Extended in Medical Technology

FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents

PHILADELPHIA, July 28 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY ), the global specialty biopharmaceutical company, announces that it has received a Complete Response letter today for INTUNIV(TM) (guanfacine) Extended Release from the Food and Drug Administration (FDA). Thi...

Shire Announces Study Results of the Effects of INTUNIV(TM) (Guanfacine) Extended Release on Secondary Measures in Children with ADHD and Oppositional Symptoms

SAN FRANCISCO, May 18 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY ), the global specialty biopharmaceutical company, today announced new findings on INTUNIV (guanfacine) extended release, a selective alpha-2A-agonist, at a major psychiatric meeting. This randomized placebo con...

Three Clinical Presentations on Tapentadol Extended Release Tablets for Chronic Pain Featured at 2009 American Pain Society Annual Meeting

Safety and Efficacy Data from Phase 3 Study will be Highlighted SAN DIEGO, May 7 /PRNewswire-USNewswire/ -- Chronic pain is a significant medical challenge in the United States, and chronic low back pain is the most common cause of disability in developed countries. An estimated 100 million A...

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

Data indicated comparable efficacy and safety for extended release and immediate release formulations of pramipexole SEATTLE, April 29 /PRNewswire/ -- New findings from two double-blind studies investigating the efficacy, safety and tolerability of pramipexole dihydrochloride tablets in an ...

SCOLR Pharma Announces Completion of Patient Enrollment and Dosing for Pivotal Clinical Trial Evaluating Extended Release Ibuprofen

Top Line Clinical Results Expected in November 2008 BOTHELL, Wash., Oct. 9 /PRNewswire-FirstCall/ -- SCOLR Pharma, Inc. (Amex: DDD ) announced today the completion of patient enrollment and dosing for the third of its three pivotal trials to evaluate the safety and efficacy of its formulati...

Spherics, Inc. Announces Reduced Cognitive Impairment of Novel Extended Release Topiramate (SRx-502) as Compared to Topamax(R)

Findings Presented At The American Society Of Clinical Psychopharmacology Meeting WELLESLEY HILLS, Mass., Sept. 15 /PRNewswire/ -- Joseph F. Finn, Jr., C.P.A. ("Finn"), Assignee of the assets of Spherics, Inc. ("Spherics") for the benefit of creditors, announced t...

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

WELLESLEY HILLS, Mass., Aug. 25 /PRNewswire/ -- Joseph F. Finn, Jr., C.P.A. ("Finn"), Assignee of the assets of Spherics, Inc. ("Spherics") for the benefit of creditors, announced today that all pharmaceutical intellectual property will be sold at a sealed bid auction on October 10, 2008. SR...

Shire's Investigational Nonstimulant ADHD Treatment INTUNIV(TM) (Guanfacine Extended Release) Demonstrated Significant Efficacy in Reducing ADHD Symptoms at All Measured Time Points Up to 24 Hours Postdose

WASHINGTON, May 7 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, presented today at a major scientific meeting findings from analyses of pivotal trial results of INTUNIV, a selective alpha-2A-agonist. This compound is an investiga...

NKTR-118 Shows Substantial Oral Bioavailability and Extended Half-Life in Phase 1 Clinical Data Presented at American Pain Society Meeting

SAN CARLOS, Calif., May 7 /PRNewswire-FirstCall/ -- New Phase 1 clinical trial results for NKTR-118 (oral PEG-naloxol) were presented by Nektar Therapeutics (Nasdaq: NKTR ) this week at the Annual Meeting of the American Pain Society (APS) in Tampa, Florida. In this multiple-dose Phase 1 stud...

Update From Mipomersen Extended Dosing Study Continues to Show That Mipomersen Is Well Tolerated and Maintains Activity in Patients Treated for Up to 16 Months

Isis Will Host a Conference Call on Monday, April 14, at 8:30 a.m. E.T. at http://www.isispharm.com CARLSBAD, Calif., April 14 /PRNewswire-FirstCall/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIS ) announced additional results from its ongoing Phase 2 open-label extensio...

