AstraZeneca Submits NDA for Low Dose Aspirin/Esomeprazole Combination Product
- Company Also Submits sNDA for NEXIUM Capsules for Risk Reduction of Low-Dose Aspirin-Associated Peptic Ulcer -
WILMINGTON, Del., May 4 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN ) today announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administrati...
ANA598 Demonstrates Potent Antiviral Activity at all Dose Levels in Completed Phase Ib Study in Hepatitis C Patients
Data Being Presented Today at 44th Annual Meeting of EASL
Management to Discuss Study Results and Program Status During Q1 Financial Results Call at 5 P.M. EDT Today
SAN DIEGO, April 23 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS ) today announced that ANA598,...
MAP Pharmaceuticals Announces Phase 3 Study of Unit Dose Budesonide in Children With Asthma Did Not Meet Primary Endpoints
MOUNTAIN VIEW, Calif., Feb. 23 /PRNewswire-FirstCall/ -- MAP
Pharmaceuticals, Inc. (Nasdaq: MAPP ) announced today results of its initial
Phase 3 clinical trial of Unit
Dose Budesonide (UDB) for the potential
treatment of children with asthma. The Company announced that the clinical
trial d...
AstraZeneca's Partner, MAP Pharmaceuticals, Announces Phase 3 Study of Unit Dose Budesonide in Children with Asthma Did Not Meet Primary Endpoints
LONDON, Feb. 23 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. announced today that its initial Phase 3 clinical trial of Unit
Dose Budesonide (UDB) for the potential treatment of children with asthma did not meet its co-primary endpoints: asthma control as assessed by changes from baseline i...
Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics Results for ANA598 in Healthy Volunteers
Phase I Clinical Data and Additional Preclinical Results for Non-Nucleoside HCV Polymerase Inhibitor Being Presented at AASLD
SAN DIEGO, Nov. 1 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals,
Inc. (Nasdaq: ANDS ) announced today the results of a Phase I clinical trial
of ANA598 in h...
CIMZIA(R) (Certolizumab Pegol) Provides Long-Term Benefit Without Dose Escalation in Crohn's Disease Patients
Several abstracts highlighting CIMZIA's long-term benefits and value in
moderate to severe Crohn's disease patients presented at American College
of Gastroenterology (ACG)
ORLANDO, Fla. Oct. 7 /PRNewswire-FirstCall/ -- Data from two studies
presented this week by UCB at the American College ...
Xalieve(TM) Gains Momentum as Calabar AB Launches a Phase II Repeated Dose Study in Dry Mouth Patients
GOTEBORG, Sweden, October 2 /PRNewswire/ -- Calabar AB announced today
that their Phase II repeated
dose study in xerostomia ("dry mouth")
patients has been initiated. Specifically, the drug will be studied in 45
dry mouth patients between the ages of 20 to 75. The objective of the study
is to...
Bronchitol Cystic Fibrosis Dose Trial Results Positive
Bronchitol Demonstrates Dose-Related Improvements in Lung Function of Cystic Fibrosis Patients
SYDNEY, Australia, Aug. 11 /Xinhua-PRNewswire-FirstCall/ -- Speciality
pharmaceutical company Pharmaxis (ASX: PXS; Nasdaq: PXSL) today announced
results from its Phase II tria...
New Diabetes Compound AVE0010 Showed Clear Dose Response Results With Once-A-Day Injection in Phase IIb Study
Results Presented at the ADA's Annual Scientific Sessions
SAN FRANCISCO, June 7 /PRNewswire-FirstCall/ -- Sanofi-aventis
announced today that the results of the dose-finding study for its new
injectable diabetes compound AVE0010, a GLP-1 agonist, were presented at
the American Diabetes ...
Fuisz Tobacco Announces Clinical Study Results for Fuisz Tobacco Sheet Strip; Super Enhanced Bioavailability of Nicotine From Its Tobacco Sheet Strip Supports Efficacy of Low Dose Tobacco Product
WASHINGTON, May 20 /PRNewswire-USNewswire/ -- Fuisz Tobacco today
announces the results of a cross-over clinical study comparing the
absorption of nicotine from the use of Fuisz Tobacco's dissolving tobacco
strip and the use of a nicotine 2mg chewing gum -- the study's control.
(Photo: http...
