The President's Council of Advisors on Science and Technology (PCAST) has released the report Combating Antibiotic Resistance to the President in conjunction with the National Strategy on Combating Antibiotic Resistant Bacteria and the Presidential Executive Order on the importance of addressing this concerning issue.
The American Association of Clinical Endocrinologist (AACE) and the American College of Endocrinology (ACE) announced the publication of its position statement that describes its framework for a new diagnosis of obesity as a chronic disease.
Navidea announced that the Food and Drug Administration (FDA) has granted Lymphoseek (technetium Tc 99m tilmanocept) injection an Orphan Drug Designation for use in sentinel lymph node detection in patients with head and neck cancer.
Novo Nordisk announced new data from the Phase 3a DUAL clinical trial comparing Xultophy (insulin degludec and liraglutide [IDegLira]) to insulin degludec (Tresiba) and liraglutide (Victoza) alone in insulin-naive and insulin-treated patients.
Reductions in heart events and death last for many years after stopping therapy in patients with type 2 diabetes that take antihypertensives, Australian researchers have found.
The Food and Drug Administration (FDA) has approved Trulicity (dulaglutide; Eli Lilly) pen as adjunct to diet and exercise to improve glycemic control in in adults with type 2 diabetes.
The investigational drug alpelisib (previously known as BYL719) appears to inhibit activation of the pathway that leads to resistance to cetuximab, an anti-epidermal growth factor receptor agent used in the treatment of head and neck cancer.
The Advisory Committee on Immunization Practice (ACIP) recommends that all healthcare personnel (HCP) be vaccinated against influenza every year.
Eli Lilly and Company announced results from a global Phase 3 study with Cyramza (ramucirumab) in combination with paclitaxel for patients with advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma.
Vivus and Auxilium announced that the Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Stendra (avanafil) to be taken ~15 minutes before sexual activity in the treatment of erectile dysfunction.
Baxter announced a voluntary recall of one lot of Potassium Chloride Injection 10mEq/100mL at the hospital/pharmacy/nurse level.
Reducing dementia risk factors should be incorporated into national and global public health programs alongside other major non-communicable diseases (NCD), urges the organization Alzheimer's Disease International.
Merck announced results from the Phase 3 clinical program for omarigliptin, once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes.
The American Orthopaedic Foot & Ankle Society (AOFAS) has released a list of tests and procedures that are commonly ordered but not always necessary.
It is suspected that glutamate (Glu), an excitatory CNS neurotransmitter, may have a role in the pathophysiology of fibromyalgia; memantine, an N-methyl-D-aspartate (NMDA) receptor antagonist, could assist in reducing glutamate's neurotoxic effect by preventing the entry of excess calcium.
The Centers for Disease Control and Prevention (CDC) has issued an update regarding the outbreak of severe respiratory illness caused by the rare Enterovirus D68 (EV-D68) and recommendations for clinicians.
The Food and Drug Administration has approved Movantik (naloxegol; AstraZeneca) for the treatment of opioid-induced constipation in adults with chronic non-cancer pain.
The Food and Drug Administration (FDA) has granted Eylea (afilbercept; Regeneron) Injection Breakthrough Therapy designation for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME).
infirst Healthcare announced the launch of the Dr. Cocoa for Children product line, which consists of 3 over-the-counter (OTC) cough and cold medicines with 10% real cocoa for real chocolate taste to improve compliance.
Roche announced the launch of Accu-Chek Aviva Expert system, the first blood glucose meter with a built-in insulin calculator.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to Lynovex (NM001; NovaBiotics) for the treatment of cystic fibrosis (CF).
Salix announced that the Food and Drug Administration (FDA) has granted tentative approval for Uceris (budesonide) rectal foam for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis (UC) extending up to 40cm from the anal verge.
The National Lipid Association (NLA) has released new recommendations for the management of dyslipidemia that incorporate the need for a multifaceted approach incorporating each patient risk and risk factors, rather than specific medication categories.
Merck announced results from the Phase 3 LOFT study with odanacatib in postmenopausal women with osteoporosis.
Baxter and Halozyme announced that the Food and Drug Administration has approved Hyqvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) for adult patients with primary immunodeficiency (PI).
