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Daily in Medical Technology

Jazz Pharmaceuticals and UCB Announce Second Phase III Study of Sodium Oxybate in Patients With Fibromyalgia Meets Primary Endpoints

... decreases in pain and fatigue and improved daily function in fibromyalgia patients and confirm ... decreased pain and fatigue and improved daily function and patient global impression of change. ... physical functioning and ability to perform daily tasks, as measured by the FIQ, were highly ...

MacroGenics and Lilly Achieve Targeted Patient Enrollment in PROTEGE, a Global Phase 2/3 Clinical Trial of Teplizumab in Type 1 Diabetes

... for PROTEGE includes both the patient's total daily insulin usage and his/her HbA1c levels at 12 ... per day and take multiple insulin injections daily or continually infuse insulin through a pump. ... balance insulin doses with their food intake and daily activities, people with this form of diabetes ...

Afinitor(R) Phase II Data Show Positive Results for Patients With Multiple Types of Lymphoma, Leading to Phase III Trial

... ORR)(1). Patients received everolimus 10 mg daily and were evaluated monthly. Dose reductions to 5 mg daily and 5 mg every other day were permitted. Response ... and Drug Administration (FDA) as the first oral, daily therapy (5 mg and 10 mg tablets) to treat ...

New Study Showed Lantus(R) Plus One, Two or Three Shots of Apidra(R) Lowered Patients' Blood Sugar

... and severe hypoglycemia with Apidra(R) 3 times daily compared with those receiving Apidra(R) once or ... in the group receiving Apidra(R) three times daily (45.1%) versus the group receiving Apidra(R) one time daily (29.7%, P=0.017) and the group receiving ...

Arena Pharmaceuticals Announces Lorcaserin Data Demonstrating Highly Significant Categorical and Absolute Weight Loss and Improvements in Secondary Endpoints Associated with Cardiovascular Risk

... trial evaluated 10 mg of lorcaserin dosed twice daily versus placebo over a two-year treatment period ... 10 mg of lorcaserin dosed once or twice daily versus placebo over a one-year treatment period ... 10 mg of lorcaserin dosed once or twice daily versus placebo over a one-year treatment period ...

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

... linaclotide or placebo administered orally once daily to adults meeting modified Rome II criteria for ... followed by a two-week post-treatment period. daily assessments of bowel habits and symptom severity, ... had to demonstrate <3 CSBM/week and mean daily abdominal pain of at least mild severity. ...

New Preliminary Data from Two Studies Show Clinical Activity of Neratinib in Combination with Trastuzumab and in Combination with Paclitaxel in Advanced HER-2 Positive Breast Cancer

... being administered neratinib (160 mg or 240 mg) daily plus weekly trastuzumab (4 mg/kg IV loading dose ... receive a weekly dose of trastuzumab with daily neratinib (240 mg). To date, 45 patients ... 1/2, open-label, 2-part study, ascending multiple daily oral doses of neratinib (160 mg, 240 mg) were ...

Video: Data on More Than 15 Novartis Oncology Compounds at ASCO Highlight Progress Toward Targeted Therapies for Diverse Tumor Types

... hepatocellular carcinoma (HCC) who received daily treatment with Afinitor(R) (everolimus) tablets ... a global Phase III clinical trial to study the daily everolimus regimen in patients with advanced HCC ... Afinitor is approved in the US as the first oral, daily therapy (5 mg and 10 mg tablets) to treat ...

Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS)

... patients were randomized 2:2:1 to receive a total daily dose of 2403 mg pirfenidone, or placebo, or a total daily dose of 1197 mg pirfenidone, respectively. The ... Patients were randomized 1:1 to receive a total daily dose of 2403 mg pirfenidone, or placebo. ...

Study Reported Tadalafil Taken Once Daily Improved Erectile Function in Men with ED and Sexual Quality of Life in Couples

... which showed that tadalafil 5 mg dose taken once daily was generally well-tolerated, improved erectile ... before and after treatment with a tadalafil once daily dose. The study appears in the May issue of the ... "This is the first study of tadalafil 5 mg once daily dose in the treatment of men with ED in which the ...

