FDA Grants Approval for Use of RISPERDAL(R) CONSTA(R) as Both a Monotherapy and Adjunctive Therapy in the Maintenance Treatment of Bipolar I Disorder
RISPERDAL(R) CONSTA(R) is the First and Only Long-Acting Antipsychotic Therapy Available for Bipolar I Disorder
TITUSVILLE, N.J., May 18 /PRNewswire/ -- Janssen(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved ...
Amylin, Lilly Update on FDA Review of BYETTA(R) (exenatide) Injection Monotherapy Submission
SAN DIEGO and INDIANAPOLIS, Dec. 8 /PRNewswire-FirstCall/ -- Amylin
Pharmaceuticals, Inc. (Nasdaq: AMLN ) and Eli Lilly and Company (NYSE: LLY )
today announced that the U.S. Food and Drug Administration (FDA) is continuing
with its review of the regulatory application for use of BYETTA(R) (ex...
Pharmasset Presents R7128 14-Day Monotherapy Study Results for the Treatment of Chronic Hepatitis C
-Nucleoside polymerase inhibitor demonstrates >99% mean decrease in HCV RNA with no serious adverse events-
PRINCETON, N.J., Nov. 2 /PRNewswire-FirstCall/ -- Pharmasset, Inc.
(Nasdaq: VRUS ) announces the results of a 14-day Phase 1 multiple ascending
Combination Therapy More Effective Than Monotherapy for Treating Migraine
Combining two different types of treatment for migraine results in better symptom relief than taking either one of the medications//, according to a study.
"Migraine is a prevalent, often debilitating disease manifested by attacks of bilateral or unilateral headache and associated symptoms, s...
Novel Actemra monotherapy in treating patients with early aggressive rheumatoid arthritis
The first Phase III study involving the use of Actemra in the treatment of rheumatoid arthritis has revealed that it is superior to conventional treatment modality that uses disease modifying anti-rheumatic drugs (DMARDs to inhibit // joint destruction. It has also been found to provide symptomatic...
News briefs from the August issue of Chest
...rs, MD, of McMaster University in Hamilton, ON, Canada, discusses the familiar debate about the safety of using long-acting β2-agonists (LABA) in monotherapy
for asthma. The commentary focuses on data provided in the metaanalysis recently undertaken by the FDA of safety outcomes of 60,954 individuals in 110...
INVEGA(R) Approved as the First and Only Treatment for Schizoaffective Disorder
...chizoaffective disorder. INVEGA(R) (paliperidone) extended-release tablets were approved for the acute treatment of schizoaffective disorder either as monotherapy
or adjunctive therapy to mood stabilizers and/or antidepressants. INVEGA(R) was approved in 2006 for the treatment of schizophrenia. Janssen(R), Divis...
AstraZeneca Submits New Drug Applications for ZACTIMA(TM) in Second-Line Advanced Non-Small Cell Lung Cancer
Evaluation of vandetanib is ongoing, as monotherapy
or in combination with other anti-cancer therapies...ng thyroid cancer. Results from the ZEPHYR (300mg monotherapy
study in EGFR failures in advanced NSCLC, Phase III) and ZETA (300 mg monotherapy
in advanced medullary thyroid cancer, Phase III) s...
QLT Announces Second Quarter Results for 2009
...combined with Lucentis is not inferior to Lucentis monotherapy
with respect to the mean change from baseline in v...ared with a 4.4 letter improvement in the Lucentis monotherapy
group. In the combination therapy group, 96% of pa...t-free interval, compared with 92% in the Lucentis monotherapy
* Announced 12-month primary analysis ...
Lilly Reports Solid Second-Quarter 2009 Results, Raises EPS Guidance
...s not progressed after four cycles of platinum-based first-line chemotherapy.
The European Commission granted approval for the use of Alimta as monotherapy
for maintenance treatment of patients with other than predominantly squamous cell histology in locally-advanced or metastatic NSCLC, whose disease has...
monotherapy in Medical Technology
RAD001 Combined with Sandostatin LAR(R) Depot and as Monotherapy Controls Growth of Rare Pancreatic Neuroendocrine Tumors
- 82% of patients with pancreatic neuroendocrine tumors (NET) experienced
clinical benefit when treated with daily RAD001 and monthly Sandostatin LAR Depot
- 77% of patients with pancreatic NET experienced clinical benefit when treated with ...
Results Published in the Journal 'Cancer' Demonstrate that Oral Talactoferrin Alfa is Active as Monotherapy in Previously Treated Patients with Metastatic Renal Cell Carcinoma
HOUSTON, July 1 /PRNewswire/ -- Agennix Incorporated today announced
the publication of final results from a Phase 2 monotherapy
talactoferrin alfa in patients who had failed previous treatment for
advanced or metastatic renal cell carcinoma (RCC). Results from the study,
Phase 3 Results for Alogliptin Demonstrated Significant Blood Sugar Reductions in Monotherapy and Four Add-on Therapy Studies
Data from five pivotal phase 3 studies presented at the American Diabetes Association 68th Scientific Sessions
SAN FRANCISCO, June 7 /PRNewswire/ -- Results from five pivotal phase 3
studies of alogliptin were announced today at the American Diabetes
Association (ADA) 68th Scie...