Baxter announced that the Food and Drug Administration (FDA) has approved Rixubis (coagulation factor IX [recombinant]) for routine prophylaxis, control, and prevention of bleeding episodes, and perioperative management in children with hemophilia B.
The Food and Drug Administration (FDA) is warning consumers that several products promoted and sold for weight loss have been found to contain undeclared ingredients and should not be purchased or used.
Bayer HealthCare announced the launch of Aleve PM (naproxen and diphenhydramine) caplets for occasional sleeplessness associated with minor aches and pains.
The Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for review for Tuzistra XR (CCP-01; Vernalis and Tris Pharma) in the acute treatment of cough cold.
The Food and Drug Administration (FDA) has accepted for filing Shire's supplemental New Drug Application (sNDA) with priority review for Vyvanse (lisdexamfetamine dimesylate) Capsules (CII) for the treatment of adults with binge eating disorder (BED).
Plexison announced that the Food and Drug Administration (FDA) has approved Pleximmune, a first-in-class blood test to predict acute cellular rejection of transplanted livers and intestines in children.
A new study suggests that inflammation may be the driving force behind damage to blood vessels caused by elevated blood glucose levels, with the potential for the use of anti-inflammatory medications in reducing the risk of blood vessel disease in patients with diabetes.
Global Kinetics Corporation has announced that it has received marketing clearance for their Personal KinetiGraph (PKG), the first wrist-worn device approved in the U.S. to improve the assessment and monitoring of symptoms of Parkinson's disease and other neurological disorders that impact movement.
A Food and Drug Administration (FDA) Advisory Committee has voted in favor of recommending liraglutide for chronic weight management in individuals with obesity or who are overweight with at least one weight-related comorbidity
Hospira has announced a voluntary nationwide user-level recall of one lot of Heparin Sodium Injection due to a confirmed customer report of particulate in a single unit.
Biogen Idec announced five-year results from the ENDORSE Phase 3 extension study with Tecfidera (dimethyl fumarate) in patients with relapsing-remitting multiple sclerosis (RRMS).
Biogen Idec announced new data from the second year of its Phase 3 ADVANCE clinical trial for Plegridy (peginterferon beta-1a) in patients with relapsing forms of multiple sclerosis (RMS).
AbbVie announced results from the Phase 3 PIONEER 1 study with Humira (adalimumab) in patients with moderate-to-severe hidradenitis suppurativa (HS).
The Food and Drug Administration (FDA) has granted Orphan Drug designation to VT-1129 (Viamet Pharmaceuticals), a selective oral antifungal agent, for the treatment of cryptococcal meningitis.
Astellas and Medivation announced that the Food and Drug Administration has approved a new indication for Xtandi (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).
Takeda and Orexigen announced that the Food and Drug Administration (FDA) has approved Contrave (naltrexone HCl and bupropion HCl) extended-release tablets as adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults
Vasalgel, the first male contraceptive injection, is anticipated to enter its first clinical trial beginning in 2015, according to the Parsemus Foundation.
Over 90% of school-age children in the United States are consuming more than the recommended daily allowance of sodium, with 10 common food types contributing to over 40% of the total sodium consumed by children, according to the Centers for Disease Control and Prevention (CDC).
The Food and Drug Administration (FDA) is warning healthcare professionals and consumers again about all sterile-use drug products made and distributed by Downing Labs LLC/NuVision.
Obese adults may be more susceptible to environmental food cues than lean adults due to differences in brain chemistry that make eating more habitual and less rewarding, according a new study.
Regular consumption of mango by obese adults may lower blood sugar levels without a negative impact on body weight, a recent study suggests.
Marathon announced the launch of Zingo (lidocaine HCl monohydrate) powder intradermal injection system for the management of venous access pain.
Tesaro has submitted a New Drug Application (NDA) to the FDA for approval of oral rolapitant for the prevention of chemotherapy-induced nausea and vomiting (CINV).
Boehringer Ingelheim announced results from a pre-specified, pooled subgroup sensitivity analysis from the Phase 3 INPULSIS-1 and INPULSIS-2 trials that evaluated the use of nintedanib in patients with idiopathic pulmonary fibrosis (IPF) based on the severity of lung function impairment at baseline.
