Cessation in Medical Technology

Secretary Reinforces VA's Commitment to Research Safety and Veteran Focus

... Times about a VA research program on smoking cessation involving veterans with post-traumatic stress ... most effective medication available for smoking cessation with six million prescriptions written. Peake ... calling it ridiculous. The smoking cessation study was solely funded by the VA, with no ...

Nabi Biopharmaceuticals Announces Successful Completion of NicVAX(R) Phase 2b Trial; Drug Shows Statistically Significant Rates of Smoking Cessation and Continuous Long-Term Smoking Abstinence at 12 Months

... data at six and nine months for both smoking cessation and long-term smoking abstinence. These data were ... to quit as well as for the field of smoking cessation vaccines," said Dr. Rennard. "Only a short time ... Smoking Abstinence * The rate of smoking cessation and ability to achieve long-term abstinence ...

Par Pharmaceutical Begins Shipment of Additional Dosage Strength of Generic TOPROL-XL(R)

... succinate extended release should avoid abrupt cessation of therapy. Following abrupt cessation of therapy with certain beta-blocking agents, ... tablets, including boxed WARNING regarding abrupt cessation of therapy, call 1-800-828-9393 or visit ...

DOR BioPharma Receives EMEA Agreement on the Design of its Confirmatory Phase 3 Clinical Trial of orBec(R) in GI GVHD

... a 50-day course of treatment with orBec(R) (i.e., 30 days following cessation of treatment). The confirmatory Phase 3 clinical trial will be conducted ... 0.02). Additionally, the GVHD treatment response at Day 40 (10 days post cessation of therapy) was 16 of 31 (52%) vs. 5 of 29 (17%) in the orBec(R) and ...

Roche and Pharmasset Initiate Phase IIb Clinical Trial of R7128, Most Advanced Nucleoside Polymerase Inhibitor in Development for Chronic Hepatitis C

... including without limitation, the risk that adverse events could cause the cessation or delay of any of the ongoing or planned clinical trials and/or our ... partner of a patient during treatment or during 6 months after treatment cessation to the Ribavirin Pregnancy Registry at 1-800-593-2214. Chronic ...

VA Statement on Smoking Cessation Research Program

... our research is to learn if it is easier to stop smoking when smoking cessation treatment is combined with PTSD therapy, or whether the two therapies are ... monitored clinically by mental health professionals who provide smoking cessation methods patients agree to use. More than six million prescriptions were ...

Pharmasset Announces R7128 Achieves 85% Rapid Virologic Response in a 4-week Combination Study for the Treatment of Chronic Hepatitis C

... including without limitation the risk that adverse events could cause the cessation of the Phase 3 registration studies and/or our development of clevudine, the risk that adverse events could cause the cessation of the Phase 1 combination study and/or our development of R7128, ...

Pharmasset Announces Clevudine and R7128 Presentations at HEP-DART

... including without limitation the risk that adverse events could cause the cessation of the Phase 3 registration studies and/or our development of clevudine, the risk that adverse events could cause the cessation of the Phase 1 combination study and/or our development of R7128, the risk ...

RediClinic Offers Affordable New Plan Clinically Shown to Double a Person's Chance to Stop Smoking

... for Good' plan can significantly increase the chances of successful cessation and puts a nicotine-free life within reach." The new RediClinic "Stop ... This is significantly lower than the cost of other smoking cessation programs. -- RediClinic nurse practitioners are available beyond the ...

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

... are "forward-looking statements" that involve risks and uncertainties, including, without limitation, the risk that adverse events could cause the cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously ...

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

... low blood pressure (hypotension), edema and multiple organ failure. Capillary leak syndrome affects as many as 65% of patients and can lead to the cessation of therapy. Dr. Epstein has developed an IL-2 analog that eliminates the side effect of capillary leak syndrome while retaining the cytokine and ...

Pharmasset to Present at Goldman Sachs and Needham Healthcare Conferences

... are "forward-looking statements" that involve risks and uncertainties, including without limitation, the risk that adverse events could cause the cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously ...

Swine Flu (H1N1) Infectivity to Increase Markedly and Lethality to Remain Low According to Latest Replikin* Peptide Genomic Data

... flu) vaccine that successfully blocked low path H5N1. It has not previously been possible to correlate virus structures with a virus outbreak or cessation of outbreak, let alone to predict six to 12 months ahead of the outbreak or its cessation. In 2001, Drs. Samuel and Elenore Bogoch first demonstrated ...

