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Keryx Biopharmaceuticals Reports Single Agent Phase 2 Data of KRX-0401 (Perifosine) Further Demonstrating KRX-0401's Activity in the Treatment of Advanced Metastatic Renal Cell Cancer

KRX-0401 Demonstrates Impressive Single Agent Efficacy in Patients who Progressed after Failing Treatment Either with a VEGF Receptor Inhibitor or after Treatment with both a VEGF Receptor Inhibitor and an mTOR Inhibitor NEW YORK, May 29 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, I...

PharmAthene Initiates Phase I Clinical Trial of Nerve Agent Bioscavenger Protexia(R)

ANNAPOLIS, Md., Oct. 27 /PRNewswire-FirstCall/ -- PharmAthene, Inc. (NYSE ALTERNEXT US: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, today announced that dosing of volunteers has begun in a U.S. Phase I clinical trial evaluating Protexi...

CeNeRx BioPharma Initiates Phase II Clinical Trial of Its Novel Antidepressant Agent Tyrima(TM)

RESEARCH TRIANGLE PARK, N.C., Oct. 17 /PRNewswire/ -- CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system, today announced that it has initiated a Phase II clinical trial for its lead product candidate...

Celator Pharmaceuticals Receives Orphan Drug Designation for Anticancer Agent CPX-351

CPX-351 awarded orphan designation for the treatment of Acute Myeloid Leukemia PRINCETON, N.J., Sept. 4 /PRNewswire/ -- Celator Pharmaceuticals today announced that the U.S. Food & Drug Administration (FDA) has granted orphan drug designation to CPX-351 (Cytarab...

BRIDION(R) (sugammadex) Injection - First and Only Selective Relaxant Binding Agent - Approved in European Union

BRIDION allows anesthesiologists to rapidly reverse both moderate and deep levels of muscle relaxation First product approval from the Schering-Plough combination with Organon BioSciences KENILWORTH, N.J., July 29 /PRNewswire-FirstCall/ -- Sch...

CeNeRx BioPharma Finalizes Plans to Initiate Phase II Trials for Its Novel Antidepressant Agent Tyrima(TM) Using Innovative Brain Imaging Study

- State-of-the-Art PET Study Confirms Tyrima Exhibits Excellent Drug-Like Properties - - Results Support Initiation of Phase II Clinical Trials - RESEARCH TRIANGLE PARK, N.C., July 22 /PRNewswire/ -- CeNeRx BioPharma, Inc., a clinical stage company developing ...

Observational Studies Assess the Potential Impact of Limiting Erythropoiesis-Stimulating Agent Availability on Frequency of Blood Transfusions

CHICAGO, May 30 /PRNewswire/ -- Data from three observational studies reported at the American Society of Clinical Oncology (ASCO) Annual Meeting evaluated transfusion-related outcomes in cancer chemotherapy patients with various hemoglobin (Hb) levels prior to or during administration of eryt...

NicOx Announces Initiation of First Phase 1 Study of Investigational Nitric Oxide-Donating Agent in Hypertensive Patients by Merck & Co., Inc.

SOPHIA ANTIPOLIS, France, May 13 /PRNewswire-FirstCall/ -- NicOx S.A. (Eurolist: COX) today announced that Merck & Co., Inc. has initiated the first in a series of planned clinical studies, in mild to moderate hypertensive patients, under the companies' collaborative agreement to develop new n...

Tolerx Advancing Novel Type 1 Diabetes Agent into Phase III Clinical Trial Program Following End of Phase II FDA Meeting

Phase III study will evaluate effects of otelixizumab, an investigational anti-CD3 monoclonal antibody, on preservation of endogenous insulin secretion CAMBRIDGE, Mass., April 9, 2008 /PRNewswire/ - Tolerx, Inc., a biopharmaceutical company engaged in the discover...

Clinical Experience With Peregrine's Anti-Cancer Agent Bavituximab Presented at Leading Symposium on Anti-Angiogenic Agents

- Researcher Participating in Bavituximab U.S. Cancer Trial Presents Data on Novel Anti-PS Monoclonal Antibody to Anti-Angiogenesis Experts - TUSTIN, Calif., Feb. 8 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM ), a clinical stage biopharmaceutical company developing...

