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New Safety Regulations Drive Greater Need for Resources and Expertise at Every Stage of Clinical Development

DUBLIN, June 18 /PRNewswire-FirstCall/ -- According to a report issued today, drug safety leaders in pharmaceutical and biotechnology companies recognise the need to increase resources, either internally or through partnerships, to comply with the safety regulations recently issued by the U.S....

Study Data Show Positive European Experience With DuraHeart Left Ventricular Assist Device for Advanced Stage Heart Failure Patients

Sustained Benefits for Patients Awaiting Transplantation ANN ARBOR, Mich., April 7 /PRNewswire/ -- The DuraHeart(TM) Left Ventricular Assist System (LVAS) shows sustained benefits in providing safe and reliable long-term circulatory support with an improved survival rate and an acceptable adv...

Breast Cancer Clinical Results Show Test Can Differentiate Normal, Early and Later Stage Cancers

TORONTO, Feb. 5 /PRNewswire-FirstCall/ - Predictive medicine company PreMD Inc. (TSX: PMD; PREMF.pk) today announced that its recently completed clinical trial data was presented at the 4th Annual Academic Surgical Congress in Fort Myers, FL. The peer reviewed data was presented by Dr. Anees B. Ch...

Alseres Pharmaceuticals Completes Enrollment in First Stage of the Altropane(R) POET-2 Phase III Program

HOPKINTON, Mass., Feb. 3 /PRNewswire-FirstCall/ -- Alseres Pharmaceuticals, Inc. (Nasdaq: ALSE ), announced today that it has completed enrollment in the first stage of the Altropane Parkinson's or Essential Tremor (POET-2) Phase III clinical program. The objective of the first part of the pr...

Peregrine Pharmaceuticals Completes Patient Enrollment in First Stage of Its Second Bavituximab Phase II Breast Cancer Trial

- Planned 15 Patient Cohort Enrolled in Stage A of Trial Assessing Regimen of Bavituximab in Combination With Carboplatin and Paclitaxel - TUSTIN, Calif., Oct. 7 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM ), a clinical stage biopharmaceutical company developing ...

AEterna Zentaris Reaches 2nd Stage of Patient Recruitment for Phase 2 Trial in Ovarian Cancer with the Innovative LHRH Receptor Targeted Conjugate, AEZS-108

QUEBEC CITY, Oct. 2 /PRNewswire-FirstCall/ - AEterna Zentaris Inc. (NASDAQ: AEZS ; TSX: AEZ), a global biopharmaceutical company focused on endocrine therapy and oncology, today reported that it has entered the second stage of patient recruitment for its Phase 2 trial in ovarian cancer with A...

Electronic Brachytherapy a Viable Option for Early Stage Breast Cancer, According to Study Presented at ASCO Breast Cancer Symposium

Researcher Says, New Non-Isotope Based Delivery System Has Potential to Help Solve Radiation Therapy Access and Treatment Disparities Reported at ASCO Symposium WASHINGTON, Sept. 8 /PRNewswire/ -- Early clinical experience with the FDA cleared Axxent(R) Electronic ...

Sound Pharmaceuticals Files Second IND with the FDA for the Prevention of Chemotherapy Induced Hearing Loss in Advanced Stage Cancer

SEATTLE, July 23 /PRNewswire/ -- Sound Pharmaceuticals (SPI) has filed an Investigational New Drug Application with the FDA for the clinical testing of a proprietary formulation of ebselen for the prevention of chemotherapy induced hearing loss or ototoxicity. The oral capsule containing ebsel...

Long-Term Pegylated Interferon Alfa-2b Therapy in Stage III Melanoma Demonstrated Significant and Sustained Impact on Relapse-Free Survival

EORTC 18991 Phase III Study Results Published in The Lancet KENILWORTH, N.J., July 11 /PRNewswire-FirstCall/ -- Today, Schering-Plough (NYSE: SGP ) and the EORTC announced that long-term treatment with pegylated interferon alfa-2b in stage III melanoma patients had a significant and sus...

