FDA Continues Review of Controversial DMD Treatment

By May 26, 2016

Sarepta announced that the Food and Drug Administration (FDA) is continuing the pending New Drug Application (NDA) review for eteplirsen for the treatment of Duchenne muscular dystrophy (DMD).

FDA Approves First-of-its-Kind Implant to Help Combat Opioid Dependence

By May 26, 2016

The FDA has approved Probuphine, the first buphrenorphine implant for the maintenance treatment of opioid dependence.

Medical Groups Call for Highest Possible Funding to Combat Zika

By May 26, 2016

A collection of some of the most prominent medical groups have written a letter calling for Congress to pass legislation to provide the highest possible funding level for research, prevention, control and treatment of the Zika virus.

Filgotinib Achieves Clinical Remission in Crohn's Disease Study

By May 26, 2016

Galapagos announced positive study data from the Phase 2 trial, FITZROY, evaluating filgotinib for the treatment of Crohn's Disease. Detailed results were presented at Digestive Disease Week 2016 in San Diego, CA.

FDA Committee Votes in Favor of IDegLira

May 26, 2016

Novo Nordisk announced that the Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted in favor (16-0) for the safety and efficacy of IDegLira in treating of adults with type 2 diabetes.

Air Pollution Linked to Higher CVD Risk

May 26, 2016

Three months of exposure associated with higher cholesterol levels, especially for those with diabetes

Glioblastoma Immune Genes Identified in New Study

May 26, 2016

Researchers have identified immune genes that may affect mortality in patients with glioblastoma multiforme, according to a study published online in Neurology.

Positive Results for Potential Bacterial Vaginosis Treatment Announced

By May 26, 2016

Symbiomix announced positive results from the second pivotal Phase 3 trial of SYM-1219 (secnidazole) for the treatment of bacterial vaginosis (BV).

Study Shows Promise For New Therapy to Treat Severe Hemophilia

May 26, 2016

Two new studies could pave the way to major changes in how severe cases of hemophilia are treated. Both studies were published in the New England Journal of Medicine.

Maternal β-Cells Expansion Tied to Prolactin Receptor Signaling

May 26, 2016

Prolactin receptor (PRLR) signaling plays a role in expansion of maternal β-cells during pregnancy, according to a study published online in Diabetes.

Smoking Marijuana During Pregnancy Ups Odds of Preterm Birth

May 26, 2016

Mothers who smoke marijuana in pregnancy more than five times likelier to suffer a preterm birth

Ocular Complications ID'd in Infants with Zika-Related Microcephaly

May 26, 2016

Finding adds to growing understanding of damage virus causes in these infants, researchers say

Prenatal Smoking May Up Schizophrenia Risk in Offspring

By May 26, 2016

In the most definitive study to date, cigarette smoking during pregnancy was linked to a greater likelihood of schizophrenia in offspring. Those are the findings of a new long-term study which assessed maternal nicotine exposure (via cotinine levels) during pregnancy.

Teledermatology May Improve Access to Dermatology Care

May 26, 2016

The study compared rates of dermatology visits for patients affiliated with primary care practices that referred patients to teledermatology and those that did not.

Investigational Tx Granted Orphan Drug Status for Spinocerebellar Ataxia

By May 25, 2016

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Biohaven's investigational agent BHV-4157 for the treatment of Spinocerebellar Ataxia (SCA).

FDA Grants Antifungal Orphan Drug Status for Valley Fever

By May 25, 2016

The Food and Drug Administration (FDA) has granted Orphan Drug designation to VT-1598 (Viamet) for the treatment of coccidioidomycosis or Valley Fever, a common lung infection in the southwestern US.

Clear Liquids Only Before Colonoscopy? Study Says Maybe Not

May 25, 2016

Low-residue diet leads to improved bowel prep, more rested patients

Four Lifestyle Changes Linked to Reduced Cancer Death

May 25, 2016

Four key lifestyle factors include weight, exercise, no smoking, and limiting alcohol

Colorectal Cancer Increasing Among Under 50s in the U.S.

