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A gastroenterologist guide to probiotics

In recent years, scientists have introduced us to a paradigm shift in the microscopic world. We've moved from thinking about all bacteria as bad guys to be wiped out with antibiotics and hand sanitizer to recognizing that some microbes are helpers, good bacteria that live in our GI tract (and all over our bodies) that keep us healthy.

11 Jun 2015

UC San Diego researchers launch clinical trial to evaluate safety, efficacy of suramin drug for autism

Researchers at the University of California, San Diego School of Medicine have launched a clinical trial to investigate the safety and efficacy of an unprecedented drug therapy for autism.

11 Jun 2015

Amgen to discuss data supporting Repatha BLA for high cholesterol treatment with FDA EMDAC

Amgen today announced that the Company will discuss the data supporting the Repatha (evolocumab) Biologics License Application (BLA) for the treatment of high cholesterol with the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC).

10 Jun 2015

LEO Pharma reports encouraging data from PSO-FAST clinical trial of Enstilar for psoriasis treatment

LEO Pharma A/S today announced that new data being presented at the 23rd World Congress of Dermatology shows aerosol foam Enstilar® (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g), the Company's dual-action investigational aerosol foam for the treatment of psoriasis vulgaris, provided rapid itch relief and improvements in itch-related sleep loss for patients suffering from psoriasis.

10 Jun 2015

Catalan researchers first to use liposomes to fight against diabetes

For the first time liposomes that imitate cells in the process of natural death have been used to treat Diabetes. Researchers at Germans Trias Research Institute (at UAB-Campus of International Excellence Sphere) generated liposomes in collaboration with professionals from the ICN2. PLOS ONE Journal publishes the work.

10 Jun 2015

FDA agrees to Oncogenex' proposed amendment to Phase 3 AFFINITY protocol

OncoGenex Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has agreed to the Company's proposed amendment to the Phase 3 AFFINITY protocol and statistical analysis plan.

10 Jun 2015

Single dose of Cervarix vaccine effective in preventing HPV infections

A single dose of the human papillomavirus (HPV) vaccine Cervarix appears to be as effective in preventing certain HPV infections as three doses, the currently recommended course of vaccination.

10 Jun 2015

Phase 2 study of AR101 meets primary endpoint in patients with peanut allergy

Aimmune Therapeutics, Inc., a privately held biopharmaceutical company developing desensitization treatments for food allergies, announced today that a Phase 2 study (ARC001) evaluating the company's lead investigational product, AR101 for the treatment of peanut allergy, met its primary endpoint and additional endpoint of desensitizing patients to cumulative amounts of peanut protein of 443 mg and 1,043 mg, respectively.

10 Jun 2015

Weekly sessions of non-invasive brain stimulation improve outcomes in patients with post-stroke pain

Weekly sessions of non-invasive repetitive transcranial magnetic stimulation provided sufficient long-term pain relief in 61 percent of patients with central post-stroke pain, and delivered long-term relief for patients who continued for one year, according to a study presented at the International Neuromodulation Society 12th World Congress by Masahito Kobayashi, MD, PhD, of the Department of Neurosurgery, Saitama Medical University - Department of Neurology, Institute of Brain and Blood Vessels, Mihara Memorial Hospital in Saitama, Japan.

10 Jun 2015

Time for a switch for patients with rheumatoid arthritis and ankylosing spondylitis

The comparable safety and efficacy of switching patients to a biosimilar anti-TNF-α monoclonal antibody from the reference medicinal product (RMP) has been further established in data presented at EULAR 2015, the annual meeting of the European League Against Rheumatism.

10 Jun 2015

FDA's Advisory Committee recommends approval of Praluent (alirocumab) Injection

Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration recommended the approval of the investigational therapy Praluent (alirocumab) Injection.

9 Jun 2015

Stemedica receives FDA's IND approval for itMSC Phase IIa clinical trial to treat Alzheimer's disease

Stemedica Cell Technologies, Inc. received the FDA's investigational new drug (IND) approval for a United States-based, Phase IIa clinical study using its allogeneic stem-cell therapy to treat subjects with mild to moderate dementia due to Alzheimer's disease (AD), the sixth leading cause of death in the United States.

9 Jun 2015

Jazz enrolls first patients in JZP-110 Phase 3 study for treatment of EDS in patients with narcolepsy or OSA

Jazz Pharmaceuticals plc announced today that the first patients have been enrolled in a Phase 3 clinical development program evaluating the safety and efficacy of its investigational drug candidate, JZP-110, as a wake-promoting agent in the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy or with obstructive sleep apnea (OSA).