DiabetOmics announced a new point-of-care test to detect preeclampsia, assess the severity of the disease, and monitor its complications in as early as the 1st trimester.
Boehringer Ingelheim announced results from its Phase 3 UniTinA-asthma trial program evaluating tiotropium in adults, adolescents, and pediatric patients with different severities of asthma.
A six-month clinical trial to evaluate gabapentin enacarbil (Horizant; XenoPort) as a potential treatment for alcohol use disorder (AUD) is set to begin in the first half of 2015, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) reported.
Sanofi Pasteur announced that the Food and Drug Administration (FDA) has approved the use of Menactra (meningococal [Groups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate vaccine) for booster vaccination against meningococcal disease in patients aged 15-55 years.
The Centers for Disease Control and Prevention (CDC) has issued an update on an outbreak of severe respiratory illness in over 1,000 children in at least 10 states caused by a rare enterovirus.
The United States Department of Justice (DOJ) has announced the creation of a new Drug Enforcement Agency (DEA) regulation that would allow pharmacies, hospitals, clinics, and other authorized collectors to serve as authorized drop-off sites for unused prescription medications.
The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for isavuconazole (Astellas) for the treatment of invasive aspergillosis and invasive mucormycosis.
Gilead Sciences announced results from the Phase 3 AMBITION) study with ambrisentan and tadalafil for the treatment of pulmonary arterial hypertension.
Teva announced positive results from its Phase 3 studies of reslizumab in patients with uncontrolled moderate to severe asthma with elevated eosinophils, treated with standard of care therapies.
Silvergate announced that the Food and Drug Administration (FDA) has approved Epaned (enalapril maleate powder for oral solution) for two additional indications.
AstraZeneca announced the availability of Bydureon (exenatide extended-release for injectable suspension) Pen in pharmacies across the country.
The Food and Drug Administration (FDA) announced that it has allowed marketing of the NephroCheck test, a first-of-a-kind laboratory test to assist in determining if some critically ill hospitalized patients are at risk of developing moderate-to-severe acute kidney injury (AKI) in the 12 hours post-test.
Keryx Biopharmaceuticals announced that the Food and Drug Administration (FDA) has approved Ferric Citrate (formerly known as Zerenex) for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.
The Boston division of the Federal Bureau of Investigation (FBI) has announced the arrest of a former supervising pharmacist at the New England Compounding Center (NECC) on one count of mail fraud related to a nationwide fungal meningitis outbreak.
The Food and Drug Administration (FDA) has granted accelerated approval for Keytruda (pembrolizumab; Merck) for the treatment of advanced or unresectable melanoma in patients who are no longer responsive to other drugs.
The humble horseshoe crab is an unlikely source of an extract used in the limulus amebocyte lysate (LAL) contamination test, but declining population numbers are driving the development of new tests to detect bacteria on medical equipment.
The World Health Organization (WHO) has issued its first report on suicide prevention to increase awareness of suicide and suicide attempts, as well as urge governments to develop comprehensive suicide prevention strategies.
Eli Lilly and Company announced results from its IMAGINE-1 and IMAGINE-3 Phase 3 trials with basal insulin peglispro (BIL) in patients with type 1 diabetes.
The Food and Drug Administration (FDA) has granted Fast Track status to Pulmaquin for the treatment of non-cystic fibrosis bronchiectasis (non-CF BE) patients who develop chronic lung infections with Pseudomonas aeruginosa.
The Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product with designated Fast Track status to relebactam (MK-7655; Merck) for intravenous use, in the treatment complicated urinary tract infections, complicated intra-abdominal infections, and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia.
Prolacta Bioscience announced the launch of Prolact RTF, the first ready-to-feed (RTF) human milk-derived premature infant formula.
The national drug store chain CVS Health (formerly CVS Caremark) announced that it has removed cigarettes and tobacco products from the shelves of all 7,700 locations, ahead of its previously targeted date.
Tetraphase announced positive results from the lead-in portion of its IGNITE 2 clinical trial with IV and oral formulations of eravacycline for the treatment of complicated urinary tract infections (cUTI).
Vicks announced the launch of QlearQuil, a line of over-the-counter (OTC) products for the treatment of sinus and allergy symptoms.
