15 months," said Joseph K. Belanoff, M.D., Chief (…)
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23.02.2012 | BioSpace: Skinvisible, Inc. (SKVI) Formulation Submitted to European Union for Orphan Drug Designation
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LAS VEGAS, Feb. 23, 2012 (GLOBE NEWSWIRE) - Skinvisible, Inc. (OTCQB:SKVI), a developer of topical and transdermal formulations using its patented Invisicare technology, today announced it has submitted an Orphan Drug Designation application to the European Medicines Agency (EMA) for its proprietary formulation to treat Netherton Syndrome. Furthermore, Skinvisible has received notice that the application has been validated by the EMA and has begun the review process by the EMA's Committee for (…)
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21.02.2012 | BioSpace: Arno Therapeutics Receives Two Orphan-Drug Designations for AR-42 in Treatment of Central-Nervous-System Tumors
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FLEMINGTON, N.J.-(BUSINESS WIRE)-Arno Therapeutics, Inc. (OTCBB: ARNI) announced today that its investigational compound, AR-42, has been granted orphan-drug designation by the U.S. Food and Drug Administration for the treatment of meningioma and schwannoma of the central nervous system. Meningioma and schwannoma are benign tumors that can present in different locations within the brain and the spinal cord and may cause substantial morbidity for those affected individuals.
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21.02.2012 | BioSpace: Corcept Therapeutics Inc. (CORT) Wins FDA Approval for First Drug to Treat Cushing s Syndrome
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MENLO PARK, CA-(Marketwire - February 17, 2012) - Corcept Therapeutics Incorporated (NASDAQ: CORT) announced today that the U.S. Food and Drug Administration (FDA) has approved Korlym (mifepristone 300 mg tablets) as a once-daily oral medicine to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have diabetes mellitus type 2 or glucose intolerance and have failed surgery or are not candidates for surgery. "We appreciate the FDA's (…)
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14.02.2012 | BioSpace: Biogen Idec, Inc. (Massachusetts) (BIIB) to Pay Up to $562.5 Million for Stromedix, Inc.
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WESTON & CAMBRIDGE, Mass.-(BUSINESS WIRE)-Biogen Idec (NASDAQ: BIIB) and Stromedix, Inc. today announced that they have entered into a definitive agreement under which Biogen Idec will acquire Stromedix Inc., a privately held biotechnology company focused on innovative therapies for fibrosis and organ failure. Under the terms of the agreement, Biogen Idec will make an upfront cash payment of $75 million and additional contingent value payments of up to $487.5 million based on the achievement (…)
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14.02.2012 | BioSpace: Pharming Group (PHGUF.PK) and Transmedic Announce Distribution Agreement for RUCONEST
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LEIDEN, NETHERLANDS-(Marketwire - February 14, 2012) - Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) announced today that it has entered into an agreement with Transmedic Pte Ltd. (Transmedic), a privately owned Singapore based specialty healthcare company, for the commercialization of RUCONEST() (recombinant human C1 inhibitor) for the treatment of acute attacks of Hereditary Angioedema (HAE) in parts of South- East Asia. The South- East Asian (…)
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14.02.2012 | BioSpace: Nationally Recognized Glenveigh Medical Announces Orphan Drug Designation for Treatment for Severe Preeclampsia and Eclampsia
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CHATTANOOGA, Tenn. (February 14, 2012) Glenveigh Medical announced today that the U.S. Food and Drug Administration (FDA) has granted its request for orphan drug designation for a potential new therapy to treat severe preeclampsia and eclampsia. The compound, digoxin immune fab (ovine), is an existing biologic approved for use in cases of digoxin toxicity. Glenveigh, a nationally renowned life science company, has extensive clinical and in vitro evidence to support continued development of (…)
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09.02.2012 | BioSpace: BioSante Pharmaceuticals, Inc. (BPAX) Reports Positive LibiGelSafety Data Review for Phase III Program
