The Phase 3 study (COMPOSE II) for oral naldemedine (Shionogi) met its primary endpoints for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.
A study appearing in Neuroscience and Biobehavioral Reviews suggests that pharmacokinetics play a significant role in the risk of abuse and misuse associated with varying drugs, from nicotine to cocaine.
Postmenopausal women did not experience beneficial effects on bone mineral density, muscle function, muscle mass or falls with high-dose vitamin D, according to a study published in JAMA Internal Medicine.
Aprecia announced that the Food and Drug Administration (FDA) has approved Spritam (levetiracetam) tablets as adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures in patients with epilepsy.
Could soybean oil contribute more to the development of diabetes and obesity than sugar? In a study published in PLOS ONE, mice that were fed a diet high in soybean oil had greater signs of metabolic syndrome compared to those who were fed a diet high in coconut oil or fructose.
Sanofi Pasteur announced positive results from an analysis of a large-scale, multicenter efficacy trial that evaluated patients who received a higher-dose split-virus inactivated influenza vaccine (IIV-HD; Fluzone High-Dose) vs. a standard-dose split-virus inactivated influenza vaccine (IIV-SD; Fluzone).
Lexicon announced top-line results from the Phase 3 study, TELESTAR, which evaluated oral telotristat etiprate in cancer patients with carcinoid syndrome that is not adequately controlled by the current standard of care.
Use of certain medications indicated for the treatment of dementia could lead to harmful weight loss in older adults, researchers are reporting.
The New York City Department of Health and Mental Hygiene is currently investigating an outbreak of Legionnaires' disease that has been linked to 31 reported cases and two deaths to prevent the further spread of Legionella.
Bayer HealthCare announced that the Food and Drug Administration (FDA) has approved Finacea (azelaic acid) Foam 15% for the topical treatment of inflammatory papules and pustules of mild to moderate rosacea.
The New Drug Application (NDA) for EDO-S101 (Mundipharma) has been accepted by the Food and Drug Administration (FDA) for the treatment of relapsed or refractory hematologic malignancies and solid tumors.
Unichem Pharmaceuticals issued a voluntary nationwide recall of Hydrochlorothiazide 25mg tablets after the discovery of a Clopidogrel tablet in a bottle.
The diuretic triamterene, which is often used in combination with hydrochlorothiazide (HCTZ) for the treatment of hypertension, appears to enhance the effect of HCTZ in lowering blood pressure (BP) in addition to its potassium-sparing action.
Lundbeck and Otsuka announced that the Food and Drug Administration (FDA) has expanded the label of Abilify Maintena (aripiprazole) extended-release injectable suspension to include a new injection site, the deltoid muscle of the arm.
A nationwide survey showed that female physicians made close to $15,000 less than male physicians.
The Food and Drug Administration (FDA) announced modifications to the Tanzeum (albiglutide [recombinant fusion protein]; GlaxoSmithKline) and Trulicity (dulaglutide; Eli Lilly) Approved Risk Evaluation and Mitigation Strategies (REMS) program following the safety labeling changes that were approved in March 2015.
The Food and Drug Administration (FDA) announced changes to the Kynamro (mipomersen sodium; Genzyme) Approved Risk Evaluation and Mitigation Strategies (REMS) program.
Unilife Corporation announced the launch of the Imperium, the first instant patch pump for insulin with Bluetooth connectivity for patients with diabetes.
The Food and Drug Administration (FDA) is warning healthcare providers and patients that the name confusion between Brintellix (vortioxetine; Takeda and Lundbeck) and Brilinta (ticagrelor; AstraZeneca) has led to the wrong medication being prescribed or dispensed.
Research in the Journal of the American Geriatrics Society states that older adults have far higher rates of psychotropic use compared to younger adults, but they are also less likely to receive psychotherapy or care from psychiatrists.
Synergy announced positive top-line results from the second Phase 3 trial of plecanatide 3mg and 6mg doses in adult patients with chronic idiopathic constipation (CIC).
The Food and Drug Administration (FDA) has granted Orphan Drug designation to dactinomycin nanoparticle formulation (NanoSmart) for the treatment of Ewing's sarcoma.
The New Drug Application (NDA) for NT-0202 (amphetamine XR-ODT, Neos) has been resubmitted to the Food and Drug Administration (FDA) for the treatment of attention-deficit/hyperactivity disorder (ADHD).
The American College of Physicians (ACP) expressed support for eliminating currently existing exemptions, except for medical reasons, from immunization laws.