CeNeRx BioPharma Announces Successful Completion of Phase l Clinical Program for Novel Antidepressant Agent Tyrima(TM)

- Tyrima Exhibits Excellent Safety Profile and Favorable Pharmacokinetics in Phase I Studies - RESEARCH TRIANGLE PARK, N.C., Jan. 16 /PRNewswire/ -- CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the...

Data Presented at 2007 ASH Meeting Demonstrate Activity of Forodesine HCl as a Single Agent or in Combination With Bendamustine in Certain Types of Leukemia and Lymphoma

BIRMINGHAM, Ala., Dec. 14 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX ) today reported clinical trial and in vitro data evaluating forodesine HCl, the Company's lead anti-cancer compound, in the treatment of certain types of leukemias and lymphomas. Madeline Duvic...

CV Therapeutics' Anti-Ischemic Agent Ranexa(R) Significantly Reduces HbA1c and Other Markers of Diabetes in MERLIN TIMI-36

- Data confirms safety and HbA1c reductions seen in ischemic patients with diabetes in earlier clinical trials - ORLANDO, Fla., Nov. 6 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX ) announced today that data from a prospectively identified analysis of 2,220 dia...

SuperGen's Novel Hypomethylating Agent Highlighted at AACR Plenary Session

S110 preclinical data presented by Dr. Peter Jones, Director of USC's Norris Cancer Center SAN FRANCISCO, Oct. 25 /PRNewswire-FirstCall/ -- SuperGen Inc. (Nasdaq: SUPG), a pharmaceutical company dedicated to the discovery, rapid development and commercialization of th...

KineMed Presents Preclinical Data for Investigational Agent Demonstrating Neurogenesis and Confirming Improvements in Behavioral Model

EMERYVILLE, Calif., Oct. 11 /PRNewswire/ -- KineMed Inc., a pathway-based drug discovery and development company, announced today presentation of data demonstrating the ability of an investigational agent to regenerate nerve cells in the hippocampus, a part of the brain involved with cognition...

Survival Data in FDA Approval for ERBITUX(R) (Cetuximab) Supports use as a Single Agent in Patients with Advanced Colorectal Cancer

NEW YORK, Oct. 2 /PRNewswire-FirstCall/ -- ImClone Systems Incorporated (Nasdaq: IMCL ) and Bristol-Myers Squibb Company (NYSE: BMY ) today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the ERBITUX(R) (Cetuximab) product labeling to include overall surv...

Replidyne's Investigational Antibacterial Agent REP3123 Prevents Toxin Production in Clostridium difficile

Poster to be Presented at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy LOUISVILLE, Colo., Sept. 19 /PRNewswire-FirstCall/ -- Replidyne, Inc. (Nasdaq: RDYN ) announced today that in preclinical studies, its antibacterial candidate REP3123 i...

Replidyne's Investigational Antibacterial Agent REP3123 Prevents Sporulation in Clostridium difficile

Poster to be Presented at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy LOUISVILLE, Colo., Sept. 19 /PRNewswire-FirstCall/ -- Replidyne, Inc. (Nasdaq: RDYN ) announced today that in preclinical studies, its antibacterial candidate REP3123 i...

FDA Approves Tekturna HCT(R) as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent

EAST HANOVER, N.J., July 21 /PRNewswire/ -- The US Food and Drug Administration (FDA) has approved Tekturna HCT((R)) (aliskiren and hydrochlorothiazide) tablets as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals. Tek...

ImQuest BioSciences Receives Phase I SBIR Grant to Develop a Novel Hepatitis C Virus Therapeutic Agent

FREDERICK, Md., April 21 /PRNewswire/ -- ImQuest BioSciences and Arisyn Therapeutics jointly announced today the successful acquisition of funding from the National Institutes of Health to support the development of novel small molecule therapeutics for the treatment of hepatitis C virus (HCV) inf...

