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Clinical Update - Debio 9902 SR (ZT-1) for Alzheimer Patients Debiopharm Starts Tablet Formulations Bridging Study under IND

LAUSANNE, Switzerland, October 21 /PRNewswire/ -- Debiopharm Group (Debiopharm), a global biopharmaceutical development specialist that focuses on serious medical conditions and particularly oncology, announced today that the first healthy elderly subjects have been randomised in a clinical bi...

Abbott's Kaletra(R) Tablet Dosed Once-Daily or Twice-Daily Demonstrated Similar Clinical Results Across Race and Gender Lines

HIV-Infected Women and Non-Whites New to Antiretroviral Therapy Respond Similarly to Men and Whites MEXICO CITY, Aug. 5 /PRNewswire-FirstCall/ -- Initial treatment regimens containing once-daily or twice-daily dosing of Abbott's (NYSE: ABT) protease inhibitor Kaletra(R) (l...

European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection

- Product Developed Through Joint Venture Between Bristol-Myers Squibb and Gilead Sciences, the First of Its Kind in HIV Treatment - PRINCETON, N.J. and FOSTER CITY, Calif., Dec. 17 /PRNewswire-FirstCall/ -- The European Commission has granted marketing authorization for ATRIPLA(R) (efavi...

Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV

- Product Developed Through Joint Venture Between Bristol-Myers Squibb Company and Gilead Sciences, the First of Its Kind in HIV Treatment - PRINCETON, N.J. and FOSTER CITY, Calif., Oct. 17 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: BMY ) and Gilead Sciences, Inc. (Nasd...

Stallergenes S.A.: Positive Results From a Phase IIb/III Clinical Trial on the House Dust Mite Desensitization Tablet

ANTONY, France, April 29 /PRNewswire-FirstCall/ -- Stallergenes S.A. announces the release of the first year outcome of its phase IIb/III clinical trial (VO 57.07) on a sublingual house dust mite desensitization tablet. "We are very pleased with the outcome of this study, which is the f...

New Results From ARTEN Study of Nevirapine Plus Tenofovir and Emtricitabine (TDF/FTC) Versus Boosted Protease Inhibitor Regimen of Atazanavir/Ritonavir Plus TDF/FTC Revealed

...re liver problems. The dose of VIRAMUNE for adults is one 200-mg tablet daily for the first 14 days, followed by one 200-mg tablet twice daily. VIRAMUNE is always taken with other anti-HIV medications. The ...

Tibotec Pharmaceuticals Announces Agreement to Develop and Commercialize a New Fixed-Dose Combination of TMC278 and Truvada(R) With Gilead Sciences

...vir disoproxil fumarate 300 mg) for treatment-naive adult patients with HIV-1. Fixed-dose combinations contain multiple medicines formulated into one tablet and help to simplify HIV therapy. "A simplified regimen may help improve patient adherence and decrease overall pill burden," said Roger Po...

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

...therapy and subsequent regimens for future use." In the study, the virologic benefit of vicriviroc administered once-daily as a single 30 mg tablet in combination with ritonavir-boosted atazanavir(2) is being compared to a control group receiving Truvada (emtricitabine and tenofovir disoproxil fum...

Procter & Gamble Pharmaceuticals Launches Asacol(R) HD (mesalamine) Delayed-Release Tablets

...HD at 4.8 g/day at six weeks, as compared to 59 percent of patients (n=77/130) who took Asacol 400 mg tablets at 2.4 g/day.(1,2) One Asacol HD 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets. In addition, Asacol HD at 4.8 g/day demonstrated rapid improvement in recta...

Acura and King Receive FDA Complete Response Letter Regarding Acurox(R)

...meet with the FDA following submission of their response. About Acurox Tablets Acurox is a patented, orally administered, immediate release tablet containing oxycodone HCl as its sole active analgesic ingredient with a proposed indication for the relief of moderate-to-severe pain. Acurox utilize...

King Pharmaceuticals Showcases Data From Pain Pipeline of Medicines Designed to Deter Common Methods of Non-Therapeutic Use

... assess and verify these findings About ACUROX(R) Tablets ACUROX(R) is an investigational patented, orally administered, immediate release tablet containing oxycodone HCl as its sole active analgesic ingredient with a proposed indication for the relief of moderate- to-severe pain. ACUROX(R) util...

Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets Once Daily

... are related directly to the ED tablets or to other factors. If a man has a sudden decrease or loss of vision or hearing, he should stop taking any ED tablet including CIALIS and seek medical attention right away. For full patient information and/or full prescribing information, visit http://www.cial...

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

... for oral administration as a single product consisting of two tablets; one tablet is intended to release BDP in the proximal portions of the GI tract, and the other tablet is intended to release BDP in the distal portions of the GI tract. In ...