Optimer Pharmaceuticals Presents Results From Fidaxomicin Phase 3 Study for the Treatment of Clostridium difficile Infection

... vancomycin. However, approximately 20% to 30% of CDI patients who initially respond to these treatments experience a clinical recurrence following cessation of antibiotic administration. Primary risk factors for CDI include broad-spectrum antibiotic use, advanced age (over 65), emerging ...

Schering-Plough Highlights Hepatitis C Clinical Data Presentations at the European Association for the Study of the Liver (EASL) Annual Meeting

... outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment, and for 6 months following cessation of treatment. Physicians and patients are encouraged to report such cases by calling 1-800-593-2214. Incidence of Adverse Events Most ...

Ground-Breaking Combination of All-Oral Agents Demonstrates Potential as Hepatitis C Treatment Regimen

... are strongly encouraged to immediately report any pregnancy in a patient or partner of a patient during treatment or during 6 months after treatment cessation to the Ribavirin Pregnancy Registry at 1-800-593-2214. Chronic hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic ...

Final Results of Boceprevir Phase II HCV SPRINT-1 Study Showed Significantly Higher SVR Rates Compared to Standard of Care in Treatment-Naive Genotype 1 Hepatitis C Patients

... outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment, and for 6 months following cessation of treatment. Physicians and patients are encouraged to report such cases by calling 1-800-593-2214. Incidence of Adverse Events Most ...

Pharmasset Voluntarily Halts Clinical Studies with Clevudine in Hepatitis B Infected Patients

... are "forward-looking statements" that involve risks and uncertainties, including without limitation, the risk that adverse events could cause the cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously ...

Pharmasset Initiates First Time in Human Study of PSI-7851 for the Treatment of Hepatitis C (HCV)

... are "forward-looking statements" that involve risks and uncertainties, including without limitation, the risk that adverse events could cause the cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously ...

FDA Approves an Expanded Indication for Peginterferon-Based Combination Therapy for Patients With Chronic Hepatitis C

... outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment, and for 6 months following cessation of treatment. Physicians and patients are encouraged to report such cases by calling 1-800-593-2214. Incidence of Adverse Events Most common ...

Human Genome Sciences Announces Positive Results in Second of Two Phase 3 Trials of Albuferon(R) in Chronic Hepatitis C

... for these treatment groups. We were pleased to see that serious pulmonary adverse events in the 900-mcg group were infrequent and all resolved with cessation of treatment." Key Topline Findings from ACHIEVE 1 Treatment Group Receiving Albinterferon Alfa-2b 900-mcg Every Two Weeks, vs. ...

Nplate(R) Approved in the European Union for the Treatment of Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

... contusion, diarrhoea, bone marrow disorder, influenza like illness, insomnia and pruritus. Reoccurrence of thrombocytopenia and bleeding after cessation of treatment and increased bone marrow reticulin have been associated with romiplostim treatment in the clinical trials. Thrombotic/thromboembolic ...

February 2009 Mayo Clinic Women's HealthSource Highlights Diabetes and Heart Disease, Going Vegetarian and Tinnitus

... for men. A physician can help with a treatment plan to meet these guidelines. A healthy diet, regular physical activity, weight loss, smoking cessation and limited alcohol consumption all are beneficial. Medications also may be needed. For example, research has shown that most adults with high blood ...

Pharmasset Reports Fiscal Year End 2008 Financial Results

... are "forward-looking statements" that involve risks and uncertainties, including without limitation, the risk that adverse events could cause the cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously ...

Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients

... discontinue treatment with Nplate and consider a bone marrow biopsy, including staining for fibrosis. Worsened Thrombocytopenia After cessation of Nplate -- Discontinuation of Nplate may result in thrombocytopenia of greater severity than was present prior to Nplate therapy. This ...

Schering-Plough Provides Update on Boceprevir Clinical Development and Introduces Potent Next-Generation Oral HCV Protease Inhibitor for Treating Patients With Chronic Hepatitis C

... outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment, and for 6 months following cessation of treatment. Physicians and patients are encouraged to report such cases by calling 1-800-593-2214. Incidence of Adverse Events ...

Nplate(TM) (Romiplostim) Receives Positive Opinion for Marketing Authorisation in the European Union

... contusion, diarrhea, bone marrow disorder, influenza like illness, insomnia and pruritus. Reoccurrence of thrombocytopenia and bleeding after cessation of treatment and increased bone marrow reticulin have been associated with romiplostim treatment in the clinical trials. Thrombotic/thromboembolic ...

