Relistor Approved for Opioid-Induced Constipation in Chronic Non-Cancer Pain Patients

Relistor Approved for Opioid-Induced Constipation in Chronic Non-Cancer Pain Patients

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.

FDA Approves New Formulation for Abilify Maintena

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 Resubmits NDA for Eye Disorders

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.

Scalp Plaque Psoriasis Tx Approved for Pediatric Patients

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.

HHS to Fund Novel Drug for Cytokine Storm Prevention

The United States Department of Health and Human Services announced the development of an investigational drug, AB103, to treat a condition called cytokine storm.

Amino Acids May Be Early Marker of Pancreatic Cancer

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.

Adcetris Extends Survival in Post-Transplant Hodgkin Lymphoma Study

Seattle Genetics and Takeda announced results from the Phase 3 AETHERA trial with Adcetris (brentuximab vedotin) in patients with post-transplant Hodgkin lymphoma.

Combination Breast Cancer Therapy Extends Overall Survival

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.

Egg-Free Flu Vaccine Now Available for 2014/15 Season

Egg-Free Flu Vaccine Now Available for 2014/15 Season

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.

Cobimetinib + Zelborif Increased PFS in Melanoma Trial

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.

Phase 3 Results for Tafinlar in Mutant Metastatic Melanoma

GlaxoSmithKline announced updated results for Tafinlar (dabrafenib) from the Phase 3 BREAK-3 study in patients with BRAF V600E mutant metastatic melanoma.

Ozurdex Gains General DME Indication

Ozurdex Gains General DME Indication

Allergan announced that the Food and Drug Administration (FDA) has approved Ozurdex (dexamethasone intravitreal implant) for the treatment of diabetic macular edema (DME).

FDA Grants Aldoxorubicin Orphan Drug Designation

The Food and Drug Administration (FDA) has granted multiple Orphan Drug designations to aldoxorubicin for glioblastoma multiforme, small cell lung cancer, and ovarian cancer.

American Physician Admitted to NIH for Ebola Exposure

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.

Iluvien Implant Gains FDA Approval for DME

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).

Lead Poisoning Risk in Children's Powdered Product

Lead Poisoning Risk in Children's Powdered Product

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.

FDA: Asthma Drug May Increase Risk of CV, Cerebrovascular Events

FDA: Asthma Drug May Increase Risk of CV, Cerebrovascular Events

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.

$5 Million Worth of Kratom Seized by U.S. Marshals

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.

Levemir FlexPen to be Discontinued End of September

Levemir FlexPen to be Discontinued End of September

Novo Nordisk announced the discontinuation of Levemir (insulin detemir [rDNA origin] injection) FlexPen on September 30, 2014.

Vesneo Reduces Intraocular Pressure in Trials

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.

Alternative Pain Management Research for Veterans Announced by NIH

Alternative Pain Management Research for Veterans Announced by NIH

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.

First Glucose Monitoring System Cleared for All Hospitalized Patients

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.

Humira Gains Pediatric Crohn's Disease Indication

Humira Gains Pediatric Crohn's Disease Indication

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.

Spiriva Respimat Approved for COPD Maintenance

Spiriva Respimat Approved for COPD Maintenance

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).

Minivelle Patch Gains New Strength, New Indication

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.

Efficacy of Oral Testosterone in Hypogonadal Men Demonstrated in Study

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.

First OTC Conception Assistance Device Cleared

First OTC Conception Assistance Device Cleared

Rinovum Women's Health announced that the Food and Drug Administration (FDA) has cleared The Stork OTC, the first home-use conception assistance device.

Nonalcoholic Steatohepatitis Agent Fast Tracked by FDA

The Food and Drug Administration (FDA) has granted Fast Track designation to aramchol (Galmed) for the treatment of nonalcoholic steatohepatitis (NASH).

Investigational Single Tablet Regimen Noninferior to Stribild for HIV-1 Infection

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.

Otezla Tabs Gain New Psoriasis Indication

Otezla Tabs Gain New Psoriasis Indication

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.

FDA Launches Site to Warn Against Unlicensed Drug Distributors

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.

New Test for Candida Blood Stream Infection Offers Faster Results

New Test for Candida Blood Stream Infection Offers Faster Results

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.

Nosocomial Pneumonia Agent Designated Fast Track Status

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.

Olaptesed Pegol Designated Orphan Drug for Glioblastoma

The FDA has granted Orphan Drug designation to olaptesed pegol (NOX-A12; NOXXON Pharma) for the treatment of glioblastoma in conjunction with radiotherapy.