New Studies on Once-Daily Extended Release Pramipexole Presented at American Academy of Neurology Annual Meeting

... extended release formulation, at the same daily dose. 84.5 percent of patients who completed the ... trials. UPDRS Part II relates to activities of daily living and UPDRS Part III relates to motor ... perceived warning signs during activities of daily living, including operation of a motor vehicle, ...

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

... SCH 900518 in 200 mg, 400 mg or 600 mg once daily (QD) doses with low-dose ritonavir (100 mg) in ... (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily based on patient weight) therapy followed by the ... with PEGINTRON and low-dose REBETOL (400-1000 mg daily based on patient weight) for 48 weeks. In Part I ...

Pfizer and Medivation Initiate Phase 3 Trial of Dimebon Added to Donepezil in Patients with Alzheimer's Disease

... at least six months and at a stable dose of 10 mg daily for at least four months prior to enrollment in ... Disease Cooperative Study - Activities of daily Living (ADCS-ADL) - a measure of self-care and daily function. For more information on the ...

Neurocrine Announces Top-Line Results From 702 Study (Lilac PETAL Study) of Elagolix for Treatment of Endometriosis Pain

... These exploratory endpoints included three daily assessments using an electronic diary: a numeric ... 150 mg 250 mg Numeric Rating Scale (mean daily pain, 0-10) -0.90 -1.19 -1.25 Numeric ... Pelvic Pain (mean daily pain, 0-3) -0.24 -0.27 -0.25 ...

New, Published GELNIQUE Data Show Efficacy, Convenience and Excellent Tolerability

... across the U.S. Patients reported a mean 5.4 daily UI episodes and a mean daily urinary frequency of 12.2-12.4. The majority of ... (n=389) or a matching placebo gel (n=400) once daily for 12 weeks. GELNIQUE delivers a consistent ...

Nektar Announces Positive Results from Phase 2 Study of Oral NKTR-118 in Patients with Opioid-Induced Constipation (OIC)

... at two different dose levels of 25 mg once daily and 50 mg once daily. The study achieved a ... cohorts (5 mg, 25 mg, and 50 mg given as a single daily oral dose) for a treatment period of four weeks. ... to measures of SBMs, patients also recorded daily use of opiates and pain NRS scores. ...

Sequoia Pharmaceuticals Presents Proof of Clinical Concept of SPI-452, a Novel Pharmacokinetic Enhancer

... efficacy, reduced pill burden, and reduced daily dosing. Because of the risk of developing drug ... 15 days of SPI-452 (25 mg, 50 mg, or 200 mg) once daily or placebo. On day 15, subjects also received, ... and well tolerated when dosed up to 200 mg once daily for 15 days. No subjects withdrew from the study ...

Merck Serono's Safinamide Significantly Improved Motor Function in Patients With Advanced Parkinson's Disease in a Phase III Pivotal Trial

... 016) met its primary endpoint by increasing daily "ON" time in mid- to late-stage Parkinson's ... (receiving either safinamide 50 mg orally once daily or safinamide 100 mg orally once daily as adjunctive therapy to levodopa) demonstrated a ...

RAD001 Shows Potential to Reverse Resistance to Herceptin(R)* in Metastatic Breast Cancer Patients, Leading to Phase III Trial

... to RAD001 5 mg daily, eight to RAD001 10 mg daily and nine to RAD001 30 mg weekly. Among the five patients evaluated in the 5 mg daily treatment arm, one patient had a complete ... four patients had partial responses. In the 10 mg daily treatment arm, one patient had a partial ...

New Keppra XR(TM) Data Highlight Its Role for Patients with Partial-Onset Seizures

... effects than those taking the same dose of twice daily levetiracetam," said James Zackheim, Medical ... with any tolerability advantages versus the same daily dose of levetiracetam IR. According to the ... mg Extended-Release Tablets from 1 g to 3 g Once daily Poster Session 3, Monday, December 8, ...

