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CDC Details New Ebola Response and Prep Teams

October 23, 2014 2:11 pm | by MIKE STOBBE, AP Medical Writer | News | Comments

New federal Ebola response squads — likened to public health SWAT teams — are being readied to rush to any U.S. city where a new Ebola case might be identified, officials say.             

EMA to Start Assessment of Ebola Vaccines and Treatments as Soon as Data are Made Available

October 23, 2014 1:35 pm | News | Comments

The EMA has established a form of rolling review that allows experts to continuously assess...

New Warning for Dietary Supplement Users

October 23, 2014 10:46 am | Videos | Comments

Researchers at Harvard found that two-thirds of dietary supplements that have previously been...

Poll: Many Doubt Hospitals Can Handle Ebola

October 23, 2014 8:19 am | by LAURAN NEERGAARD, Associated Press; EMILY SWANSON, Associated Press | News | Comments

Most Americans have some confidence that the U.S. health care system will prevent Ebola from...

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Vaxart Accelerates Development of Ebola Tablet Vaccine

October 23, 2014 8:10 am | News | Comments

Vaxart, a privately held company developing vaccines that are administered by tablet rather than by injection, today announced that the company is accelerating its Ebola tablet vaccine program. Following a recent meeting with the FDA, Vaxart anticipates commencing human clinical trials in the first quarter of 2015.

US to Track Everyone Coming from Ebola Nations

October 22, 2014 2:04 pm | by CONNIE CASS, Associated Press | News | Comments

Stepping up their vigilance against Ebola, federal authorities said Wednesday that everyone traveling into the U.S. from Ebola-stricken nations will be monitored for symptoms for 21 days. That includes returning American aid workers, federal health employees and journalists, as well as West African travelers.

GlobalData Analyst: Harvoni Will Keep Gilead Atop Hepatitis C Virus Treatment Landscape

October 22, 2014 10:43 am | News | Comments

The recent FDA approval of Harvoni, Gilead Sciences’ once-daily, single-tablet regimen to treat chronic hepatitis C virus genotype 1 infection in adults, will enable the company to maintain its dominance in an increasingly competitive market, says an analyst with research and consulting firm GlobalData.

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Study Finds Drugs Still in Recalled Supplements

October 22, 2014 8:58 am | by LINDSEY TANNER, AP Medical Writer | News | Comments

Dietary supplements containing potentially dangerous prescription drug ingredients may still be for sale even years after safety recalls, a study found. In supplements bought online, researchers detected hidden steroids, similar ingredients to Viagra and Prozac and a weight loss drug linked with heart attacks.

FDA Recommends Approval of KALYDECO®

October 22, 2014 8:51 am | News | Comments

Vertex announced that the FDA’s Pulmonary Allergy Drugs Advisory Committee voted 13-2 to recommend approval of KALYDECO® in people with cystic fibrosis ages 6 and older who have the R117H mutation in the cystic fibrosis transmembrane regulatory gene, which is the indication being reviewed by the FDA.

Off-Label Prescribing of Antipsychotic Drug Highlights Lack of Oversight

October 22, 2014 8:38 am | by Adam Miller, The Canadian Press | News | Comments

An increase in the number of prescriptions of a powerful antipsychotic drug for conditions not approved by Health Canada is raising concern about what medical experts call lack of professional and government oversight of doctors' prescribing practices.

Ebola Airport Checks Expand; Nurses Get Training

October 22, 2014 8:02 am | by CONNIE CASS, Associated Press; ALICIA A. CALDWELL, Associated Press | News | Comments

The federal government is closing a gap in Ebola screening at airports while states from New York to Texas to California work to get hospitals and nurses ready in case another patient turns up somewhere in the U.S. with the deadly disease.   

FDA Accepts NDA for Empagliflozin/Metformin Fixed-Dose Combination

October 21, 2014 9:01 am | News | Comments

The FDA has accepted the filing of a New Drug Application for empagliflozin plus immediate-release metformin hydrochloride fixed-dose combination, an investigational compound being studied for the treatment of adults with type 2 diabetes.  

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CDC Releases Revised Ebola Gear Guidelines

October 21, 2014 8:07 am | by MIKE STOBBE, Associated Press; EMILY SCHMALL, Associated Press | News | Comments

Federal officials are going on the road with new guidelines to promote head-to-toe protection for health workers treating Ebola patients. Centers for Disease Control and Prevention officials will be demonstrating the recommended techniques Tuesday at a massive training at New York City's Javits Center, with an expected attendance of thousands.

WHO: Ebola Vaccine Trials Could Start in West Africa in January

October 21, 2014 8:00 am | News | Comments

A top World Health Organization official says the hunt for an Ebola vaccine will produce data about whether they are safe by December — and they could be in experimental field use by January.          