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LINCOLNSHIRE, Ill.-(BUSINESS WIRE)-BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), announced today that the independent Data Monitoring Committee (DMC) has completed the eighth unblinded review of the LibiGel Phase III cardiovascular and breast cancer safety study, which has completed enrollment of subjects. The independent DMC has recommended that the LibiGel safety study should continue as per the FDA-agreed protocol, without modifications. LibiGel (testosterone gel) is in development for (…)
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07.02.2012 | BioSpace: Cytokinetics, Inc. (CYTK) to Present at Biotechnology Industry Organization (BIO) CEO and Investor Conference
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SOUTH SAN FRANCISCO, CA-(Marketwire - February 06, 2012) - Highlighted Links CYTK Website Cytokinetics, Incorporated (NASDAQ: CYTK) announced today that Robert I. Blum, President and Chief Executive Officer, is scheduled to present a corporate update at the BIO CEO and Investor Conference on Monday, February 13, 2012 at 1:00 p.m. Eastern Standard Time in the Duke of Windsor Room of the Waldorf=Astoria Hotel in New York, New York. Interested parties may access the live audio webcast of this (…)
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01.02.2012 | BioSpace: AB Science (AB.PA) Reports Positive Clinical Study Data: Masitinib Significantly Extends Overall Survival as Compared to Pfizer Inc. (PFE)'s Sutentin Gleevec-resistant GIST
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PARIS-(BUSINESS WIRE)-Regulatory News: AB Science SA (Paris:AB) (NYSE Euronext - FR0010557264 - AB) today announced encouraging results from a phase 2 study with its investigational drug, masitinib, in Gleevec-resistant gastrointestinal stromal tumors (GIST). Masitinib significantly improved overall survival in patients with Gleevec-resistant gastrointestinal stromal tumors (GIST) as compared to Sutent (sunitinib) from Pfizer, a drug approved for second-line treatment of GIST, currently the (…)
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01.02.2012 | BioSpace: European Medicines Evaluation Agency Approves Orphan Medicinal Product Application of Dcprime's Acute Myeloid Leukemia Vaccine
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Amsterdam, February 1, 2012 - Biotechnology company DCPrime today announces that the Committee for Orphan Medical Products (COMP) of the European Medicines Agency has issued a positive opinion recommending DCPrime s application for orphan drug designation of, the company s dendritic cell-based cancer vaccine candidate, which targets Acute Myeloid Leukemia (AML). Major step towards approval of vaccine "This orphan drug designation is a major step in DCPrime s work towards approval of our AML (…)
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27.01.2012 | BioSpace: Cytokinetics, Inc. (CYTK) to Announce Fourth Quarter and Year End Results on February 2, 2012
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SOUTH SAN FRANCISCO, CA-(Marketwire - January 26, 2012) - Highlighted Links CYTK Website Cytokinetics, Incorporated (NASDAQ: CYTK) announced today that it is scheduled to report fourth quarter and year end results on Thursday, February 2, 2012 at 4:00 PM Eastern Time. Following the announcement, Cytokinetics' senior management will host a conference call at 4:30 PM Eastern Time to discuss operational and financial results and the company's outlook for the future. The conference call will be (…)
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26.01.2012 | BioSpace: AEterna Zentaris (AEZS): Updated Interim Phase 1 Trial Results for AEZS-108 in Prostate Cancer to be Presented at Upcoming AEterna Zentaris (AEZS) GCS Meeting in San Francisco
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Québec City, Canada, January 26, 2012 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the Company ) today announced that Jacek Pinski, MD, PhD, Associate Professor of Medicine at the Norris Comprehensive Cancer Center of the University of Southern California, will present updated interim results from a Phase 1 clinical trial in prostate cancer with AEZS-108 (zoptarelin doxorubicin), the Company s targeted cytotoxic luteinizing hormone releasing hormone ( LHRH ) analog. The (…)
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18.01.2012 | BioSpace: Ceptaris Therapeutics, Inc. Receives EMA Orphan Drug Designation for Proprietary Mechlorethamine Gel
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MALVERN, Pa.-(BUSINESS WIRE)-Ceptaris Therapeutics, Inc., a privately held specialty pharmaceutical company, announced today that the European Medicines Agency (EMA) has granted Orphan Drug Designation to Ceptaris investigational drug, chlormethine gel (also known as mechlorethamine gel in the US), for the treatment of Cutaneous T-Cell Lymphoma (CTCL).