Video: Tasigna(R) Demonstrates Rapid Response as Initial Therapy in Life-Threatening Form of Leukemia

... the QT interval, and a dose reduction to 1/2 the daily dose is recommended (400 mg once daily). If the ... other potential drug interactions.) For daily dosing of 800 mg and above, dosing should be ... and Molecular Response with Nilotinib 800 Mg daily as First Line Treatment of Ph-Positive ...

Novel Therapeutic Approaches May Transform Treatment and Improve Patient Outcomes in Several Platelet Disorders

... eltrombopag at a starting dose of 50 mg once daily (135 patients) or placebo once daily (62 patients). Depending on individual platelet ... could be titrated within a range from 25 mg once daily to a maximum dose of 75 mg once daily. ...

More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies

... Multicenter Phase I clinical trial of daily and weekly RAD001 (everolimus) in combination ... other potential drug interactions.) For daily dosing of 800 mg and above, dosing should be ... the QT interval, and a dose reduction to 1/2 the daily dose is recommended (400 mg once daily). If the ...

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

... III development and has the potential for once daily dosing. 518 also has shown decreased emergence ... (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily based on patient weight) therapy followed by the ... with PEGINTRON and low-dose REBETOL (400-1000 mg daily based on patient weight) for 48 weeks, compared ...

Jazz Pharmaceuticals and UCB Announce Positive Phase III Results for Sodium Oxybate (JZP-6) in Fibromyalgia

... DECREASES IN PAIN AND FATIGUE, AND IMPROVEMENT IN daily FUNCTION, IN ... decreased pain and fatigue, and improved daily function, in patients with fibromyalgia. ... physical functioning and ability to perform daily tasks, as measured by the FIQ, were significantly ...

FDA Approves Rapid-Acting Insulin Apidra(R) for Treatment of Children with Diabetes

... concomitant treatment with insulin glargine once daily or NPH twice daily as basal insulin. The majority of the patients ... insulin, people with type 1 diabetes require daily injections of insulin for their entire lives. ...

Long-Term Study Evaluates Boosted PREZISTA(R) Vs. Lopinavir/Ritonavir as Part of HIV Combination Therapy in Treatment-Naive Adults

... 400 mg tablets) with 100 mg ritonavir (r) once daily reached an undetectable viral load (<50 ... taking lopinavir/ritonavir 800 mg/200 mg once daily (or 400 mg/100 mg twice daily), each with a fixed ... of 689 patients, PREZISTA/r 800/100 mg once daily was shown to be non-inferior to lopinavir/r ...

Sirion Therapeutics Announces Positive Pivotal Uveitis Data for Durezol(TM)

... ophthalmic emulsion) 0.05% dosed four times daily (QID) to Pred Forte(R) (prednisolone acetate ... sac of the affected eye(s) 4 times daily beginning 24 hours after surgery and continuing ... of the postoperative period, followed by 2 times daily for a week with tapering based on the response. ...

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

... Analysis of the data indicates that once- daily oral dosing of linaclotide, across a range ... linaclotide or placebo administered orally once daily to adults meeting modified Rome II criteria for ... and two-week-post-treatment evaluations with daily assessments of bowel habits and symptom ...

New Analyses Indicate that Divigel(R) (estradiol gel) 0.1% Is a Valuable Option for Certain Postmenopausal Women With Hot Flashes

... packets. One packet of gel is applied daily to an area that measures approximately 5 x 7 ... and 7.1 years of treatment, respectively, with daily oral conjugated estrogens (CE) 0.625 mg alone, ... 65 or older during 5.2 years of treatment with daily oral CE 0.625 mg alone and during 4 years of ...

AstraZeneca Receives Six Months Pediatric Exclusivity for CASODEX(R) (bicalutamide) from the FDA

... currently approved in the US at a dose of 50 mg daily tablet for use in combination with a luteinizing ... Tablets CASODEX at a dose of 50 mg daily is a prescription medication approved for use in ... Stage D2). CASODEX at a dose of 150 mg daily is not approved for use alone or with other ...