CSL Behring Study in Animal Models Shows Feasibility of Developing a Half-Life Extended Recombinant FVIIa that Retains Biologic Activity

In data presented at the ASH 49th annual meeting recombinant factor VIIa-albumin fusion protein seen as first step toward more convenient treatment option for hemophilia patients with inhibitors ATLANTA, Dec. 10 /PRNewswire/ -- CSL Behring today announced the results of a pre-clini...

Takeda Provides Update on the Investigational Fixed-Dose Combination of alogliptin and ACTOS(R) (pioglitazone HCl)

...ment Center, Inc., a wholly owned United States (U.S.) subsidiary, received notification from the U.S. Food and Drug Administration (FDA) that the FDA extended the review of the New Drug Application (NDA) for the fixed-dose combination (FDC) of alogliptin and ACTOS((R)) (pioglitazone HCl). The new Prescriptio...

BioCryst Pharmaceuticals Reports Positive Results of Shionogi & Co. Sponsored Phase 3 Studies of i.v. Peramivir for Influenza

...evelop and commercialize peramivir in Japan for the treatment of seasonal and potentially life-threatening influenza. In 2008, Shionogi's rights were extended to include Taiwan. Under the terms of the agreement, BioCryst may receive future clinical and commercial event milestone payments up to $116 million,...

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

.../ -- Schering-Plough Corporation (NYSE: SGP ) today announced that it has extended to stage two an ongoing Phase II clinical study with vicriviroc, its invest...t Data Safety Monitoring Board. Based on these results, the study has been extended to stage two, in which the enrollment target is an additional 105 patients....

Bioniche Life Sciences Inc. and Endo Pharmaceuticals Sign Licensing Agreement for Urocidin(TM)

... appropriate; OPANA(R) ER tablets for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time; and VOLTAREN(R) Gel, a nonsteroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable t...

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

...sedronate sodium) tablets, Asacol(R) (mesalamine) delayed-release tablets, Asacol(R) HD (mesalamine) delayed-release tablets, Enablex(R) (darifenacin) extended release tablets, Prilosec OTC(R), Align(R), Metamucil(R), Fibersure(R), Pepto-Bismol(R), Vicks(R), PUR(R), Crest(R) and Oral-B(R). The P&G communi...

Cancer Treatment Centers of America(R) Studies Treatment That Aims Chemotherapy Directly at Ovarian Cancer Cells

...rugs and diagnostic agents to treat many types of cancer and other serious diseases. The DGS platform makes it possible to use highly-potent drugs on extended and frequent dosing schedules and in combination with other drugs to maximize efficacy. The technology improves drug targeting and reduces the risk o...

Study Shows GSK's Novel Diabetes Treatment SYNCRIA(R) (albiglutide) Improves Glucose Control and Reduces Weight

... Albiglutide is the only medication which fuses modified human GLP-1 to human albumin, a protein found in the blood plasma. It is designed to have an extended duration of action and allow for weekly or less-frequent injections. The Phase III programme for albiglutide began with five studies in early 2009 and...

IMPACT Study Showed Longer Valcyte(R) (valganciclovir hydrochloride tablets) Treatment Demonstrated Better Protection Against Cytomegalovirus (CMV) Disease One Year Post-Transplant

... to 37% with 100-day Valcyte prophylaxis (p<0.0001). No significant difference was detected in overall safety and tolerability, demonstrating that extended treatment poses no additional risk to patients. "As transplant physicians, we go to significant lengths to safeguard the health of the organ and ...

