Unique Issues Voluntary Recall of Non-Expired Drugs

The FDA is alerting healthcare professionals and consumers of a voluntary recall of all non-expired drug products for sterile use by Unique Pharmaceuticals, as they may be contaminated.

Pradaxa Data Questioned in BMJ, Boehringer Ingelheim Responds

Boehringer Ingelheim has issued a statement regarding a recent article published in BMJ on the use of Pradaxa (dabigatran etexilate mesylate) and monitoring of anticoagulant activity and plasma levels.

hGH Use in Teens Troubling, Reports New Survey

Reports of lifetime use of synthetic human growth hormone (hGH) without a prescription has more than doubled since 2012 among teens, while alcohol consumption has significantly decreased and marijuana use has remained steady, states a new study from the Partnership for Drug-Free Kids.

Zydelig Approved for Three B-Cell Blood Cancers

The FDA has approved Zydelig (idelalisib; Gilead Sciences) for relapsed chronic lymphocytic leukemia (CLL), follicular B-cell non-Hodgkin lymphoma (FL), and small lymphocytic lymphoma (SLL).

Devices Used with Tyvaso Therapy Being Recalled

United Therapeutics announced a voluntary recall of the medical devices Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A due to incorrect software programming.

Ryanodex FDA-Approved To Treat Inherited Life-Threatening Condition

Eagle Pharmaceuticals announced that the FDA has approved Ryanodex (dantrolene sodium) for injectable suspension, an antidote for the management of malignant hyperthermia (MH), along with the appropriate supportive measures.

FDA Designates Orphan Drug for Rare Degenerative Eye Disease

The FDA has designated Recombinant Human Nerve Growth Factor (rhNGF; Dompe) Orphan Drug status for the treatment of neurotrophic keratitis.

Neratinib Demonstrates Potential in Breast Cancer Trial

Puma Biotechnology announced results from its Phase 3 ExteNET trial of neratinib (PB272) for the extended adjuvant treatment of breast cancer.

Tainted Sexual Supplement Contains Hidden Ingredient

Tainted Sexual Supplement Contains Hidden Ingredient

The FDA is warning consumers not to purchase or use O.M.G., a product marketed for sexual enhancement.

New Genetic Links to Schizophrenia Discovered

Researchers have unmasked 108 chromosomal sites harboring inherited variations in the genetic code linked to schizophrenia, of which 83 have never been reported before in the largest genomic dragnet of any psychiatric disorder to date.

FDA Accepts sBLA, Grants Priority Review for Avastin in Ovarian Cancer

The FDA grants Genentech's sBLA for Avastin (bevacizumab) plus chemotherapy Priority Review for the treatment of women with recurrent platinum-resistant ovarian cancer.

First Lots of Fluzone Shipped for 2014-2015 Flu Season

First Lots of Fluzone Shipped for 2014-2015 Flu Season

Sanofi Pasteur has announced that the first lots of Fluzone (Influenza vaccine) for the 2014-2015 season have been shipped.

Status Epilepticus Therapy Granted Fast Track Status

The FDA has designated Fast Track status to SAGE-547 (SAGE Therapeutics) for the treatment of adult patients with refractory status epilepticus who have not responded to standard regimens.

Sitavig Launched for Herpes Labialis

BioAlliance Pharma announced the launch of Sitavig (acyclovir) in the U.S. by Innocutis Holdings LCC for the treatment of recurring Herpes labialis.

Common Gene Variants Linked to Autism

New research has found that the majority of the genetic risk for autism is due to a common genetic variation, rather than rare or spontaneous mutations.

FDA Warns of Potential Sterile Drugs Contamination

The FDA is advising healthcare professionals and consumers against the use of drugs marketed as sterile by Downing Labs LLC, also known as NuVision Pharmacy in Dallas, TX, as they may be contaminated.

Mislabeling Causes Ibuprofen, Oxcarbazepine Recall

American Health Packaging announced a voluntary recall of Ibuprofen Tablets 600mg and Oxcarbazepine Tables 300mg due to mislabeled inner unit dose blister packaging.

