Efficacy News and Research

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Ferring announces availability of LYSTEDA for cyclic heavy menstrual bleeding in U.S.

Ferring Pharmaceuticals Inc. announced today the U.S. commercial availability of LYSTEDA™ (tranexamic acid) tablets, the only non-hormonal and non-surgical therapy indicated specifically for the treatment of women with cyclic heavy menstrual bleeding (HMB). In clinical studies, LYSTEDA significantly reduced menstrual blood loss (MBL) over three and six cycles of use with the reduction seen as early as the first cycle of use.

21 Jun 2010

LIVALO for primary hyperlipidemia or mixed dyslipidemia now available in U.S.

Kowa Pharmaceuticals America, Inc., and Eli Lilly and Company today announced that LIVALO® (pitavastatin) tablets is now available in retail pharmacies throughout the United States. LIVALO, a statin medication approved by the U.S. Food and Drug Administration (FDA) in August 2009 is indicated for adults as an adjunctive therapy to diet for the treatment of primary hyperlipidemia or mixed dyslipidemia. LIVALO is available in doses of 1 mg, 2 mg and 4 mg.

21 Jun 2010

NanoViricides' anti-Dengue drug candidates demonstrate potential against severe virus infection

NanoViricides, Inc. reports that its anti-Dengue drug candidates demonstrated significant protection in the initial animal survival studies of Dengue virus infection. The studies were performed in the laboratory of Dr. Eva Harris, Professor of Infectious Diseases at the University of California, Berkeley.

21 Jun 2010

Ostarine increases muscle mass and strength in postmenopausal women: Study

GTx, Inc. announced that Ostarine (GTx-024, formerly MK-2866) increased lean body mass and leg press strength in a head to head study evaluating Ostarine and another selective androgen receptor modulator, MK-3984, in postmenopausal women. The data were presented yesterday at the 2010 Annual Meeting of the Endocrine Society. GTx is developing its lead SARM, Ostarine, for the treatment of cancer induced muscle wasting (cancer cachexia).

21 Jun 2010

Preliminary top-line results from Hematide Phase 3 program for anemia in chronic renal failure patients

Affymax, Inc. and Takeda Global Research & Development Center, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, today announced preliminary top-line results from the Phase 3 clinical program for the investigational drug, Hematide™/peginesatide, for the treatment of anemia in chronic renal failure patients.

21 Jun 2010

Staloral 300 demonstrates efficacy in phase III study for control of asthma in China

Stallergenes S.A. announces the results of a phase III clinical trial (VO55.06) conducted in China aimed at assessing the efficacy and safety of sublingual immunotherapy (Staloral(R) mites 300) in adult patients suffering from asthma triggered by house dust mites.

21 Jun 2010

Boehringer Ingelheim disappointed with FDA Advisory Committee recommendations on flibanserin NDA for HSDD

The Reproductive Health Drugs Advisory Committee met today to discuss the new drug application (NDA) for flibanserin 100 mg as a treatment for Hypoactive Sexual Desire Disorder (HSDD) in pre-menopausal women. The advisory committee was convened by and makes recommendations to the U.S. Food and Drug Administration (FDA). The FDA will consider the committee's advice as part of its final assessment of the NDA.

19 Jun 2010

Advisory panel recommends FDA approve new "morning after" pill

The New York Times: A Food and Drug Administration advisory panel Thursday recommended that the agency approve "a medicine that could help prevent pregnancy if taken as late as five days after unprotected sex. The pill, called ella, sprang from government labs and appears to be more effective than Plan B, a morning-after pill now available over the counter to women 18 and older that gradually loses efficacy after intercourse and can be taken at latest three days after sex.

18 Jun 2010

Neupro improves wellbeing impaired by pain related to Restless Legs Syndrome

The first data to show that Neupro® (rotigotine transdermal system) significantly improved wellbeing and daily activities that are often impaired by pain related to Restless Legs Syndrome (RLS) were presented this week at the 14th International Congress of Parkinson's Disease and Movement Disorders in Buenos Aires, Argentina.

18 Jun 2010

Additional positive data from Ardea Biosciences' RDEA594 Phase 2 program presented at EULAR

Ardea Biosciences, Inc. announced that additional positive data from its Phase 2 program for RDEA594, its lead product candidate for the treatment of hyperuricemia and gout, are being presented at the Annual European Congress of Rheumatology hosted by the European League Against Rheumatism (EULAR) in Rome, Italy. RDEA594, a first-in-class selective inhibitor of the URAT1 transporter, treats the underlying cause of gout by increasing the excretion of uric acid in order to bring the body's levels of uric acid into a normal range.

18 Jun 2010

Children's Hospital Boston receives $2.4M Gates Foundation grant to develop novel neonatal vaccines

Children's Hospital Boston announced today that it has received a $2.4 million grant from the Bill & Melinda Gates Foundation. The grant will support the development of novel vaccines for newborns – research that is spearheaded by Ofer Levy, MD, Ph.D., a principal investigator in the Division of Infectious Diseases at Children's.