May 25, 2016

Although overall colorectal cancer (CRC) rates are declining, the rates among Americans under 50 have increased in the past decade, according to a study presented at the annual Digestive Disease Week, held in San Diego.

Study Finds Atherosclerosis Is Not Linked to Telomere Length

May 25, 2016

Average leucocyte telomere length (LTL) and the abundance of short telomeres (percent LTL <3 kb) are not significant independent determinants of subclinical atherosclerosis, according to a study published in the Journal of the American College of Cardiology.

Forecast Model for Chemotherapy Toxicity Validated

May 25, 2016

A predictive model for chemotherapy toxicity has been validated for older patients with solid tumors, according to a study published online in the Journal of Clinical Oncology.

Ruling Out PE in Primary Care: Wells Rule vs. 'Gestalt'

May 25, 2016

Wells rule is more efficient and pulmonary embolism can be ruled out in larger proportion of cases

Fecal Transplant May Help Patients with Treatment-Resistant Ulcerative Colitis

May 25, 2016

Fecal microbiota transplantation found to improve symptoms in treatment-resistant patients

A Therapeutic Option for Treatment-Resistant Alopecia Universalis

May 25, 2016

Significant effects for some AU patients who are resistant to other treatments

Labeling for Anaphylaxis Txs Updated to Include Injury, Infection Information

By May 25, 2016

The labeling for several epinephrine injection products has been updated to include information regarding injection-related injury and serious infections at the injection site.

Novel Ingestible Balloon Shows Promise in Curbing Obesity

May 25, 2016

A new ingestible and inflatable balloon system, Obalon, shows promise as a noninvasive way to curb appetite and assist weight loss efforts, according to research presented at the annual Digestive Disease Week, held in San Diego.

Alzheimer's Patients Show Higher Loss of Y Chromosome, Possible Risk Predictor

May 25, 2016

Men who experience the loss of chromosome Y (LOY) from their blood cells as they age may have an increased risk of developing Alzheimer's disease, according to a study published online in the American Journal of Human Genetics.

Treatment Significantly Improves Symptoms in Severe RLS

By May 24, 2016

For patients with severe restless legs syndrome (RLS), gabapentin enacarbil (GEn) was shown to significantly improve RLS symptoms and the consequences of these symptoms.

First Clinical Guidelines to Recommend Surgery as Diabetes Treatment

By May 24, 2016

A consensus statement endorsed by numerous international organizations is calling for metabolic surgery to be recognized as a treatment option for certain patients with diabetes, including those who are mildly obese and fail to respond to conventional treatment.

Maintenance Treatment with Stelara Evaluated in Crohn's Disease Study

By May 24, 2016

Janssen announced new data from the Phase 3 study, IM-UNITI, showing that a significantly greater proportion of adult patients with moderate to severe Crohn's disease receiving maintenance treatment of Stelara (ustekinumab) achieved clinical remission at one year. Study findings were presented for the first time at Digestive Disease Week 2016.

Flucelvax Quadrivalent Gets FDA Approval

By May 24, 2016

The Food and Drug Administration (FDA) has approved Flucelvax Quadrivalent, the first four-strain (two influenza A strains + two influenza B strains), cell-culture-derived, inactivated seasonal influenza vaccine for patients 4 years of age and older. Cell-culture technology utilizes a well-characterized mammalian cell line rather than chicken eggs to grow virus strains.

Invokamet Approved as First-Line Diabetes Treatment

By May 24, 2016

Invokamet (canagliflozin/metformin HCl) has been approved for the first-line treatment of adults with type 2 diabetes.

Antidepressants Rxs Up for Non-Depressive Uses, Study Suggests

By May 24, 2016

A long-term study of two major urban centers in Quebec, Canada, found that almost half of all antidepressant prescriptions were written for non-depressive indications.

FDA to Review Topical Rosacea Treatment

By May 24, 2016

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for oxymetazoline HCl cream 1% (Allergan) for the treatment of persistent facial erythema associated with rosacea in adults.

Popular Wearable Heart Monitors May Be 'Highly Inaccurate'

May 24, 2016

But Fitbit manufacturer challenges the study results

Critical Fertility Information Lacking For Women Battling Cancer

May 24, 2016

Many young female cancer survivors say they don't receive enough information about preserving their fertility, according to a study published online in Cancer.

