New Data on First-in-Class Schizophrenia Drug Announced

By September 29, 2016

Intra-Cellular Therapies have announced inconclusive results from the second Phase 3 trial of ITI-007 (Study '302), a first-in-class investigational medicine for the treatment of schizophrenia.

For Some Older Adults, Anticholinergics May Provide Cognitive Benefits

By September 29, 2016

Older adults with questionable cognitive impairment exposed to anticholinergics demonstrated higher global cognitive scores compared to those not exposed to anticholinergics, according to a study published in Drugs & Aging.

FDA Approval Expands Orkambi Use in Pediatric Patients with Cystic Fibrosis

By September 29, 2016

Vertex announced that the Food and Drug Administration (FDA) has approved Orkambi (lumacaftor and ivacaftor) tablets for use in children with cystic fibrosis aged 6-11 years who have 2 copies of the F508del mutation.

Pregabalin for Generalized Anxiety Disorder: Is it Effective?

By September 29, 2016

A systematic review and meta-analysis published in the journal International Clinical Psychopharmacology found that pregabalin was superior to placebo for the amelioration of generalized anxiety disorder (GAD) symptoms.

Erenumab Reduces Monthly Migraine Days in Phase 3 Study

September 29, 2016

Amgen announced positive top-line results from their Phase 3 trial ARISE, evaluating erenumab (AMG 334) for safety and efficacy in preventing migraines.

Blood-Based Companion Diagnostic Test for Osimertinib Approved

By September 29, 2016

AstraZeneca announced that the Food and Drug Administration (FDA) has approved cobas EGFR Mutation Test v2, a companion diagnostic for Tagrisso (osimertinib).

Pediatric Migraine Drug Now Available

By September 29, 2016

Pernix Therapeutics announced the availability of Treximet (sumatriptan and naproxen sodium) 10mg/60mg.

Clobazam Tolerance Potential 'Overstated' in Lennox-Gastaut, Study Suggests

By September 29, 2016

A study published in Neurology found that the majority of patients with Lennox-Gastaut syndrome do not develop tolerance to the antiseizure effects of clobazam (Onfi).

Lubiprostone Significantly Improves Abdominal Pain, Bloating in IBS-C

By September 29, 2016

Lubiprostone was significantly more effective in improving abdominal pain or bloating than placebo, according to results from a post-hoc analysis published in Alimentary Pharmacology and Therapeutics.

N-acetylcysteine Explored as Adjunct Therapy in Schizophrenia

By September 29, 2016

Researchers from the St. Louis University School of Medicine report that adjunctive N-acetylcysteine (NAC) may be effective in reducing negative and general symptoms in schizophrenia.

Do Hormonal Contraceptives Increase Depression Risk?

September 29, 2016

Study also ties hormonal patches, IUDs to greater antidepressant use, especially in teens

Cannabis Use and Psychosis Relapse: What's the Link?

September 29, 2016

But researchers note effect is small, and the research isn't definitive

Systolic BP Variability Linked to Increased Risk of Death, Morbidity

September 29, 2016

Increased SBP variability tied to mortality, coronary heart disease, stroke, end-stage renal disease

Reasons for Inappropriate Antibiotic Prescribing Explored in Elderly

September 29, 2016

Constitutional symptoms, including mentation, often lead to diagnostic testing and potentially inappropriate antibiotic prescribing in older patients suspected of having a urinary tract infection (UTI) or pneumonia, according to a study published online in the Journal of the American Geriatrics Society.

Neonatal Herpes Simplex Drug Designated Orphan Drug

By September 29, 2016

Neonatal herpes simplex, a life-threatening infection, often produces severe long-term sequelae in the newborn.

Adding External Beam Radiation Therapy to Brachytherapy: Is It Beneficial?

September 29, 2016

Among men with intermediate-risk prostate cancer, the addition of external beam therapy (EBT) to transperineal interstitial permanent brachytherapy (B) does not improve five-year progression-free survival.

Intensity-Modulated Radiation Therapy Tied to Reduced Toxicity in Certain Cancers

September 29, 2016

For women with cervical and endometrial cancer, treatment with intensity-modulated radiation therapy (IMRT) is associated with reduced toxicity.