After several cases of Hansen's disease (formerly known as leprosy) were reported in Florida, the state's Department of Health has alerted residents that armadillos may play a role in the transmission of the disease but that their role is not fully understood.
A new survey by the American Gastroenterological Association (AGA) found that the majority of gastroenterologists reported prescribing biologic medicines to their patients, but that would also consider prescribing biosimilars even with concerns about their safety and efficacy.
The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Rayaldee (calcifediol modified-release capsules, Opko) for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
inSleep Health announced that the Food and Drug Administration (FDA) has cleared its Cloud9 Anti-Snoring System to reduce or eliminate asymptomatic ("simple") snoring in adults.
Sanofi announced that the Phase 3 trial of the fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide met its primary endpoint in patients with type 2 diabetes treated with metformin.
The Food and Drug Administration (FDA) has approved ReShape Integrated Dual Balloon System, the first non-surgical weight loss procedure for people with mild-to-moderate obesity.
Two new potential methods for diagnosing diabetes - one from a biomarker and one from fingernail clippings - could lead to easier, timelier, and more affordable options for identifying and treating diabetes in its standard and gestational forms. Research findings on both new tests were presented at the 2015 AACC Annual Meeting & Clinical Lab Expo in Atlanta.
ChiRhoClin announced that the shortage of ChiRhoStim (human secretin for injection) has been resolved, after the company worked with the Food and Drug Administration (FDA), the Center for Drug Evaluation and Research (CDER), the Drug Shortage Team, and the Office of Pharmaceutical Quality (OPQ) to resolve the shortage.
A new study in the American College of Clinical Pharmacology found that patients on a low-salt diet (LSD) and one of three antihypertensive drug regimens saw a greater reduction in blood pressure (BP) compared to those on a non-low-salt diet (NLSD) and antihypertensive medications, although all groups saw significant reduction in BP.
Patients who received a novel high frequency form of spinal cord stimulation (SCS) therapy experienced significantly greater, long-term relief for both chronic back and leg pain, when compared to a traditional low frequency form of SCS therapy.
Patients with greater variations in blood pressure over multiple office visits have a greater risk of cardiovascular disease (CVD) and all-cause mortality, reports research in the Annals of Internal Medicine.
The Food and Drug Administration (FDA) has accepted CSL Behring's Biologics License Application (BLA) for its novel investigational recombinant factor VIII single-chain (rVIII-SingleChain) for the treatment of hemophilia A.
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lenvatinib for use in patients with advanced or metastatic renal cell carcinoma (RCC) who were previously treated with a vascular endothelial growth factor (VEGF)-targeted therapy.
The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for grazoprevir/elbasvir (Merck) for the treatment of adult patients infected with chronic hepatitis C virus (HCV) genotypes (GT) 1, 4, or 6.
The U.S. Preventive Services Task Force (USPSTF) issued a draft recommendation today stating that all adults over the age of 18, including pregnant and postpartum women, should be screened for depression in a primary care setting.
The Food and Drug Administration (FDA) is investigating the safety risk associated with repeated use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI).
Eli Lilly announced the continuation of the Phase 3 trial of evacetrapib in participants with high-risk atherosclerotic cardiovascular disease (ASCVD).
Many new mothers do not receive advice from clinicians on infant care or receive advice from healthcare professionals or family members that is not consistent with recommendations and guidelines, reports a new study in Pediatrics.
Upsher-Smith announced that the Food and Drug Administration (FDA) has approved the supplemental abbreviated new drug application (sNDA) and request for an alternate active pharmaceutical ingredient (API) manufacturer for Androxy (fluoxymesterone) tablets.
Adapt Pharma announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Narcan (naloxone) Nasal Spray for the treatment of opioid overdose.
The FDA has approved Praluent (alirocumab; Sanofi Aventis and Regeneron) injection as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C.
Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has approved Daklinza (daclatasvir) in combination with sofosbuvir for the treatment of chronic hepatitis C virus (HCV) genotype 3 infection.
AbbVie announced that the Food and Drug Administration (FDA) has approved Technivie (ombitasvir, paritaprevir, ritonavir) tablets in combination with ribavirin for the treatment of adults with genotype 4 (GT4) chronic hepatitis C virus (HCV) infection who do not have cirrhosis.
Teva announced a voluntary recall of 6 lots of Adrucil (fluorouracil injection) 5g/100mL (50mg/mL) due to potential particulate matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
The FDA has approved Kyprolis (carfilzomib; Amgen) in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received 1-3 prior lines of therapy.