Genasense(R) Chemotherapy Program Yields High Response Rate in Patients with Stage 4 Melanoma

Related Clinical Study Shows Potential Utility of Short-Course High-Dose Therapy BERKELEY HEIGHTS, N.J., May 30 /PRNewswire-FirstCall/ -- Genta Incorporated (OTC Bulletin Board: GNTA) announced preliminary results that have shown a high objective response rate in...

Node-Negative Early Stage Breast Cancer Patients Benefit from Taxotere(R)-Based Chemotherapy

First Phase III study performed solely in high risk node-negative population to show significant improvement in Disease Free Survival (DFS) BRIDGEWATER, N.J., May 27 /PRNewswire-FirstCall/ -- Sanofi-aventis and GEICAM (Grupo Espanol de Investigacion en Cancer de Mama) announced today that ...

New Data Shows 45 Percent of Patients with Stage 1 Hypertension Reached Normotension with BENICAR(R) and BENICAR HCT(R)

Data Presented at the American Society of Hypertension's Twenty-Third Annual Scientific Meeting - A cumulative forty-five percent (45%) of patients with stage 1 hypertension treated with a regimen of BENICAR(R) (olmesartan medoxomil) and BENICAR HCT(R) (olmesartan ...

AviaraDx Confirms That Combination of Two Molecular Biomarkers Improves Prediction of Disease Recurrence in Early Stage Breast Cancer Patients

-Specific biomarkers for molecular tumor grade and endocrine benefit offer better prediction of individual patient outcome- SAN DIEGO, May 13 /PRNewswire/ -- AviaraDx, Inc. today announced the publication of an article describing the discovery, development and validation of a new mol...

Intercell AG to Acquire Iomai Corporation to Expand Late Stage Product Pipeline and Strengthen Leadership in Vaccine Innovation

- Intercell AG ('Intercell') to acquire Iomai Corporation ('Iomai') in a fully recommended share/cash transaction for USD 6.60 per share of Iomai's common stock representing a fully diluted equity value of Iomai of approximately USD 189 million (EUR 122 million). Acquisition to be accompli...

Peregrine Pharmaceuticals Completes Patient Enrollment in First Stage of Bavituximab Phase II Breast Cancer Trial

- First 15 Patients Are Enrolled and Dosing With Bavituximab Plus Docetaxel Combination Regimen is Underway - TUSTIN, Calif., April 29 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM ), a clinical stage biopharmaceutical company developing monoclonal an...

Alseres Pharmaceuticals Expands Sites for the First Stage of the ALTROPANE(R) Phase III Clinical Trial Program

HOPKINTON, Mass., April 17 /PRNewswire-FirstCall/ -- Alseres Pharmaceuticals, Inc. (Nasdaq: ALSE ) announced today that seven sites for the first stage of the ALTROPANE(R) Parkinson's or Essential Tremor - 2 (POET-2) Phase III clinical trial program are now open for patient enrollment. ALTROP...

HUYA Bioscience Int'l Announces First Pre-IND Outcome for a Development Stage Compound Sourced From China - HBI-8000, Promising New Cancer Compound

FDA feedback validates HUYA's Integrated Co-Development Model for China-sourced Drug Candidates SAN DIEGO, April 14 /PRNewswire/ -- HUYA Bioscience International (HUYA), the leader in U.S./China pharmaceutical co-development, today announced the outcome of the first pre-...

Shire Strives to Increase Adherence Among Chronic Kidney Disease Stage 5 Patients

'On Track' Initiative Provides Broader Access to FOSRENOL(R) and Resources for Enhanced Hyperphosphatemia Management PHILADELPHIA, April 3, 2008 /PRNewswire/ -- Shire Pharmaceuticals, the global biopharmaceutical company, today announced the launch of On Track, an innovative progr...

Regado Biosciences Presents Early Stage Clinical Data for REG1 Anticoagulation System at American Heart Association 2007 Scientific Sessions

In Phase I Clinical Evaluation Anticoagulant Inhibits Clotting Factor IXa; Matched Antidote Rapidly Reverses Anticoagulant Effect ORLANDO, Fla., Nov. 6 /PRNewswire/ -- Regado Biosciences today presented encouraging data from Phase Ia and Phase Ib dose escalation studies of the Company's...