Low Tx Adherence in Psoriasis Represents a Challenge to Dermatologists

September 29, 2016

For patients with mild-to-moderate psoriasis, adherence to topical treatment is low, but an internet-based reporting intervention can improve adherence.

Review Examines C-Sections and Related Risks of Postpartum VTE

September 29, 2016

Cesarean section (CS) is associated with increased risk of postpartum venous thromboembolism (VTE).

FDA Approves First-of-its-Kind Insulin Delivery Device for Type 1 Diabetes

By September 28, 2016

The MiniMed 670G hybrid closed looped system, referred to as an "artificial pancreas" adjusts insulin levels with little or no interaction from the user.

Novel Continuous Glucose Monitoring System Approved for Clinician Use

By September 28, 2016

The new CGM system provides healthcare professionals with a patient's ambulatory glucose profile (AGP), showing a clearer overview of glucose levels, patterns, and trends.

Antidepressant Efficacy Evaluated in Pediatric Abdominal Pain

By September 28, 2016

The review included children aged 5-21 years with functional abdominal pain treated with SSRI or TCA.

Trends Study Shows Dramatic Changes in Diabetes Drug Use

September 28, 2016

Increase in metformin, DPP-4 inhibitors, insulin use; decrease in sulfonylureas and thiazolidinediones

LARC Acceptability Assessed in Women Seeking Short-Acting Contraception

September 28, 2016

High continuation rates, even among women presenting to initiate short-acting contraception

USPSTF: Preeclampsia Screening with BP Measurements Throughout Pregnancy Beneficial

September 28, 2016

Substantial net benefit for preeclampsia screening with BP measurements throughout pregnancy

Multiple Methods Effective for Lowering LDL, Study Finds

September 28, 2016

Treatments other than statins also can effectively reduce cardiovascular risk, according to a review and meta-analysis published in the Journal of the American Medical Association.

Dupilumab Granted Priority Review for Atopic Dermatitis

By September 27, 2016

Regeneron and Sanofi announced that the Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for dupilumab for the treatment of adults with inadequately controlled moderate-to-severe atopic dermatitis (AD).

Phase 3 Study Initiated for Patient-Controlled Analgesia System Zalviso

By September 27, 2016

AcelRx has announced the initiation of the Phase 3 IAP312 study of Zalviso (sufentanil sublingual tablet system), an investigational treatment for the management of moderate-to-severe acute pain in adult patients.

Impact of Insomnia-Specific Therapy on Daytime Functioning

By September 27, 2016

Insomnia-specific treatment proved effective at improving daytime and psychological functioning in the short-term, and maintenance therapy added further value to optimizing long-term outcomes, according to a study published in Behaviour Research and Therapy.

NDA Submitted for Spinal Muscular Atrophy Treatment

By September 27, 2016

Biogen and Ionis have completed the rolling submission of a New Drug Application (NDA) to the FDA for the approval of nusinersen, an invesigational treatment for spinal muscular atrophy (SMA), for which there is currently no approved treatment.

FDA to Review Fycompa for Monotherapy Use in Partial-Onset Seizures

By September 27, 2016

Eisai announced the submission of a supplemental application for a proposed label change for Fycompa (perampanel) which would include use as monotherapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy ≥12 years.

What's in a Name: Kratom Products Analyzed

By September 27, 2016

Kratom, a plant indigenous to Southeast Asia, is used by individuals for its stimulant effects and as an opioid substitute, but because of its uncertain and inconsistent purity levels and quantities, the drug can pose significant health risks to users.

Duchenne Muscular Dystrophy Drug Granted Fast Track Status

By September 27, 2016

Summit Therapeutics announced it has received a Fast Track designation from the Food and Drug Administration (FDA) for Ezutromid in the treatment of Duchenne muscular dystrophy (DMD).

New Ready-to-Use Ketorolac Prefilled Syringe Strength Launched

By September 27, 2016

Fresenius Kabi announced the availability of Ketorolac Tromethamine Injection 15mg/mL in Simplist prefilled syringes.