RG-102 Desginated Orphan Drug for Alport Syndrome

The FDA has granted Orphan Drug designation to RG-012 (Regulus), a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21 for the treatment of Alport syndrome.

FedEx Indicted for Illegal Drug Shipments From Online Pharmacies

The FedEx Corporation has been indicted with charges relating to conspiracies with two separate but related online pharmacy organizations to distribute misbranded prescription drugs and controlled substances to U.S. consumers without requiring a valid prescription.

Positive Phase 3 Results in Secondary Hyperparathyroidism with AMG 416

Positive Phase 3 results announced for AMG 416 (Amgen) for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD), receiving hemodialysis.

Eylea Efficacious in Diabetic Macular Edema Trial

Regeneron announced results from its Phase 3 VIVID-DME trial of Eylea (afilbercept) injection for the treatment of diabetic macular edema (DME).

Vyvanse, Concerta Go Head-to-Head in ADHD Study

Shire announced top-line results from two Phase 4 efficacy and safety studies of Vyvanse (lisdexamfetamine dimesylate) compared to Concerta (methylphenidate HCl) in patients with Attention Deficit Hyperactivity Disorder (ADHD).

Multivitamin Launched for Malabsorptive Conditions

Multivitamin Launched for Malabsorptive Conditions

Libertas Pharma announced the launch of Multivitamins with A, B, D, E and K plus Zinc in three different formulations for patients with malabsorptive conditions, including cystic fibrosis.

FDA Designates Antifungal Agent QDIP Status

The FDA has designated isavuconazole (Astellas) as a Qualified Infectious Disease Product (QDIP) for the treatment of invasive candidiasis.

Vials of Dengue, Influenza, Q Fever, Rickettsia Uncovered in FDA Labs

The FDA has issued an update regarding the discovery of vials containing the smallpox virus in a FDA storage room on July 1, 2014.

Ruconest Approved for Acute Angioedema Attacks in HAE

Salix and Pharming Group NV announced that the FDA has approved Ruconest (C1 Esterase Inhibitor [Recombinant]) for the treatment of acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE).

Baxter Recalls Potassium Chloride, Sodium Chloride Injections

Baxter announced a voluntary recall of one lot of highly concentrated Potassium Chloride Injection 20mEq/50mL in a ViaFlex Container and three lots of 0.9% Sodium Chloride Injection due to particulate matter, found in the solutions.

Nintedanib Granted Breakthrough Therapy for Idiopathic Pulmonary Fibrosis

The FDA has granted Breakthrough Therapy designation to Boehringer Ingelheim's nintedanib for the treatment of idiopathic pulmonary fibrosis (IPF).

More Dosing Options for Butrans

Purdue Pharma announced that it has received FDA approval for a new 7.5mcg/hour dosage strength of Butrans (buprenorphine) Transdermal System CIII and the use of two patches to facilitate dose adjustments during titration, with a total max dose from both patches of 20mcg/hour.

Positive Phase 3 Results for Once Weekly Prophylaxis for Hemophilia B

Positive Phase 3 Results for Once Weekly Prophylaxis for Hemophilia B

Pfizer announced positive results of a Phase 3 study comparing BeneFIX Coagulation Factor IX (Recombinant) to on-demand treatment in patients with moderately severe to severe hemophilia B.

Olysio + Sofosbuvir sNDA Designated Priority Review

The FDA has designated Priority Review to the supplemental New Drug Application (sNDA) for Olysio (simeprevir) in combination with sofosbuvir for 12 weeks of treatment in adults with genotype 1 chronic hepatitis C.

FDA Accepts NDA Resubmission for PA32540/PA8140

The FDA has accepted for review Pozen's resubmitted New Drug Application (NDA) for aspirin and omeprazole (PA32540/PA8140) delayed-release tablets.

Octagam 10% Approved for Platelet Disorder

The FDA has approved Octagam 10% [Immune Globulin Intravenous (Human)] liquid preparation for the treatment of adults with chronic immune thrombocytopenic purpura (ITP).