UPDATE: Nebivolol Lowers Blood Pressure in African Americans With Stage I-II Hypertension as Demonstrated in a Study Published in the Journal of Clinical Hypertension

NEW YORK, Nov. 1 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX ) today announced the results of a double-blind, randomized, placebo-controlled clinical trial, published in the November 2007 issue of the Journal of Clinical Hypertension, which demonstrated that nebivolol signi...

Nebivolol Lowers Blood Pressure in African Americans With Stage I-II Hypertension as Demonstrated in a Study Published in the Journal of Clinical Hypertension

NEW YORK, Nov. 1 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX ) today announced the results of a double-blind, randomized, placebo-controlled clinical trial, published in the November 2007 issue of the Journal of Clinical Hypertension, which demonstrated that nebivolol signi...

Chemokine Therapeutics Announces Preliminary Results of CTCE-9908 Phase Ib/II Clinical Trial in Late Stage Cancer Patients

TSX: CTI OTCBB: CHKT VANCOUVER, March 12, 2007 /PRNewswire-FirstCall/ - Chemokine Therapeutics Corp. ("Chemokine Therapeutics" or the "Company") , a biotechnology company developing chemokine-based therapies to treat cancer, blood disorders, and vascular disease today announced positive preliminar...

Long-Term Pegylated Interferon Alfa-2b Therapy in Stage III Melanoma Demonstrated Significant and Sustained Impact on Relapse-Free Survival

-- EORTC 18991 Phase III Study Results Presented At ASCO -- CHICAGO – June 2, 2007 – Long-term treatment with pegylated interferon alfa-2b in stage III melanoma had a significant and sustained impact on relapse-free survival (RFS), according to the results of the largest adjuvant tri...

Nektar Therapeutics Reports Second Quarter 2009 Financial Results

...nd those of its collaboration partners are in various stages of clinical development and the risk of failure is high and can unexpectedly occur at any stage of development prior to regulatory approval for numerous reasons including, without limitation, safety and efficacy findings; (ii) the timing or succe...

Amgen Announces Positive Top-Line Results for Denosumab in Trial for Delay of Skeletal Related Events in Bone Metastases Patients Compared to Zometa(R)

... compared with Zometa. About Denosumab and Amgen's Research in Bone Biology Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, the essential regulator of osteoclasts (the cells that break down bone). With more than 19...

Telik Announces Publication of Positive Phase 1 Results of a Multicenter Study of Ezatiostat Hydrochloride (TELINTRA(R), TLK199) Tablets In Patients With Myelodysplastic Syndrome

... lines. Additional information on TELINTRA is available at www.telik.com . About Telik Telik, Inc. of Palo Alto, CA, is a clinical stage drug development company focused on discovering and developing small molecule drugs to treat cancer and inflammatory diseases. The company's most adv...

Pharmasset Reports Positive Preliminary Antiviral Data With PSI-7851 for the Treatment of Hepatitis C

...ys(R) and Copegus(R) to treat chronic HCV. These clinical studies are being conducted through a strategic collaboration with Roche. Our other clinical stage candidates are PSI-7851, an unpartnered, next generation HCV nucleotide analog which recently began Phase 1 clinical studies and Racivir, for the trea...

Diabetes Gene Raises Odds of Lower Birth Weight

...s also predisposes children to having a lower birth weight. The finding sheds light on a possible genetic influence on how prenatal events may set the stage for developing diabetes in later childhood or adulthood. Researchers from The Children's Hospital of Philadelphia and the University of Pennsyl...

European Division of Global Top 20 Pharmaceutical Company Awards Phase III Trial to DATATRAK

...cts to meet customer and market needs; fluctuations in the Company's quarterly results; the viability of the Company's business strategy and its early stage of development; the timing of clinical trial sponsor decisions to conduct new clinical trials or cancel or delay ongoing trials; the Company's depende...