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09.01.2012 | BioSpace: Apogenix Receives Additional ¬2.3 Million BMBF Grant as Partner of the Biotech Cluster Rhine-Neckar
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Heidelberg, January 3, 2012 - The biopharmaceutical company Apogenix GmbH today announced that it has received an additional ¬ 2.3 million BMBF grant (German Federal Ministry of Education and Research) for the further advancement of its lead substance APG101. Apogenix will use the proceeds to develop APG101 for the treatment of myelodysplastic syndromes (MDS). More specifically, the grant will be used for the production of clinical material and for the development of a biomarker program. (…)
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05.01.2012 | BioSpace: Apogenix Raises ¬7.5 Million to Further Advance APG101 to Treat Glioblastoma and Other Tumors
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Heidelberg, January 5, 2012 - The biopharmaceutical company Apogenix GmbH today announced the successful completion of a ¬ 7.5 million financing round led by dievini Hopp BioTech holding GmbH & Co. KG (dievini). Other investors include the German Cancer Research Center (DKFZ), the founders and the executive management team of Apogenix. These funds will enable Apogenix to further advance the phase II clinical trial of APG101 to treat Glioblastoma Multiforme (GBM) and other cancer indications. (…)
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05.01.2012 | BioSpace: AiCuris Receives Orphan Drug Designation for Letermovir (AIC246) from FDA
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Wuppertal, Germany, January 5, 2012 / B3C newswire / - AiCuris announced today that AIC246 (Letermovir), the Company s novel inhibitor against the human cytomegalovirus HCMV, has been granted Orphan Drug Designation in the US for the prevention of HCMV viremia and disease in at risk populations. This decision was made on 12 December 2011 by the FDA Office of Orphan Products Development. Letermovir has recently successfully completed a phase IIb trial for the prophylaxis of HCMV infection and (…)
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05.01.2012 | BioSpace: EyeGate Pharma Initiates Phase III Study of EGP-437 in Patients With Anterior Uveitis
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WALTHAM, MA-(Marketwire - January 05, 2012) - EyeGate Pharma today announced that it has enrolled the first patient in a milestone Phase III pivotal study of its lead product EGP-437 (a late-stage asset with multiple indications for inflammatory ocular indications), for the treatment of anterior uveitis. The company, a private specialty pharmaceutical company developing therapeutics designed to address two major issues in ophthalmic medicine, patient compliance and patient throughput, (…)
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05.01.2012 | BioSpace: Canbas Co., Ltd.' CBP501 Receives FDA Orphan Drug Designation for Malignant Mesothelioma
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Numazu, Shizuoka, Japan - January 5, 2012 - CanBas Co., Ltd. today announced that the United States Food and Drug Administration (FDA) granted Orphan drug designation for CBP501 "for use in combination with cisplatin and pemetrexed for treatment of patients with mesothelioma." CBP501 is in late Phase II development as first-line treatment for patients with advanced malignant pleural mesothelioma (MPM) who are not eligible for curative surgery. Dr. Takumi Kawabe, CEO of CanBas, said, "We are (…)
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03.01.2012 | BioSpace: AEterna Zentaris (AEZS) Partner, Yakult Honsha, Initiates Phase 1/2 Trial with Perifosine in Colorectal Cancer in Japan
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Québec City, Canada, January 3, 2012 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the Company ) today announced that its Japanese partner, Yakult Honsha ( Yakult ), has initiated a Phase 1/2 trial in Japan to assess the safety and efficacy of the Company s PI3K/Akt inhibitor, perifosine, in combination with chemotherapeutic agent, capecitabine, in patients with refractory advanced colorectal cancer ( CRC ). The initiation of this trial will trigger a milestone payment of an (…)
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29.12.2011 | BioSpace: Alexion Pharmaceuticals Inc. (ALXN) to Pay $1 Billion for Enobia Pharma