TARGETED GENE DELIVERY IN VIVO: Rexin-G Monotherapy Reveals Significant Biological Activity Without Toxicity in Chemo-Resistant Metastatic Breast Cancer (ASCO 2008)
SAN MARINO, Calif., May 22 /PRNewswire/ -- Epeius Biotechnologies
announced today the promising results of an on-going United States-based
Phase I/II study of Rexin-G for metastatic breast cancer that is refractory
to conventional chemotherapy (J Clin Oncol 26:14509, 2008). This clinical
Roche and Pharmasset To Present the R7128 Monotherapy Resistance Profile
-- Study concludes there was no evidence of the development of viral
resistance to R7128 after 2 weeks of monotherapy
in hepatitis C patients --
PRINCETON, N.J., Feb. 6 /PRNewswire-FirstCall/ -- Pharmasset (Nasdaq:
VRUS) and Roche will present the R7128 monotherapy
resistance profile at
King Pharmaceuticals Announces Plan to Present Results from Phase
III Clinical Trial Evaluating ALTACE as Monotherapy and in
Combination with Hydrochlorothiazide at the American Society of
Hypertension Annual Meeting
BRISTOL, Tenn.--(BUSINESS WIRE)--May 8, 2007 - King
Pharmaceuticals, Inc. (NYSE:KG) announced today that the results
from a Phase III clinical trial for its ALTACE(R) (ramipril)
diuretic combination product will be presented at the American
Society of Hypertension's Twenty-Second Annual Scientific ...
Data Presented at ASH Demonstrate Nebivolol Lowers Blood Pressure
as Long-Term Monotherapy and in Combination Therapy
Data Also Show Nebivolol Lowers Blood Pressure in Obese and
Non-Obese Hypertensive Patients
CHICAGO, May 21, 2007 /PRNewswire-FirstCall/ -- Forest
Laboratories, Inc. today presented positive data from two clinical
studies and one pooled analysis of nebivolol, a selective beta
1-blocker with vasodi...
Vectibix(R) in Combination With Chemotherapy Significantly Improved Progression-Free Survival in First-Line Metastatic Colorectal Cancer
... of mCRC. Vectibix was approved in the United States in September 2006 as a monotherapy
for the treatment of patients with EGFR expressing mCRC after disease progr...007, the EMEA granted a conditional marketing authorization for Vectibix as monotherapy
for the treatment of patients with EGFR-expressing mCRC with wild-type KRA...
Isis Reports Strong Financial Results and Highlights for Second Quarter of 2009
...axel of 23.8 months compared to 16.9 months for patients treated with docetaxel alone.
OncoGenex reported that OGX-427 was well tolerated as a monotherapy
in a Phase 1 study and demonstrated declines in circulating tumor cells and evidence of reduction in tumor markers.
Eli Lilly and Company rece...
Access Pharmaceuticals Provides Update on ProLindac Clinical Development Program
...uman 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 safety database. Two ovarian cancer patients hav...
monotherapy in Medical Dictionary
...pocytes has not been investigated. ... Discussion: This trial was designed to rigorously establish the lipid -lowering efficacy of policosanol as monotherapy
and its potential additive and possibly ... The European Bioinformatics Institute ... The structure of lipid A is relatively invariant ... Lipi...
monotherapy in Biological News
REGiMMUNE presents enhanced efficacy data in preclinical transplantation models
...amide, is a small molecule that potently activates natural killer T (NKT) cells. RGI-2001 is a proprietary liposomal formulation of KRN7000. RGI-2001 monotherapy
has shown to induce antigen-specific immune suppression by inducing regulatory T cells (Tregs). Tregs are believed to play a central role in inducing...
Peregrine's PS-targeting antibodies highlighted in AACR Annual Meeting studies
...e treatment of advanced breast cancer and a Phase II combination therapy trial for the treatment of non-small cell lung cancer. A Phase I bavituximab monotherapy
trial in advanced solid cancers is also continuing.
UC Davis bench-to-bedside research: Promising treatment in clinical trials
...ry said. "With this promising drug profile, AR9281 has the potential to provide safe and effective therapy for patients with type 2 diabetes either as monotherapy
or in combination with existing treatment regimens."
Said Arte's chief medical officer Randall Whitcomb: "The Phase IIa trial will further validat...
Synthetic biology can help extend anti-malaria drug effectiveness
...larial drug "cocktail" rather than selling it as a monotherapy
should delay or even prevent malaria parasites fro...that some manufacturers have sold artemisinin as a monotherapy
rather than as a co-therapy as is recommended by t...producing artemisinin. "Any drug that is used as a monotherapy
raises the possibility of microbes developing resi...
Researchers identify new anti-tumor gene
... number of solid tumors and hematological malignancies, such as melanoma, renal cell carcinoma, malignant glioma, lymphomas and leukemias, either as a monotherapy
or as an adjuvant to chemotherapy of radiotherapy.
"We have uncovered a new way by which interferon can induce anti-tumor activity. The identificat...