Tylactin RESTORE Powder Available for Tyrosinemia Management

By September 27, 2016

Cambrooke Therapeutics announced the launch of Tylactin RESTORE Powder, a new medical hydration beverage for the dietary management of tyrosinemia.

GoNitro Sublingual Powder Now Available

By September 27, 2016

Espero announced the launch of GoNitro (nitroglycerin) sublingual powder for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

Screening Colonoscopy After 70: Is It Beneficial?

September 27, 2016

But risk for adverse events low

Adipose Tissue May Provide Greater Insight to Cardiovascular Health Than BMI

September 27, 2016

Visceral adipose tissue - particularly in the abdominal region - may indicate increased risk for cardiovascular disease, and lower fat density may equal higher risk, according to a study published in the Journal of the American College of Cardiology.

Gliptins and Pancreatitis Risk: Analysis from 3 Large Trials

September 27, 2016

Data from three large trials show increased risk with saxagliptin, alogliptin, sitagliptin treatment

Reduction of Memory, Processing Speed Linked to Mercury Exposure

September 27, 2016

In young Faroese adults, aerobic fitness is associated with short-term memory and processing speed, and the correlation is attenuated by prenatal methylmercury exposure, according to a study published in Environmental Health Perspectives.

Reaching Optimal Medical Tx Prior to Stent Implantation is Key

September 27, 2016

In patients with coronary artery disease (CAD), achievement of optimal medical therapy (OMT) before implantation of a drug-eluting stent significantly reduces subsequent cardiac events

CDC: Confirm Penicillin Allergy in Patients Who Report One

By September 27, 2016

The Centers for Disease Control and Prevention (CDC) suggest that doctors evaluate patients who report penicillin allergy for true allergy.

Prevalence of Noninfectious Uveitis in U.S. Analyzed in New Study

By September 27, 2016

Noninfectious uveitis (NIU) is more prevalent among female than male adults and the number of cases increase in tandem with age. These are the findings of a new study published in JAMA Ophthalmology that focused specifically on noninfectious uveitis prevalence.

Study Indicates Low Number of U.S. Teens Exercise

September 27, 2016

Over 90% of U.S. high school students don't get enough moderate-to-vigorous exercise, and the pattern persists after they graduate, according to a study published online September 26 in Pediatrics.

HIV Testing Among MSM on the Rise

September 27, 2016

There seems to be a trend toward increased HIV testing and earlier HIV diagnosis among men who have sex with men (MSM), according to a report published in the U.S. Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report.

The Importance of Being Empathetic

September 27, 2016

Empathetic listening can help physicians navigate difficult situations and forge deeper connections with patients, leading to greater professional satisfaction and joy, according to the American Medical Association.

Significant PFS Improvement With Combo Tx in Melanoma Study

By September 26, 2016

Array BioPharma and Pierre Fabre announced top-line data from part 1 of the Phase 3 COLUMBUS study evaluating LGX818 (encorafenib) and MEK162 (binimetinib) in patients with BRAF-mutant advanced, unresectable or metastatic melanoma.

Intepirdine Gets Fast Track Status for Lewy Body Dementia

By September 26, 2016

The Food and Drug Administration has granted Fast Track status to Axovant Sciences for their investigational New Drug application for intepirdine for the treatment of dementia with Lewy bodies.

Positive Data for Oral Cannabidiol in Lennox-Gastaut Syndrome Study

By September 26, 2016

GW Pharmaceuticals announced positive data from the second randomized, double-blind, placebo-controlled Phase 3 trial of Epidiolex (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS).

Warnings and Precautions Updated for Brilinta

By September 26, 2016

The FDA has approved the supplemental New Drug Application (sNDA) for Brilinta (Ticagrelor; AstraZeneca) for an addition to the label under the Warnings and Precautions concerning bradyarrhythmias.

FDA to Review Imbruvica for Rare Lymphoma Indication

By September 26, 2016

Janssen announced the submission of a supplemental New Drug Application (sNDA) for Imbruvica (ibrutinib; Janssen and Pharmacyclics) for the treatment of patients with marginal zone lymphoma (MZL) who require systemic therapy.