Heart Failure Guidelines Updated with Two New Drugs

By May 23, 2016

The American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Failure Society of America updated their heart failure guidelines to include an angiotensin receptor-neprilysin inhibitor (ARNI) (sacubitril/valsartan [Entresto]), and a sinoatrial node modulator (ivabradine [Corlanor]) to the list of treatment options.

Positive Phase 3 Results for Chronic Idiopathic Constipation Drug

By May 23, 2016

Synergy announced additional clinical data from two Phase 3 trials, Study-00 and Study-03, evaluating the efficacy and safety of plecanatide for the treatment of chronic idiopathic constipation (CIC). Study findings were presented at Digestive Disease Week (DDW) in San Diego.

After Dual T2DM Therapy Failure, GLP-1 Receptor Agonist or Insulin?

By May 23, 2016

Compared with insulin, the use of GLP-1 receptor agonist appears to be linked to reduced cardiovascular events and mortality in T2DM patients requiring treatment intensification after failure with oral dual therapy.

Latuda Efficacy, Safety Assessed in Long-Term Bipolar Disorder Study

By May 23, 2016

Sunovion announced positive results from an extension study evaluating the long-term safety, tolerability and efficacy of Latuda (lurasidone HCI) as monotherapy or as an adjunct to lithium or valproate in adults with major depressive episodes associated with bipolar I disorder. Study findings were published in the journal Depression and Anxiety.

Are Potatoes Contributing to a Public Health Problem?

By May 23, 2016

Consuming ≥4 servings of baked, boiled, mashed potatoes or French fries, a week, compared to <1 serving of these foods a month, was associated with an increased adjusted risk of developing hypertension.

Prescription Data Showing New Trend for Opioid Prescribing

May 23, 2016

In a sign that the opioid epidemic might be waning, new data show that the number of opioid prescriptions has dropped for the first time in 20 years.

Researchers Find Urine Metabolomics May Act as Asthma Identifier

May 23, 2016

Increased urine metabolomic lipid metabolites are associated with clinical parameters in non-obese asthma patients, according to a study published online May 18 in Allergy.

Patients With Previous Nonmelanoma Skin Cancer Need to Seek Shade, Avoid Sun More

May 23, 2016

Individuals with previous nonmelanoma skin cancer (NMSC) are more likely to engage in certain sun protection behaviors than those without previous NMSC, according to a study published online in the Journal of the American Academy of Dermatology.

Controversial Study Finds Low-Salt Diet May Up Cardiovascular Risk

May 23, 2016

Restricting dietary salt to below 3,000mg a day appears to increase the risk for cardiovascular disease similar to that of hypertension patients who eat too much salt, according to research published online in The Lancet.

FDgard Available For the Dietary Management of Functional Dyspepsia

By May 23, 2016

FDgard is a medical food for the dietary management of functional dyspepsia.

Rise in Zika Infected Pregnancies Attributed to More Comprehensive Counting

May 23, 2016

The number of pregnant women in the United States infected with the Zika virus has just tripled because cases are now being counted in a more comprehensive way, federal health officials said Friday.

Time to Reperfusion Vital to Improved Acute Stroke Outcomes

May 23, 2016

Among patients with acute stroke treated with stent retrievers, fast reperfusion leads to improved functional outcome, according to a study published in the June issue of Radiology.

Nutrition Facts Label Gets a Much Needed Update

By May 20, 2016

The Food and Drug Administration today announced new updates to the nutritional facts label to appear on most packaged foods sold across the U.S.

Long-Term Survival Benefit Seen with Pembrolizumab in Melanoma

May 20, 2016

Three-year overall survival rate of 40 percent; median overall survival of 24.4 months

Treating Cellulitis: Does Obesity Up Cephalexin Failure Rate?

By May 20, 2016

Morbidly obese patients with cellulitis have the same rates of treatment failure with cephalexin as non-obese patients. Those are the findings of a new retrospective study of patients hospitalized or in inpatient observation from January 2005 through February 2015, at the Mayo Clinic Hospital-Rochester, Minnesota.