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CHESHIRE, Conn. & MONTREAL, CANADA-(BUSINESS WIRE)-Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) and Enobia Pharma Corp. today announced that the companies have signed a definitive agreement under which Alexion will acquire 100% of the capital stock of Enobia. Enobia is a private biopharmaceutical company based in Montreal, Canada and Cambridge, Massachusetts, which is focused on the development of therapies to treat patients with ultra-rare and life-threatening genetic metabolic disorders. (…)
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20.12.2011 | BioSpace: Provectus Pharmaceuticals Inc. and its Subsidiaries Complete Unregistered Offering of Units to Facilitate Spin-off of Pure-ific Corporation
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KNOXVILLE, Tenn.-(BUSINESS WIRE)-Provectus Pharmaceuticals, Inc. (OTCBB: PVCT, http:/www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announced today that it and its five wholly owned subsidiaries, Pure-ific Corporation, Provectus Biotech, Inc., Provectus Devicetech, Inc., Provectus Imaging, Inc., and Xantech Pharmaceuticals, Inc. (the Subsidiaries ), have completed an unregistered offering of Units pursuant to the exemption from registration (…)
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19.12.2011 | BioSpace: Celsion Corporation (CLN) Completes Consultative Review Process With EMA for Phase III HEAT Study of ThermoDox(R) in Primary Liver Cancer
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LAWRENCEVILLE, NJ-(Marketwire - December 19, 2011) - Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, announced today that it has received written, scientific advice from the European Medicines Agency (EMA) confirming that the Company's Phase III HEAT Study, a multinational, double-blind, placebo controlled pivotal study of ThermoDox in combination with radio frequency ablation (RFA) for the treatment of hepatocellular carcinoma (HCC), or primary liver (…)
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14.12.2011 | BioSpace: ProtAffin AG Receives Key Grant for Preclinical and Clinical Development of PA401 in Inflammatory Lung Disease
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Graz, Austria and London, UK- 14th December 2011: ProtAffin AG, a biotechnology company developing a novel class of next-generation biopharmaceuticals for respiratory disease, inflammation and oncology, today announced that it has received an award of ¬2.1 million for the preclinical and clinical development of its lead product PA401 in inflammatory lung disease, including chronic obstructive pulmonary disease (COPD). The grant was awarded by the Austrian Forschungs-Förderungs-Gesellschaft (…)
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07.12.2011 | BioSpace: Avedro, Inc. Announces its Second FDA Orphan Drug Designation for Corneal Cross-linking
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WALTHAM, Mass.-(BUSINESS WIRE)-Avedro, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the Company s VibeX (riboflavin ophthalmic solution) for use with its KXL System (UVA irradiation) for Corneal Cross-linking to treat corneal ectasia following refractive surgery, such as Lasik and photorefractive keratectomy (PRK). Corneal ectasia is a rare outcome of refractive surgery but is a progressive condition that is difficult to manage. (…)
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01.12.2011 | BioSpace: Emergent BioSolutions (EBS) Receives Orphan Drug Designation for Its TRU-016 Protein Therapeutic for the Treatment of Chronic Lymphocytic Leukemia
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ROCKVILLE, Md.-(BUSINESS WIRE)-Emergent BioSolutions Inc. (NYSE: EBS) announced today that its humanized anti-CD37 mono-specific protein therapeutic, TRU-016, in development for the treatment of B-cell malignancies has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of chronic lymphocytic leukemia (CLL) patients. This designation is given to drugs and biologics that are being developed to treat rare medical conditions, specifically those (…)
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29.11.2011 | BioSpace: OncoVista Innovative Therapies, Inc. Engages Oncology Therapeutic Development to Initiate a Phase Ib Study of Cordycepin in Patients With Refractory TdT Positive Leukemia
