17 Nov 08 Ferumoxytol Resubmission Designated Complete, Class 1 Response By FDA - Iron Deficiency Anemia In Chronic Kidney Disease Patients
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) has designated the Company’s resubmission to the October 2008 Complete Response letter for its New Drug Application (NDA) for ferumoxytol as a complete, Class 1 response. The FDA has established a December 30, 2008 Prescription Drug User Fee Act (PDUFA) target action date.
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Tags: Anemia, Chronic Kidney Disease, Disease Patients, Drug Application, Fda, Ferumoxytol, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Iron Anemia, Iron Deficiency, Iron Deficiency Anemia, Nasdaq, Nda, Pharmaceuticals Inc, Prescription Drug, Response Letter, Target Action
09 Nov 08 Poniard Pharmaceuticals Announces Final Top-Line Results From Phase 1 Trial Demonstrating Positive Bioavailability With Oral Picoplatin
Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, announced top-line results from its Phase 1 clinical trial of an oral formulation of picoplatin in patients with solid tumors showing that picoplatin achieves linear and dose-dependent plasma exposure when given by the oral route.
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Tags: Bioavailability, Biopharmaceutical Company, Clinical Trial, Nasdaq, Oncology, Oral Formulation, Oral Route, Pharmaceuticals Inc, Phase 1, Picoplatin, Plasma, Poniard Pharmaceuticals, Tumors
05 Nov 08 Avineuro Announced Advancing Potent Small Molecule For Treatment Of Alzheimer’s Disease To Clinical Development
Avineuro Pharmaceuticals, Inc. announced today the completion of preclinical studies of AVN-101, a potent small molecule for treatment of Alzheimer’s disease. These studies demonstrate that AVN-101 is safe and well tolerated, and that it has a favorable pharmacokinetic profile. Based on these and other results, Avineuro Pharmaceuticals, Inc. plans to advance AVN-101 into clinical trials in Q1 2009.
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Tags: Alzheimer Disease, Alzheimer S Disease, Avn, Clinical Trials, Molecule, Pharmaceuticals Inc, Pharmacokinetic Profile, Preclinical Studies, Q1
05 Nov 08 Alvine Pharmaceuticals Reports Positive Results With ALV003 In Phase 1 Trial Of Therapy In Development For Celiac Disease
Alvine Pharmaceuticals, Inc., today announced proof of concept in a Phase 1 Trial of ALV003, an oral protease therapy in development to detoxify gluten, intended for use by patients with celiac disease. The trial results confirmed that single doses of up to 1,800 mg of ALV003 were safe and tolerable in healthy volunteers. Doses at the 300 mg level achieved up to a 96% reduction of gluten in a meal in the stomach at 30 minutes, and were well tolerated by patients with celiac disease.
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Tags: 30 Minutes, Alvine Pharmaceuticals, Celiac Disease, Gluten, Oral, Pharmaceuticals Inc, Phase 1, Proof Of Concept, Protease, Stomach, Volunteers
04 Nov 08 Avineuro Announced Advancing Potent Small Molecule For Treatment Of Alzheimer’s Disease To Clinical Development
Avineuro Pharmaceuticals, Inc. announced today the completion of preclinical studies of AVN-101, a potent small molecule for treatment of Alzheimer’s disease. These studies demonstrate that AVN-101 is safe and well tolerated, and that it has a favorable pharmacokinetic profile. Based on these and other results, Avineuro Pharmaceuticals, Inc. plans to advance AVN-101 into clinical trials in Q1 2009.
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Tags: Alzheimer Disease, Alzheimer S Disease, Avn, Clinical Trials, Molecule, Pharmaceuticals Inc, Pharmacokinetic Profile, Preclinical Studies, Q1
20 Oct 08 Provectus Pharmaceuticals Adds Fourth Center To Phase 2 Clinical Trial Of PV-10 For Stage III And IV Metastatic Melanoma Treatment
Provectus Pharmaceuticals, Inc. (OTCBB: PVCT) has begun recruitment for its Phase 2 clinical trial of the Company’s lead oncology agent PV-10 at a fourth major center, now covering Adelaide, Australia in addition to Sydney and Brisbane, Australia, as well as M.D. Anderson in Houston, Texas, USA. Over the next several months, the Company expects to continue expansion of the study to include sites in other major population centers in Australia as well as several sites in the United States.
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Tags: Adelaide Australia, Australia Sydney, Brisbane Australia, Clinical Trial, Houston Texas Usa, M D Anderson, Melanoma, Melanoma Treatment, Metastatic Melanoma, Oncology, Otcbb, Pharmaceuticals Inc, Phase 2, Population Centers, Provectus Pharmaceuticals, Pv, Pvct, Recruitment, Stage Iii, Sydney Australia
16 Oct 08 FDA Grants Orphan Drug Status To Reata’s RTA 402 For Treatment Of Pancreatic Cancer
Reata Pharmaceuticals, Inc. announces that RTA 402 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. RTA 402 is currently being studied in a Phase 1/2 trial in patients with pancreatic cancer, and is also in Phase 2 development for chronic kidney disease. “Pancreatic cancer is a devastating disease with few effective therapies,” said Warren Huff, CEO of Reata.
