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CUMC researchers clarify three fundamental issues about Alzheimer's disease

Using high-resolution functional MRI imaging in patients with Alzheimer's disease and in mouse models of the disease, Columbia University Medical Center researchers have clarified three fundamental issues about Alzheimer's: where it starts, why it starts there, and how it spreads. In addition to advancing understanding of Alzheimer's, the findings could improve early detection of the disease, when drugs may be most effective.

22 Dec 2013

Lilly, Boehringer Ingelheim announce FDA acceptance of NDA filing for new insulin glargine product

Eli Lilly and Company and Boehringer Ingelheim today announced that the U.S. Food and Drug Administration has accepted the filing of the New Drug Application for LY2963016, an investigational basal (long-acting) insulin.

21 Dec 2013

Orenitram Extended-Release Tablets get FDA approval for pulmonary arterial hypertension treatment

United Therapeutics Corporation announced today that the United States Food and Drug Administration has approved Orenitram (treprostinil) Extended-Release Tablets for the treatment of pulmonary arterial hypertension in WHO Group I patients to improve exercise capacity.

21 Dec 2013

Icahn School of Medicine at Mount Sinai joins NIH Stroke Trials Network

The Icahn School of Medicine at Mount Sinai joins a top-flight network of 25 regional stroke centers announced by the National Institute of Health that will focus on prevention, treatment, and recovery from stroke. As part of the NIH Stroke Trials Network (NIHStrokeNet), the medical school will receive a 5-year, $1.3 million grant to build a collaborative research infrastructure for a regional coordinating stroke center.

20 Dec 2013

Amgen reports that Phase 3 DESCARTES study for high cholesterol meets primary endpoint

Amgen today announced that the Phase 3 DESCARTES (Durable Effect of PCSK9 Antibody CompARed wiTh PlacEbo Study) study evaluating the long-term 52-week safety and efficacy of evolocumab for the treatment of high cholesterol met its primary endpoint of percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 52.

20 Dec 2013

FibroGen starts patient enrollment in FG-3019 Phase 2 study for idiopathic pulmonary fibrosis treatment

FibroGen, Inc., announced today that patient enrollment has started in a new Phase 2 clinical study of FG-3019 in patients who suffer from idiopathic pulmonary fibrosis.

20 Dec 2013

Researchers reveal how metabolic system breaks down in obesity

Researchers at University of Michigan have illuminated an aspect of how the metabolic system breaks down in obesity. The findings provide additional evidence that a drug entering clinical trials at the university could reverse obesity, Type 2 diabetes and fatty liver disease in humans.

20 Dec 2013

Study: Standard treatment approaches yield modest to large improvement in TMD patients

empromandibular pain disorders (TMDs) are characterized by a dysfunction of the TMD joint and cause orofacial pain, masticatory dysfunction or both.

20 Dec 2013

New research assesses nanomedicine-based approaches for treating cancer

As cancer maintains its standing as the second leading cause of death in the U.S., researchers have continued their quest for safer and more effective treatments. Among the most promising advances has been the rise of nanomedicine, the application of tiny materials and devices whose sizes are measured in the billionths of a meter to detect, diagnose and treat disease.

20 Dec 2013

BCG vaccine highly protective against pulmonary TB: Study

The BCG vaccine has been found to be more effective against the most common form of tuberculosis than previously thought, according to a new study in Clinical Infectious Diseases.

20 Dec 2013

Takeda to acquire exclusive license to develop Natrogen's Natura-alpha compound

Takeda Pharmaceutical Company Limited and Natrogen Therapeutics International, Inc. jointly announced today an agreement whereby Takeda will acquire an exclusive license to develop Natrogen's Natura-alpha compound as well as an option to acquire Natrogen. Natura-alpha is a synthetic small molecule oral compound that is believed to inhibit pro-inflammatory cytokine expression, which may help to reduce gastrointestinal inflammation. Natura-alpha is currently in Phase 2 development for the treatment of ulcerative colitis.

20 Dec 2013

BeiGene doses first patient in Phase 1 study of BGB-283

BeiGene (Beijing), Co., Ltd., today announced dose administration for the first patient in a Phase 1 study of BGB-283 in patients with B-RAF or K-RAS mutations. BGB-283 is an investigational, oral, selective, potent second generation inhibitor of B-RAF, making it a targeted therapeutic candidate to potentially treat and bring benefit to patients with cancers that harbor BRAF mutations and/or aberrations in the RAS-MAPK (mitogen-activated protein kinase) pathway.