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SAN ANTONIO, TX-(Marketwire - November 28, 2011) - OncoVista Innovative Therapies, Inc. (OTCBB: OVIT), a biopharmaceutical company engaged in the development and commercialization of targeted cancer therapies with reduced toxicity and improved patient safety, announced today that it has entered into an agreement with Oncology Therapeutic Development (OTD), a consulting and early Clinical Development focused CRO, to initiate a Phase Ib clinical trial of Cordycepin associated to Pentostatin for (…)
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23.11.2011 | BioSpace: Cytokinetics, Inc. (CYTK) to Present Clinical Trial Data Relating to CK-2017357 in Patients With Amyotrophic Lateral Sclerosis
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SOUTH SAN FRANCISCO, CA-(Marketwire - November 22, 2011) - Highlighted Links CYTK Website Cytokinetics, Incorporated (NASDAQ: CYTK) announced today that two posters are scheduled to be presented at the 22nd International Symposium on ALS/MND to be held November 30, 2011 - December 2, 2011 at the Hilton Sydney in Sydney, Australia. One poster will present data from the first cohort, or Part A, of an ongoing Phase II clinical trial evaluating multiple fixed doses of CK-2017357 in patients with (…)
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22.11.2011 | BioSpace: S*Bio's Novel JAK2 Inhibitor Pacritinib (SB1518) and Histone Deacetylase Inhibitor Pracinostat (SB939) Demonstrate Promising Activity in Phase 2 Studies For Patients with Myelofibrosis (MF)
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SINGAPORE, Nov. 22, 2011 - S*BIO Pte Ltd today announced that data from Phase 2 studies for its JAK2 inhibitor pacritinib (SB1518) and histone deacetylase inhibitor pracinostat (SB939) demonstrate promising activity in patients with myelofibrosis (MF). Results will be presented at the 53rd ASH Annual Meeting and Exposition in San Diego, Calif. Pacritinib has been well tolerated and has shown activity in alleviating MF-associated splenomegaly and constitutional symptoms with lack of (…)
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10.11.2011 | Business Wire: Phase 2 Data on Provectus s PV-10 for Metastatic Melanoma Will Be Presented at the 2011 International Melanoma Congress on November 12, 2011 | Business Wire
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KNOXVILLE, Tenn.-(BUSINESS WIRE)-Provectus Pharmaceuticals, Inc. (OTC BB: PVCT, http:/www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announces that data from its Phase 2 PV-10 metastatic melanoma study will be presented at the 2011 International Melanoma Congress on November 12, 2011, during the 5th Meeting of Interdisciplinary Melanoma/Skin Cancer Centres meeting. As we prepare for a multi-center, global Phase 3 trial for PV-10 for metastatic (…)
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09.11.2011 | Business Wire: BioSante Pharmaceuticals Reports Financial Results for Third Quarter 2011 and Pipeline Update | Business Wire
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LINCOLNSHIRE, Ill.-(BUSINESS WIRE)-BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced financial results for the third quarter ended September 30, 2011 and provided an update on the Company s pipeline. As of September 30, 2011, BioSante s cash and cash equivalents were approximately $69.6 million, compared to $38.2 million at December 31, 2010. BioSante s net loss was $12.7 million or $(0.12) per share for the third quarter of 2011, compared to a net loss of $11.6 million or (…)
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10.11.2011 | Business Wire: BrainStorm Cell Therapeutics Reviews 3 Quarters of 2011 Achievements | Business Wire
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NEW YORK & PETACH TIKVAH, Israel-(BUSINESS WIRE)-BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI), a developer of adult stem cell technologies and therapeutics, today provided a review of recent accomplishments for shareholders and investors. Since the beginning of the Phase I/II clinical trial for BrainStorm s autologous adult stem cell therapy at the Hadassah Medical Center, significant progress has been made towards achieving the goals of enrolling and treating patients with amyotrophic (…)