Priority Review, sBLA Granted for Cervical Cancer Tx

The FDA has accepted Genentech's supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer.

Methylphenidate XR-ODT Effective in Phase 3 ADHD Study

Neos Therapeutics announced the completion of a positive Phase 3 study for its investigational methylphenidate XR-ODT (NT-0102) drug candidate in children with Attention Deficit/Hyperactivity Disorder (ADHD).

Albuterol MDPI NDA Accepted for Review for Bronchospasms

The FDA has accepted for review Teva's New Drug Application (NDA) for albuterol multi-dose dry-powder inhaler (MDPI) for the treatment or prevention of bronchospasm in patients with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm (EIB) both in patients ≥12 years of age.

FDA Accepts Investigational Basal Insulin NDA for Review

The FDA has accepted for review the New Drug Application (NDA) for Toujeo (insulin glargine [rDNDA origin]; Sanofi) injection, an investigational basal insulin.

Eosinophilic Esophagitis May Have Genetic Cause

Eosinophilic Esophagitis May Have Genetic Cause

Genetic markers associated with eosinophilic esophagitis (EoE) have been identified, suggesting that several genes are involved in the development of EoE.

NDA Submitted for Brexpiprazole in Schizophrenia, MDD

Otsuka and Lundbeck announced the submission of a New Drug Application (NDA) to the FDA for brexpiprazole for the treatment of schizophrenia and as adjunctive treatment of major depressive disorder (MDD).

Sterile Drugs Possibly Contaminated, Warns FDA

The FDA is alerting healthcare professionals not to use drugs marketed as sterile by Unique Pharmaceuticals as they may be contaminated.

sNDA Submitted for Invega Sustenna Label Expansion

Janssen submitted a supplemental New Drug Application (sNDA) to the FDA for a label change to include new data demonstrating significantly delayed time to relapse in patients taking Invega Sustenna (paliperidone palmitate) compared to other selected oral antipsychotics for the treatment of schizophrenia.

FDA Approves Rasuvo Injection for RA, JIA, Psoriasis

FDA Approves Rasuvo Injection for RA, JIA, Psoriasis

Medac Pharma announced that the FDA has approved Rasuvo (methotrexate) subcutaneous auto-injector for the management of rheumatoid arthritis, polyarticular-course juvenile idiopathic arthritis (pJIA), and severe, recalcitrant, disabling psoriasis.

Combination Melanoma Therapy Effective in Phase 3 Trial

Genentech announced results from coBRIM, a Phase 3 trial evaluating cobimetinib in combination with Zelboraf (vemurafenib) in previously untreated patients with unresectable locally advanced or metastatic melanoma harboring the BRAFV600 mutation.

CDC Addresses Recent Anthrax, Bird Flu Safety Lapses

The CDC released a report reviewing the incident in June that involved the unintentional exposure of potentially viable anthrax at the CDC's Roybal Campus.

Lactated Ringers and 5% Dextrose Inj Found to Contain Mold

Hospira announced a voluntary nationwide recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000mL, Flexible Container.

Antiretroviral Drugs Recommended for All MSM, Says WHO

Antiretroviral Drugs Recommended for All MSM, Says WHO

For the first time, the WHO is strongly recommending that men who have sex with men (MSM) consider pre-exposure prophylaxis for the prevention of HIV infection in addition to the use of condoms.

DEA: Pain Drug Tramadol Now a Controlled Substance

The Drug Enforcement Administration (DEA) has officially declared tramadol as a Class IV substance.

Restoring Memory via Implants for TBI Patients

Restoring Memory via Implants for TBI Patients

The Defense Advanced Research Projects Agency (DARPA) announced that two universities will lead the agency's Restoring Active Memory (RAM) program to develop and test wireless, implantable devices to restore memory incurred due to traumatic brain injury (TBI) or disease.

Isavuconazole NDA Submitted for Invasive Fungal Infections

Astellas has submitted a New Drug Application (NDA) to the FDA for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis.