Shire Presented Results of a New Database Analysis on Lialda(R) (Mesalamine) and Other 5-ASAs for Ulcerative Colitis at Digestive Disease Week

...ntioned 5-ASAs between March and September 2007. Persistency is defined as the proportion of patients who remained on their prescribed therapy over an extended period of time. The study evaluated a total of 44,191 5-ASA prescription and refill records (Lialda, n = 6,170; Asacol, n = 25,887; balsalazide, n = 4...

Neurobiological Technologies' Partner, Celtic Pharma, Announces Results of XERECEPT(R) Phase 3 Clinical Program

...r complete elimination of corticosteroid treatment, and to sustain this for extended periods of time. The NTI-0501 study also showed that XERECEPT(R) therapy was well tolerated over extended periods up to two years or more. "We are delighted to see the results...

AIMSPRO is Awarded TGA Orphan Status for the Treatment of Amyotrophic Lateral Sclerosis

...rogressive Multiple Sclerosis. Both trials are expected to report in the first quarter of 2010. Additional open label experience with AIMSPRO, over an extended period, has led Daval to consider Proof of Concept studies in Adhesive Arachnoiditis, treatment resistant Myasthenia Gravis and Psoriatic arthritis. ...

Keryx Biopharmaceuticals Reports Positive Data from a Randomized, Multi-Center, Placebo-Controlled, Phase 2 Combination Study of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Colon Cancer

... KRX-0401 + Capecitabine More Than Doubled Time to Progression and Overall Response Rate as well as extended Overall Survival vs. Capecitabine + Placebo in Patients with 2nd or 3rd Line Metastatic Colon Cancer NEW YORK, May 31 /PRNewswire-FirstCall/ -- K...

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

...nly reported side effects include vaginal bleeding, blood clots, other cancers, osteoporosis, stroke, heart attack and endometrial cancer. In the extended adjuvant setting, commonly reported side effects are generally mild to moderate. Commonly reported side effects for Femara include hot flashes, fatigu...

Bethesda-Based NHSi Wins $2M Grant for Blood Technology

...ter preserved blood been used." "Our technology aims to address this problem and in doing so, reduce the human and economic costs associated with extended hospitalization ," Cannon said. Research has documented that the rate of complications increases with the number of units of blood transfused. ...

New Phase 3 Study of Tapentadol Immediate Release Tablets Published in Current Medical Research and Opinion Journal

...wo mechanisms, which affect established pain pathways, are thought to be responsible for pain relief with tapentadol. It is also being developed in an extended release formulation for chronic pain. Study Design This Phase 3, double-blind, randomized, active- and placebo-controlled, parallel group, m...

Ascenta Therapeutics Announces Multiple Presentations on AT-101 at 2009 ASCO Annual Meeting

...n patients with advanced solid tumors and extensive-stage small cell lung cancer (ES-SCLC). Abstract #e13502; Publication only. Saleh M, et al. extended phase I trial of the oral pan-Bcl-2 inhibitor AT-101 by multiple dosing schedules in patients with advanced cancers. Abstract #e14537; Publication on...

TriLink BioTechnologies, Inc. Announces Supply Agreement With Osmetech Molecular Diagnostics

...ystem is designed to support a broad test menu. A cytochrome P450 2C9 genotyping test (RUO) is now available while planned menu expansion includes an extended warfarin panel with the proprietary 4F2 marker, a venous thrombosis panel (Factor II, Factor V Leiden and MTHFR) and a RESPLEX(R) respiratory pathogen...

Metabolic Solutions Development Company Announces Preliminary Results from Phase IIa Clinical Trial

...al target will produce a significantly improved safety profile for individuals with type 2 diabetes. If the results of this study can be successfully extended to longer trials, we might be able to achieve our long-term goal of a therapeutic option that could be used early in the course of the disease to prev...

Tris Pharma Announces Acceptance of Its First Two NDAs

...he company's proprietary OralXR platform. Only two extended release liquid pharmaceuticals exist today. If FDA...rst-ever liquid dosage form available in a 24-hour extended release formulation. "LiquiXR offers the comp...ing future, with a robust pipeline of more than 20 extended release products in different therapeutic categori...

