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Researchers develop new malaria vaccine strategy based on ingestion of genetically modified starch

Researchers from two laboratories in northern France have successfully vaccinated and protected mice by feeding them starch derived from green algae and genetically modified to carry vaccine proteins.

21 Dec 2010

Wellcome Trust awards additional £390,000 for investigation of Allergen Delivery Inhibitors

Scientists at St George's, University of London and the University of Manchester have received an additional Seeding Drug Discovery award of £390,000 from the Wellcome Trust to explore a new class of experimental drugs that block the trigger of allergic reactions before symptoms show.

21 Dec 2010

Amylin submits metreleptin rolling submission BLA for treatment of rare forms of lipodystrophy

Amylin Pharmaceuticals, Inc. today announced that it has submitted the initial sections of a rolling submission for a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the use of metreleptin to treat diabetes and/or hypertriglyceridemia (high levels of triglycerides in the bloodstream) in patients with rare forms of lipodystrophy.

21 Dec 2010

Motivational interviewing may not be an ideal treatment choice for smoking-cessation

Motivational interviewing, a popular counseling technique for many addictive behaviors, might not be the ideal treatment choice for those who smoke cigarettes.

21 Dec 2010

Biomet Biologics completes enrollment in Recover Kit clinical trial for chronic tennis elbow

Biomet, Inc., a global leader in the manufacture of orthopedic and biotechnology products, announced today that its subsidiary, Biomet Biologics, LLC, has completed the required 230 subject enrollment for its Recover® Kit clinical trial. This clinical trial studies the use of the Recover® Kit device, which produces autologous platelet-rich plasma (PRP) to treat chronic tennis elbow (lateral epicondylitis).

21 Dec 2010

Positive results from Incyte's COMFORT-I INCB18424 pivotal Phase III clinical trial in myelofibrosis

Incyte Corporation announced today positive top-line results from COMFORT-I, the pivotal Phase III clinical trial of INCB18424 (also known as INC424) in patients with myelofibrosis (MF) being conducted under a Food and Drug Administration (FDA) Special Protocol Assessment (SPA) Agreement. COMFORT-I (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Treatment) is a double-blind, placebo-controlled Phase III trial involving 309 patients.

21 Dec 2010

'CART' treatment better than traditional cognitive therapy at altering hyperventilation and panic symptoms

A new treatment program teaches people who suffer from panic disorder how to reduce the terrorizing symptoms by normalizing their breathing.

21 Dec 2010

Ambit commences Phase I advanced solid tumor trials for AC430 and AC480 inhibitors

Ambit Biosciences, today announced that it has initiated separate Phase I trials for two products AC430, a selective Janus Kinase 2 (JAK2) inhibitor, and AC480, a pan-HER inhibitor.

20 Dec 2010

Brilinta – AstraZeneca’s new blood thinner faces FDA hurdle

AstraZeneca’s new blood thinner that was pitched against Plavix, the world’s second-best selling drug failed to live up to expectations making stocks drop to a two year low, the steepest decline since Nov. 21, 2008, and the worst performance today on the 18-company Bloomberg Europe Pharmaceutical Index.

20 Dec 2010

Itamar Medical, Roche enter development agreement for EndoPAT device

Itamar Medical, the leader in non-invasive vascular health diagnostics, announced today that an agreement has been signed with Roche by which Itamar will develop an EndoPAT device designated for use with animal models, enabling pre-clinical studies examining the efficacy of various compounds in the early stage of drug development essential for later stage development in humans.

20 Dec 2010

Arrowhead launches new company, Ablaris to commercialize novel weight loss technology

Arrowhead Research Corporation today announced that it has executed an exclusive world-wide license on technology developed by Drs. Wadih Arap and Renata Pasqualini at MD Anderson Cancer Center for use in weight loss and obesity-related metabolic conditions, and that it has launched a new company, Ablaris Therapeutics Inc., to commercialize this platform.

20 Dec 2010

VIVUS seeks marketing approval of QNEXA in the EU

VIVUS, Inc. today announced that the company filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for QNEXA® (phentermine/topiramate) Controlled Release Capsules in the European Union (EU). The proposed indication in the EU is for the treatment of obesity, including weight loss and maintenance of weight loss, and should be used in conjunction with a mildly hypocaloric diet.

20 Dec 2010

Chelsea completes successful NORTHERA pre-NDA assessment with FDA

Chelsea Therapeutics International, Ltd. announced it has completed a pre-NDA assessment with the U.S. Food and Drug Administration (FDA) and intends to accelerate its new drug application (NDA) for NORTHERA™(droxidopa) for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH), a chronic and potentially debilitating drop in blood pressure upon standing commonly associated Parkinson's disease, multiple system atrophy and pure autonomic failure.

