New Once-Daily Inhaler for Asthma Approved

GlaxoSmithKline announced that the Food and Drug Administration (FDA) has approved Arnuity Ellipta (fluticasone furoate inhalation powder) for the maintenance treatment of asthma as prophylactic therapy in patients ≥12 years old.

New First-Line Oral Therapy for Gaucher Disease Approved

Genzyme announced that the Food and Drug Administration (FDA) has approved Cerdelga (eliglustat) capsules for the treatment of certain adult Gaucher disease type 1 patients.

Rare Gene Mutation May Explain Cause of Mental Disorders

A recent study has shown how a rare mutation in a suspect gene disrupts the turning on and off of dozens of other genes underlying neuron connections, which may help explain the root of major mental disorders.

New Prenatal Test ID's Multiple Chromosomal Abnormalities

LabCorp announced the launch of the informaSeq Prenatal Test, a non-invasive prenatal screening assay that can assess for multiple fetal chromosomal aneuploidies, or abnormalities in the number of chromosomes from a single maternal blood draw.

Positive Results for AMG 416 in Secondary Hyperparathyroidism Trial

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

Combination Antibiotic Effective for Complicated Intra-Abdominal Infections

Actavis announced positive topline results from its Phase 3 studies, RECLAIM-1 and -2, evaluating the use of ceftazidime-avibactam for the treatment of hospitalized adults with complicated intra-abdominal infections (cIAI).

First Needle-Free Inactivated Flu Vaccine Approved

First Needle-Free Inactivated Flu Vaccine Approved

bioCSL and PharmaJet announced that the Food and Drug Administration (FDA) has approved the PharmaJet Stratis 0.5mL Needle-Free Jet Injector for delivery of Afluria (trivalent, inactivated "split virus" influenza vaccine) in patients aged 18-64 years.

New Basal Insulin Granted Tentative FDA Approval

New Basal Insulin Granted Tentative FDA Approval

The Food and Drug Administration (FDA) has granted tentative approval for Basaglar (insulin glargine injection; Boehringer Ingelheim and Lilly) to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with type 1 diabetes.

Could Early Antibiotic Exposure Contribute to Future Obesity?

Antibiotic exposure during a critical window of early development alters the gut microbes and permanently reprograms the body's metabolism, which may increase one's susceptibility to obesity.

Potential Allergen in Gluten-Free Foods, Warns FDA

Potential Allergen in Gluten-Free Foods, Warns FDA

The Food and Drug Administration (FDA) has issued an alert regarding an ingredient commonly found in gluten-free products that may cause anaphylaxis in patients with a legume allergy.

Fresenius Kabi Launches Acetylcysteine 10% Solution

Fresenius Kabi announced the launch of Acetylcysteine Solution, 10%.

First Peginterferon Beta Approved for Relapsing Multiple Sclerosis

First Peginterferon Beta Approved for Relapsing Multiple Sclerosis

Biogen Idec announced that the Food and Drug Administration (FDA) has approved Plegridy (peginterferon beta-1a) for the treatment of relapsing forms of multiple sclerosis (RMS).

Palbociclib NDA Submitted for Advanced Breast Cancer

Palbociclib NDA Submitted for Advanced Breast Cancer

Pfizer announced that it has submitted an NDA to the FDA for palbociclib in combination with letrozole for the treatment of postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for the advanced disease.

Once-Daily Amoxicillin Tabs Set to Relaunch

Once-Daily Amoxicillin Tabs Set to Relaunch

Pragma Pharmaceuticals announced the relaunch of Moxatag (amoxicillin extended-release) tablets.

Avastin Gains New Indication for Metastatic Cervical Cancer

Genentech has announced that the Food and Drug Administration (FDA) has approved Avastin (bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of women with persistent, recurrent, or metastatic cervical cancer.

Investigational Meningococcal B Vaccine BLA Under Review

The FDA has accepted for review Pfizer's Biologics License Application (BLA) for bivalent recombinant LP2086 (rLP2086), a vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10-25 year olds.

Beware of Ebola Supplements Sold Online, Warns FDA

The Food and Drug Administration (FDA) is warning consumers not to purchase or use products sold online claiming to prevent or treat the Ebola virus.

CDC Updates Flu Vaccine Recommendations for 2014-15

The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) has issued updated recommendations regarding the use of seasonal influenza vaccines for the 2014-2015 influenza season.

ACIP Recommends Prevnar 13 for Seniors

ACIP Recommends Prevnar 13 for Seniors

The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) has issued updated recommendations on the use of pneumococcal vaccines in adults ≥65 years of age.

Steel, Fiber, PVC ID'd in Dianeal Dialysis Solution

Steel, Fiber, PVC ID'd in Dianeal Dialysis Solution

Baxter announced a voluntary recall of 2 lots of Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II).

