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Officials: Little Risk of Ebola Outbreak in US

July 29, 2014 8:49 am | by MIKE STOBBE, AP Medical Writer | News | Comments

U.S. health officials are monitoring the Ebola outbreak in Africa but say the risk of the deadly germ spreading to the United States is remote.                  

European Commission Approves Eliquis for the Treatment of Deep Vein Thrombosis and Pulmonary Embolism

July 29, 2014 8:38 am | News | Comments

Bristol-Myers Squibb and Pfizer announced that the European Commission has approved Eliquis for...

FDA Inspects Impax's Taiwan Facility – Finds Ten Issues

July 29, 2014 8:11 am | News | Comments

Impax Laboratories announced that the FDA performed a general GMP  inspection and a Pre-...

FDA Grants Full Approval for IMBRUVICA for Two Indications

July 28, 2014 2:39 pm | News | Comments

Pharmacyclics, Inc. announced that the FDA has granted IMBRUVICA regular (full) approval for the...

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FDA Approves Aqua Pharmaceuticals' ACTICLATE™ Tablets

July 28, 2014 9:11 am | News | Comments

ACTICLATE™ is a tetracycline-class antibacterial indicated for the treatment of a number of infections, including adjunctive therapy in severe acne.                 

Processes for the Inspection of Cleaned Equipment in the Pharmaceutical Industry to Evolve

July 25, 2014 9:06 am | by The ISPE Cleaning Process Development and Validation Guide Task Team | Articles | Comments

When it comes to the inspection of cleaned equipment of pharmaceutical manufacturing equipment, there are currently no industry-mandated standards. Instead, various companies have had their own internal procedures for inspecting cleaned equipment, with visual inspection widely used as the primary method.

Lou Gehrig's Disease is Rare, First US Count Finds

July 25, 2014 8:54 am | News | Comments

The government has issued its first national estimate for Lou Gehrig's disease, confirming the devastating disease is rare.                     

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Ruling on Antibiotics in Livestock Reversed

July 25, 2014 8:36 am | News | Comments

The U.S. Food and Drug Administration isn't required to hold public hearings to evaluate the health risks of widespread use of antibiotics in animal feed, a federal appeals court ruled Thursday.         

FDA Reviewing What Could Be First Biosimilar Drug

July 24, 2014 3:51 pm | News | Comments

Five years after Congress passed a law allowing biosimilars, for the first time the FDA has accepted an application to sell a similar, but not identical, version of a biologic drug.            

More US Girls Now Getting Cervical Cancer Vaccine

July 24, 2014 2:00 pm | News | Comments

Last year's rise follows a couple of years when the girls' HPV vaccination rate was flat and health officials worried that it wouldn't budge. For girls ages 13 to 17, the rate is now up to about 38 percent of girls, from 33 percent.   

GSK Asks European Regulator to OK Malaria Shot

July 24, 2014 8:18 am | News | Comments

The experimental shot is the most advanced candidate vaccine for malaria but results from previous trials have been disappointing. Research published in 2012 showed the shot only reduced malaria cases by about 30 percent in babies aged six to 12 weeks, the target age for immunization.

EU Regulator: Morning-After Pill OK for All Women

July 24, 2014 8:11 am | News | Comments

The European Medicines Agency says a commonly used morning-after pill is suitable for use by heavier women after reviewing the evidence, sparked by a French pharmaceutical company's declaration last year that the drugs didn't work in women weighing more than 176 pounds.

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FDA Approves New Extended-Release Oxycodone with Abuse-Deterrent Properties

July 24, 2014 7:59 am | News | Comments

The FDA has approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Head of Troubled CDC Anthrax Lab Has Resigned

July 23, 2014 4:13 pm | by The Associated Press | News | Comments

The head of the government lab that potentially exposed workers to live anthrax has resigned, an agency spokesman said Wednesday. Michael Farrell was head of the Centers for Disease Control and Prevention lab since 2009. He submitted his resignation Tuesday, the spokesman said.

FDA Warns of Compounded Drug Recall by Texas Firm

July 23, 2014 3:38 pm | News | Comments

The agency says FDA inspectors recently uncovered unsanitary conditions at Unique Pharmaceuticals' plant in Temple, Texas. The inspections revealed production problems in several lots of drugs that were supposed to be sterile.    

FDA Approves Gilead Sciences Drug for Three Cancers

July 23, 2014 1:07 pm | News | Comments

Regulators approved the drug for patients with forms of chronic lymphocytic leukemia, follicular lymphoma and small lymphocytic lymphoma. The cancers affect an estimated 200,000 patients in the U.S., according to Gilead. The company's tablet, Zydelig, works by blocking signals inside some cancer cells that allow them to grow and survive.