8 Jun 2015

Results from Intarcia's two phase 3 clinical trials of ITCA 650 to be presented at ADA's Scientific Session

Intarcia Therapeutics, Inc. today announced the presentation of results from its first two phase 3 clinical trials (FREEDOM-1 and FREEDOM-1 HBL) of its late-stage investigational candidate ITCA 650 (exenatide delivered continuously via a small matchstick-size subcutaneous osmotic mini-pump just once or twice yearly) at the 75th Scientific Sessions of the American Diabetes Association.

8 Jun 2015

Celtaxsys closes $40M Series D financing and receives $5M CFFT grant to conduct CTX-4430 Phase 2 trial

Celtaxsys, Inc., a clinical stage drug development company focused on developing novel therapies for inflammatory diseases, today announced the successful completion of a $40M Series D financing led by Domain Partners VIII. Additional investors in the financing include Lumira Capital, RMI Partners, Masters Capital Management and the Georgia Research Alliance Venture Fund.

8 Jun 2015

DalCor, MHI partner to conduct Phase III clinical trial of investigational cardiovascular drug

DalCor Pharmaceuticals and the Montreal Heart Institute announced today a collaboration in principle to conduct an international Phase III clinical trial which could result in a major clinical advance in cardiovascular personalised medicine.

8 Jun 2015

Braeburn reports positive topline results from Probuphine Phase 3 study for treatment of opioid addiction

Braeburn Pharmaceuticals, an Apple Tree Partners company, today reported positive topline results from the Phase 3 double-blind, double-dummy clinical study of Probuphine, the investigational subdermal implant containing buprenorphine HCl for the long-term maintenance treatment of opioid addiction.

8 Jun 2015

Nuvo obtains Health Canada approval to conduct WF10 Phase 2 trial for treatment of allergic rhinitis

Nuvo Research Inc., a specialty pharmaceutical company with a diverse portfolio of topical and immunology products, today announced it has received Health Canada approval to conduct a new Phase 2 clinical trial (the 2015 WF10 Trial) to assess WF10 for the treatment of allergic rhinitis.

8 Jun 2015

Non-invasive prenatal testing for Down's syndrome acceptable to parents

Non-invasive prenatal testing (NIPT) for Down's syndrome is feasible, acceptable to parents, and could be introduced into the National Health Service, UK researchers say. The results of a National Institute for Health Research study carried out by the first NHS laboratory to provide NIPT testing will be reported to the annual conference of the European Society of Human Genetics today (Saturday).

8 Jun 2015

Scientists identify new agent to combat tuberculosis

According to figures of the World Health Organization, some 8.7 million people contracted tuberculosis in 2012 and this disease is fatal for approximately 1.3 million people throughout the world each year. One of the main problems is that the tuberculosis pathogens have become resistant to the antibiotics used to fight them.

5 Jun 2015

Efficacy News and Research

A gastroenterologist guide to probiotics

UC San Diego researchers launch clinical trial to evaluate safety, efficacy of suramin drug for autism

Amgen to discuss data supporting Repatha BLA for high cholesterol treatment with FDA EMDAC

LEO Pharma reports encouraging data from PSO-FAST clinical trial of Enstilar for psoriasis treatment

Catalan researchers first to use liposomes to fight against diabetes

FDA agrees to Oncogenex' proposed amendment to Phase 3 AFFINITY protocol

Single dose of Cervarix vaccine effective in preventing HPV infections

Phase 2 study of AR101 meets primary endpoint in patients with peanut allergy

Weekly sessions of non-invasive brain stimulation improve outcomes in patients with post-stroke pain

Time for a switch for patients with rheumatoid arthritis and ankylosing spondylitis

FDA's Advisory Committee recommends approval of Praluent (alirocumab) Injection

Stemedica receives FDA's IND approval for itMSC Phase IIa clinical trial to treat Alzheimer's disease

Jazz enrolls first patients in JZP-110 Phase 3 study for treatment of EDS in patients with narcolepsy or OSA

Results from Intarcia's two phase 3 clinical trials of ITCA 650 to be presented at ADA's Scientific Session

Celtaxsys closes $40M Series D financing and receives $5M CFFT grant to conduct CTX-4430 Phase 2 trial

DalCor, MHI partner to conduct Phase III clinical trial of investigational cardiovascular drug

Braeburn reports positive topline results from Probuphine Phase 3 study for treatment of opioid addiction

Nuvo obtains Health Canada approval to conduct WF10 Phase 2 trial for treatment of allergic rhinitis

Non-invasive prenatal testing for Down's syndrome acceptable to parents

Scientists identify new agent to combat tuberculosis

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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