Rayaldee Efficacious in Secondary Hyperparathyroidism Trial

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.

First-in-Class Antifungal Available for Toenail Onychomycosis

Anacor announced the launch of Kerydin (tavaborole) topical solution, which is being distributed and commercialized by Sandoz.

Blinatumomab BLA Submitted for Acute Lymphoblastic Leukemia

Blinatumomab BLA Submitted for Acute Lymphoblastic Leukemia

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).

Government Plan to Fight Antibiotic-Resistant Bacteria Announced

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.

AACE/ACE Position Statement: Obesity is a Chronic Disease

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.

Lymphoseek Gains Orphan Drug Designation for Head, Neck Cancer Detection

Lymphoseek Gains Orphan Drug Designation for Head, Neck Cancer Detection

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.

Xultophy Shows Improved Glycemic Control, Weight Loss in T2DM

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.

Effects of Antihypertensives Last for T2DM Patients, Even After Stopping Tx

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.

Trulicity Pen Approved for Type 2 Diabetes

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.

Head, Neck Cancer Cancer Drug May Overcome Cetuximab Resistance

Head, Neck Cancer Cancer Drug May Overcome Cetuximab Resistance

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.

Healthcare Personnel Should Receive Flu Vaccine Yearly, Says ACIP

The Advisory Committee on Immunization Practice (ACIP) recommends that all healthcare personnel (HCP) be vaccinated against influenza every year.

Cyramza + Paclitaxel Demonstrates Efficacy in Cancer Trial

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.

FDA Approves Stendra's Rapid Onset of Action

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 Recalls Mislabled Lot of Potassium Chloride Injection

Baxter Recalls Mislabled Lot of Potassium Chloride Injection

Baxter announced a voluntary recall of one lot of Potassium Chloride Injection 10mEq/100mL at the hospital/pharmacy/nurse level.

Greater Awareness of Dementia Risk Factors Needed

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.

Omarigliptin Significantly Lowers HbA1c Levels in Trial

Merck announced results from the Phase 3 clinical program for omarigliptin, once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes.

Orthopedists Release Choosing Wisely Recommendations

The American Orthopaedic Foot & Ankle Society (AOFAS) has released a list of tests and procedures that are commonly ordered but not always necessary.

Memantine for Fibromyalgia: Results from First Randomized, Controlled Study

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.

CDC Advises Clinicians on Rare Respiratory Illness Outbreak

CDC Advises Clinicians on Rare Respiratory Illness Outbreak

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.

First-in-Class Movantik Approved for Opioid-Induced Constipation

The Food and Drug Administration has approved Movantik (naloxegol; AstraZeneca) for the treatment of opioid-induced constipation in adults with chronic non-cancer pain.

Eylea Granted Breakthrough Therapy for Diabetic Retinopathy

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).

Chocolate-Flavored OTC Cough/Cold Products Launched

Chocolate-Flavored OTC Cough/Cold Products Launched

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.

First Glucose Meter with Insulin Calculator Available

First Glucose Meter with Insulin Calculator Available

Roche announced the launch of Accu-Chek Aviva Expert system, the first blood glucose meter with a built-in insulin calculator.

Lynovex Designated Orphan Drug for Cystic Fibrosis

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Lynovex (NM001; NovaBiotics) for the treatment of cystic fibrosis (CF).

Uceris Rectal Foam for Distal Ulcerative Colitis Granted Tentative Approval

Uceris Rectal Foam for Distal Ulcerative Colitis Granted Tentative Approval

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.

NLA Issues New Dyslipidemia Management Recommendations

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.

Odanacatib Reduces Fracture Risk in Postmenopausal Women

Merck announced results from the Phase 3 LOFT study with odanacatib in postmenopausal women with osteoporosis.

New SC Inj for Primary Immunodeficiency Approved

New SC Inj for Primary Immunodeficiency Approved

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).

Rixubis Gains Pediatric Hemophilia B Indication

Rixubis Gains Pediatric Hemophilia B Indication

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.

Hidden Ingredients Found in Multiple Weight Loss Supplements

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.

Aleve PM Available for Overnight Pain Relief

Aleve PM Available for Overnight Pain Relief

Bayer HealthCare announced the launch of Aleve PM (naproxen and diphenhydramine) caplets for occasional sleeplessness associated with minor aches and pains.

FDA to Review Tuzistra XR NDA for Cough Cold

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.