FDA Designates Dompe’s rhNGF-Based Treatment for Neurotrophic Keratitis Orphan Drug Status

July 23, 2014 8:25 am | News | Comments

The candidate drug, developed by the research of Dompe, has been designated as an orphan drug for the treatment of neurotrophic keratitis, a degenerative corneal disease that affects less than 1 in 5,000 people and is currently without a cure.

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Report: GSK Flu Vaccine Plant Inspection Finds Ten Actionable Issues

July 23, 2014 8:14 am | by Helen Branswell, The Canadian Press | News | Comments

A recent Health Canada inspection of the country's only flu vaccine production plant identified 10 issues that need to be addressed, a report from the regulatory agency reveals. The summary report of the June inspection said none of the problems found poses a critical risk to public health, but seven fall into the major observation category.

FDA Approves Eagle Pharmaceuticals’ Ryanodex®

July 23, 2014 8:09 am | News | Comments

Eagle Pharmaceuticals today announced that the FDA has approved Ryanodex® (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia (MH), along with the appropriate supportive measures.    

FDA Warns About Dangers of Caffeine Powder

July 22, 2014 9:10 am | Videos | Comments

The medical alert came after an Ohio teen died from a caffeine overdose days before his high school graduation.                       

Sanofi Pasteur Begins Shipping Seasonal Influenza Vaccine for Upcoming 2014-2015 Season in United States

July 22, 2014 9:04 am | News | Comments

Sanofi Pasteur, the vaccines division of Sanofi, announced today that the first lots of Fluzone (Influenza Vaccine) for the 2014-2015 influenza season have been released by the U.S. Food and Drug Administration (FDA) for distribution.   

Judge: FDA Can't Use Tobacco Panel Menthol Report

July 22, 2014 8:32 am | by MICHAEL FELBERBAUM, AP Tobacco Writer | News | Comments

The FDA can't use an advisory panel's 2011 report on menthol cigarettes because its members had conflicts of interest, a federal judge ruled Monday. While the agency has since conducted an independent review on the public health impact of menthol cigarettes, the ruling could hinder the FDA's ability to defend any future regulation of the minty smokes.

FDA Grants Genentech’s Avastin Priority Review for Recurrent Platinum-Resistant Ovarian Cancer

July 22, 2014 8:13 am | News | Comments

Genentech, a member of the Roche Group, today announced that the FDA has accepted the company's supplemental Biologics License Application and granted Priority Review for Avastin® plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer.

OpenFDA – the Good, the Bad, and the Ugly

July 21, 2014 3:39 pm | by Brian Overstreet, CEO, AdverseEvents | Blogs | Comments

In an ideal world, OpenFDA could usher in a world of new and improved tools and products that would improve patient safety and adherence, increase physician awareness of drug safety dangers, assist healthcare decision makers who are driving prescribing behavior with better decision support, and lower the overall cost of care by reducing avoidable side effects. But we don’t live in an ideal world.

Teen's Death Puts Focus on Caffeine Powder Dangers

July 21, 2014 8:56 am | by ANN SANNER, Associated Press | News | Comments

The  Food and Drug Administration said Friday that it's investigating caffeine powder and will consider taking regulatory action. The agency cautioned parents that young people could be drawn to it. Caffeine powder is sold as a dietary supplement, so it's not subject to the same federal regulations as certain caffeinated foods.

States Sue 5-Hour Energy Over Ad Claims

July 21, 2014 8:35 am | by STEVEN DUBOIS, Associated Press | News | Comments

The Oregon lawsuit filed Thursday in Portland contends 5-Hour Energy falsely claims customers get extra energy and focus from a unique blend of ingredients, when the boost actually comes from a concentrated dose of caffeine.     

Aduro BioTech Receives FDA Breakthrough Therapy Designation for Innovative Pancreatic Cancer Combination Immunotherapy

July 21, 2014 8:28 am | News | Comments

Aduro BioTech, Inc., a clinical-stage biotechnology company, today announced that the FDA has granted Breakthrough Therapy Designation for its pancreatic cancer combination treatment that consists of its CRS-207 and GVAX Pancreas immunotherapies.

Regulus Receives FDA Orphan Drug Designation for RG-012, a microRNA Therapeutic for the Treatment of Alport Syndrome

July 21, 2014 8:07 am | News | Comments

Regulus Therapeutics Inc., announced today that the FDA has granted orphan drug designation to RG-012, a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21, as a therapeutic for the treatment of Alport syndrome, a life-threatening genetic kidney disease with no approved therapy.

FDA Approves New Product to Treat Rare Genetic Disease

July 17, 2014 10:22 am | News | Comments

The FDA has approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).           

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