20 Dec 2013

FDA approves Baxter's FEIBA for prophylactic treatment of hemophilia patients with inhibitors

Baxter International Inc. today announced that the United States Food and Drug Administration granted approval of Baxter's FEIBA [Anti-Inhibitor Coagulant Complex], the first and only FDA-approved treatment for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A or B who have developed inhibitors.

From Baxter International Inc. 20 Dec 2013

Australian Therapeutic Goods Administration approves Genzyme's Lemtrada for multiple sclerosis

Genzyme, a Sanofi company, announced today that the Australian Therapeutic Goods Administration has approved Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis for patients with active disease defined by clinical or imaging features to slow the accumulation of physical disability and reduce the frequency of clinical relapses.

19 Dec 2013

BioLineRx enrolls first patient in BL-7010 Phase 1/2 trial for treatment of celiac disease

BioLineRx, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today enrollment of the first patient in a Phase 1/2 trial of BL-7010, for the treatment of celiac disease. The first patient was enrolled at Tampere Hospital in Finland, a world-leading site for celiac disease research. Results are expected in mid-2014.

18 Dec 2013

Merck initiates clinical trial to evaluate MK-3475 and pazopanib in advanced renal cell carcinoma

Merck, known as MSD outside the United States and Canada, today announced the initiation of a clinical trial to evaluate the combination of the company's investigational anti-PD-1 immunotherapy, MK-3475, and GlaxoSmithKline's orally administered kinase inhibitor, pazopanib, in advanced renal cell carcinoma.

18 Dec 2013

Omeros' OMS721 receives FDA orphan drug designation for prevention of TMAs

Omeros Corporation today announced that OMS721, the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the key regulator of the lectin pathway of the immune system, has received orphan drug designation from the U.S. Food and Drug Administration for prevention of complement-mediated thrombotic microangiopathies.

18 Dec 2013

arGEN-X reports that Phase Ib cancer study with ARGX-110 antibody meets translational development goals

arGEN-X announces that the dose-escalation part of a Phase Ib study with its lead antibody ARGX-110 has met its translational development goals: all pre-specified biological activity measures (e.g. target engagement, effector functions, immune-modulation) were met.

17 Dec 2013

Scientists establish a goal of creating vaccine gene chip to speed up vaccine testing

Testing the efficacy of vaccines in clinical trials takes years, even decades. Yet challenging infections like HIV, malaria and dengue are striking today. To speed up vaccine testing, scientists at the Emory Vaccine Center have established a goal of creating a "vaccine gene chip."

17 Dec 2013

Scientists continue work to end chemotherapy pain

With this year's $600,000 grant from the Leukemia & Lymphoma Society and $1.5 million grant from the NIH, a Saint Louis University investigator is continuing her work to end chemotherapy pain. Noted pain researcher Daniela Salvemini, Ph.D., is using the funding to capitalize on her recent finding published in Pain, a breakthrough that helps scientists understand a molecular pathway by which pain occurs with certain anti-cancer drugs.

17 Dec 2013

Efficacy News and Research

CUMC researchers clarify three fundamental issues about Alzheimer's disease

Lilly, Boehringer Ingelheim announce FDA acceptance of NDA filing for new insulin glargine product

Orenitram Extended-Release Tablets get FDA approval for pulmonary arterial hypertension treatment

Icahn School of Medicine at Mount Sinai joins NIH Stroke Trials Network

Amgen reports that Phase 3 DESCARTES study for high cholesterol meets primary endpoint

FibroGen starts patient enrollment in FG-3019 Phase 2 study for idiopathic pulmonary fibrosis treatment

Researchers reveal how metabolic system breaks down in obesity

Study: Standard treatment approaches yield modest to large improvement in TMD patients

New research assesses nanomedicine-based approaches for treating cancer

BCG vaccine highly protective against pulmonary TB: Study

Takeda to acquire exclusive license to develop Natrogen's Natura-alpha compound

BeiGene doses first patient in Phase 1 study of BGB-283

FDA approves Baxter's FEIBA for prophylactic treatment of hemophilia patients with inhibitors

Australian Therapeutic Goods Administration approves Genzyme's Lemtrada for multiple sclerosis

BioLineRx enrolls first patient in BL-7010 Phase 1/2 trial for treatment of celiac disease

Merck initiates clinical trial to evaluate MK-3475 and pazopanib in advanced renal cell carcinoma

Omeros' OMS721 receives FDA orphan drug designation for prevention of TMAs

arGEN-X reports that Phase Ib cancer study with ARGX-110 antibody meets translational development goals

Scientists establish a goal of creating vaccine gene chip to speed up vaccine testing

Scientists continue work to end chemotherapy pain

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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