Hepatitis C Drug Incivek to Be Discontinued

Hepatitis C Drug Incivek to Be Discontinued

Vertex Pharmaceuticals announced that it will be discontinuing the sale and distribution of Incivek (telaprevir) tablets in the United States by October 16, 2014.

First-in-Class Drug Approved for Insomnia

The Food and Drug Administration (FDA) has approved Belsomra (suvorexant; Merck) tablets for use as needed to treat insomnia.

FDA Approves New Parenteral Nutrition Therapy

B. Braun Medical Inc. announced that the FDA has approved Nutrilipid 20% (IV fat emulsion) for parenteral nutrition therapy in adult and pediatric patients.

XVIVO Perfusion System Approved to Preserve Donor Lungs

XVIVO Perfusion System Approved to Preserve Donor Lungs

The FDA has approved the XVIVO Perfusion System (XPS) with STEEN Solution for preserving donated lungs that do not initially meet the standard criteria for lung transplantation.

One-Third of ER Visits for Zolpidem Due to Overdose

One-Third of ER Visits for Zolpidem Due to Overdose

The Drug Abuse Warning Network (DAWN) Report evaluated zolpidem involvement in ER visits that were linked to overmedication.

23andMe, Pfizer to Study Genetic Link in Inflammatory Bowel Disease

23andMe, Pfizer to Study Genetic Link in Inflammatory Bowel Disease

23andMe announced an agreement with Pfizer about a research initiative designed to study the genetic factors associated with the onset, progression, severity, and response to treatment for inflammatory bowel disease (IBD).

Rifaximin Efficacious in Irritable Bowel Syndrome with Diarrhea Trial

Salix announced top-line results from its Phase 3 TARGET 3 clinical trial evaluating rifaximin 500mg in patients with irritable bowel syndrome with diarrhea (IBS-D), who respond to an initial treatment course with rifaximin 500mg.

First Stool DNA Colorectal Cancer Screening Test OK'd by FDA

First Stool DNA Colorectal Cancer Screening Test OK'd by FDA

Exact Sciences has announced the Food and Drug Administration (FDA) approval of Cologuard, the first non-invasive DNA screening test for colorectal cancer.

Two Hidden Ingredients Found in Sex Enhancement Supplements

Two Hidden Ingredients Found in Sex Enhancement Supplements

The Food and Drug Administration (FDA) is advising consumers to not buy or use Arize and Herbal Vigor Quick Fix, products marketed for sexual enhancement.

Diprivan Now Available in 10mL Vials

Fresenius Kabi announced the introduction of Diprivan (propofol) injectable emulsion in 10mL single patient infusion vials.

Velcade Gains Retreatment Indication for Multiple Myeloma

Millennium announced that the Food and Drug Administration (FDA) has approved Velcade (bortezomib) for the retreatment of adult patients with multiple myeloma (MM) who had previously responded to Velcade therapy and relapsed at least six months following completion of prior Velcade treatment.

Mocetinostat Designated Orphan Drug for Diffuse Large B-Cell Lymphoma

The FDA has granted Orphan Drug designation to mocetinostat (Mirati Therapeutics) for diffuse large B-cell lymphoma (DLBCL).

New Combination Tablet OK'd for Type 2 Diabetes

Janssen Pharmaceuticals announced that the FDA has approved Invokamet (canagliflozin and metformin HCl) tablets for the treatment of adults with type 2 diabetes.

Lucentis sBLA Submitted for Diabetic Retinopathy

Genentech has submitted a supplemental Biologics License Application (sBLA) to the FDA for Lucentis (ranibizumab) injection for the treatment of diabetic retinopathy.

FDA OK's Potential Ebola Drug Use in Humans

Tekmira announced that the FDA has confirmed its modification to the full clinical hold on the TKM-Ebola Investigational New Drug Application (IND) to a partial clinical hold.

FDA Approves Name Change for Lomustine

FDA Approves Name Change for Lomustine

NextSource Biotechnology announced that it has gained FDA approval for the use of tradename Gleostine (lomustine) as part of the company's plan to re-launch the medication.

DMAA Found in Lots of RegenESlim Capsules

Regeneca announced a voluntary nationwide recall of its RegenESlim appetite control dietary supplement.

FDA Warns of Infection Risk in Home Tattoo Kits

FDA Warns of Infection Risk in Home Tattoo Kits

Inks in some home tattoo kits are contaminated and could cause skin infections.

Could Creutzfeldt-Jakob Disease Be Diagnosed with a Nasal Brush?

Testing of olfactory epithelium samples obtained from nasal brushing may be an accurate means of diagnosis for Creutzfeldt-Jakob disease (CJD), according to a new study funded by the National Institutes of Health (NIH).

