Ebola Traced to Single Animal Source, Spread at Funeral

Ebola Traced to Single Animal Source, Spread at Funeral

The origin of the latest Ebola outbreak has been traced to a single transmission from animal to human that spread during the course of a funeral.

New Biosensor Monitors Vital Signs, Detects Falls

New Biosensor Monitors Vital Signs, Detects Falls

Vital Connect announced that the Food and Drug Administration (FDA) has granted clearance for its HealthPatch MD biosensor for 24-hour patient monitoring in their homes.

Elelyso Gains Pediatric Gaucher Disease Indication

Elelyso Gains Pediatric Gaucher Disease Indication

Pfizer and Protalix BioTherapeutics announced that the Food and Drug Administration (FDA) has approved Elelyso (taliglucerase alfa) for injection for pediatric patients.

Pioglitazone, Bladder Cancer Risk: No Link in 10-Year Study

Pioglitazone, Bladder Cancer Risk: No Link in 10-Year Study

Takeda announced their completion and data submission of a 10-year epidemiology study to regulatory authorities, including the United States Food and Drug Administration (FDA).

BLA for Novel Cholesterol Drug Submitted to FDA

BLA for Novel Cholesterol Drug Submitted to FDA

Amgen announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for evolocumab for the treatment of high cholesterol.

FDA Fast Tracks Clostridium Difficile Vaccine

The Food and Drug Administration (FDA) has granted Fast Track status for Pfizer's investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090).

Experimental Ebola Vaccine Testing Accelerated for Human Trials

An experimental Ebola vaccine, being co-developed by the United States National Institutes of Health (NIH) and GlaxoSmithKline, is to undergo accelerated human trials with funding from an international consortium in response to the epidemic.

First Treatment for Common Anemia Shows Promise

A recent study has demonstrated potential for lexaptepid pegol as the first treatment for anemia of inflammation, the most common form of anemia.

Chronic Heart Failure Drug Designated Priority Review Status

Chronic Heart Failure Drug Designated Priority Review Status

The Food and Drug Administration (FDA) has granted Priority Review to Amgen's New Drug Application (NDA) for ivabradine for the treatment of chronic heart failure.

First-in-Class Drug Gains New Indication for Severe Aplastic Anemia

First-in-Class Drug Gains New Indication for Severe Aplastic Anemia

GlaxoSmithKline announced that the Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the use of Promacta (eltrombopag) in patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).

Doctor Dies After Receiving Experimental Ebola Drug

Doctor Dies After Receiving Experimental Ebola Drug

Dr. Abraham Borbor, a Liberian doctor who contracted Ebola, has died after receiving one of the last doses of the experimental drug ZMapp.

Sulfonylurea Use, Cardiovascular Disease Connection Reviewed

In women with diabetes, long-term use of sulfonylureas may be associated with an increased risk of developing coronary heart disease (CHD), says a new study published in the journal Diabetes Care.

Will That Extra Cup of Coffee Lead to Death?

In a new study published in the American Journal of Therapeutics, data from the National Health and Nutrition Examination Survey III was used to determine whether coffee has an effect on cardiovascular and all-cause mortality.

Does Naltrexone Work for Impulse Control Disorders in Parkinson's Disease?

Does Naltrexone Work for Impulse Control Disorders in Parkinson's Disease?

A new study published in the journal Neurology looks at the use of naltrexone, an opioid antagonist, as a possible treatment for impulse control disorders (ICDs) in Parkinson's disease (PD).

Dangers Associated with the Ice Bucket Challenge

Dangers Associated with the Ice Bucket Challenge

While the Ice Bucket Challenge has raised significant funds for the ALS Association, there are risks associated with the stunt when it's done incorrectly.

Long-Term Data Reported for Ulcerative Colitis Drug Adalimumab

Long-Term Data Reported for Ulcerative Colitis Drug Adalimumab

New research published in The American Journal of Gastroenterology now reports on study data for up to 4 years of adalimumab treatment.

Second Increlex Batch Available in September

Ipsen announced its second resupply of Increlex (mecasermin [rDNA origin]) injection will be available in September 2014.