Sublingual Cyclobenzaprine Shows Promise in PTSD Study

By May 20, 2016

Tonix Pharmaceuticals announced topline results from the Phase 2 AtEase Study, evaluating TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of military-related Post-Traumatic Stress Disorder (PTSD).

CDC: Dirty Pools Pose Serious Health Risks

May 20, 2016

Serious health and safety violations force the closure of thousands of public pools, hot tubs, and water playgrounds every year, according to research published in the U.S. Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report.

Number of Visually Impaired Americans Expected to Double by 2050

May 20, 2016

As baby boomers age, the number of Americans with visual impairment and blindness is expected to double over the next 3 decades, according to a study published online in JAMA Ophthalmology.

Aspirin Immediately After TIA May Cut Major Stroke Risk

May 20, 2016

Taking aspirin immediately after a transient ischemic attack (TIA) significantly reduces the risk of a major stroke, according to research published online in The Lancet.

KATP Channel May Be Inhibited by Sulfonylureas; Increasing Stroke Risk

May 20, 2016

Treatment with sulfonylureas (ATP-sensitive potassium [KATP] channel blockers) may inhibit the neuroprotective effects of KATP channel activation and increase the risk of stroke, according to an experimental study published online in Diabetes.

Company Discontinues Development of Plumiaz Nasal Spray

By May 20, 2016

Acorda Therapeutics announced that it will discontinue development of Plumiaz (diazepam) Nasal Spray, a therapy under investigation for the treatment of seizure clusters in patients with epilepsy.

Side of Colon Tumor Development Can Impact Survival Length in CRC

May 20, 2016

Survival odds for colorectal cancer may depend on which side of the colon the primary tumor develops, according to a study released Wednesday during a media briefing that previewed some of the research to be presented at the upcoming annual meeting of the American Society of Clinical Oncology.

Blood Test Results For Tens of Thousands of Patients Voided by Theranos

By May 19, 2016

Theranos, the life sciences company that claimed their blood testing device was revolutionary, have corrected, voided and revised tens of thousands of blood test results issued in 2014 and 2015, according to the Wall Street Journal.

Unapproved Use of Antifungal Linked to Patient Death

By May 19, 2016

The labeling had been updated back in 2013 to remove certain indications but the drug continues to be prescribed for these conditions.

The Gluten-Free Diet: Separating Fact from Fiction

By May 19, 2016

A new commentary published in the Journal of Pediatrics calls for healthcare providers to play a greater role in educating non-celiac disease patients on the consequences of converting to a gluten-free diet (GFD).

Many Unaware of HCV Status and the Dangers of Drink

By May 19, 2016

A new study has tied former and current excessive alcohol drinking to a higher prevalence of chronic hepatitis C (HCV) infection. With an estimated 50% of those HCV-infected unaware of their infection, the link to alcohol has led researchers to call for greater testing and public health interventions.

Mirvaso Gel Available in New Pump Delivery System

By May 19, 2016

Mirvaso (brimonidine; Galderma) Topical Gel 0.33% is now available in a pump dispenser.

Impaired Insulin Sensitivity Tied to Worse Outcomes in GDM

May 19, 2016

Among women with gestational diabetes mellitus (GDM), impaired insulin sensitivity, but not insulin secretion defects, is associated with a greater risk of adverse outcomes compared with normal glucose tolerance (NGT), according to a study published online May 13 in Diabetes Care.

FDA Grants Vyxeos Breakthrough Therapy Status for AML

By May 19, 2016

Celator announced that the FDA has granted Breakthrough Therapy designation to Vyxeos (CPX-351) for the treatment of adults with therapy-related acute myelogenous leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

Pregabalin Demonstrates Efficacy in Restless Legs Syndrome

By May 19, 2016

Pregabalin may help improve symptoms of restless legs syndrome (RLS) and decrease sleep disturbances, according to a recent study in Annals of Pharmacotherapy.

Researchers ID Gene Associated With Reduced Non-HDL Cholesterol Levels

May 19, 2016

ASGR1 mutation carriers have reduced levels of non-high-density lipoprotein cholesterol (HDL-C) and reduced risk of coronary artery disease.