Study Examines Insulin Glargine + Lixisenatide in Type 2 Diabetes

September 26, 2016

For patients with inadequately controlled, basal insulin-treated type 2 diabetes, a novel, titratable, fixed-ratio combination of insulin glargine (iGlar) and lixisenatide (iGlarLixi) is associated with improvements in glycemic control and reduced body weight.

Cytoprotective Agent Ethyol Now Available

By September 26, 2016

Cumberland announced the relaunch of Ethyol (amifostine) for Injection indicated to reduce the incidence of xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, and to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer.

FDA Approves New Schizophrenia Data for Rexulti

By September 26, 2016

Otsuka and Lundbeck announced that the Food and Drug Administration (FDA) has approved the labeling update for Rexulti (brexpiprazole) to reflect clinical data for maintenance treatment of schizophrenia.

Stelara Approved to Treat Crohn's Disease

By September 26, 2016

Janssen Biotech announced that the Food and Drug Administration (FDA) has approved Stelara (ustekinumab) for the treatment of moderately to severely active Crohn's disease in adult patients.

Drug-Resistant Bacteria in Water System Hospitalizes Thousands in the U.S.

September 26, 2016

The thousands of miles of aging, corroding pipes that bring water to Americans each day may be home to drug-resistant bacteria, according to a report published online September 12 in the Journal of Public Health Policy.

Study Evaluates Oxytocin as Potential Therapy for Tinnitus

September 26, 2016

Patients with tinnitus may find some immediate relief with nasally-administered oxytocin, according to a study presented at the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery.

FDA Approves Fourth Biosimilar Drug Amjevita

By September 23, 2016

The Food and Drug Administration (FDA) has approved Amjevita (adalimumab-atto; Amgen) as a biosimilar to Humira (adalimumab; AbbVie) for various inflammatory diseases.

Ilaris Approved for Expanded Use in Periodic Fever Syndrome Conditions

By September 23, 2016

The Food and Drug Administration (FDA) has granted three approvals for the expanded use of Ilaris (canakinumab; Novartis) for patients with rare Periodic Fever Syndrome conditions.

DEA: Drug 10,000 Times Stronger than Morphine Linked to Overdose Deaths

By September 23, 2016

This potent drug has recently been linked to a significant amount of overdose deaths across the country.

Efficacy of Some Vaccines May Be Weaker in Peds With T1DM

By September 23, 2016

The seroprotection rate of the hepatitis B and measles vaccines was reduced in some diabetic children, according to a new study published in the Journal of Pediatric Endocrinology and Metabolism.

Standard vs. Double Dose Pantoprazole Assessed for Gastric Adenoma

September 23, 2016

or patients with gastric adenoma or early gastric cancer, standard dose or double dose intravenous pantoprazole for 48 hours is equally effective for prevention of delayed bleeding after endoscopic resection, according to a study published online in the Journal of Gastroenterology and Hepatology.

Genetic Basis for Cisplatin Resistance ID'd in Men with Germ Cell Tumors

September 23, 2016

In germ cell tumors (GCTs), TP53 and MDM2 alterations correlate with cisplatin resistance and are associated with inferior outcome, according to a study published online September 19 in the Journal of Clinical Oncology.

Study Links High uPAR Levels in Bronchial Tissue to Non-Atopic Asthma

September 23, 2016

High urokinase plasminogen activator receptor serum levels linked to severe, non-atopic disease

Can Prior Gabapentin Use Affect Pregabalin Efficacy in Treating Pain?

September 23, 2016

Pregabalin is beneficial for neuropathic pain, regardless of previous gabapentin use, according to research published online September 9 in Pain Practice.

New Oral Solution Form of Epaned Gains Approval

By September 23, 2016

The Food and Drug Administration (FDA) has approved Epaned (enalapril maleate; Silvergate Pharmaceuticals) Oral Solution for the treatment of hypertension in adults and children >1 month.

BLA Submitted for Investigational RA Drug

By September 23, 2016

Janssen Biotech announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for the approval of sirukumab for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).

Gene Mutation ID'd That May Predict Dementia, Mortality Risk for Parkinson's Patients

September 23, 2016

Parkinson's disease (PD) patients with glucocerebrosidase gene (GBA) mutations have increased risk for dementia and death, according to a study published online in the Annals of Neurology.