Vyvanse Under Review for Binge Eating Disorder

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).

First-in-Class Test to Predict Liver, Intestine Transplant Rejection in Children

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.

Inflammation May Drive Blood Vessel Damage in Diabetes Patients

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.

New Wrist-Worn Device Monitors Parkinson's Symptoms, Sends Medication Reminders

New Wrist-Worn Device Monitors Parkinson's Symptoms, Sends Medication Reminders

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.

Saxenda for Obesity Recommended by FDA Panel

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

Heparin Sodium Recalled Due to Visible Particulate

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.

Tecifdera Efficacious for Relapsing-Remitting Multiple Sclerosis

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).

Plegridy Maintains Efficacy in Relapsing Multiple Sclerosis Trial

Plegridy Maintains Efficacy in Relapsing Multiple Sclerosis Trial

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).

Results for Humira in Chronic Skin Disease Trial

AbbVie announced results from the Phase 3 PIONEER 1 study with Humira (adalimumab) in patients with moderate-to-severe hidradenitis suppurativa (HS).

FDA Designates Antifungal Agent Orphan Drug Status

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.

Xtandi Approved for Metastatic Castration-Resistant Prostate Cancer

Xtandi Approved for Metastatic Castration-Resistant Prostate Cancer

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).

New Combo Tablet for Weight Management Approved

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

First Male Contraceptive Injection to Undergo Testing in 2015

First Male Contraceptive Injection to Undergo Testing in 2015

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 Kids Exceed Recommended Sodium Intake

Over 90% of Kids Exceed Recommended Sodium Intake

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).

Beware of Sterile Drugs from Downing Labs/NuVision, Warns FDA

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.

Dopamine May Explain Overeating in Obese, Says Study

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.

Mangos May Lower Blood Sugar in Obese, Study Suggests

Mangos May Lower Blood Sugar in Obese, Study Suggests

Regular consumption of mango by obese adults may lower blood sugar levels without a negative impact on body weight, a recent study suggests.

Needle-Free Lidocaine Delivery System Launched

Needle-Free Lidocaine Delivery System Launched

Marathon announced the launch of Zingo (lidocaine HCl monohydrate) powder intradermal injection system for the management of venous access pain.

Rolapitant NDA Submitted for Chemotherapy-Induced Nausea and Vomiting

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).

Nintedanib Efficacious in Idiopathic Pulmonary Fibrosis Trials

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.

Early Preeclampsia Detection Test Under Development

Early Preeclampsia Detection Test Under Development

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.

Tiotropium Improves Lung Function in Asthma Patients

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.

New Drug for Alcohol Use Disorder to Undergo Clinical Trial

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.

Menactra Gets OK for Booster Vaccination

Menactra Gets OK for Booster Vaccination

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.

CDC: Rare Respiratory Virus Outbreak Reported in Over 1000 Children in the U.S.

CDC: Rare Respiratory Virus Outbreak Reported in Over 1000 Children in the U.S.

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.

DEA: Pharmacies, Clinics Now Rx Drop-Off Sites

DEA: Pharmacies, Clinics Now Rx Drop-Off Sites

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.

Isavuconazole Under Review for Invasive Fungal Infections

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.

Ambrisentan + Tadalafil Efficacious for Pulmonary Arterial Hypertension

Ambrisentan + Tadalafil Efficacious for Pulmonary Arterial Hypertension

Gilead Sciences announced results from the Phase 3 AMBITION) study with ambrisentan and tadalafil for the treatment of pulmonary arterial hypertension.

Positive Results for Reslizumab in Asthma Trials

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.

Epaned Oral Solution Gains Two New Indications

Epaned Oral Solution Gains Two New Indications

Silvergate announced that the Food and Drug Administration (FDA) has approved Epaned (enalapril maleate powder for oral solution) for two additional indications.

Once-Weekly Pen for Diabetes Launched

Once-Weekly Pen for Diabetes Launched

AstraZeneca announced the availability of Bydureon (exenatide extended-release for injectable suspension) Pen in pharmacies across the country.

First-of-Kind Kidney Injury Risk Test Gets FDA Nod

First-of-Kind Kidney Injury Risk Test Gets FDA Nod

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.

Ferric Citrate OK'd for Hyperphosphatemia in CKD Patients

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.

Pharmacist Arrested in Fungal Meningitis Outbreak Case

Pharmacist Arrested in Fungal Meningitis Outbreak Case

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.

Sign Up for Free e-newsletters