Novartis announced that the Food and Drug Administration (FDA) has approved Odomzo (sonidegib) capsules for the treatment of adults with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
Janssen Therapeutics announced the submission of a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) to update the label for once-daily, all-oral Olysio (simeprevir) in combination with sofosbuvir for adults with genotype 1 chronic hepatitis C (CHC) infection with or without cirrhosis.
The Food and Drug Administration (FDA) proposed the inclusion of percent daily value (%DV) for added sugars to the Nutrition Facts label of packaged foods.
Life & More LLC announced a voluntary recall of 783 bottles of Akttive High Performance Fat Burner Gold capsules marketed as weight loss supplements.
The FDA has granted Fast Track designation to OMS721 (Omeros) for the treatment of patients with atypical hemolytic uremic syndrome (aHUS).
The "Mediterranean lifestyle," characterized by high intake of monounsaturated fats (MUFAs), fiber, legumes, dairy, and fish; moderate alcohol intake; and more quality sleep, has a positive impact on cardiovascular health, study authors concluded.
The sNDA for Kyprolis (carfilzomib, Amgen) was submitted to the FDA for the treatment of patients with relapsed multiple myeloma, who has received at least one prior therapy.
The FDA has accepted for filing the New Drug Application (NDA) for ready-to-use (RTU) bivalirudin (Eagle) for the treatment of patients undergoing percutaneous coronary intervention (PCI) with use of glycoprotein IIb/IIa inhibitor; undergoing PCI with, or at risk of heparin-induced thrombocytopenia and thrombosis syndrome; or with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).
Older adults who have migraines may have a higher risk of stroke if they smoke, new study findings published in Neurology suggest.
Capsaicin may be a treatment option for patients with idiopathic non-allergic rhinitis, concluded study authors from the Cochrane Ears, Nose and Throat Group.
Drinking beet juice regularly may help improve exercise performance and endurance.
New nutrition guidelines on the management of gastrointestinal symptoms in children with autism spectrum disorder (ASD) have been published in the Journal of the Academy of Nutrition and Dietetics.
According to a recent Morbidity and Mortality Weekly Report (MMWR), more than half of Americans now report taking action towards reducing the amount of sodium in their diets.
Use of emergency contraception by female teenagers has increased over the past decade while the percentage of both male and female teenagers who have had sexual intercourse has decline since 1988, according to new data from the Centers for Disease Control and Prevention's (CDC) National Center for Health Statistics (NCHS).
Eli Lilly and Company announced results from the Phase 3 study evaluating whether the treatment effect of solanezumab was preserved within a pre-specified amount in patients with mild Alzheimer's disease who received solanezumab earlier in the disease compared to patients who began treatment at a later point.
An investigational drug to treat hot flashes and other menopausal symptoms selectively delivers estrogen only to the brain, sparing other organs from hormone exposure and potential side effects.
Treatment visits for use of anticoagulants are on an upward trend and driven largely by the popularity of new direct oral anticoagulants, which tripled in use from 2013-2014.
A smartphone app to measure oxygen saturation may help patients suffering from chronic cardiopulmonary diseases accurately monitor their health, particularly for early warning signs of declining health status.
Propeller Health announced that the FDA has given clearance to market its Propeller platform for use with drugs using the Diskus dry powder inhaler device for asthma and COPD, and clearance for use with drugs using the Respimat inhaler for COPD.
Gilead Sciences announced results from Study 109, a Phase 3 study evaluating once daily single tablet regimen (STR) of elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg, and tenofovir alafenamide 10mg (E/C/F/TAF) in adults switching from tenofovir disoproxil fumarate (TDF) containing regimens.
National Pharma announced the launch of Naramin (diphenhydramine), an oral solution in prefilled single-dose whistles.
Researchers from the University of California, San Diego School of Medicine reported a new combination therapy that effectively treated hepatitis C virus (HCV) in patients co-infected with HIV.
The Medicines Company announced the launch of a new formulation of Minocin (minocycline) for Injection.
A 10-point questionnaire may be a better identifier of patients at risk of future drinking-related trauma than a blood alcohol content test, findings from a study published in The Journal of the American Osteopathic Association have shown.
Shire announced positive top-line results from a Phase 3 study of Vyvanse (lisdexamfetamine dimesylate) Capsules (CII) in adults with moderate-to-severe binge eating disorder (BED).
The Food and Drug Administration (FDA) has granted Orphan Drug designation to Osmolex ER (amantadine HCl extended release tablets; Osmotica) for the treatment of levodopa induced dyskinesia (LID) for patients with Parkinson's disease.