Boehringer Ingelheim Unveils Diabetes Pipeline

...olved with regulating blood sugar.(2) Linagliptin is a compound discovered by Boehringer Ingelheim and is being developed as an oral once-daily tablet for the treatment of type 2 diabetes. The compound is currently being studied in five pivotal Phase III clinical trials including more than 4,000 pat...

Horizon Therapeutics' HZT-501 Significantly Reduces Incidence of NSAID-Induced Upper Gastrointestinal Ulcers in Patients With Mild-to-Moderate Pain

...th ibuprofen alone. HZT-501 is a novel, proprietary fixed-dose combination tablet containing the most prescribed non-steroidal anti-inflammatory drug (NSAID)...on (FDA). About HZT-501 HZT-501 is a novel, proprietary fixed-dose tablet combining the world's most prescribed NSAID, ibuprofen, with a high dose of...

Tris Pharma Announces Acceptance of Its First Two NDAs

...ewable tablets, and films - Upon approval will provide both liquid and tablet forms as alternative to current twice-a-day immediate release tablet SOUTH BRUNSWICK, N.J., May 13 /PRNewswire/ -- Tris Pharma, a privately...

New Data Shows AZOR(R) (amlodipine and olmesartan medoxomil) Significantly Improves 24-Hour Ambulatory Blood Pressure

...e and end of study. A total of 134 patients (72.4%) were titrated to AML/OM 10/40 mg. About AZOR (R) AZOR is a convenient, once daily, single tablet combination of amlodipine, the most prescribed CCB on the market(12), which inhibits the entrance of calcium into the blood vessel walls, with olmesar...

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

... are related directly to the ED tablets or to other factors. If a man has a sudden decrease or loss of vision or hearing, he should stop taking any ED tablet including Cialis and seek medical attention right away. For full patient information and/or full prescribing information, visit http://www.ci...

Strativa Pharmaceuticals Provides Product Pipeline Update

...DA for Loramyc(R) (miconazole) mucoadhesive buccal tablet (MBT) based on the lack of an imprint code on the ...ioAlliance initiated the development of a debossed tablet to fulfill this requirement. BioAlliance will wor...ely with the FDA on the introduction of a debossed tablet and will soon after resubmit the Loramyc applicati...

Premier Research Announces Milestone New Drug Application

...accomplishment and our people," commented Dr. Troy McCall, Chief Operating Officer. Acurox(R), a patented, orally administered, immediate release tablet containing oxycodone HCl as its sole active analgesic ingredient, has a proposed indication for the relief of moderate to severe pain. Acurox(R) util...

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Announces FDA Filings for Paliperidone Palmitate and INVEGA(R)

...vided, or crushed. Do not be worried if you see something that looks like a tablet in your stool. This is what is left of the tablet after all the medicine has been released. The most common side effects...

STALLERGENES: Oralair(R) Grasses Obtains a Pediatric MA(1) in Germany

...tallergenes. About Oralair(R) Grasses Oralair(R) Grasses is a tablet for desensitization to grass pollens, the allergen that causes rhinoconjunc...re than 50% of patients in Europe. With a safe and easy-to-use daily tablet of Oralair(R) Grasses, patients enjoy a very significant alleviation of all...

Catalyst Reaches Enrollment Target for its U.S. Phase II Cocaine Trial

...at it has reached its patient enrollment target in its Phase II trial evaluating CPP-109 for the treatment of cocaine addiction. CPP-109 is Catalyst's tablet formulation of vigabatrin being developed as a treatment for cocaine and methamphetamine addiction, as well as other addictions and obsessive-compulsi...

US Testing Proves Glyc'n Go(TM) Increases NO in the Blood Stream

... the reduction of muscle tissue damage due to lactic acid build up. Glyc'n Go(TM) delivers more pure GlycoCarn(R) per serving than any other GPLC tablet or capsule on the market today. Glyc'n Go(TM) is the only chewable form of GlycoCarn(R) and has been proven to dissolve 26% faster than tablets, enab...

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

...y Subjects This study demonstrated that an investigational 750 mg tablet strength of Keppra XR is bioequivalent to the approved 500 mg tablet when these are each combined to achieve a 1,500 mg dose. Results show that ...

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

...bing Information for other potential drug interactions.) For daily dosing of 800 mg and above, dosing should be accomplished using the 400 mg tablet to reduce exposure to iron. Common side effects of Gleevec tablets The majority of adult Ph+ CML patients who received Gleevec in ...

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

...bing Information for other potential drug interactions.) For daily dosing of 800 mg and above, dosing should be accomplished using the 400 mg tablet to reduce exposure to iron. Common side effects of Gleevec tablets The majority of adult Ph+ CML patients who received Gleevec in clini...