CDC: Falls are Primary Threat to Senior's Health, Mortality

September 23, 2016

Falls are the leading cause of injury and death among older people in the United States, according to research published in the U.S. Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report.

Researchers Move Closer to Effective Zika Vaccine

September 23, 2016

An experimental DNA-based vaccine for Zika virus has proceeded to human safety trials, according to findings published online in 'Science'.

Rheumatoid Arthritis Tx Shows Promise for Hair Regrowth in Alopecia

September 23, 2016

A drug used for rheumatoid arthritis might regrow hair in alopecia areata (AA) patients, according to a study published online September 22 in JCI Insight.

When Treating IBD, Is Sequential Combo Therapy Best?

By September 22, 2016

Based on long-term clinical outcomes in patients with inflammatory bowel disease (IBD), the benefits of sequentially added combination therapy appear diminished.

Malaria Vaccine Receives Fast Track Status from FDA

By September 22, 2016

The Food and Drug Administration (FDA) has granted Fast Track designation to Sanaria PfSPZ Vaccine, a preventative vaccine for malaria.

Namzaric Available in Two New Strengths for Alzheimer's Disease

By September 22, 2016

Allergan and Adamas announced that all 4 dosage strengths of Namzaric (memantine and donepezil HCl) extended-release capsules are now available for the treatment of moderate to severe Alzheimer's disease in patients stabilized on 10mg of donepezil HCl once daily.

Experimental MS Drug Shows Promise in Early Study

September 22, 2016

An experimental drug, laquinimod, appears to prevent or slow the progression of multiple sclerosis (MS) in mice, according to a study published online in Neurology: Neuroimmunology & Neuroinflammation.

Could Natural Killer Cells Treat Acute Myeloid Leukemia?

September 22, 2016

A new type of immunotherapy involving natural killer (NK) cells may help treat acute myeloid leukemia (AML) patients, according to a study published in the Science Translational Medicine.

High-Flow Therapy vs. CPAP in Preemies with Respiratory Distress

September 22, 2016

For preterm infants with early respiratory distress, high-flow therapy used as primary support is associated with a higher rate of treatment failure than continuous positive airway pressure (CPAP), according to a study published in the New England Journal of Medicine.

Blood Sample May ID Liver Fibrosis Among Obese Individuals

September 22, 2016

In obese patients, changes in blood microbiota are associated with liver fibrosis, according to a study published online in Hepatology.

Identifying Zika Virus via Imaging, New Findings May Aid Radiologists

September 22, 2016

Congenital brain abnormalities are similar for confirmed and presumed Zika infections, according to a study published in the October issue of Radiology.

Fatty Acid Consumption Tied to T2DM Risk

September 22, 2016

Findings for arachidonic acid, docosapentaenoic acid, and alpha-linolenic acid

Does Colchicine Reduce the Risk of Recurrent Pericarditis?

September 22, 2016

More GI side effects with colchicine treatment, resulting in higher incidence of discontinuation

Post-Mastectomy Radiotherapy Guidelines Updated by Leading Institutes

September 22, 2016

New guidelines have been issued by three leading cancer organizations for postmastectomy radiotherapy (PMRT).

Organ Transplants and Incidence of Skin Cancer in Nonwhite Patients

September 22, 2016

Patients who have an organ transplant may be more likely to develop skin cancer, and that applies to all transplant patients, even those who are nonwhite and dark-skinned, according to research published online Sept. 21 in JAMA Dermatology.

Study Finds Smoking Alters Over 7,000 Genes

September 22, 2016

Smoking cigarettes can leave a lasting imprint on human DNA, altering more than 7,000 genes in ways that may contribute to the development of smoking-related diseases, according to research published online in Circulation: Cardiovascular Genetics.

New Cluster of Gonorrhea Cases Has Clinicians Worried

By September 21, 2016

An experimental oral antibiotic is being evaluated in a clinical study that may offer a new single-dose treatment option.