Drug-Related Suicide Attempts Up Among Young Adults, Middle-Aged Americans

Drug-Related Suicide Attempts Up Among Young Adults, Middle-Aged Americans

Drug-related emergency department (ED) visits involving suicide attempts increased significantly between 2005 and 2011, particularly for patients ages 18-29 and ages 45-64.

Orbactiv Gets FDA Nod to Treat Severe Skin Infections

The Medicines Company announced that the FDA has approved Orbactiv (oritavancin), the first and only single dose antibiotic administered intravenously for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible designated Gram-positive bacteria.

BLA Submitted for Investigational IV Anthrax Immune Globulin

Emergent BioSolutions announced that it has submitted a Biologics License Application (BLA) to the FDA for Anthrax Immune Globulin Intravenous (Human) [AIGIV] as an intravenous therapy for inhalation anthrax.

Pacritinib Designated Fast Track for Myelofibrosis

The FDA has granted Fast Track designation to pacritinib (CTI BioPharma) for the treatment of intermediate and high risk myelofibrosis.

Should Parkinson's Gene Test Results Be Available to Study Participants?

Should Parkinson's Gene Test Results Be Available to Study Participants?

A letter of the editor questions whether the results of genetic testing in clinical trials should be transparent to the study participants, particularly with Parkinsonism.

"Gluten-Free" Definition Standardized by FDA

"Gluten-Free" Definition Standardized by FDA

The FDA published a new regulation to provide a uniform definition of the term "gluten-free" for voluntary food labeling to help those who have celiac disease.

Potential Glass Particulate in Cubicin Vials

Cubist announced a voluntary recall of certain lots of Cubicin (daptomycin for injection) to the user level due to potential presence of glass particulate matter in vials.

Cannabis-Based Epilepsy Treatment to Undergo Testing

Cannabis-Based Epilepsy Treatment to Undergo Testing

PuraMed BioScience announced its plans to initiate testing of a new hemp-based epilepsy treatment in the 4th quarter of 2014.

Updated Treatment Recommendations for IBS, CIC

The American College of Gastroenterology (ACG) has issued a new systematic review regarding the management of irritable bowel syndrome (IBS) and chronic idiopathic constipation (CIC).

New Recommendations on Prostate Cx Active Surveillance

A multi-specialty team comprised of pathologists, radiation oncologist, surgeons, and urologists published their recommendations for determining prostate cancer active surveillance.

Shingles Vaccine Still Effective Post-Chemotherapy

The herpes zoster vaccine is effective in protecting older adults against shingles, even if they later undergo chemotherapy, according to new research.

Jakafi sNDA Accepted for Polycythemia Vera

The FDA has accepted for filing the supplemental New Drug Application (sNDA) for Jakafi (ruxolitinib) for the treatment of polycythemia vera in patients who have inadequate response to or intolerant of hydroxyurea.

Inhaled Pirfenidone Designated Orphan Drug for IPF

The FDA has granted Orphan Drug designation to pirfenidone (inhaled GP-101) for the treatment of idiopathic pulmonary fibrosis (IPF).

Afluria Flu Vaccine Shipment Has Begun

Afluria Flu Vaccine Shipment Has Begun

bioCSL Inc. announced that shipping has begun for Afluria influenza vaccine for the 2014-2015 flu season.

Novel Antibiotic Launched for ABSSSI, MRSA

Novel Antibiotic Launched for ABSSSI, MRSA

Cubist announced that Sivextro (tedizolid phosphate) is now available for the treatment of adult acute bacterial skin and skin structure infections (ABSSSI) in both the IV and oral formulations.

Growing Uncertainty in BP Treatment Targets

Growing Uncertainty in BP Treatment Targets

A new study has found that blood pressure (BP) below and above the current Eighth Joint National Committee (JNC 8) recommended targets is linked to an increased risk of renal disease and mortality.

New Flexbumin 5% Strength Approved

Baxter announced that the FDA has approved Flexbumin (albumin [human]) 5% solution for the treatment of hypovolemia, hypoalbuminemia due to general causes, burns, and for use during cardiopulmonary bypass surgery as a component of the pump prime.

Jentadueto Label Gets Clinical Trial Data Update

Jentadueto Label Gets Clinical Trial Data Update

Boehringer Ingelheim and Lilly announced that the U.S. prescribing information for Jentadueto (linagliptin and metformin HCl) now includes new clinical data from a prospective 24-week Phase 4 trial.

Glioblastoma Multiforme Therapy Designated Orphan Drug

The FDA has granted Orphan Drug designation to AbbVie's ABT-414 for patients with glioblastoma multiforme.

Pompe Disease Drug Now Approved for All Ages

The FDA announced the approval of Lumizyme (alglucosidase alfa; Genzyme) for the treatment of all patients with infantile-onset Pompe disease.

