Efficacy News and Research

RSS

NEJM publishes results from Amgen's brodalumab Phase 2 trial on plaque psoriasis

Amgen announced today that results from a Phase 2 trial evaluating the safety and efficacy of brodalumab in 198 patients with moderate to severe plaque psoriasis were published in the New England Journal of Medicine.

29 Mar 2012

FDA approves Omontys - new anemia drug for chronic kidney disease patients

The Food and Drug Administration (FDA) on Tuesday approved a new drug called Omontys (peginesatide). This is expected to oust Amgen Inc.’s from its near monopoly in the roughly $6 billion U.S. anemia treatment market.

28 Mar 2012

Identity of probiotics a key factor in determining safety, efficacy of popular ingredient

Regulators, manufacturers and academic researchers from around the world will convene for a two-day workshop on the scientific and regulatory challenges posed by the use of probiotic ingredients in food products. Discussions will focus on how public standards can assist in supporting transparency, consistency and competitiveness of ethical industry players as health claims surrounding probiotic products undergo increased scrutiny.

28 Mar 2012

Non-HDL-C levels appear to increase risk of heart attack or stroke in statin-treated patients

Levels of non-high-density lipoprotein cholesterol (non-HDL-C) among statin-treated patients appears to be associated with the risk of developing a major cardiovascular event, such as a heart attack or stroke, as are levels of low-density lipoprotein cholesterol (LDL-C) and apolipoprotein B, according to a meta-analysis of data from previously published studies appearing in the March 28 issue of JAMA.

28 Mar 2012

Researchers develop gut-on-a-chip microdevice

Researchers at the Wyss Institute for Biologically Inspired Engineering at Harvard University have created a gut-on-a-chip microdevice lined by living human cells that mimics the structure, physiology, and mechanics of the human intestine-even supporting the growth of living microbes within its luminal space.

28 Mar 2012

Rivaroxaban found safe and effective in pulmonary embolism

Rivaroxaban has been found to be effective in the prevention of venous thromboembolism (VTE) after orthopedic surgery, for the prevention of stroke in AF (Atrial fibrillation) patients, and as additional therapy to conventional antiplatelet therapy in ACS (Acute coronary syndrome) patients.

27 Mar 2012

Surfaxin receives FDA approval for prevention of RDS in premature infants

The U.S. Food and Drug Administration today approved Surfaxin (lucinactant) for the prevention of respiratory distress syndrome (RDS), a breathing disorder that affects premature infants.

27 Mar 2012

Study reveals clinically relevant differences between on pump and off pump bypass

A large randomized trial comparing bypass surgery done with a heart-lung machine (on pump) and without it (off pump) found no differences in results between techniques overall but some clinically relevant differences, according to research presented today at the American College of Cardiology's 61st Annual Scientific Session.

27 Mar 2012

Pfizer to present data on ADCs at AACR 2012

Pfizer Oncology will present data from a variety of preclinical and clinical studies of Pfizer's early-stage compounds, including data from Pfizer's investigational antibody-drug conjugate (ADC) portfolio and research evaluating several molecules targeting novel pathways that play a crucial role in basic cellular functions, at the American Association for Cancer Research (AACR) Annual Meeting 2012 in Chicago, IL, from March 31-April 4.

27 Mar 2012

Promotion and education of female condom prevent HIV and save medical care costs

A new economic analysis, conducted by Johns Hopkins Bloomberg School of Public Health and featured in the current issue of Springer's journal AIDS and Behavior, showed that the DC Female Condom program, a public-private partnership to provide and promote female condoms, prevented enough HIV infections in the first year alone to save over $8 million in future medical care costs.

27 Mar 2012

Hapten licenses HPT-721 to prevent poison ivy dermatitis

Hapten Sciences Inc. of Memphis, Tenn., has licensed a compound developed by ElSohly Laboratories Inc. and University of Mississippi pharmaceutical researchers to prevent reactions to poison ivy, oak and sumac.

27 Mar 2012

Rivaroxaban safer, effective than standard therapy in treating PE

A novel oral anti-coagulant outperformed the injected standard therapy on important safety measures for initial and long-term treatment of pulmonary embolism - a blockage of lung blood vessels usually caused by a clot - and showed comparable efficacy, according to data from the EINSTEIN-PE trial presented today at the American College of Cardiology's 61st Annual Scientific Session.

