Salix and Progenics announced that the Food and Drug Administration (FDA) has approved Relistor (methylnaltrexone) subcutaneous injection for the treatment of opioid-induced constipation (OIC) in patients taking opioids for chronic non-cancer pain.
Otsuka and Lundbeck announced that the Food and Drug Administration (FDA) has approved Abilify Maintena (aripiprazole) for extended-release injectable suspension as a prefilled dual-chamber syringe.
Avedro announced that it has resubmitted its New Drug Application (NDA) to the Food and Drug Administration (FDA) for riboflavin ophthalmic solution/KXL System for the treatment of progressive keratoconus or corneal ectasia following refractive surgery.
LEO Pharma announced that Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension has been approved for the treatment of plaque psoriasis of the scalp in patients aged 12-17 years.
The United States Department of Health and Human Services announced the development of an investigational drug, AB103, to treat a condition called cytokine storm.
An increase in certain amino acids may be an early sign of pancreatic cancer, occurring before the disease is diagnosed and symptoms appear, reports a new study.
Seattle Genetics and Takeda announced results from the Phase 3 AETHERA trial with Adcetris (brentuximab vedotin) in patients with post-transplant Hodgkin lymphoma.
Roche announced results from the Phase 3 CLEOPATRA study evaluating the addition of Perjeta (pertuzumab; Genentech) to Herceptin (trastuzumab; Genentech) and docetaxel chemotherapy in patients with previously untreated HER2-positive metastatic breast cancer.
Protein Sciences announced that doses of Flublok (trivalent recombinant hemagglutinin [Types A and B]) influenza vaccine are now available for shipment for the 2014/2015 flu season.
Roche announced positive data from the coBRIM Phase 3 study with cobimetinib plus Zelboraf (vemurafenib) in patients with previously untreated BRAF V600 mutation-positive, advanced melanoma.
GlaxoSmithKline announced updated results for Tafinlar (dabrafenib) from the Phase 3 BREAK-3 study in patients with BRAF V600E mutant metastatic melanoma.
Allergan announced that the Food and Drug Administration (FDA) has approved Ozurdex (dexamethasone intravitreal implant) for the treatment of diabetic macular edema (DME).
The Food and Drug Administration (FDA) has granted multiple Orphan Drug designations to aldoxorubicin for glioblastoma multiforme, small cell lung cancer, and ovarian cancer.
The National Institutes of Health (NIH) has admitted an American patient who has been exposed to the Ebola virus to its Clinical Center for observation and to enroll in a clinical protocol.
Alimera Sciences announced that the Food and Drug Administration (FDA) has approved Iluvien (fluocinolone acetonide intravitreal implant) for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP).
The Food and Drug Administration (FDA) is warning parents and caregivers not to use "Bo Ying compound" manufactured by Eu Yan Sang (Hong Kong) Ltd. due a potential lead poisoning risk associated with the product.
The Food and Drug Administration (FDA) is warning about a slightly increased risk of cardiovascular and cerebrovascular events among patients being treated with Xolair (omalizumab; Genentech and Novartis) for asthma compared to those not treated with Xolair.
The United States Marshals seized over 25,000 pounds of raw kratom material valued at more than $5 million from Rosefield Mangement, Inc. in Van Nuys, CA.
Novo Nordisk announced the discontinuation of Levemir (insulin detemir [rDNA origin] injection) FlexPen on September 30, 2014.
Bausch + Lomb announced positive results from the pivotal Phase 3 studies with Vesneo (latanoprostene bunod) for the reduction of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.
The National Institutes of Health (NIH) has announced thirteen research projects totaling approximately $21.7 million over five years to explore non-drug approaches to pain management and related health conditions in U.S. military personnel, veterans, and their families.
The Food and Drug Administration (FDA) has expanded the indication of the Nova StatStrip Glucose Hospital Meter System (Nova Biomedical) for use in critically ill patients who have been hospitalized.
AbbVie announced that the Food and Drug Administration (FDA) has approved Humira (adalimumab) for reducing signs and symptoms, and achieving and maintaining clinical remission, in pediatric Crohn's disease for patients ≥6 years old.
Boehringer Ingelheim announced that the Food and Drug Administration (FDA) has approved Spiriva Respimat (tiotropium bromide) inhalation spray for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD).
Noven announced that the Food and Drug Administration (FDA) has approved a new indication with a new dose of Minivelle (estradiol transdermal system) for the prevention of postmenopausal osteoporosis.
Lipocine announced top-line results from its Phase 3 SOAR clinical trial evaluating the efficacy and safety of LPCN 1021, an oral testosterone agent in hypogonadal men with low testosterone.
Rinovum Women's Health announced that the Food and Drug Administration (FDA) has cleared The Stork OTC, the first home-use conception assistance device.
The Food and Drug Administration (FDA) has granted Fast Track designation to aramchol (Galmed) for the treatment of nonalcoholic steatohepatitis (NASH).
Gilead announced results from Study 104 and Study 111 evaluating a once-daily single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults.
Celgene announced that the Food and Drug Administration (FDA) has approved Otezla (apremilast) for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate.
The Food and Drug Administration (FDA) has launched "Know Your Source," an educational program to advise healthcare professionals and practice administrators on the purchasing of prescription drugs to protect patients from unsafe and ineffective medications.
T2 Biosystems announced that it has received marketing clearance from the Food and Drug Administration (FDA) for their T2Candida Panel and T2Dx Instrument, the first blood test for the direct detection of Candida species in human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections.
The Food and Drug Administration (FDA) has granted Fast Track status to MedImmune's investigational monoclonal antibody (mAb), MEDI3902 for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa.
The FDA has granted Orphan Drug designation to olaptesed pegol (NOX-A12; NOXXON Pharma) for the treatment of glioblastoma in conjunction with radiotherapy.
OPKO Health announced top-line results from the final Phase 3 trial of Rayaldee for the treatment of secondary hyperparathyroidism (SHPT) in patients with Stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
Anacor announced the launch of Kerydin (tavaborole) topical solution, which is being distributed and commercialized by Sandoz.
Amgen announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for blinatumomab for the treatment of Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).
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.