18 Jun 2010

St. Jude Medical's Therapy Cool Flex Ablation Catheter granted European CE Mark approval

St. Jude Medical, Inc., a global medical device company, today announced European CE Mark approval of the Therapy™ Cool Flex™ Ablation Catheter at the 17th World Congress in Cardiac Electrophysiology and Cardiac Techniques (CardioStim). The ablation catheter is the industry's first to have a fully-irrigated and flexible tip, which can potentially improve the safety and efficacy of cardiac ablation procedures.

18 Jun 2010

Inspire's TIGER-1 Phase 3 clinical trial data with denufosol for CF presented at 33rd ECFS

Inspire Pharmaceuticals, Inc. announced today that data is being presented on denufosol tetrasodium, an investigational therapy for cystic fibrosis (CF), during an oral presentation and poster presentations at the 33rd Annual European Cystic Fibrosis Society (ECFS) Conference June 16 - 19, 2010 in Valencia, Spain.

18 Jun 2010

Additional results from BLISS-52 Phase 3 trial of BENLYSTA for SLE to be presented at EULAR 2010

Human Genome Sciences, Inc. and GlaxoSmithKline PLC today announced the presentation of additional results from BLISS-52, one of two pivotal Phase 3 trials of BENLYSTA (belimumab) in seropositive patients with systemic lupus erythematosus. The additional data will be presented in Rome at the 2010 Congress of the European League against Rheumatism on Saturday, June 19.

18 Jun 2010

Agilent launches 1260 Infinity bio-inert quaternary liquid chromatography system

Agilent Technologies Inc. today introduced the 1260 Infinity bio-inert quaternary liquid chromatography (LC) system designed to characterize and confirm large biomolecules, especially new biological entities (NBEs) and therapeutic monoclonal antibodies.

18 Jun 2010

Special public meeting to spotlight stem cell-based therapies for ALS

Local scientists, health advocates and leaders from the California Institute for Regenerative Medicine will gather in San Diego June 23 for a special public meeting to spotlight a new University of California, San Diego grant to pursue novel, fast-tracked stem cell-based therapies for amyotrophic lateral sclerosis, or Lou Gehrig's disease.

18 Jun 2010

Data on BYETTA and SYMLIN injections, BYDUREON drug candidate to be presented at ADA 2010

Amylin Pharmaceuticals, Inc. today announced that the Company will present data for its FDA-approved diabetes drugs, BYETTA (exenatide) injection and SYMLIN (pramlintide acetate) injection, and its investigational diabetes drug candidate BYDUREON (exenatide extended-release for injectable suspension) at the American Diabetes Association's 70th Annual Scientific Sessions being held in Orlando, FL from June 25 to June 29.

18 Jun 2010

DURATION-4 study tests superiority of BYDUREON as compared to other type 2 diabetes medications

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced results from DURATION-4, the fourth in a series of studies designed to test the superiority of BYDUREON (exenatide extended-release for injectable suspension), an investigational type 2 diabetes therapy, as compared to other type 2 diabetes medications.

18 Jun 2010

University of Utah makes progress against SMA with support of Families of Spinal Muscular Atrophy

18 Jun 2010

Researchers make significant headway in fight against SMA

Researchers at the University of Utah are making strides in understanding and combating a motor neuron disease known as Spinal Muscular Atrophy. The spinal muscular atrophies are a group of inherited diseases that cause progressive degeneration of motor nerves resulting in muscle weakness. The most common form of the disorder, due to the deletion of a critical gene on chromosome 5, is currently the leading cause of inherited infant and child mortality.

18 Jun 2010

Efficacy News and Research

Ferring announces availability of LYSTEDA for cyclic heavy menstrual bleeding in U.S.

LIVALO for primary hyperlipidemia or mixed dyslipidemia now available in U.S.

NanoViricides' anti-Dengue drug candidates demonstrate potential against severe virus infection

Ostarine increases muscle mass and strength in postmenopausal women: Study

Preliminary top-line results from Hematide Phase 3 program for anemia in chronic renal failure patients

Staloral 300 demonstrates efficacy in phase III study for control of asthma in China

Boehringer Ingelheim disappointed with FDA Advisory Committee recommendations on flibanserin NDA for HSDD

Advisory panel recommends FDA approve new "morning after" pill

Neupro improves wellbeing impaired by pain related to Restless Legs Syndrome

Additional positive data from Ardea Biosciences' RDEA594 Phase 2 program presented at EULAR

Children's Hospital Boston receives $2.4M Gates Foundation grant to develop novel neonatal vaccines

St. Jude Medical's Therapy Cool Flex Ablation Catheter granted European CE Mark approval

Inspire's TIGER-1 Phase 3 clinical trial data with denufosol for CF presented at 33rd ECFS

Additional results from BLISS-52 Phase 3 trial of BENLYSTA for SLE to be presented at EULAR 2010

Agilent launches 1260 Infinity bio-inert quaternary liquid chromatography system

Special public meeting to spotlight stem cell-based therapies for ALS

Data on BYETTA and SYMLIN injections, BYDUREON drug candidate to be presented at ADA 2010

DURATION-4 study tests superiority of BYDUREON as compared to other type 2 diabetes medications

University of Utah makes progress against SMA with support of Families of Spinal Muscular Atrophy

Researchers make significant headway in fight against SMA

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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