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

...neuropathy (HIV-DSP) and painful diabetic neuropathy (PDN). NeurogesX' late stage product portfolio is led by its product candidate Qutenza, a dermal patch d...ating the timing of entering Phase 2 development. NeurogesX' early stage product pipeline includes pre-clinical compounds, which are prodrugs of ace...

First Skin Cancer Patients Treated With Electronic Brachytherapy (eBx) At University of Wisconsin Riverview Cancer Center

... a shielded vault is not needed. Available for treatment of early stage breast cancer, endometrial cancer, and skin cancer, the Axxent eBx System i...radioactive medical isotopes. Commercially available for treatment of early stage breast cancer, skin cancer, and endometrial and rectal indications, the Axx...

Northern California Cancer Center's First-of-Its-Kind Research Reveals Low Socioeconomic Status Often Equals Poor Chance of Lymphoma Survival

...phoma in California, those in poorer neighborhoods had as much as a 37% increased risk of death from the disease, regardless of race/ethnicity, or the stage of their disease when diagnosed. The study results were published in the Journal of Clinical Oncology , June, 2009. NCCC's research is the first t...

Human Genome Sciences and GlaxoSmithKline Announce Positive Phase 3 Study Results for BENLYSTA(TM) in Systemic Lupus Erythematosus

..., Senior Vice President, Biopharm Development, GSK. "BENLYSTA is the first medicine being developed specifically for lupus that has reached this late stage of clinical development with positive results. We look forward to completing the pivotal studies, with the hope of bringing this potentially importan...

Cognition Therapeutics Closes Series A Financing to Advance Drug Candidates for Alzheimer's Disease

...ny that has investments is a wide variety of asset classes, including venture capital. Over the past two years Ogden CAP, LLC has invested in 10 early stage companies. Besides its investment in Cognition, Ogden CAP, LLC has two other investments in the Pittsburgh area: FASTTAC, a document control and mana...

Schering-Plough Expands Vicriviroc Phase II Study in Treatment-Naive Patients With HIV

...E: SGP ) today announced that it has extended to stage two an ongoing Phase II clinical study with vicriv...y is being conducted in two stages, with the first stage initiated in January 2008 and having enrolled 95 p...d on these results, the study has been extended to stage two, in which the enrollment target is an addition...

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

...s to differ materially are the following: our ability to successfully complete clinical trials for KRX-0401; our ability to successfully finalize late stage protocols for KRX-0401 with the FDA; our ability to meet anticipated development timelines for KRX-0401 due to recruitment, clinical trial results, ma...

Bioniche Life Sciences Inc. and Endo Pharmaceuticals Sign Licensing Agreement for Urocidin(TM)

...eive a transfer price for supply. "We are excited about the opportunity to expand our portfolio in bladder cancer treatment and enhance our late stage development pipeline," said David Holveck, president and chief executive officer of Endo Pharmaceuticals. "In August Endo plans to launch Valstar(TM),...

CEL-SCI to Present Data from Multikine Clinical Trials at National Institutes of Health (NIH), National Cancer Institute (NCI) Seminar Series

... VIENNA, Va., July 10 /PRNewswire-FirstCall/ -- CEL-SCI Corporation (NYSE Amex: CVM ), a late stage cancer immunotherapy company, announced today that Dr. Eyal Talor, CEL-SCI's Senior Vice President of Research and Manufacturing, has been invited t...

Denosumab Demonstrates Superiority Over Zometa(R) in Pivotal Phase 3 Head-to-Head Trial in Breast Cancer Patients With Bone Metastases

...b compared with Zometa. About Denosumab and Amgen's Research in Bone Biology Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, the essential regulator of osteoclasts (the cells that break down bone). With more than 19...

USC Keck School of Medicine's Dr. Alan Epstein Receives Prestigious National Cancer Institute RAID Award for Breakthrough IL-2 Molecule Therapeutic

... will enable us to apply to the FDA for a Phase I clinical trial. This fortuitous award enables us to bridge the funding gap that so many pre-clinical stage biotechnology companies have experienced lately; we are looking forward to working with Dr. Epstein and USC Stevens to see this important project th...
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