Journal of the American Dental Association Publishes Key Clinical Data for the Use of OraVerse(TM) a Local Anesthetic Reversal Agent

SAN DIEGO, Aug. 12 /PRNewswire/ -- Novalar Pharmaceuticals, Inc., a dental specialty pharmaceutical company, announced the publication of three clinical trials on the use of OraVerse (phentolamine mesylate) injection as a local dental anesthetic reversal agent in the August 2008 issue of the J...

FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the First and Only Selective Relaxant Binding Agent

Committee Recommends FDA Approve Novel Anesthesia Drug to Reverse Muscle relaxation within Minutes KENILWORTH, N.J., March 11 /PRNewswire-FirstCall/ -- Schering-Plough (NYSE: SGP ) today announced that the U.S. Food and Drug Administration (FDA) Advisory Committee on Ane...

Avid Announces Results of AV-1 Molecular Imaging Agent for Alzheimer's Disease Presented at AD/PD Meeting

PHILADELPHIA--(BUSINESS WIRE)--Mar 19, 2007 - Avid Radiopharmaceuticals, Inc. (Avid), a product-focused molecular imaging company, today announced the presentation of the first results from a clinical study of 18F-AV-1/ZK (AV-1), a novel radiopharmaceutical for positron emission tomography (PET) im...

Onconase has Potential as Chemopreventive Agent in Mesothelioma, Reports World-Renowned Mesothelioma Researcher at AACR Annual Meeting

BLOOMFIELD, N.J., April 18, 2007 /PRNewswire-FirstCall/ -- ONCONASE (ranpirnase), Alfacell Corporation's lead drug candidate, may have potential as a chemopreventive agent, according to world-renowned mesothelioma researcher Michele Carbone M.D., Ph.D., at this week's American Association for Canc...

Prolexys Pharmaceuticals and Columbia University Researchers Publish Study on Anti-Tumor Properties of a Selective Small Molecule Anti-Tumor Agent With Novel Mechanism of Action

SALT LAKE CITY, June 14, 2007 /PRNewswire/ -- Prolexys Pharmaceuticals and announced today a publication describing the properties of the selective small molecule anti-tumor agent, erastin. Prolexys and Columbia applied the company's chemi-proteomics technology to understand the mechanism of actio...

ImmuneRegen BioSciences Announces Promising Data on Homspera Suggesting Potential as a Co-Therapeutic Agent

Compound Could Be Utilized as an Adjuvant and Play Key Role in the Treatment of Influenza and Cancer SCOTTSDALE, Ariz., March 20, 2007 /PRNewswire-FirstCall/ -- ImmuneRegen BioSciences, a wholly owned subsidiary of IR BioSciences Holdings, Inc. , announced today that data obtained by the Company o...

Vectibix(R) in Combination With Chemotherapy Significantly Improved Progression-Free Survival in First-Line Metastatic Colorectal Cancer

...on on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. The effectiveness of Vectibix as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma is based on progression-free survival. Currently no data are available that demo...

Radius' Investigational Bone Anabolic Agent, BA058, Increased Bone Mineral Density (BMD) at Key Fracture Sites in Phase 2 Clinical Trial in Postmenopausal Osteoporosis

...relative to placebo. The study also included a Forteo(R) reference arm. Forteo(R), a form of parathyroid hormone, is the only anabolic (bone-building) agent approved for marketing by the U.S. Food and Drug Administration for the treatment of osteoporosis in women and men at high risk of fracture. B...

FDA Advisory Committee Votes in Favor of SAPHRIS(R) (asenapine) for Acute Bipolar I Disorder and Acute Schizophrenia

...d more than four million people in Europe. Although there are a number of medications available for patients, treatment success for any antipsychotic agent can be unpredictable because patients often respond differently to various medications. Among patients with schizophrenia who are being treated with ...

VisEn Molecular Imaging Technology Enables Key Insights Into Newly Discovered Biologic Pathway Published in SCIENCE

... this important pathway." About VisEn Medical Inc. VisEn's in vivo fluorescence imaging technologies, including its Fluorescence agent Portfolio and its Fluorescence Molecular Tomography (FMT (TM) ) Imaging Systems, provide robust fluorescence molecular imaging performance in identify...