Bayer and Regeneron Dose First Patient in Second Phase 3 Study for VEGF Trap-Eye in Wet Age-Related Macular Degeneration
International Study to Evaluate Efficacy and Safety in Treating a Leading Cause of Blindness
LEVERKUSEN, Germany, MONTVILLE, New Jersey and TARRYTOWN, New York, May
8 /PRNewswire-FirstCall/ -- Bayer HealthCare AG and Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN ) tod...
Divigel(R) (estradiol gel) 0.1 Percent Offers Lowest Approved Dose of Estradiol for Treatment of Moderate to Severe Hot Flashes Associated with Menopause
-Estrogen Continues to be Gold Standard for Management of Hot Flashes-
MAPLE GROVE, Minn., May 5 /PRNewswire/ -- Medical specialists from
around the country will gather this week to discuss the latest research in
obstetrics and gynecology, and menopause and estrogen therapy will be among
the ...
Studies Point to Benefits of Personalized Chemotherapy Dose Management in Colorectal Cancer
BETHLEHEM, Pa., May 2 /PRNewswire/ -- Can a blood test improve
treatment outcomes for colorectal cancer patients? Recently published
studies indicate that personalized chemotherapy
dose management --
measuring drug levels in patients' blood and adjusting them for optimal
dosing -- can substant...
Interim Analysis of Phase I/II Study of Rexin-G Confirms Efficacy With No Dose Limiting Toxicity in Metastatic Pancreatic Cancer
Second Phase Opens With Higher
Dose Regimens
SAN MARINO, Calif., April 21 /PRNewswire/ -- Epeius Biotechnologies
Corporation announced today that Interim Analysis of an on-going Phase I/II
study of Rexin-G for pancreatic cancer confirmed Rexin-G's anti-tumor
activity with no majo...
Multiple Dose Clinical Trial of TorreyPines Therapeutics' Tezampanel Demonstrates Compound is Safe and Well-Tolerated
- Findings Support Continued Development for Chronic Pain and Non-Pain Indications -
LA JOLLA, Calif., Feb. 5 /PRNewswire/ -- TorreyPines Therapeutics, Inc.
(Nasdaq: TPTX ) today announced that data from its multiple
dose clinical
trial of tezampanel, an antagonis...
Phase III Data Published for Once Monthly Dose of Risedronate to Treat Postmenopausal Osteoporosis
BRIDGEWATER, N.J. and CINCINNATI, Jan. 14 /PRNewswire-FirstCall/ --
Results from a Phase III clinical trial evaluating the efficacy and safety
of risedronate 150 mg once monthly for the treatment of postmenopausal
osteoporosis were published this month in the January issue of the peer-
reviewe...
Pharmacopeia Announces Additional Positive Findings from Phase 1 Multiple Ascending Dose Study of PS433540 (DARA)
Results Show Statistically Significant Indications of PS433540's Potential in Treating Hypertension
PRINCETON, N.J., Dec. 3 /PRNewswire-FirstCall/ -- Pharmacopeia (Nasdaq:
PCOP), an innovator in the discovery and development of novel small
molecule therapeutics, announced...
Pharmacopeia Announces Positive Results from Phase 1 Multiple Ascending Dose Study of PS433540 (DARA)
Pharmacopeia Elects to Expand Study to Include 1,000 mg Dose
PRINCETON, N.J., Sept. 12 /PRNewswire-FirstCall/ -- Pharmacopeia
(Nasdaq: PCOP ), an innovator in the discovery and development of novel
small molecule therapeutics, today announced that based on initial results
from the Compa...
Pharmasset Presents R7128 Phase 1 Single Ascending Dose Study in Healthy Volunteers
-R7128 Demonstrates Safety and Tolerability with No Clinically Significant Adverse Events- -Conference Call Scheduled for 8:30AM (ET) Today-
PRINCETON, N.J., Sept. 10 /PRNewswire-FirstCall/ -- Pharmasset, Inc.
(Nasdaq: VRUS ) is presenting safety, tolerabil...
TorreyPines Therapeutics Completes Phase I Multiple Dose Clinical Trial of NGX267, a Selective M1 Agonist for the Potential Treatment of Cognitive Impairment Associated with Schizophrenia
LA JOLLA, Calif., Sept. 10 /PRNewswire-FirstCall/ -- TorreyPines
Therapeutics, Inc. (Nasdaq: TPTX ) today announced completion of its third
Phase I clinical trial for NGX267, in clinical development for the
treatment of cognitive impairment associated with schizophrenia (CIAS). The
compound, ...