27 Mar 2012

Study clarifies conflicting reports for clot aspiration and abciximab administration

The anti-platelet drug abciximab, delivered directly to lesions caused by a heart attack, significantly decreased damage to the heart muscle in high-risk patients while clot aspiration showed no impact, according to research presented today at the American College of Cardiology's 61st Annual Scientific Session.

From Medtronic 27 Mar 2012

FDA issues Complete Response letter to MAP's NDA for LEVADEX

MAP Pharmaceuticals, Inc. today announced that the United States Food and Drug Administration (FDA) has issued a Complete Response letter to its New Drug Application (NDA) for LEVADEX (dihydroergotamine) inhalation aerosol.

27 Mar 2012

Medtronic Resolute DES found effective through two years

According to new clinical data presented today at ACC.12 -- the 61st Annual Scientific Session & Expo of the American College of Cardiology (ACC) -- the Resolute drug-eluting stent (DES) from Medtronic, Inc. maintains a powerful and persistent treatment effect for a wide variety of patients with coronary artery disease, including those with diabetes mellitus, through two years of follow-up.

From Medtronic 27 Mar 2012

CardioFocus introduces HeartLight Endoscopic Ablation System for AF in the Netherlands

CardioFocus, Inc., developer of the HeartLight Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), announces its technology is now available in the Netherlands. Physicians at Isala Klinieken in Zwolle were the first in the country to incorporate visually guided ablation into their regular therapeutic practice and have successfully treated several patients.

26 Mar 2012

CSL Behring commences enrollment in SCIg PATH trial for CIDP

CSL Behring has announced that the first patient has been enrolled in the PATH study, an international clinical trial designed to evaluate the efficacy, safety, and tolerability of two different doses of subcutaneous immunoglobulin (SCIg), compared with placebo, in maintenance treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).

26 Mar 2012

FDA approves Teva's QNASL nasal aerosol corticosteroid

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has approved QNASL Nasal Aerosol, a new, "dry" nasal aerosol corticosteroid that treats seasonal nasal and year-round nasal allergy symptoms in adults and adolescents 12 years of age and older.

26 Mar 2012

Theracurmin shows positive impact on human diastolic functions

The research group led by Dr. Koji Hasegawa, Director of the Translational Research Division at the National Hospital Organization Kyoto Medical Center and Dr. Tatsuya Morimoto, Professor at the Molecular Medicine School of Pharmaceutical Sciences, University of Shizuoka, announced today based on the recent human clinical trials, that Theracurmin has continuously shown positive impact on human diastolic functions.

26 Mar 2012

Promising results from Esperion ETC-1002 Phase 2 clinical trial for dyslipidemia

Esperion Therapeutics, a privately held biotechnology company working to discover, develop and commercialize treatments for cardiovascular and metabolic diseases, today announced positive results from a Phase 2 clinical trial for ETC-1002.

26 Mar 2012

Efficacy News and Research

NEJM publishes results from Amgen's brodalumab Phase 2 trial on plaque psoriasis

FDA approves Omontys - new anemia drug for chronic kidney disease patients

Identity of probiotics a key factor in determining safety, efficacy of popular ingredient

Non-HDL-C levels appear to increase risk of heart attack or stroke in statin-treated patients

Researchers develop gut-on-a-chip microdevice

Rivaroxaban found safe and effective in pulmonary embolism

Surfaxin receives FDA approval for prevention of RDS in premature infants

Study reveals clinically relevant differences between on pump and off pump bypass

Pfizer to present data on ADCs at AACR 2012

Promotion and education of female condom prevent HIV and save medical care costs

Hapten licenses HPT-721 to prevent poison ivy dermatitis

Rivaroxaban safer, effective than standard therapy in treating PE

Study clarifies conflicting reports for clot aspiration and abciximab administration

FDA issues Complete Response letter to MAP's NDA for LEVADEX

Medtronic Resolute DES found effective through two years

CardioFocus introduces HeartLight Endoscopic Ablation System for AF in the Netherlands

CSL Behring commences enrollment in SCIg PATH trial for CIDP

FDA approves Teva's QNASL nasal aerosol corticosteroid

Theracurmin shows positive impact on human diastolic functions

Promising results from Esperion ETC-1002 Phase 2 clinical trial for dyslipidemia

Industry Focus eBook - Cell biology (5th edition) eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Latest News