Topical Analgesics for Chronic Pain: An Evidenced-Based Review

By September 21, 2016

An overall lack of quality evidence exists for the use of topical analgesics and anesthetics (creams, gels and patches) as a therapeutic method for treating chronic pain, according to a new review published in the journal Dermatitis.

New Information on Edoxaban Reversal, Interactions Added to Labeling

By September 21, 2016

The FDA has approved the supplemental New Drug Application (sNDA) for Savaysa (edoxaban tosylate; Daiichi Sankyo) that provides for changes to the labeling based on a trial that evaluated the effects of Prothrombin Complex Concentrate (PCCs) on reversing the pharmacological activity of the drug.

Plavix Labeling Updated with Several Changes

By September 21, 2016

The Food and Drug Administration (FDA) has approved several changes to the prescribing information for Plavix (clopidogrel bisulfate tablets; Bristol-Myers Squibb and Sanofi).

Pediatric Anxiety Disorders: What's the Best Approach?

By September 21, 2016

An Opinion Statement published in Current Treatment Options in Psychiatry concluded that based on current data, selective serotonin reuptake inhibitors (SSRIs) and and selective serotonin norepinephrine reuptake inhibitors (SSNRIs) are effective in the treatment of pediatric anxiety disorders in addition to some forms of psychotherapy (eg, cognitive-behavioral therapy [CBT]).

Multifaceted Response Needed to Address Antibiotic Resistance

September 21, 2016

Antimicrobial resistance (AMR) remains a major public health threat, and only a multipronged attack can address the problem, according to a report published in the September 20 issue of the Journal of the American Medical Association.

How Stress May Mediate the Body's Response to 'Good' Fats

September 21, 2016

Stressful events from the day before appear to eradicate any health benefits a person might have gained from choosing a breakfast rich in monounsaturated fats

AACR: Immunotherapy Shows Significant Progess in CA Treatment

September 21, 2016

More Americans are benefiting from immunotherapy, according to the sixth annual American Association for Cancer Research (AACR) Cancer Progress Report.

Different Gut Flora Composition May Help ID Kids' Obesity Risk

September 21, 2016

Obese children and adolescents have different gut flora composition than their normal-weight peers, according to a study published online September 20 in the Journal of Clinical Endocrinology & Metabolism.

Study Looks at Next Steps for RA Patients with Insufficient Response to TNF Inhibitor

September 21, 2016

A non-tumor necrosis factor (TNF)-targeted biologic is more effective than a second anti-TNF drug for treatment of rheumatoid arthritis in patients with insufficient response to a first anti-TNF drug

Most Buprenorphine Prescribers' Patients Censuses Considerably Low

September 21, 2016

For buprenorphine prescribers, the monthly patient census is 13 patients, according to a research letter published in the September 20 issue of the Journal of the American Medical Association.

Preeclampsia Risk Linked to Binding Protein 4 in T1DM

September 21, 2016

For women with type 1 diabetes, elevated fatty acid binding protein 4 (FABP4) in early pregnancy and in the second trimester is associated with subsequent preeclampsia, according to a study published online September 14 in Diabetes Care.

Invokamet XR Approved as First-Line Treatment for T2DM

By September 21, 2016

Janssen announced that the Food and Drug Administration (FDA) has approved Invokamet XR (canagliflozin, metformin HCl extended-release) for first-line use as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes when treatment with the two medications is appropriate.

Study Finds Allergen Introduction in Infancy May Help Prevent Allergies

September 21, 2016

Early introduction of egg and peanuts could help prevent 24 cases of egg allergy per 1,000 people and 18 cases of peanut allergy per 1,000 people, according to research published in the September 20 issue of the Journal of the American Medical Association.

CDC: Another Mosquito-Borne Virus is Possibly Circulating in the Caribbean

September 21, 2016

Another mosquito-borne virus may be starting to circulate in the Caribbean, according to findings published online recently in the U.S. Centers for Disease Control and Prevention's Emerging Infectious Diseases.

No Link Between H1N1 Vaccine and Congenital Malformation, Study Finds

September 21, 2016

The vaccine against the H1N1 strain of influenza doesn't appear to be linked to congenital malformations, according to research published online in the Annals of Internal Medicine.