FDA Recommends Approval of Novartis’ AIN457 (secukinumab) for Moderate-to-Severe Plaque Psoriasis

October 20, 2014 3:28 pm | News | Comments

Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the FDA voted 7 to 0 to support the approval of AIN457, a selective interleukin-17A inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

Pharmaceutical Processing's October 2014 Issue

October 20, 2014 11:34 am | Digital Editions | Comments

The October issue of Pharmaceutical Processing describes Capsugel’s merger with Bend Research and Encap to create a comprehensive solid dosage form solutions group. The issue also features articles on supply chain trends including how to reduce risk, managing a clinical supply chain,  a look at the best printing and coding solutions, and the move to the fully connected enterprise. Other articles focus on particle size analysis, disposable chromatography technologies, and monitoring potency assays.

Halozyme Receives FDA Approval for Additional Manufacturing Facilities For Hylenex Recombinant

October 20, 2014 9:02 am | News | Comments

The FDA approved the use of the Cook Pharmica manufacturing facility in Bloomington, Indiana for the production of bulk rHuPH20, the active ingredient used in Hylenex, and the Patheon facility in Greenville, North Carolina, for production of finished Hylenex product.

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Ebola Lapses Persisted for Days at Dallas Hospital

October 20, 2014 8:31 am | by MATT SEDENSKY, Associated Press | News | Comments

Just minutes after Thomas Eric Duncan arrived for a second time at the emergency room, the word is on his chart: "Ebola." But despite all the warnings that the deadly virus could arrive unannounced at an American hospital, for days after the admission, his caregivers are vulnerable.

WHO: Nigeria's Ebola Outbreak is Officially Over

October 20, 2014 8:19 am | by BASHIR ADIGUN, Associated Press; MARIA CHENG, Associated Press | News | Comments

The World Health Organization declared on Monday that Nigeria is free of Ebola, a rare victory in the months-long battle against the fatal disease.                 

Clinics Recommend Hospitals for Ebola Testing

October 20, 2014 8:14 am | by JULIE WATSON, Associated Press | News | Comments

When a Dallas County sheriff's deputy who had entered the apartment of the first patient to die from Ebola in the U.S. started feeling ill himself, he didn't rush to the nearest hospital. He chose an urgent care clinic.     

Anti-Abuse Label Approved for Painkiller Embeda

October 17, 2014 8:36 pm | by The Associated Press | News | Comments

The U.S. Food and Drug Administration says it has approved new labeling for another opioid designed to limit painkiller abuse. The FDA said Friday that Pfizer Inc.'s Embeda can have labeling indicating that it has properties expected to reduce abuse of the drug when it is crushed and taken orally or snorted.

Chimerix Gets FDA OK to Test Drug for Ebola

October 17, 2014 11:39 am | News | Comments

Chimerix has received FDA clearance to proceed with a trial examining the safety and effectiveness of its brincidofovir tablets in patients who have the virus.               

Nurses Infected With Ebola Being Treated With Experimental Drugs

October 17, 2014 8:26 am | Videos | Comments

Both Dallas nurses infected while treating an Ebola patient have been flown to better equipped facilities.                        

Obama Weighs Ebola Czar; Texas Toughens Monitoring

October 17, 2014 8:06 am | News | Comments

Facing renewed criticism about the U.S. response to Ebola, President Barack Obama is conceding that it may make sense to have a single person lead the administration's effort. But he says imposing a travel ban from disease-ravaged West Africa, as Republicans have demanded, would be counterproductive.

FDA Panel Votes to Keep Boxed Warning on Chantix

October 16, 2014 4:36 pm | by The Associated Press | News | Comments

Federal health advisers say a bold-letter warning about suicide risks with Pfizer's Chantix should remain on the anti-smoking drug until it can reevaluated based on new, rigorous study information. Eleven advisers to the Food and Drug Administration voted to retain the so-called black box warning.

HHS Advances Development of Third Ebola Vaccine

October 16, 2014 3:39 pm | News | Comments

The development of a vaccine to prevent Ebola virus disease will be accelerated with support from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).      

FDA Approves Esbriet to Treat Idiopathic Pulmonary Fibrosis

October 16, 2014 8:41 am | News | Comments

Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities.  

Existing Protocols Might Not Be Enough for Ebola

October 16, 2014 8:31 am | by MARTHA MENDOZA, AP National Writer | News | Comments

As Thomas Eric Duncan's health deteriorated, nurses Amber Joy Vinson and Nina Pham were at the Ebola patient's side. They wore protective gear including face shields, hazardous materials suits and protective footwear as they inserted catheters, drew blood and dealt with his body fluids. Still, the two somehow contracted Ebola from the dying man.

US Steps Up Domestic Response to Ebola Crisis

October 16, 2014 8:24 am | by JIM KUHNHENN, Associated Press | News | Comments

The federal government is ramping up its response to the Ebola crisis after a second Dallas nurse became ill and it was disclosed that she had been cleared to fly a day before her diagnosis.          

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