Secukinumab Demonstrates Potential in Phase 3 Psoriasis Trials

Novartis announced results from two Phase 3 trials evaluating secukinumab in patients with moderate-to-severe plaque psoriasis.

First Naloxone Product for Caregiver Administration Now Available

First Naloxone Product for Caregiver Administration Now Available

Kaléo, Inc. announced that Evzio (naloxone HCl injection) auto-injector is now commercially available for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or CNS depression.

Novel Gene Mutations Linked to Common Lung Cancer ID'ed

Novel Gene Mutations Linked to Common Lung Cancer ID'ed

Researchers at The Cancer Genome Atlas (TCGA) Research Network have identified genetic mutations in the cell signaling pathway RTK/RAS/RAF that can lead to lung adenocarcinoma, the most common subtype of lung cancer.

Monistat Introduces Complete Care Products Line

Monistat announced the launch of Monistat Complete Care products, which include a vaginal health test, probiotics, and an odor-neutralizing gel.

Tainted Weight Loss Supplement Warning from FDA

The FDA is warning consumers to not buy or use 6 supplements that are promoted for weight loss.

EpiCeram Airless Pump Now Available

EpiCeram Airless Pump Now Available

PuraCap announced the introduction of EpiCeram Airless Pump, the latest addition to the EpiCeram line.

AMD Patients See Depression Risk Reduced with Behavioral, Occupational Therapy

A new study funded by the National Eye Institute (NEI) has found that behavior activation and low-vision occupational therapy can reduce the risk of depression by 50% in patients with age-related macular degeneration (AMD).

Smallpox Discovery Leads to Government Investigation

Scientists of the National Institutes of Health (NIH) found vials labeled "variola" in an unused portion of a storage room in a FDA laboratory on the NIH Bethesda campus.

Extreme Obesity May Cut 14 Years Off One's Life

Extreme Obesity May Cut 14 Years Off One's Life

Adults with extreme obesity have increased risks of dying at a young age from cancer and other conditions, including heart disease, stroke, diabetes, and kidney and liver diseases, according to results of a pooled analysis.

New Flublok Vaccine Strain for 2014/15 Season

New Flublok Vaccine Strain for 2014/15 Season

Protein Sciences announced that the FDA has approved the strain change amendment for its 2014/15 seasonal influenza vaccine, Flublok.

Positive Results for AuriPro in Pediatric Patients

Otonomy announced positive results from two Phase 3 trials of AuriPro (ciprofloxacin) for intra-operative treatment of middle ear effusion in pediatric patients requiring tympanostomy tube placement surgery.

New Data on Arformoterol for Respiratory Death, COPD Hospitalization

Sunovion announced data from a one-year study on the risk of respiratory death or chronic obstructive pulmonary disease (COPD) exacerbation-related hospitalization in patients taking arformoterol tartrate (Brovana).

Low-Volume, Short Infusion Time Tx Designated Orphan Drug for Hematological Cancers

The FDA has granted Orphan Drug designation to bendamustine HCl (Eagle Pharmaceuticals) for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin's lymphoma (NHL).

NDA Granted Priority Review for Hydrocodone Bitartrate

The FDA has granted Priority Review designation to hydrocodone bitartrate tablets (HYD), an investigational once-daily pain medication.

OTC Wearable Device for Chronic Pain Cleared by FDA

NeuroMetrix announced that it has received FDA premarket clearance for its wearable technology for the treatment of chronic pain.

Novel Antifungal Solution Approved for Toenail Onychomycosis

Anacor announced that the FDA has approved Kerydin (tavaborole) 5% topical solution for the treatment of onychomycosis of the toenails.

NovoSeven RT Gains Expanded Indication

The FDA announced the approval of NovoSeven RT for the treatment of patients with refractory Glanzmann's Thrombasthenia (GT).

ENMD-2076 Designated Orphan Drug for Hepatocellular Carcinoma

CASI Pharmaceuticals announced that the FDA has granted Orphan Drug designation to ENMD-2076 for the treatment of hepatocellular carcinoma (HCC).