RAD001 Combined with Sandostatin LAR(R) Depot and as Monotherapy Controls Growth of Rare Pancreatic Neuroendocrine Tumors

... experienced clinical benefit when treated with daily RAD001 and monthly Sandostatin LAR ... benefit when treated with daily RAD001 - Data show RAD001, an oral mTOR ... resistant to chemotherapy were given either daily RAD001 combined with monthly Sandostatin LAR ...

Neurocrine Biosciences Announces Successful Elagolix PETAL Study in Endometriosis

... baseline at Month 6 for the elagolix 75 mg twice daily dosing arm was -1.30% for the spine (lower bound ... Scale (VAS) to assess pelvic pain levels using daily electronic diary. Elagolix provided a ... (16%) than those receiving elagolix 150 mg once daily (5%) or 75 mg ...

New Data Highlight Positive Results of Namenda(R) (memantine HCl) Once-Daily Extended-Release Formulation

... evaluating cognition, behavior, and activities of daily living. Results for a secondary endpoint and ... and p=0.004 for verbal fluency). Measurement of daily living activities using the 19-item AD Cooperative Study-Activities of daily Living scale (ADCS-ADL) demonstrated maintenance ...

Tibotec Conducts Two Pivotal Phase III Clinical Trials Studying TMC278 in Treatment-Naive Adults with HIV

... safety and tolerability of TMC278 (25 mg) once daily oral tablet versus efavirenz (EFV), each ... and EFV), will evaluate TMC278 (25 mg) once daily oral tablet versus EFV (600 mg) once daily, when ... or THRIVE (TMC278 against HIV, in a once daily RegImen Versus Efavirenz), will evaluate TMC278 ...

Online Coverage of International AIDS Conference Includes Daily Webcasts, Podcasts and Interviews

... the Official Webcaster for AIDS 2008, providing daily coverage of conference developments on ... by a few hours and available on-demand. daily updates will also be sent via email (signup at ... as on kaisernetwork.org. An outline of what the daily coverage will include is available at ....

The ED Conversation Dilemma: Forty Percent of Men with ED Don't Talk to Their Doctor, Survey Finds

... treatment options. For instance, Cialis for once daily use is a new low-dose ED treatment option taken ... on an as-needed basis or in a daily regimen. The recommended starting dose of Cialis ... and tolerability. Cialis also has a new, low-dose daily option which can be taken without regard to the ...

Ardea Biosciences Reports Additional Positive Phase 2a Results for Lead HIV Candidate, RDEA806, Demonstrating Up to 1.9 Log Reduction in Plasma Viral Load with Once-Daily Dosing

... Patients receiving either 800 mg or 1000 mg once daily with the enteric-coated tablet formulation, and ... Day 8; the 600 mg capsule formulation given once daily produced a 1.4 log median reduction (adjusted for ... program will be 600 mg, 800 mg and 1000 mg once daily with the enteric-coated tablet given with or ...

Ambien CR(R) (zolpidem tartrate extended-release) CIV Tablets Improved Insomnia and Daily Functioning in Patients with Co-Morbid Major Depressive Disorder

... CR Improved Sleep Quality and Sleep Impact on daily Activities in MDD Patients Total sleep time was ... energy, morning concentration and sleep impact on daily activities. Treatment-emergent adverse events ... Researchers assessed treatment efficacy through daily patient-reported Morning Sleep Questionnaires ...

New Data From Head-to-Head Study Confirms Once-Daily Levemir(R) is as Effective as Glargine over a 24-Hour Period in Subjects with Type 2 Diabetes

... scale study of once-daily Levemir versus a single daily dose of glargine to generate the first robust ... were randomized to receive a single daily injection of Levemir or glargine at 8 p.m. for ... paired t-test. Levemir Shows Similar daily Average Consumption versus Glargine A ...
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