New Oral Diabetes Drug Approved

New Oral Diabetes Drug Approved

The FDA announced the approval of Jardiance (empagliflozin; Boehringer Ingelheim) tablets as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

FDA Seeks Diagnostic Test Regulation

FDA Seeks Diagnostic Test Regulation

The FDA has issued a final guidance on the development, review, and approval or clearance of companion diagnostics and is intending to publish a proposed risk-based oversight framework for laboratory developed tests (LDTs).

New Smaller ChloraPrep Applicator Launched

CareFusion announced the launch of its ChloraPrep 1mL applicator, the latest addition to the ChloraPrep line.

Striverdi Respimat Inhaler Approved for COPD

Striverdi Respimat Inhaler Approved for COPD

The FDA has approved Striverdi Respimat (olodaterol; Boehringer Ingelheim) inhalation spray for the treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema with airflow obstruction.

"Druggable Genes" Focus of New NIH Initiative

"Druggable Genes" Focus of New NIH Initiative

The National Institutes of Health (NIH) has announced a new collaborative initiative to explore poorly understood genes that could be altered with drug therapy, known as "druggable genes."

Tanzeum Now Available for Type 2 Diabetes

GlaxoSmithKline announced that Tanzeum (albiglutide) subcutaneous injection is now available.

Alirocumab Meets Primary Endpoint in Hypercholesterolemia Trials

Results announced from nine new Phase 3 ODYSSEY trials of alirocumab (Sanofi and Regeneron) in patients with hypercholesterolemia.

FDA Approves New Indication for Eylea

FDA Approves New Indication for Eylea

Regeneron announced that the FDA has approved Eylea (aflibercept) injection for the treatment of diabetic macular edema (DME).

Discolored Lidocaine Solution Prompts Recall

Hospira announced a voluntary recall of one lot of Lidocaine HCl Injection, 2% due to a report of discolored solution with visible particles.

Gene Chip Finds New Genetic Risk Factors for Parkinson's Disease

New research has identified over two dozen genetic risk factors involved in Parkinsonism, including six that were previously unknown.

Expanded Use of Imbruvica Approved

Expanded Use of Imbruvica Approved

The FDA has approved the expanded use of Imbruvica (ibrutinib; Pharmacyclics and Janssen Biotech) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion).

New Oral Doxycycline Formulation Approved

The FDA has approved the New Drug Application (NDA) for Acticlate (doxycycline hyclate) for the treatment of susceptible infections including adjunctive therapy in severe acne.

FDA Issues Complete Response Letter for Zalviso

The FDA has issued a Complete Response Letter (CRL) for AcelRx's NDA for Zalviso (sufentanil sublingual tablet system) for the management of moderate-to-severe acute pain in adult patients in the hospital setting.

Updated Jakafi Labeling Approved by FDA

The FDA has approved supplemental labeling for Jakafi (ruxolitinib; Incyte) to include new Kaplan-Meier overall survival curves as well as additional safety and dosing information.

GE Healthcare Issues Class I Recall for CO2 Detectors

GE Healthcare announced a Class I recall of Single-Width Airway Modules (E-MiniC), and Accessories and Extension Modules (N-FC, N-FCREC).

Clinicians Not Recommending HPV Vaccine Enough to Parents

Despite a slight increase in the number girls and boys ages 13-17 receiving a human papillomavirus (HPV) vaccine since 2012, approximately one third of parents of girls and over half of parents of boys reported that their child's clinician had failed to recommended the HPV vaccination during office visits.

CDC TB Lab Transfers Resume as New Safety Group Formed

After an extensive review by the CDC's internal Laboratory Safety Improvement Working Group, CDC Director Tom Frieden, MD, MPH, has lifted the moratorium on a specific type of material transfer for the CDC's Clinical Tuberculosis Laboratory.

OTC Version of Flonase Approved by FDA

GlaxoSmithKline announced that the FDA has approved Flonase Allergy Relief (fluticasone propionate 50mcg spray) as a once-daily over-the-counter (OTC) treatment indicated for symptoms of seasonal and perennial allergic and nonallergic rhinitis in patients ≥4 years of age

Abuse-Deterrent Opioid Targiniq ER Gets FDA Approval

The FDA has approved Targiniq ER (oxycodone HCl/naloxone HCl controlled-release; Purdue Pharma) Tablets, an extended-release/long-acting (ER/LA) opioid analgesic with abuse-deterrent properties.

Significant Physical, Emotional Burden Seen in Patients with Hypoparathyroidism

A new study reports that that the majority of patients with the rare endocrine disorder hypoparathyroidism report multiple physical, emotional, and cognitive symptoms that impact their lives personally and professionally.

Similac Launches Breastfeeding Supplement for Nursing Mothers

Similac Launches Breastfeeding Supplement for Nursing Mothers

A new Similac breastfeeding supplement is specially designed to enhance the levels of DHA, lutein, and vitamin E in breastmilk.

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.

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