First Genetic Identifier for Autism Found

New research has found a genetic identifier for autism that includes physical features that may eventually allow clinicians to identify babies at risk for autism before they are born.

FDA Approves Beleodaq for Peripheral T-cell Lymphoma

The FDA has approved Beleodaq (belinostat; Spectrum Pharmaceuticals) for the treatment of patients with peripheral T-cell lymphoma (PTCL).

Flu Vaccines Hitting U.S. Shelves Soon

Flu Vaccines Hitting U.S. Shelves Soon

Novartis announced that it has begun shipment of its seasonal influenza vaccines for the 2014-2015 season, with a minimum shipment of 30 million doses of the Influenza Virus Vaccines Flucelvax and Fluvirin prior to the influenza season peak.

Contact-Free Vital Signs Monitoring Device Gets FDA Clearance

Contact-Free Vital Signs Monitoring Device Gets FDA Clearance

EarlySense has announced that the FDA has issued clearance for the Chair Sensor Solution, the first automatic contact-free sensor for continuous monitoring of patients' vital signs in a chair.

NDA for Idiopathic Pulmonary Fibrosis Drug Granted Priority Review

The FDA has accepted for filing and granted priority review designation to Boehringer Ingelheim's New Drug Application (NDA) for nintedanib for the treatment of idiopathic pulmonary fibrosis (IPF).

This Map Will Tell You if Your State is Overprescribing Opioids

The CDC's Vital Report evaluated prescribing rates by state for various types of opioid painkillers, long-acting/extended-release (LA/ER) opioid painkillers, high-dose opioid painkillers, and benzodiazepines.

Typhoid-Causing Foodborne Bacteria Increasing Resistance

The most recent data from the Centers for Disease Control and Prevention (CDC) shows that while multi-drug resistant foodborne Salmonella decreased during the past 10 years and drug resistance remained low in 2012, resistance in the germ that causes typhoid fever to quinolone drugs increased significantly in 2012.

Coumadin Injection Recalled for Visible Particulate

Bristol-Myers Squibb announced a voluntary recall of 6 lots of Coumadin for Injection, 5mg single-use vials, in the U.S.

Positive Outcomes for Sebelipase Alfa in Lysosomal Acid Lipase Deficiency Trial

Synageva BioPharma announced that the Phase 3 ARISE trial of sebelipase alfa in patients with lysosomal acid lipase deficiency (LAL Deficiency) met the primary endpoint.

Breakthrough Therapy for Acute Lymphoblastic Leukemia Granted

The FDA has granted Breakthrough Therapy designation to blinatumomab for adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).

Somatuline Depot sNDA Submitted for GEP-NETs

Ipsen Biopharmaceuticals announced that it has submitted a supplemental New Drug Application (sNDA) to the FDA for Somatuline Depot 120mg injection for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Positive Response with Repeat Rifaximin Treatment in IBS-D

Salix announced results from the Phase 3 TARGET 3 trial evaluating the use of repeat treatment with rifaximin 550mg in patients with irritable bowel syndrome with diarrhea (IBS-D).

Lead Linked to Child Behavioral Problems, Even at Lower Levels

Even at lower levels, blood lead concentrations have been linked to an increased risk of behavioral problems in preschool children, including internalizing and pervasive developmental problems.

FDA: Injectable Vitamins Being Recalled

The FDA is alerting healthcare professionals not to use injectable vitamin products distributed by Medical Supply Liquidators LLC in Clive, IA, with "Sunshine Labs" on the label.

New OTC Gel for Bacterial Infection Prevention, Treatment

SteriWeb Medical announced that it has received FDA over-the-counter (OTC) clearance for Omnicide Antimicrobial Gel, a long-lasting non-antibiotic petroleum-based topical gel for the treatment and prevention of bacterial infections and protection of the affected area.

New Dermatoses Ointment Launched

Aqua Pharmaceuticals announced the launch of Cordran Ointment (flurandrenolide) 0.05% for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Liver Supercooling May Preserve Organs Longer

Liver Supercooling May Preserve Organs Longer

A new supercooling technique to increase the amount of time that organs can remain viable outside of the body has succeeded in clinical trials involving rats, and could improve transplantation outcomes in humans.