Aspirin, a Possible Alternative to Long-Term Anticoagulant Therapy

Aspirin, a Possible Alternative to Long-Term Anticoagulant Therapy

According to new research, aspirin may be a possible alternative for patients who can't take long-term anticoagulant drugs to prevent blood clots.

Jardiance Launched for Type 2 Diabetes

Jardiance Launched for Type 2 Diabetes

Boheringer Ingelheim and Eli Lilly announced that Jardiance (empagliflozin) tablets are now available in pharmacies.

Unique 3-Chamber Parenteral Nutrition Bag Approved

Unique 3-Chamber Parenteral Nutrition Bag Approved

Fresenius Kabi announced the Food and Drug Administration has approved Kabiven and Perikabiven in a 3-chamber bag.

Aripiprazole Lauroxil NDA Submitted for Schizophrenia

Alkermes announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for aripiprazole lauroxil for the treatment of schizophrenia.

Nipro Approved for Two Blood Glucose Monitoring Systems

Nipro Approved for Two Blood Glucose Monitoring Systems

Nipro Diagnostics announced that the Food and Drug Administration (FDA) has granted clearance for its True Metrix Self-Monitoring blood glucose system and the True Metrix Pro Professional Monitoring blood glucose system.

New Combo Tablets Approved for HIV-1 Infection

New Combo Tablets Approved for HIV-1 Infection

ViiV Healthcare announced that the Food and Drug Administration (FDA) has approved Triumeq (abacavir, dolutegravir, lamivudine) tablets for the treatment of HIV-1 infection.

Zorvolex Gains New Pain Indication

Zorvolex Gains New Pain Indication

Iroko announced that the Food and Drug Administration (FDA) has approved Zorvolex (diclofenac) capsules for the management of osteoarthritis pain.

CDC's Shingles Vaccine Recommendation Revisited

After reviewing evidence on the safety and efficacy of the herpes zoster vaccine in adults ages 50-59, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) has decided to maintain the current recommendation of routine herpes zoster immunization in adults aged ≥60 years of age.

Eliquis Gains Three New Indications

Eliquis Gains Three New Indications

Bristol-Myers Squibb and Pfizer announced that the Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Eliquis (apixaban) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE following initial therapy.

DEA Makes Official Change for Hydrocodone Combination Products

The U.S. Drug Enforcement Administration (DEA) announced it will publish the Final Rule moving hydrocodone combination products (HCPs) from Schedule III to Schedule II tomorrow in the Federal Register.

Blood Transfusions May Reduce Silent Strokes in Sickle Cell Anemia Children

Regular blood transfusion therapy could significantly reduce the incidence of recurrent cerebral infarcts in children with sickle cell anemia, which occur in approximately one-third of children with the disease.

Ixekizumab vs. Etanercept for Plaque Psoriasis: Phase 3 Results Announced

Eli Lilly and Company announced results from its Phase 3 UNCOVER studies of ixekizumab for the treatment of moderate-to-severe plaque psoriasis, in which ixekizumab was found to be superior to etanercept.

Investigational Hemophilia A Therapy Sees Positive Results

Investigational Hemophilia A Therapy Sees Positive Results

Baxter announced positive results from its Phase 3 trial of BAX 855, an extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A.

Xiaflex Demonstrates Efficacy in Cellulite Study

Auxilium announced positive results from a Phase 2a study of Xiaflex (collagenase clostridium histolyticum [CCH]) for the treatment of edematous fibrosclerotic panniculopathy (EEP), also known as cellulite.

Novel Autoantibody Test for Type 1 Diabetes Approved by FDA

The Food and Drug Administration (FDA) has granted marketing approval of the KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay, the first ZnT8Ab test to help determine if a person has type 1 diabetes.

First ECG App to Detect Atrial Fibrillation Gets FDA Clearance

First ECG App to Detect Atrial Fibrillation Gets FDA Clearance

AliveCor announced that the Food and Drug Administration (FDA) has granted clearance for its algorithm to detect atrial fibrillation (AFib).

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.

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