A recent study published in the Annals of Internal Medicine found that 10 percent of healthcare providers write an antibiotic prescription for nearly every patient who walks in with a cold, bronchitis, or other acute respiratory infections (ARIs).
Targeting the bacteria Helicobacter pylori with a short course of combination therapy may help decrease the risk of gastric cancer, new study findings published in the Cochrane Library suggest.
Tamsulosin was found to improve passage of larger, but not smaller, kidney stones compared to placebo, according to a study in the Annals of Emergency Medicine.
The Food and Drug Administration (FDA) is warning that black henna tattoos may cause harmful skin reactions in some people.
A case study presented at the 8th IAS Conference on HIV Pathogenesis, Treatment & Prevention suggests that long-term HIV remission after early treatment could be possible in children infected via mother-to-child transmission, as a woman who was HIV-infected at birth is in viral remission despite not having taken any antiretroviral therapy (ART) for the last 12 years.
Scientists say they may be able to create a universal flu vaccine that can provide broad protection against various influenza strains, including those that could cause future pandemics.
Phosphates artificially added to foods like dairy and cereal products have been associated with sharp increases in blood phosphorous levels that could be harmful to the kidneys, particularly for patients with existing reduced kidney function.
Kitabis Pak is now on the Preferred Drug List (PDL) for many state programs, expanding its access for patients with cystic fibrosis (CF) using nebulized antibiotic therapy.
Research in the journal Food Quality and Preference sheds new insight into the role of pill color and shape in influencing patient perceptions on expected ease/difficulty of swallowing, taste, and/or efficacy - which may influence medication adherence and treatment compliance.
Elderberry extract may protect air travelers from cold and flu-like symptoms after long flights, researchers from Griffith University reported at the 21st Annual International Integrative Medicine Conference in Melbourne, Australia.
A recent study published in JAMA found an association between treatment with dicloxacillin and a decrease in international normalized ratio (INR) levels among patients taking vitamin K antagonists (VKAs) such as warfarin or phenprocoumon.
Qiagen announced that it has received marketing approval for its therascreen EFGR RGQ PCR Kit as a companion diagnostic to Iressa (geftinib; AstraZeneca) for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC).
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to BMS-663068 (Bristol-Myers Squibb), when used in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients.
A statistically significant increased risk of bladder cancer was not found with the use of pioglitazone, although a small increased risk could not be excluded, according to an analysis published in JAMA.
Patients with new-onset type 1 diabetes showed preserved beta cell function after receiving two courses of alefacept shortly after diagnosis, according to a study in the Journal of Clinical Investigation.
Inhaled cannabis had a significant effect on neuropathic pain that appears to be dose-dependent, in the first published research on cannabinoids for painful diabetic neuropathy in humans.
Baxter announced a voluntary recall of two lots of 0.9% Sodium Chloride intravenous (IV) solutions due to potential particulate matter.
Many patients with chronic pain in managed care do not discuss use of alternative therapies (eg, chiropractic care, acupuncture) with their primary care providers, according to study results published in the American Journal of Managed Care.
New research in Pediatrics suggests that children who are exposed to antibiotics could have an increased risk of newly diagnosed juvenile idiopathic arthritis (JIA), but that antibiotic use could be a marker for abnormal immunity rather than a direct cause of JIA.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to melphalan (Delcath Systems) for the treatment of cholangiocarcinoma.
A drug used to treat rheumatoid arthritis (RA) was effective in patients with moderate to severe eczema, according to a study conducted by researchers from Yale School of Medicine.
Exelixis announced positive top-line results from the primary analysis of METEOR, a Phase 3 trial comparing Cometriq (cabozantinib) to everolomus in patients with metastatic renal cell carcinoma (RCC) who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI).
Bristol Myers Squibb Company announced that CheckMate-025, a Phase 3 study investigating Opdivo (nivolumab) vs. everolimus in previously treated patients with advanced or metastatic renal cell carcinoma (RCC) was stopped early due to the primary endpoint being met.
Heron Therapeutics announced that it has resubmitted its New Drug Application (NDA) for Sustol (granisetron) injection, extended release to the Food and Drug Administration (FDA) for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy HEC) regimens.
Current guidelines for appropriate prescribing of opioid pain medications often focus on chronic users of these drugs, but these recommendations may be missing patients with acute and intermittent use of low-dose opioids who are also at a risk of opioid overdose.