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Tags: Ceo, Chronic Kidney Disease, Fda, Fda Grants, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Huff, Kidney Cancer, Orphan Drug Designation, Orphan Drug Status, Pharmaceuticals Inc, Phase 1, Phase 2, Rta, Treatment Of Pancreatic Cancer
12 Oct 08 Cyclacel Announces Completion Of Enrollment In Phase 2 Trial Of Sapacitabine In Elderly AML
lCyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP) announced today the completion of enrollment as per protocol in the Phase 2 clinical trial of sapacitabine, the Company’s oral nucleoside analogue, in elderly patients with acute myeloid leukemia (AML). Interim results from this trial are expected to be available by the end of 2008 and final results during the second half of 2009.
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Tags: Acute Leukemia, Acute Myeloid Leukemia, Clinical Trial, Cycc, Elderly Patients, Interim Results, Leukemia, Leukemia Aml, Nasdaq, Nucleoside Analogue, Oral, Pharmaceuticals Inc, Phase 2, Protocol, Second Half
12 Oct 08 Cyclacel Announces Completion Of Enrollment In Phase 2 Trial Of Sapacitabine In Elderly AML
lCyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP) announced today the completion of enrollment as per protocol in the Phase 2 clinical trial of sapacitabine, the Company’s oral nucleoside analogue, in elderly patients with acute myeloid leukemia (AML). Interim results from this trial are expected to be available by the end of 2008 and final results during the second half of 2009.
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Tags: Acute Leukemia, Acute Myeloid Leukemia, Clinical Trial, Cycc, Elderly Patients, Interim Results, Leukemia, Leukemia Aml, Nasdaq, Nucleoside Analogue, Oral, Pharmaceuticals Inc, Phase 2, Protocol, Second Half
09 Oct 08 Study Shows EUFLEXXA(R) Patients Report Significant Improvements In Osteoarthritis Of The Knee Pain Over A Six Month Period
Ferring Pharmaceuticals Inc. recently presented results from the FLEXX Trial of Osteoarthritis of the Knee, showing that EUFLEXXA(R) (1% sodium hyaluronate), a highly pure non-avian high molecular weight form of intra-articular hyaluronic acid (IA-HA), is superior to intra-articular saline (IA-saline) for the relief of pain in knee osteoarthritis (OA) at 26 weeks.
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Tags: Euflexxa, Knee Osteoarthritis, Knee Pain, Molecular Weight, Oa, Osteoarthritis, Osteoarthritis Of The Knee, Osteoarthritis Pain, Pharmaceuticals Inc, Relief Of Pain, Saline, Significant Improvements, Sodium Hyaluronate
03 Oct 08 Preclinical Findings Highlight Novel Approach To Maximizing DsiRNAs In Rheumatoid Arthritis; Data Appear Published By Molecular Therapy
Dicerna Pharmaceuticals, Inc., a second generation RNA interference company developing novel therapeutics utilizing proprietary Dicer Substrate Technology™, announced today a paper appearing in the advance online publication of Molecular Therapy which describes the therapeutic potential for Dicer-substrate small interfering RNAs (DsiRNAs) in the treatment of rheumatoid arthritis in a murine model of arthritis.
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Tags: Arthritis, Highlight, Murine, Murine Model, Novel Approach, Novel Therapeutics, Pharmaceuticals Inc, Preclinical Findings, Rheumatoid Arthritis, Rna Interference, Second Generation, Substrate Technology, Treatment Of Rheumatoid Arthritis
26 Sep 08 Concert Pharmaceuticals Presents Preclinical Results Supporting Co-Administration Of CTP-347 And Tamoxifen
Concert Pharmaceuticals, Inc. announced today the presentation of data from a preclinical study demonstrating the potential of CTP-347, its novel deuterium-containing serotonin modulator, to avoid the risk of adverse drug-drug interactions when co-administered with tamoxifen, a widely-used breast cancer drug. These data were the subject of a poster presentation at the North American Menopause Society’s 2008 Annual Meeting.
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Tags: Annual Meeting, Breast Cancer, Breast Cancer Drug, Ctp, Deuterium, Drug Interactions, Menopause, Modulator, North American Menopause Society, Novel, Pharmaceuticals Inc, Poster Presentation, Preclinical Results, Presents, Risk, Tamoxifen
25 Sep 08 Initiation Of Clinical Trials Of CPI-613 For The Treatment Of Cancer - First-In-Class Altered Energy Metabolism-Directed Compound
Cornerstone Pharmaceuticals Inc., a privately held pharmaceutical company, announced today that it has begun dosing patients in a recently approved safety and early efficacy clinical trial of CPI-613, its novel first-in-class Altered Energy Metabolism-Directed (AEMD) compound being evaluated for potential use in a wide array of cancers. Health Canada and the US FDA have approved the initiation of studies of CPI-613, which will be conducted at clinical trial sites in both the US and Canada.