TorreyPines Therapeutics Initiates a Phase I Multiple Dose Clinical Trial of Tezampanel
- Tezampanel Development Targeting Chronic Pain Conditions; Compound Currently in Phase IIb Clinical Trial for Acute Migraine -
LA JOLLA, Calif., Aug. 27 /PRNewswire-FirstCall/ -- TorreyPines
Therapeutics, Inc. (Nasdaq: TPTX ) today announced that it has initiated a
Phase I multiple d...
Genetics Determine Optimal Drug Dose of Common Anticoagulant
WASHINGTON, Aug. 21 /PRNewswire-USNewswire/ -- Genetic testing can be
used to help personalize the therapeutic dosage of warfarin, a
commonly-used anticoagulant, according to research published in the
September 1, 2007, issue of Blood, the journal of the American Society of
Hematology. This re...
Intermezzo(R) 3.5 mg Achieves Greater Early Bioavailability Than Ambien(R) 10 mg Despite 65% Lower Dose
Data Presented as Poster Presentation at the Associated Professional Sleep Societies 2008 Annual Meeting
BALTIMORE, June 11 /PRNewswire/ -- Data was presented today at the 22nd
Annual Meeting of the Associated Professional Sleep Societies (APSS)
demonstrating that within 20 ...
Study: Identical Doses of BiDil Components Are Not Bioequivalent to
the Fixed Dose Combination-BiDil-Used in A-HeFT
NEW ORLEANS, La.--(BUSINESS WIRE)--Mar 26, 2007 - A study comparing
the formulations of isosorbide dinitrate (ISDN) and hydralazine
(HYD) used in V-HeFT I and V-HeFT II, and BiDil, the proprietary
fixed
dose combination, used in the African American Heart Failure
Trial (A-HeFT) demonstrated no bioe...
Two New Imaging Studies Show Higher Dose Lipitor Stopped the
Progression of Atherosclerosis
NEW ORLEANS--(BUSINESS WIRE)--Mar 26, 2007 - Pfizer said today that
results from two new imaging trials showed that higher
dose Lipitor
stopped the progression of atherosclerosis in patients with
coronary heart disease or familial hypercholesterolemia (FH). The
trials, which were designed to invest...
CombinatoRx Provides Topline Results from Phase 2 RA Study with
CRx-139 and Very Low Dose Prednisolone
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar 26, 2007 - CombinatoRx,
Incorporated (NASDAQ: CRXX) today announced preliminary results of
a phase 2 clinical trial studying CRx-139 (a synergistic
combination of 3mg prednisolone and the antidepressant paroxetine)
and 3mg prednisolone alone, in patients with ...
Data Published in Neurology Showed That Higher Dose of Copaxone
Increased Efficacy in Relapsing-Remitting Multiple Sclerosis (RRMS)
JERUSALEM--(BUSINESS WIRE)--Apr 17, 2007 - A 9-month, randomized,
double-blind, parallel-group Phase II study of 90 patients
comparing a 40 mg
dose of COPAXONE(R) given daily to the currently
approved COPAXONE(R) 20 mg
dose showed a 38 percent greater
reduction in inflammatory disease activity as m...
Data on Higher Dose of Copaxone and Data Showing Copaxone is Most
Cost Effective
Data Published in Neurology Showed That Higher
Dose of Copaxone
Increased Efficacy in Relapsing-remitting Multiple Sclerosis
(RRMS)
Doubled
Dose of COPAXONE Maintained Proven Safety Profile and
Further Reduced Relapses and Lesions
JERUSALEM, Israel, April 17, 2007 – A 9-month, rando...
Solstice Neurosciences Presents Escalating Dose Study at
International Congress in Istanbul, Turkey
MALVERN, Pa., June 15, 2007 /PRNewswire/ -- Solstice
Neurosciences, Inc. today reported important results from a
multicenter, forced
dose escalation study of Botulinum Toxin Type B
Injectable Solution (Myobloc(R)) recently presented at the 11th
International Congress of The Movement Disorders Soci...
MAP Pharmaceuticals to Present Unit Dose Budesonide Phase 2
Clinical Data at the World Asthma Meeting
MOUNTAIN VIEW, Calif., June 22, 2007 /PRNewswire/ -- MAP
Pharmaceuticals, Inc. today announced that it will present Phase 2
data from its Unit
Dose Budesonide (UDB) pediatric asthma therapy
clinical program at the World Asthma Meeting at the Lutfi Kirdar
Convention and Exhibition Center in Istanbu...