New cardiology research presented at CHEST 2008
...with PAH, of whom 53 percent were taking concomitant bosentan, to two study arms. The groups received either tadalafil or placebo orally once daily as monotherapy
or as add-on therapy to bosentan. Compared with placebo, tadalafil, 40 mg, increased 6-minute walk distance, delayed the time to clinical worsening, a...
Eisai announces Phase II data on E7389, a potential new therapy for the treatment of breast cancer
...r activity in vitro and in vivo. Halichondrin B was originally isolated from a type of marine sponge.
This study was designed to evaluate E7389 as a monotherapy
in patients with refractory breast cancer. The primary endpoint of this trial was response rate, measured using the RECIST (Response Evaluation Criter...
Two studies document rise of superbugs in the environment
...potential resistance to antibiotics--is known. In such cases, combination antibiotic therapy (using more than one drug at a time) may be preferable to monotherapy
(using one drug) because physicians want to "maximize the chance that the organism is sensitive to at least one of them," Dr. Pop-Vicas said. "Startin...
monotherapy in Biological Technology
OncoGenex Reports Second Quarter 2009 Financial Results
...-up for previously announced phase 2
clinical trials of OGX-011;
- completion of its phase 1 clinical trial evaluating OGX-427 as a
in patients with solid tumors;
- initiation of an investigator-sponsored phase 1 clinical trial
evaluating OGX-427 treatment in patients w...
Anadys Pharmaceuticals Receives FDA Clearance of Phase II Protocol to Study ANA598 in Combination With Interferon-Alpha and Ribavirin in HCV Patients
...lymerase. Anadys has completed three Phase I clinical studies of ANA598 that have demonstrated potent antiviral activity and good tolerability. In a monotherapy
study in naive genotype 1 patients, treatment with ANA598 for three days led to median declines in viral load ranging from 2.4 to 2.9 log10 in three s...
Oncolytics Biotech(R) Inc. Announces 2009 Second Quarter Results
...ree and six-month periods ended June 30, 2009.
"Clinical results from our monotherapy
and combination clinical trials with REOLYSIN(R) continued to emerge in the...ated anti-tumour activity in a U.S. Phase I systemic
trial. Of 18 patients treated in the
trial, eight demonstrated SD o...
Sanofi-aventis Announces Second Quarter 2009 Results
...ue to competition from clopidogrel besylate in the monotherapy
segment in Germany, where Plavix((R))/Iscover((R))...9, irbesartan generics began to be marketed in the monotherapy
segment in Spain and Portugal. In these two countr...hrough August 2012. Net sales of Aprovel((R)) as a monotherapy
in European countries with no active ingredient pa...
New Report Just Published: World Prostate Cancer Therapeutics Market Report
...ogen Hormonal Therapy Drugs
for Prostate Cancer II-34
Side Effects of Orchiectomy II-35
Androgen Deprivation Therapy (ADT) II-44
High Dose Radiation (HDR) monotherapy
Drawbacks of HRD II-45
Choosing the Optimal Treatment Method ...
Glenmark's Novel Molecule for Diabetes, Melogliptin to Enter Phase III Trials
...d with Melogliptin and are due
to start at the end of 2009 following regulatory approvals. These studies are
designed to evaluate the compound both as monotherapy
and in combination with
other anti-diabetic therapies in patients with type 2 diabetes mellitus".
said Mr. Glenn Saldanha, MD & CEO, Glenmark Phar...
Three Rivers Announces Positive Results from Phase 3 DIRECT Trial of Once-Daily INFERGEN(R) with Ribavirin in Hepatitis C Virus Treatment Failures
...r older with compensated liver disease who have anti-HCV serum antibodies and /or the presence of HCV RNA. INFERGEN is currently FDA approved for TIW monotherapy
dosing in naive and previous treatment failure patients.
Important Safety Information
Physicians and patients can obtain additional prescrib...
Clinical Pharmacology Study With AZILECT(R) (Rasagiline Tablets) Demonstrated It Does Not Increase Tyramine Sensitivity
...risk of hypertensive crisis due to the interaction between high doses of oral tyramine and therapeutic doses of rasagiline, which is indicated both as monotherapy
in patients with early Parkinson's disease (PD) and as adjunctive treatment in patients receiving levodopa. The study supported the selectivity of ras...
Proteolix Presents Clinical Data from Two Clinical Studies of Carfilzomib in Multiple Myeloma at the 14th Congress of the European Hematology Association
...ion. The median time to progression for patients in this cohort was 8.9 months. Ten additional patients achieved stable disease.
achieves durable responses in relapsed multiple myeloma patients regardless of their prior exposure to bortezomib, and notably, a number of patients r...
Peregrine Pharmaceuticals Presents Promising Data From Its Phase II Bavituximab Breast Cancer Trial at 2009 ASCO Annual Meeting
...orted that researchers will present data at ASCO today from a Phase I study assessing the safety and pharmacokinetic (PK) properties of bavituximab as monotherapy
in patients with advanced refractory cancers. This multi-center open label safety study is currently enrolling patients in the final cohort according...