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Tags: Array, Cancers, Clinical Trial, Clinical Trials, Cornerstone, Cpi, Efficacy, Energy Metabolism, Fda, Fda Approved, Health Canada, Initiation, Novel, Pharmaceutical Company, Pharmaceuticals Inc, Treatment Of Cancer
23 Sep 08 AVEO Pharmaceuticals Initiates First Clinical Trial Of Novel HGF Antagonist In Patients With Advanced Solid Tumors And Lymphomas
AVEO Pharmaceuticals, Inc., announced that it has initiated a Phase 1 clinical trial to evaluate the safety, tolerability and recommended dose of SCH900105 (AV-299), its novel, highly potent antibody to hepatocyte growth factor (HGF), administered intravenously in patients with relapsed or refractory solid tumors or lymphoma. SCH900105 (AV-299) is being developed in collaboration with Schering-Plough (NYSE: SGP).
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Tags: Antagonist, Antibody, Aveo, Clinical Trial, Collaboration, Lymphoma, Novel, Nyse, Pharmaceuticals Inc, Phase 1, Safety Tolerability, Schering Plough, Tumors
17 Sep 08 Pro-Pharmaceuticals Submits Data For Registration Of DAVANAT(R) To Treat Late-Stage Colorectal Cancer Patients
Pro-Pharmaceuticals, Inc. (AMEX: PRW), a bio-pharmaceutical company developing proprietary polysaccharide-based therapeutic compounds to treat cancer, has submitted supporting clinical and manufacturing data to the U.S. Food and Drug Administration (FDA) for a New Drug Application (NDA) registration of DAVANAT®, a new chemical entity, for the treatment of advanced colorectal cancer.
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Tags: Advanced Cancer, Amex, Cancer Patients, Chemical Entity, Colorectal, Colorectal Cancer, Davanat, Drug Application, Fda, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Pharmaceutical Company, Pharmaceuticals Inc, Therapeutic Compounds
17 Sep 08 Othera Initiates Phase I/II Clinical Trial Of OT-730 In Ocular Hypertension And Glaucoma
Othera Pharmaceuticals, Inc., announced that it has initiated dosing in a Phase I/II clinical trial to determine the safety and efficacy of topical OT-730 in patients with ocular hypertension and glaucoma. The study is a randomized, multi-center, investigator-masked, timolol- and placebo-controlled evaluation of the safety and efficacy of OT-730 in reducing the intraocular pressure in subjects with ocular hypertension or open-angle glaucoma. Subjects will be randomized to one of 0.
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Tags: Clinical Trial, Efficacy, Glaucoma, Hypertension, Intraocular Pressure, Ocular Hypertension, Open Angle Glaucoma, Ot, Pharmaceuticals Inc, Placebo, Timolol
16 Sep 08 Xel Pharmaceuticals’ Successful Completion Of Prototype Once-A-Week Huperzine A Transdermal Patch For Alzheimer’s Disease
Xel Pharmaceuticals, Inc. announced the completion of the development of its once-a-week Huperzine A transdermal patch for the treatment of Alzheimer’s disease (AD). The prototype transdermal patch can deliver 400-800 mcg of Huperzine A per day for up to seven days. Huperzine A is a naturally occurring alkaloid found from the club moss Huperzia serrata that has been used for decades in China as a prescription medication for the treatment of dementia.
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Tags: Alzheimer Disease, Alzheimer S Disease, China, Club Moss, Decades, Dementia, Huperzia Serrata, Mcg, Medication, Pharmaceuticals Inc, Prescription Medication, Prototype, Seven Days, Transdermal Patch, Treatment Of Dementia, Xel
16 Sep 08 Unibioscreen And Drais Pharmaceuticals Partner To Develop And Commercialize Unbs5162 For Treatment Of Cancer
Drais Pharmaceuticals, Inc. and Unibioscreen S.A. announced that they have entered into a global agreement to develop and commercialize UNBS5162, one of Unibioscreen’s investigational drug and potential breakthrough treatments for cancer. UNBS5162 was discovered by Unibioscreen and is currently in Phase I trials in the United States in cancer patients with advanced solid tumors or lymphoma.
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Tags: Breakthrough Treatments, Cancer Patients, Drais, Global Agreement, Investigational Drug, Lymphoma, Partner, Pharmaceuticals Inc, Treatment Of Cancer, Treatments For Cancer, Tumors, Unibioscreen, United States
15 Sep 08 Cyclacel Expands Phase 2 Sapacitabine Trial In Elderly AML To Include Patients With MDS
Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP) announced that it has advanced sapacitabine into Phase 2 development as a second-line treatment for myelodysplastic syndromes (MDS). The MDS study is designed as a protocol amendment expanding the ongoing Phase 2 trial of sapacitabine in elderly patients with acute myeloid leukemia (AML) to include a cohort of patients with MDS.
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Tags: Acute Leukemia, Acute Myeloid Leukemia, Aml, Cohort, Cycc, Cyclacel Pharmaceuticals, Elderly Patients, Leukemia, Myelodysplastic Syndromes, Nasdaq, Pharmaceuticals Inc, Protocol Amendment