Emend Shows Potential in Pediatric Chemotherapy-Induced Nausea, Vomiting

Merck announced results from a Phase 3 Emend (aprepitant) study in the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric cancer patients, aged 6 months to 17 years.

FDA Approves Labeling Update for Gattex Injection

FDA Approves Labeling Update for Gattex Injection

NPS Pharmaceuticals announced that the FDA has approved updated labeling for Gattex (teduglutide [rDNA origin]) for injection to include long-term data from the STEPS 2 study of adult patients with short bowel syndrome.

Qudexy XR Now Available for Epilepsy

Qudexy XR Now Available for Epilepsy

Upsher-Smith announced the launch of Qudexy XR (topiramate) extended-release capsules.

New Inhaled Insulin Approved

New Inhaled Insulin Approved

The FDA announced the approval of Afrezza (insulin human; MannKind) Inhalation Powder for the improvement of glycemic control in adults with diabetes mellitus.

First Wearable, Motorized Exoskeleton for Paraplegics Cleared by FDA

First Wearable, Motorized Exoskeleton for Paraplegics Cleared by FDA

The FDA has cleared the first motorized device intended to act as an exoskeleton in individuals with paraplegia due to spinal cord injuries for use at home and in the community.

Telemedicine Effective in Retinopathy of Prematurity Screening

Telemedicine Effective in Retinopathy of Prematurity Screening

Telemedicine is a valid means of screening for retinopathy of prematurity (ROP), reports a new study in JAMA Ophthalmology.

HIV Lab Testing Recommendations Updated

HIV Lab Testing Recommendations Updated

The Centers for Disease Control and Prevention (CDC) has released updated recommendations on laboratory testing for diagnosing HIV infection in patients >24 months of age.

Oral Viscous Lidocaine Not For Teething Pain, Warns FDA

The FDA has issued a warning that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain, and that OTC topical medications may also be harmful and should not be used.

Medical Practice Pleads Guilty to Unapproved Cancer Drugs

A medical practice in KY has pleaded guilty to federal charges regarding the purchasing and selling of unapproved and improperly labeled chemotherapy drugs.

Pradaxa Antidote, Idarucizumab Designated Breakthrough Therapy

The FDA has granted Breakthrough Therapy designation to idarucizumab (Boehringer Ingelheim), an investigational fully humanized antibody fragment (Fab), being evaluated as a specific antidote for Pradaxa (dabigatran etexilate mesylate).

FDA Warns of Potentially Serious Reactions to OTC Topical Acne Products

The FDA has issued a warning that certain over-the-counter (OTC) topical acne medications may cause rare but serious and potentially life-threatening allergic reactions or severe irritation.

13,000+ Bottles of Metoprolol Succinate Recalled

The FDA has announced a nationwide recall of over 13,000 bottles of Dr. Reddy's Laboratories' Metoprolol Succinate Extended-Release Tablets,

Non-Steroidal Eczema, Psoriasis Spray Launched

Non-Steroidal Eczema, Psoriasis Spray Launched

Quest Products announced the launch of ProVent Eczema and Psoriasis Spray indicated to help minimize the appearance of skin conditions often associated with eczema and psoriasis.

Superior Overall Survival with Nivolumab in Skin Cancer Trial

Bristol-Myers Squibb's Phase 3 study, CheckMate -066 evaluating nivolumab vs. dacarbazine (DTIC) in patients with previously untreated BRAF wild-type advanced melanoma was stopped early due to an analysis demonstrating evidence of superior overall survival in patients receiving nivolumab compared to the control arm.

Hidden Statin Found in Red Yeast Rice Capsules

Hidden Statin Found in Red Yeast Rice Capsules

Doctor's Best announced a voluntary nationwide recall of over 7,000 bottles of Red Yeast Rice dietary supplements 600mg capsules used to lower cholesterol.

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