Affymax Reports Phase 2 Clinical Dose Ranging Results of
Once-Per-Month Hematide for the Treatment of Anemia
PALO ALTO, Calif.--(BUSINESS WIRE)--Jun 25, 2007 - Affymax, Inc.
(Nasdaq:AFFY) today announced that additional Phase 2 clinical
trial results for Hematide(TM) were presented at the European Renal
Association-EDTA Congress being held in Barcelona, Spain by Iain C.
Macdougall, M.D., a Hematide invest...
Labopharm to Present Poster on Dose Titration of Once-daily
Tramadol at 3rd International Forum on Pain Medicine
- Article Discussing Pharmacokinetics and
Dose Proportionality of
Company's Once-Daily Tramadol to be Published in Biopharmaceutics
Journal -
LAVAL, QC, June 29, 2007 /PRNewswire-FirstCall/ - Labopharm Inc.
today announced that it will present a poster discussing the dose
titration of its once-dai...
Cancer Centers of North Carolina Offers HDR Brachytherapy for Treatment of Cancerous Tumors
...tions to its patients through the addition of High
dose Rate (HDR) brachytherapy. This latest advance in b...controlled delivery system is used to optimize the
dose distribution to the target. As a result of this pr...and side effects may be reduced.
Unlike low
dose rate brachytherapy treatment, HDR therapy can be d...
Radius' Investigational Bone Anabolic Agent, BA058, Increased Bone Mineral Density (BMD) at Key Fracture Sites in Phase 2 Clinical Trial in Postmenopausal Osteoporosis
... percent for placebo at six months for the highest
dose tested. By comparison, the mean percent change in ...h treatment period, patients receiving the highest
dose of BA058 increased lumbar spine BMD by 12.9 percen...calcemia was half that of Forteo(R) in the highest
dose of BA058 tested. Radius will submit additional det...
Amgen Announces Positive Top-Line Results for Denosumab in Trial for Delay of Skeletal Related Events in Bone Metastases Patients Compared to Zometa(R)
...randomized in a one-to-one ratio to receive either 120 mg of denosumab subcutaneously every four weeks (Q4W) or Zometa administered intravenously at a
dose of 4 mg single, 15 minute infusion every four weeks.
In clinical trials thus far to test new medications for bone metastases, treatment succes...
Telik Announces Publication of Positive Phase 1 Results of a Multicenter Study of Ezatiostat Hydrochloride (TELINTRA(R), TLK199) Tablets In Patients With Myelodysplastic Syndrome
...ALO ALTO, Calif., Aug. 3 /PRNewswire-FirstCall/ -- Telik, Inc. (Nasdaq: TELK ) today announced that the positive results from a Phase 1 multicenter,
dose escalation study of ezatiostat hydrochloride (TELINTRA, TLK199) tablets in patients with Myelodysplastic Syndrome (MDS) have been published in a leadi...
Video: FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia
...allel-group study (n=636). All patients received a
dose of 234 mg on Day 1 in the deltoid muscle. From Day... increase with the length of therapy and the total
dose received. This condition can also develop after a ...le in milligrams (mg) of paliperidone palmitate in
dose strengths of 39 mg, 78 mg, 117 mg, 156 mg and 234 ...
Access Pharmaceuticals Provides Update on ProLindac Clinical Development Program
...to be active in many solid tumors in human clinical studies. Access has commenced a new clinical study of ProLindac in France. The study will examine
dose levels and regimens of ProLindac monotherapy in cancer patients, provide additional data to support design of combinations studies, and extend the saf...
Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA
...d was a
multicenter, randomized, double-blind, two
dose study of velaglucerase alfa
in patients with Type ...monstrated. The
magnitude of changes in the 45U/kg
dose was also clinically important, and a
trend in liver volume reduction was observed. The 60U/kg
dose performed
numerically as well or better than 45U/k...
OPAXIO(TM) Combined with Alimta(R) Well Tolerated in Dose-Ranging Study of Patients with Advanced Non-Small Cell Lung Cancer
...study, led by Dr. J. R. Rigas, enrolled twelve patients, six to each of two
dose levels. Patients were treated in 21-day cycles, with cohort one receiving 1...ood vessels and trapped in the tumor bed allowing significantly more of the
dose of chemotherapy to localize in the tumor than with standard paclitaxel. Onc...