SCOLR Pharma, Inc. Reports Third Quarter 2008 Financial Results

... product candidate." Also during the quarter, SCOLR submitted an Abbreviated New Drug Application (ANDA) for a 120 milligram 12-hour pseudoephedrine tablet based on our patented Controlled Delivery Technology (CDT(R)) platform. Subsequently, we reported that the U.S. FDA had accepted our submission for re...

Study Suggests Treatment with Paliperidone ER Significantly Improves Symptoms of Schizoaffective Disorder

...vided, or crushed. Do not be worried if you see something that looks like a tablet in your stool. This is what is left of the tablet after all the medicine has been released. The most common side effects th...

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

... Recommended dosing for treatment-naive adult patients is 800 mg (two 400 mg tablets) taken with 100 mg ritonavir once daily with food. The new 400 mg tablet will be available by November 1. For treatment-experienced adult patients, the dosing for PREZISTA remains 600 mg taken with 100 mg ritonavir twice da...

Takeda Submits a New Drug Application in the U.S. for Alogliptin (SYR-322) / ACTOS(R) (pioglitazone HCl) for the Treatment of Type 2 Diabetes

....S. Food and Drug Administration (FDA) for marketing approval of alogliptin (SYR-322) and ACTOS(R) (pioglitazone HCl) ("alogliptin/ACTOS") in a single tablet for the treatment of type 2 diabetes. Alogliptin was discovered by Takeda's wholly owned subsidiary, Takeda San Diego, Inc., and is a member of the ...

Nationwide Survey Shows Infertility Patients Prefer ENDOMETRIN(R) Compared With Other Progesterone Supplements

..., progesterone supplements are used extensively for luteal phase and early pregnancy support. There are several forms: oral, injection, and vaginal -- tablet inserts, vaginal capsules, suppositories and gels. "The survey confirms what we hear all the time from patients -- that when they reach the final st...

Stallergenes: New Study VO 56 Highly Positive Results Conducted in an Allergen Challenge Chamber

...ds the variable nature of pollens and patient exposure and facilitates follow up. About oralair(R) Grasses Oralair(R) Grasses is a fast-dissolving tablet that has demonstrated high efficacy in treating allergic rhinoconjunctivitis to grass pollen starting with the first season, lasting throughout the po...

Spherics, Inc. Offers Extended Release Formulation for Sustained and Stable Levodopa Levels

...ption, high inter-subject variability and a steep wearing-off rate under its three+ times daily dosing regimen. Spherics has developed a multi-layer tablet allowing (i) faster on-set than Sinement CR, (ii) improved sustained plasma levels above minimum effective concentration enabling a 1x or 2x-day d...

Emisphere Presents Dramatic Clinical Evidence Demonstrating New Approach to Vitamin B12 Supplementation

... Eligen(R) B12 oral formulation demonstrates 240% improvement in bioavailability versus standard oral Vitamin B12 tablet and different absorption characteristics Eligen(R) B12 absorption time was 30 minutes - Public Conference Call to discuss results and future direc...

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

...adults with HIV-1, are now recruiting patients. The global trials will compare the efficacy, safety and tolerability of TMC278 (25 mg) once daily oral tablet versus efavirenz (EFV), each coadministered with a background regimen of two nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs), in tre...

Biodel Inc. Announces the Completion of Its Two Pivotal Trials and the Release of EASD Abstracts Containing Additional Interim Data From Its VIAject(TM) Program

...pe 1 or Type 2 diabetes. VIAject(TM) has been tested in two pivotal Phase III clinical trials. Biodel's pipeline also includes VIAtab(TM) a sublingual tablet formulation of insulin in the Phase I stage of clinical testing, and two pre-clinical osteoporosis product candidates. For further information regardi...

Emisphere Announces Data From Independent Clinical Study of Effects of Oral GLP-1 on Glucose and Insulin Concentrations

...mic effects of a single oral dose of GLP-1 administered 15 minutes prior to an oral glucose tolerance test. For the study, GLP-1 was formulated as a tablet with Emisphere's delivery agent known as SNAC. This was Prof. Beglinger's second clinical study of the compound, and it confirmed his earlier results ...

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

... - Once-daily dosing with enteric-coated tablet produced robust antiviral ...ted that once-daily dosing with the enteric-coated tablet formulation of RDEA806 resulted in significant red...0 mg or 1000 mg once daily with the enteric-coated tablet formulation, and patients receiving 400 mg twice d...

Quatrx Pharmaceuticals Presents Results From Ophena(TM) (Ospemifene Tablets) Phase 3 Study Related to Treatment of Symptoms of Vulvovaginal Atrophy

...solve spontaneously. They can have a significant impact on a woman's quality of life. These Phase 3 clinical study results indicate that this new oral tablet has the potential to address the most common and debilitating chronic symptoms of vaginal atrophy for millions of women in the years ahead," said Dr. ...
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