20 Dec 2010

Novartis' Gilenya uptake to increase

A study published this week by ITG revealed that Novartis recently approved drug, Gilenya, has already taken share from market leaders in the multiple sclerosis (MS) market, and uptake is expected to increase significantly over the next year. Gilenya came onto the market in late September as the first FDA-approved oral disease-modifying MS drug, and Novartis initially faced safety concerns and monitoring requirements that deterred some physicians from adopting the new drug.

20 Dec 2010

Inspire's denufosol tetrasodium TIGER-1 Phase 3 trial for CF published in AJRCCM

Inspire Pharmaceuticals, Inc. announced today that the results from its first Phase 3 clinical trial with denufosol tetrasodium for cystic fibrosis (CF), TIGER-1, have been published in the peer-reviewed publication, American Journal of Respiratory and Critical Care Medicine (AJRCCM). Denufosol is an investigational, inhaled, novel ion channel regulator currently in Phase 3 clinical development for the treatment of CF.

20 Dec 2010

4SC AG's Phase IIb study evaluates efficacy of vidofludimus in RA patients

4SC AG, a drug discovery and development company focused on autoimmune and cancer indications, today reported that it has completed enrolment of its COMPONENT Phase IIb study with vidofludimus, an oral inhibitor of IL-17 release, in rheumatoid arthritis (RA) patients. Data from the trial are expected to be announced in Q2 2011.

20 Dec 2010

$FDA approves Medtronic's Arctic Front Cardiac CryoAblation Catheter system for drug refractory PAF$

FDA approves Medtronic's Arctic Front Cardiac CryoAblation Catheter system for drug refractory PAF

Medtronic, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its Arctic Front® Cardiac CryoAblation Catheter system, the first and only Cryoballoon in the United States indicated for the treatment of drug refractory paroxysmal atrial fibrillation (PAF). The Cryoballoon treatment involves a minimally-invasive procedure that efficiently creates circumferential lesions around the pulmonary vein, which is the source of erratic electrical signals that cause the irregular heartbeat.

20 Dec 2010

RXi's dermal anti-scarring candidate selected to advance into development

RXi Pharmaceuticals Corporation, a recognized leader in RNAi-based therapeutic discovery and development, today announced the selection of its first RNAi therapeutic product candidate to advance into development.

20 Dec 2010

Taiho receives CHMP positive opinion on Teysuno in combination with cisplatin for advanced gastric cancer

Taiho Pharmaceutical Co., Ltd., and its parent company, Otsuka Holdings Co., Ltd., announced today that the Committee for Medicinal Products for Human Use (CHMP), a division of the European Medicines Agency (EMA), has issued an opinion recommending approval of Teysuno™ (S-1), a novel oral anti-cancer agent, intended for the treatment of advanced gastric cancer in adults when given in combination with cisplatin.

17 Dec 2010

Diagenic, Pfizer enter collaboration to identify biomarkers in early stages of Alzheimer's disease

DiaGenic ASA and Pfizer Inc today signed an agreement for explorative R&D collaboration to identify biomarkers in early stages of Alzheimer's disease (AD) using DiaGenic's patented gene expression technology and its blood samples from ongoing clinical studies.

17 Dec 2010

Efficacy News and Research

Researchers develop new malaria vaccine strategy based on ingestion of genetically modified starch

Wellcome Trust awards additional £390,000 for investigation of Allergen Delivery Inhibitors

Amylin submits metreleptin rolling submission BLA for treatment of rare forms of lipodystrophy

Motivational interviewing may not be an ideal treatment choice for smoking-cessation

Biomet Biologics completes enrollment in Recover Kit clinical trial for chronic tennis elbow

Positive results from Incyte's COMFORT-I INCB18424 pivotal Phase III clinical trial in myelofibrosis

'CART' treatment better than traditional cognitive therapy at altering hyperventilation and panic symptoms

Ambit commences Phase I advanced solid tumor trials for AC430 and AC480 inhibitors

Brilinta – AstraZeneca’s new blood thinner faces FDA hurdle

Itamar Medical, Roche enter development agreement for EndoPAT device

Arrowhead launches new company, Ablaris to commercialize novel weight loss technology

VIVUS seeks marketing approval of QNEXA in the EU

Chelsea completes successful NORTHERA pre-NDA assessment with FDA

Novartis' Gilenya uptake to increase

Inspire's denufosol tetrasodium TIGER-1 Phase 3 trial for CF published in AJRCCM

4SC AG's Phase IIb study evaluates efficacy of vidofludimus in RA patients

FDA approves Medtronic's Arctic Front Cardiac CryoAblation Catheter system for drug refractory PAF

RXi's dermal anti-scarring candidate selected to advance into development

Taiho receives CHMP positive opinion on Teysuno in combination with cisplatin for advanced gastric cancer

Diagenic, Pfizer enter collaboration to identify biomarkers in early stages of Alzheimer's disease

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From Discovery Biology to ELRIG Chair

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