NeurogesX Announces Preliminary Results of FDA-Requested Qutenza(TM) Study

...rug Administration (FDA) requested the study to determine whether an FDA-approved topical anesthetic would provide similar tolerability to the topical agent used as a pretreatment in the clinical development program. The NDA for Qutenza in PHN has a Prescription Drug User Fee Act (PDUFA) date of August 16,...

Poniard Pharmaceuticals Announces Positive Cardiac Safety Data From Picoplatin Phase 1 Trial Supporting NDA Filing

...ac safety study of picoplatin, a new generation platinum-based chemotherapy agent and the Company's lead product candidate. The Company worked collaborativel... Picoplatin Picoplatin is a new generation platinum-based chemotherapy agent that is in clinical development for multiple cancer indications, treatment ...

National Cancer Institute Research Identifies Unique Mechanism of Brostallicin's Anti-Tumor Effectiveness

...armacology at the National Cancer Institute presented new preclinical research identifying unique anti-tumor mechanisms of brostallicin that sets this agent apart from other currently used chemotherapy agents. CTI acquired worldwide rights to brostallicin when it acquired privately-held Systems Medicine LL...

BioCryst Pharmaceuticals Reports Positive Results of Shionogi & Co. Sponsored Phase 3 Studies of i.v. Peramivir for Influenza

... Drug Application and to receive a manufacturing approval as soon as possible in Japan. About Peramivir Peramivir is an anti-viral agent that inhibits the interactions of influenza neuraminidase, an enzyme which is critical to the spread of influenza within a host. Peramivir has demonst...

Keryx Biopharmaceuticals, Inc. Commences Phase 1 Study of KRX-0401 (Perifosine) in Recurrent Pediatric Solid Tumors at Memorial Sloan-Kettering Cancer Center

...tudy to evaluate KRX-0401 (perifosine) as a single agent treatment for recurrent solid tumors in pediatric ...n. KRX-0401 is a novel, oral, anticancer agent that modulates Akt and several other important sig...National Cancer Institute demonstrated that single agent perifosine not only induced tumor regression and d...

CeNeRx BioPharma Obtains Rights to Novel Drug Candidate for Prevention and Treatment of Neurodegeneration Disorders

... obtained the rights to develop and market a novel agent for the prevention and treatment of neuropathies a...didate, CXB909, is a small molecule, orally active agent that enhances the effects of nerve growth factor (...NeRx. "In preclinical studies, our small molecule agent CXB909 has been shown to increase the action of na...

New Analysis Shows Efficacy of SIMPONI(TM) (golimumab) in Anti-TNF Experienced Rheumatoid Arthritis Patients

..." Regardless of the particular anti-TNF-alpha agent previously used in treatment (adalimumab, etanerce...rates the efficacy and safety of an anti-TNF-alpha agent in patients previously treated with other anti-TNF...dy. Reasons for discontinuation of prior anti-TNF agent included lack of efficacy (58 percent), intoleranc...

Micromet Presents Update on Blinatumomab's Response Rate and Duration in a Phase 1 Study in Non-Hodgkin's Lymphoma Patients

...ts including partial and complete responses following treatment with single agent blinatumomab(2). The data show that 11 out of 12 patients having received a...et al. (2008). Sustained Response Duration Seen after Treatment with Single agent Blinatumomab (MT103/MEDI-538) in the Ongoing Phase I Study MT103-104 in Pat...

Arena Pharmaceuticals Announces Lorcaserin Data Demonstrating Highly Significant Categorical and Absolute Weight Loss and Improvements in Secondary Endpoints Associated with Cardiovascular Risk

...on criteria for entry into these trials and there is no monitoring by an independent board. About Lorcaserin Lorcaserin is a novel single agent that represents the first in a new class of selective serotonin 2C receptor agonists. The serotonin 2C receptor is located in areas of the brain invol...

Access Pharmaceuticals Announces Publication of Thiarabine Combination Data

...farabine provides much greater antitumor activity than achieved by either agent alone. In one colorectal cancer model, 66% of mice were cured of their tumo...f these two agents, efficacy was dramatically superior to the use of either agent alone. Tumor regression and cures were observed in several models including...
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