Many HIV-1 Symptoms Go Unobserved During Acute Infection

May 19, 2016

Few symptoms and signs are observed during acute HIV-1 infection, and these are most common before peak viremia, according to a study published online May 18 in the New England Journal of Medicine.

Large Discrepancies in Surrogates and Physician's Prognosis of Critically Ill

May 19, 2016

In more than half of recently studied cases, doctors and family members acting on behalf of critically ill patients disagreed about whether the patient would die or not.

Tiotropium-to-Anoro Ellipta Switch Studied in COPD Trial

By May 18, 2016

GlaxoSmithKline and Innovia announced new data at the ATS 2016 International Conference regarding the safety and efficacy of Anoro Ellipta (umeclidinium/vilanterol) in patients with moderate chronic obstructive pulmonary disease (COPD) who continued to have symptoms while on tiotropium monotherapy.

Does Pregabalin Use During Pregnancy Up Birth Defect Risk?

By May 18, 2016

Pregabalin, a drug often used for anxiety, pain, and other neurologic disorders, may be linked to a higher risk of major birth defects, researchers reported in a Neurology study.

FDA Approves First PD-L1 Inhibitor for Urothelial Carcinoma

By May 18, 2016

Genentech announced that the FDA has granted accelerated approval of Tecentriq (atezolizumab) for the treatment patients with locally advanced or metastatic urothelilal carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before or after surgery.

FDA: Trial Shows Increased Amputation Risk with Diabetes Drug

By May 18, 2016

Patients should alert clinicians if they experience any new pain, tenderness, sore, ulcers, or infections in their feet or legs.

Novel Gene Tx Fast Tracked for ALS

By May 18, 2016

The FDA has granted Fast Track designation for the investigational drug, VM202 (VM BioPharma/ViroMed), for the potential treatment of Amyotrophic Lateral Sclerosis (ALS).

Melatonin Shown to Stabilize BP, HR in Elderly

By May 18, 2016

According to a study published in Current Aging Science, melatonin may be a useful adjuvant medication to stabilize circadian rhythms and blood pressure in elderly patients.

Gabapentin Enacarbil May Improve Quality of Life in RLS

By May 18, 2016

A recent study published in CNS Drugs concluded that gabapentin enacarbil (GEn) taken once daily significantly improved quality of life in adults with moderate-to-severe primary restless legs syndrome (RLS) across all study time points.

Hydroxyurea May Improve Lung Function in Children With Sickle Cell Disease

By May 18, 2016

Children with sickle cell disease had improved lung function after treatment with hydroxyurea, according to a study presented at the American Thoracic Society (ATS) 2016 International Conference.

Significant Discrepancies in Cancer Treatment For HIV-Infected Patients

May 18, 2016

While powerful HIV medications are allowing patients to live longer, these same patients are less likely to get treatment for cancer if it develops, according to a study published online on Cancer.

No Benefit Found at 2 Years For High-Dose rhEPO in Preterm Infants

May 18, 2016

Prophylactic early high-dose recombinant human erythropoietin (rhEPO) given intravenously to very preterm infants does not improve neurodevelopmental outcomes at 2 years corrected age, according to a study published in the Journal of the American Medical Association.

Can Different Narrow Spectrums of Light Ease Migraine Symptoms?

May 18, 2016

A treatment involving a narrow spectrum of low-intensity green light may help ease migraine pain, according to a study published online in Brain.

Tai Chi Benefits Comparable to Physical Therapy in Knee Osteoarthritis

May 18, 2016

For knee osteoarthritis, similar benefits are seen for Tai Chi and standard physical therapy, according to a study published online May 17 in the Annals of Internal Medicine.

FDA Expands Opdivo Use for Hodgkin Lymphoma

By May 17, 2016

The FDA granted accelerated approval for Opdivo (nivolumab; Bristol-Myers Squibb) for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation Adcetris (brentuximab vedotin; Seattle Genetics).