National Hemovigilance Pilot Program Launches to Track Adverse Events Associated with Blood Transfusion

...ed $40 million or more could be saved by eliminating the need for further diagnostic patient assessments (including x-rays), respiratory treatment and extended hospital stays. "The Hemovigilance Module in NHSN is an important step forward for blood safety in the United States," said Matthew J. Kuehnert, ...

Two-Year Phase III Data Presented at AAN 61st Annual Meeting Show Positive Outcome of Cladribine Tablets in Patients With Multiple Sclerosis

...rallY) extension study: a two-year placebo-controlled extension of the CLARITY study, designed to provide data on the long-term safety and efficacy of extended administration of Cladribine Tablets for up to four years - The ORACLE MS (ORAl CLadribine in Early MS) study: a two-year Phase III placebo-contr...

Prostate Cancer Immunotherapy Significantly Prolongs Survival in Men With Advanced Prostate Cancer

...erested media will take place at 3:00 p.m. CT in the AUA Press Suite, room CC22 at the Hyatt Regency McCormick. Compared to placebo, sipuleucel-T extended median survival by 4.1 months and improved three-year survival by 38 percent. Sipuleucel-T successfully exceeded the pre-specified level of statistica...

Data Presented at AUA Demonstrate PROVENGE Significantly Prolongs Survival for Men With Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study

... - extended Median Survival by 4.1 Months and Increased 3-Year Survival by 38 Percent C...The intent-to-treat analysis demonstrated that: PROVENGE extended median survival by 4.1 months compared to placebo (25.8 months versus 21.7 ...

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

...nalysis as well as in subjects with pre-existing esophageal varices. extended Treatment Duration in Chronic Hepatitis C Genotype 1-Infected Slow Responde...EASL); April 22-26, Copenhagen, Denmark. 2. Buti M, Esteban R, et al. extended Treatment Duration in Chronic Hepatitis C Genotype 1-Infected Slow-Responde...

Intarcia Therapeutics, Inc. Announces Completion of Enrollment of ITCA 650 Phase 1b Study for the Treatment of Type 2 Diabetes

...tability of therapeutic proteins and peptides at human body temperature for extended periods of time. Exenatide, the active agent in ITCA 650, has been approved... of exenatide exposure observed with injection administration. Unlike other extended delivery technologies such as polymers or albumin fusion, DUROS delivery al...

Studies Presented at AACR Annual Meeting Highlight Multiple Immunomodulatory Mechanisms of Peregrine's PS-Targeting Antibodies

...r specific immunomodulatory activity. The unique functional characteristics of these different antibodies open the door to new product candidates and extended applications for our anti-PS technology. We are more encouraged than ever that our anti-PS platform has very broad potential, and we look forward to ...

Genes Identified That Enhance Tumor Cell Sensitivity to CTI's Cancer Drug Brostallicin

...exts of vulnerability to brostallicin, converged on cellular concepts relating to DNA repair and chromosome modification. These findings were further extended and confirmed in breast cancer cell lines, wherein the knockdown of specific genes involved in these concepts, mentioned above, resulted in an increas...

Genetic Source of Rare Childhood Cancer Found; Gene is Implicated in Other Cancers

...ct that the cancers were caused by an inherited genetic abnormality. To uncover the role of DICER1, the research team studied the genetic makeup of 11 extended families with two or more members having PPB or related childhood cancers. The scientists say that finding this variant form of a gene in some P...

Optigenex Inc. Signs New License and Distribution Agreement With Itochu Corporation of Japan

...the epidermis layer of the skin. NEW YORK, April 6 /PRNewswire-FirstCall/ -- Optigenex Inc. (Pink Sheets: OPGX) announced today the signing of an extended and expanded new contract with its distribution partner in Asia (Itochu Corporation). Under the new license, Itochu has the right to market AC-11(R) ...