Bristol-Myers Squibb and Pfizer announced results from the pre-specified secondary analysis of the Phase 3 AMPLIFY-EXT trial with Eliquis (apixaban).
The Food and Drug Administration (FDA) has accepted and granted Priority Review to Ipsen's sNDA for Somatuline Depot (lanreotide acetate) 120mg injection for the treatment of gastoenteropancreatic neuroendocrine tumors (GEP-NETs).
The Food and Drug Admnistration (FDA) has granted Orphan Drug designation for PRM-151 (Promedior) for the treatment of myelofibrosis.
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Nuplazid (pimavanserin; Acadia Pharmaceuticals) for the treatment of Parkinson's disease psychosis.
Sanofi and Regeneron announced positive results from four Phase 3 ODYSSEY trials of alirocumab in patients with hypercholesterolemia.
The Food and Drug Administration (FDA) has granted Wockhardt Limited's investigational anti-infectives, WCK 771 and WCK 2349 Qualified Infectious Disease Product (QDIP) status.
Lundbeck announced the availability of Northera (droxidopa) capsules for the treatment of orthostatic dizziness and lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension (NOH).
Ampio announced an update to the Phase 3 multicenter, double-blind STEP study of Ampion for osteoarthritis (OA) of the knee.
Janssen has announced results from its Phase 3b exploratory trial evaluating the efficacy of Xarelto (rivaroxaban) as an alternative to vitamin K antagonists (VKAs) for treating and reducing the risk of blood clots in non-valvular atrial fibrillation (NVAF) in patients undergoing elective cardioversion.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to APD811 (Arena Pharmaceuticals) for the treatment of pulmonary arterial hypertension (PAH).
The Food and Drug Administration (FDA) has granted Fast Track designation to motolimod (VTX-2337; VentiRx) in combination with pegylated liposomal doxorubicin (PLD) for the treatment of women with ovarian cancer whose disease has progressed on or recurred after platinum-based chemotherapy.
Regeneca Worldwide announced the expansion of its voluntary nationwide recall of RegeneSlim appetite control dietary supplements to include four additional lots.
The origin of the latest Ebola outbreak has been traced to a single transmission from animal to human that spread during the course of a funeral.
Vital Connect announced that the Food and Drug Administration (FDA) has granted clearance for its HealthPatch MD biosensor for 24-hour patient monitoring in their homes.
Pfizer and Protalix BioTherapeutics announced that the Food and Drug Administration (FDA) has approved Elelyso (taliglucerase alfa) for injection for pediatric patients.
Takeda announced their completion and data submission of a 10-year epidemiology study to regulatory authorities, including the United States Food and Drug Administration (FDA).
Amgen announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for evolocumab for the treatment of high cholesterol.
The Food and Drug Administration (FDA) has granted Fast Track status for Pfizer's investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090).
An experimental Ebola vaccine, being co-developed by the United States National Institutes of Health (NIH) and GlaxoSmithKline, is to undergo accelerated human trials with funding from an international consortium in response to the epidemic.
A recent study has demonstrated potential for lexaptepid pegol as the first treatment for anemia of inflammation, the most common form of anemia.
The Food and Drug Administration (FDA) has granted Priority Review to Amgen's New Drug Application (NDA) for ivabradine for the treatment of chronic heart failure.
GlaxoSmithKline announced that the Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the use of Promacta (eltrombopag) in patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).
Dr. Abraham Borbor, a Liberian doctor who contracted Ebola, has died after receiving one of the last doses of the experimental drug ZMapp.
In women with diabetes, long-term use of sulfonylureas may be associated with an increased risk of developing coronary heart disease (CHD), says a new study published in the journal Diabetes Care.
In a new study published in the American Journal of Therapeutics, data from the National Health and Nutrition Examination Survey III was used to determine whether coffee has an effect on cardiovascular and all-cause mortality.
A new study published in the journal Neurology looks at the use of naltrexone, an opioid antagonist, as a possible treatment for impulse control disorders (ICDs) in Parkinson's disease (PD).
While the Ice Bucket Challenge has raised significant funds for the ALS Association, there are risks associated with the stunt when it's done incorrectly.