Roche, InterMune and Pharmasset Announce Initiation of INFORM-1, the First Dual-Combination Clinical Trial with Oral Antivirals in Hepatitis C

... are "forward-looking statements" that involve risks and uncertainties, including without limitation, the risk that adverse events could cause the cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously ...

Boceprevir Phase II Study Showed High Rate of Sustained Response With 28- and 48-Week Regimens in Genotype 1 Treatment-Naive Hepatitis C Patients

... outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment, and for 6 months following cessation of treatment. Physicians and patients are encouraged to report such cases by calling 1-800-593-2214. Incidence of Adverse Events There are no new ...

New Study Shows that PEGASYS(R) Regimen Provides Higher Sustained Virological Response Rates for Hepatitis C Patients

... are strongly encouraged to immediately report any pregnancy in a patient or partner of a patient during treatment or during 6 months after treatment cessation to the Ribavirin Pregnancy Registry at 1-800-593-2214. Chronic hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic decompensation ...

Study Results Show Epratuzumab Provided Clinically Meaningful Reduced Disease Activity in Patients With Lupus

... courses as planned per protocol due to the interruption in drug supply but many patients remained in the study for up to 6 months despite dosing cessation and continued to be followed (number of patients receiving full treatment course was 360mg/m2, n=14, 720mg/m2, n=5, placebo, n=13). Corticosteroids ...

Ironwood and Forest Present Positive Phase 2b Study Results for Linaclotide in Patients With Irritable Bowel Syndrome With Constipation

... week of treatment) and were maintained throughout the entire 12-week treatment period; there was no indication of rebound clinical effects following cessation of treatment. Linaclotide was well tolerated at all doses with no treatment-related serious adverse events. The most common adverse event was ...

Richard E.T. Smith, Ph.D. Joins Pharmasset as Vice President of Investor Relations and Corporate Communications

... are "forward-looking statements" that involve risks and uncertainties, including without limitation, the risk that adverse events could cause the cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously ...

Novel Compound Shows Promise for Treatment of Alcoholism

... candidates than Naltrexone, the current FDA approved treatment for alcoholism", said Dr. Bartlett. "The study on SoRI-9409 and alcohol cessation has yielded vital data that will help fuel novel treatments for a devastating and very difficult-to-treat illness," said Dr. Bartlett. "To date, we ...

Phase II Results of COL-144 Presented at European Headache and Migraine Trust International Congress 2008

... due to non-serious adverse events. The most common adverse event was paresthesia, which was usually mild and transient, resolving rapidly after cessation of the infusion. No patient reported triptan-like chest symptoms in relation to the COL-144 infusion. No clinically significant changes were seen in ...

Study Shows Pine Bark Naturally Reduces Knee Osteoarthritis

... Third Clinical Trial Reconfirms Strong Evidence Pycnogenol(R) Lowers Joint Pain, Symptoms; May Now Have Lasting Effect on Joints Following cessation of the Extract HOBOKEN, N.J., Sept. 3 /PRNewswire/ -- According to the Center for Disease Control (CDC), ...

Pharmasset Reports Financial Results for Quarter Ended June 30, 2008

... are "forward-looking statements" that involve risks and uncertainties, including without limitation, the risk that adverse events could cause the cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously ...

Top-Line Results of Boceprevir Phase II Study Showed High Rate of Sustained Response (SVR) in Genotype 1 Treatment-Naive Hepatitis C Patients

... outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment, and for 6 months following cessation of treatment. Physicians and patients are encouraged to report such cases by calling 1-800-593-2214. Incidence of Adverse Events There are no new ...

Pharmasset Announces Initiation of Combination Study of Clevudine and Viread(R) for HBV by French National Agency for Research on AIDS and Viral Hepatitis (ANRS)

... will not demonstrate superiority over Hepsera in Clevudine's ongoing Phase 3 registration study, the risk that adverse events could cause the cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously ...

FDA Files Application To Convert ONTAK(R) (Denileukin Diftitox) to Full Approval for Use in Cutaneous T-Cell Lymphoma (CTCL)

... patients with vascular leak syndrome was delayed, usually occurring within the first two weeks of infusion; symptoms may persist or worsen after the cessation of denileukin diftitox. -- Cases of vascular (capillary) leak with a fatal outcome have been reported. -- Special caution should be taken in ...