Study Reveals Benzodiazepines Frequently Prescribed to High-Risk Patients

By May 17, 2016

A study published in the Journal of General Internal Medicine found that standard and high-dose benzodiazepines were prescribed more often to patients at higher risk for benzodiazepine-related adverse events.

Docs More Likely to Use Hospice, ICU/CCU at End of Life

By May 17, 2016

U.S. physicians were more likely to use hospice and intensive or critical care units at end of life compared to non-physicians, a new study in the Journal of the American Geriatrics Society has shown.

Wine, Beer, or Spirits: Which Reduces T2DM Risk the Most?

May 17, 2016

Compared with beer and spirits, wine is linked to more significantly decreased risk of T2DM

Risk Factors for Bisphosphonate-Associated Fractures, Osteonecrosis ID'd

By May 17, 2016

Use of bisphosphonates is associated with adverse drug reactions such as atypical femoral fractures (AFs) and osteonecrosis of the jaw (ONJ).

FDA Designates Selumetinib Orphan Drug for Differentiated Thyroid CA

By May 17, 2016

AstraZeneca announced that the FDA has granted Orphan Drug designation to selumetinib for the adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC).

OTC Anti-Radiation Drug Gets FDA Approval

By May 17, 2016

Mission Pharmacal announced that the Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for over-the-counter liquid Potassium Iodide Oral Solution for use in the event of a nuclear emergency.

Positive Results Seen with NeuroStar TMS for Postpartum Depression

By May 17, 2016

NeuroStar TMS Therapy, a non-pharmacologic treatment, demonstrated positive results for women with postpartum depression.

Novel Asthma Biologic Demonstrates Efficacy in Two Phase 3 Studies

By May 17, 2016

AstraZeneca announced that two pivotal Phase 3 registrational trials for benralizumab achieved their primary endpoint, demonstrating significant reductions in the annual asthma exacerbation rate compared to placebo.

Dose, Duration Impact Mortality in New Antipsychotic Users

May 17, 2016

Lower mortality risk for modified standardized daily dose of 1 or less versus greater than 1

High BP + ADHD: Is It More than a Hyperactivity Disorder?

By May 17, 2016

Pediatric patients could possibly be misdiagnosed with ADHD when in fact they have rare tumors, as many of the symptoms of pheochromocytomas and paragangliomas (PHEO/PGL) overlap with symptoms of ADHD.

Magic Mushroom Compound Investigated in Treatment-Resistant Depression

By May 17, 2016

Results from a recent study published in The Lancet Psychiatry demonstrates preliminary support for the safety and efficacy of the hallucinogenic compound, psilocybin, for the management of treatment-resistant depression.

Study Examines Effects of Hyperthermia on Reducing Depression Symptoms

May 17, 2016

Whole-body hyperthermia (WBH) may ease depression symptoms for up to six weeks, according to a study published online in JAMA Psychiatry to coincide with the annual meeting of the Society of Biological Psychiatry, held in Atlanta.

Physical Activity Linked to Total Cancer Risk Reduction of 7%

May 17, 2016

Exercise may significantly reduce risk for many types of cancer, according to a large review published online May 16 in JAMA Internal Medicine.

Tight Blood Pressure Control Improves HTN in Elderly Patients

May 17, 2016

Latest findings from national trial show it lowers chances of heart failure, even in older adults

Study Suggests Antipsychotic Agents May Up MI Risk

By May 16, 2016

Patients taking antipsychotic agents may be at an increased risk of myocardial infarction, based on a review of nine observational studies.

Onzetra Xsail Now Available for Migraine Treatment

May 16, 2016

Avanir announced that Onzetra Xsail (sumatriptan nasal powder) is now available to treat acute migraines with or without aura in adults.

Can Omega-3 Help Lower Childhood Aggression?

By May 16, 2016

Previous studies have suggested that nutritional supplementation may lower aggressive behavior in children.

Real-World Data Shows Improved Glucose Control with Invokana

May 16, 2016

Once-daily Invokana (canagliflozin; Janssen) was associated with significant improvements in blood glucose control (A1c) in adults with type 2 diabetes even though most patients were already being treated with other antidiabetic agents, including insulin, according to three data analyses.