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FDA Advisory Committee Makes Recommendation to Approve Daiichi Sankyo's SAVAYSAT

October 31, 2014 8:28 am | News | Comments

Daiichi Sankyo announced that the FDA's Cardiovascular and Renal Drugs Advisory Committee voted 9 to 1 to recommend approval of once-daily SAVAYSAT 60 mg dosing regimen for the reduction in risk of stroke and systemic embolic events in patients with non-valvular atrial fibrillation.

Fearing Ebola? Doctors Say Get a Flu Shot

October 30, 2014 3:10 pm | by LINDSEY TANNER, AP Medical Writer | News | Comments

Fever? Headache? Muscle aches? Forget about Ebola — chances are astronomically higher that you...

FTC Sues Gerber Over Claims on Infant Formula

October 30, 2014 2:02 pm | by ANNE FLAHERTY, Associated Press | News | Comments

Federal regulators announced Thursday they were suing Gerber, the well-known baby food maker,...

FDA Approves Once-Daily XIGDUO™ XR Tablets for Adults with Type 2 Diabetes

October 30, 2014 8:04 am | News | Comments

AstraZeneca today announced that the FDA has approved once-daily XIGDUO™ XR (dapagliflozin and...

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FDA Grants Accelerated Approval to Pfizer’s TRUMENBA®

October 29, 2014 3:22 pm | News | Comments

Pfizer announced that the FDA has granted accelerated approval of TRUMENBA ® (meningococcal group B vaccine) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

US Health Care Unprepared for Ebola

October 29, 2014 2:00 pm | by JEFF DONN, Associated Press; GARANCE BURKE, Associated Press | News | Comments

The U.S. health care apparatus is so unprepared and short on resources to deal with the deadly Ebola virus that even small clusters of cases could overwhelm parts of the system, according to an Associated Press review of readiness at hospitals and other components of the emergency medical network.

EMA Advises on Development Plan for GSK Ebola Vaccine

October 29, 2014 11:15 am | News | Comments

The European Medicines Agency (EMA) has given scientific advice to GSK on its development plan for an Ebola vaccine. This is the first time in the current Ebola outbreak that EMA has given ‘rapid scientific advice’ using an accelerated procedure.

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Ebola: Race for a Vaccine

October 28, 2014 9:04 am | Videos | Comments

Health officials say a vaccine against Ebola could be ready in 2015.                               

How Some Colored Contacts Could Permanently Damage Your Eyes

October 28, 2014 8:53 am | Videos | Comments

The U.S. government is working to seize all colored contacts not approved by the FDA.                            

CDC: New Restrictions for Those at High Ebola Risk

October 28, 2014 8:45 am | by MIKE STOBBE, AP Medical Writer | News | Comments

U.S. health officials are recommending that people who are at highest risk for coming down with Ebola avoid commercial travel or attending large public gatherings, even if they have no symptoms. The CDC issued the updated advice to state and local officials on Monday.

Feds vs. States: Who Decides on Ebola Quarantines

October 28, 2014 8:41 am | by JOSH LEDERMAN, Associated Press | News | Comments

For Americans wondering why President Barack Obama hasn't forced all states to follow a single, national rule for isolating potential Ebola patients, the White House has a quick retort: Talk to the Founding Fathers.      

Swissmedic Approves Trial for Ebola Vaccine

October 28, 2014 7:35 am | by The Associated Press | News | Comments

The Swiss agency that regulates new drugs has approved an application for a clinical trial with an experimental Ebola vaccine at the Lausanne University Hospital. Swissmedic said the trial will be conducted among 120 volunteer participants with support from the U.N. World Health Organization.

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Drugmakers Bet on Ebola Vaccines, Treatments

October 26, 2014 9:33 am | by Matthew Perrone - Associated Press - Associated Press | News | Comments

Drugmakers are racing to develop vaccines and drugs to address the worst outbreak of Ebola in history. It's unclear who will pay for their products, but companies are betting that governments and aid groups will foot the bill.    

WHO: Millions of Ebola Vaccine Doses Ready in 2015

October 24, 2014 11:38 am | by Maria Cheng - AP Medical Writer - Associated Press | News | Comments

The World Health Organization says millions of doses of two experimental Ebola vaccines could be ready for use in 2015 and five more experimental vaccines will start being tested in March. Still, the agency warned it's not clear whether any of these will work against the deadly virus that has...

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 incoming data and develop increasingly robust scientific opinions based on the additional data provided during the process. The initial review and subsequent updates will be shared with healthcare decision-makers in the most affected and other countries.

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 recalled still contain banned ingredients. Also, smoking may get in the way of recovering alcoholics.         

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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 spreading in this country, but they're not so sure their local hospital can safely handle a patient, according to an Associated Press-GfK poll.   

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.

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.  

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.

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