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Shares of Companies Testing Ebola Vaccines Rise

October 1, 2014 8:17 am | News | Comments

Shares of some companies that are studying potential vaccines for Ebola climbed after federal officials announced that the first case of the disease has been diagnosed in the U.S.            

FTC to Retailers: Drop Your Caffeinated Drawers

October 1, 2014 8:06 am | by JONATHAN J. COOPER, Associated Press | News | Comments

If you purchased caffeine-infused underwear because of promises it will make you thinner,...

The US Ebola Case: Five Things to Know

October 1, 2014 8:01 am | by MARILYNN MARCHIONE, AP Chief Medical Writer | News | Comments

Health officials on Tuesday announced the first case of Ebola diagnosed in the United States — a...

Child Paralysis Cases May Be Linked to Enterovirus 68

September 29, 2014 1:36 pm | Videos | Comments

Health officials are investigating whether the fast-moving respiratory disease is linked to...

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FDA Approves NeuroGenetic Pharmaceuticals Application to Begin Clinical Trials for Its Alzheimer’s Disease Compound

September 29, 2014 12:06 pm | News | Comments

The U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application from NeuroGenetic Pharmaceuticals, Inc. (NGP) to begin clinical trials on its NGP 555 compound to treat and prevent Alzheimer’s disease (AD).

Virus Probed in Paralysis Cases in Nine Colorado Kids

September 29, 2014 10:29 am | by MIKE STOBBE, AP Medical Writer | News | Comments

The Centers for Disease Control and Prevention on Friday sent doctors an alert about the polio-like cases and said the germ — enterovirus 68 — was detected in four out of eight of the sick children who had a certain medical test. The status of the ninth case is unclear.

US Doctor Exposed to Ebola Virus Admitted to NIH

September 29, 2014 10:23 am | News | Comments

An American doctor who was exposed to the Ebola virus while volunteering in Sierra Leone was admitted Sunday to a hospital at the National Institutes of Health near the nation's capital.           

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FDA Approves Revised Indication for Allergan's OZURDEX®

September 29, 2014 10:06 am | News | Comments

Allergan announced today that the U.S. Food and Drug Administration (FDA) has approved OZURDEX® (dexamethasone intravitreal implant) 0.7 mg, a sustained-release biodegradable steroid implant, for the treatment of diabetic macular edema (DME).  

Alimera, pSivida say FDA Clears Eye Implant

September 26, 2014 5:45 pm | by The Associated Press | News | Comments

Alimera Sciences and pSivida said Friday the FDA approved their eye disease implant Iluvien. Iluvien is an implant delivered by injection that is intended to treat diabetic macular edema, a condition that can cause blurred vision and blindness. 

AbbVie Gets Approval For Humira

September 26, 2014 10:48 am | News | Comments

The FDA cleared Humira as a treatment for moderate to severe Crohn's disease in children ages six and older when those children haven't been helped by other treatments, AbbVie said. Humira can be administered at home, unlike similar drugs used to treat the condition.

Report Shows Discrepancies In Access to Cancer Drugs

September 26, 2014 10:41 am | News | Comments

Access to potentially life-extending cancer drugs varies significantly in different regions of the world, two new studies show. Researchers say the results demonstrate the need for better collaboration between doctors and health authorities on an international scale, to ensure patients have access to the best treatments.

WHO: Ebola Vaccine On The Way

September 26, 2014 10:12 am | News | Comments

The World Health Organization says there should be thousands of doses of experimental Ebola vaccines available in the coming months and they could eventually be given to health care workers and other people who have had contact with the sick.

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Pacira Pharmaceuticals Shares Drop As FDA Warns On Misleading Ads

September 25, 2014 9:34 am | by Associated Press | News | Comments

Pacira Pharmaceuticals Inc. said Thursday that it received a warning letter from regulators about marketing for an injectable drug that numbs post-surgical pain that the letter says is misleading.                                        

Anti-Addiction Groups Call for New FDA Chief

September 24, 2014 3:07 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

In a letter released Wednesday, more than a dozen groups ask the Obama administration's top health official to replace FDA Commissioner Dr. Margaret Hamburg, who has led the agency since 2009. The FDA has been under fire from public health advocates, politicians and law enforcement officials since last October, when it approved a powerful new painkiller called Zohydro against the recommendation of its own medical advisers.

New FDA Label Bolsters Safety Case for Chantix

September 24, 2014 11:43 am | News | Comments

New government-approved labeling on Pfizer's drug Chantix suggests that the anti-smoking medication may not carry the risks of suicidal behavior that first earned it the government's strongest warning more than five years ago.    

Rate of Diabetes Diagnoses Slowing, Study Finds

September 24, 2014 8:38 am | Videos | Comments

CDC researchers say that the rate of people being diagnosed with diabetes has leveled off in recent years. Also, a new study says that pregnant women may not be receiving enough genetic counseling.            

WHO: Ebola Vaccine Could be Ready by Year-End

September 24, 2014 8:21 am | News | Comments

The World Health Organization says a vaccine might be available in large enough quantities by the end of the year to help control West Africa's Ebola outbreak.               

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FDA Warns Doctors to Beware Fake Drug Distributors

September 23, 2014 3:21 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

U.S. health regulators are trying to help doctors spot counterfeit and unapproved drugs by raising awareness of illegal operations that peddle bogus drugs to health professionals. Beginning Tuesday the FDA will push back with its own educational campaign, faxing flyers to physicians across the country on how to recognize bogus offers and counterfeit drugs.

FDA Approves Fast Track Designation for Galmed Pharmaceuticals’ Aramchol

September 23, 2014 11:51 am | News | Comments

Galmed Pharmaceuticals announced that the U.S. Food and Drug Administration approved its request for Fast Track Designation of its product candidate, aramchol, for the treatment of Non-Alcoholic Steato-Hepatitis, or NASH.     

Navidea Awarded $1.67M Fast Track NIH SBIR Grant for Evaluation of Lymphoseek® in Cervical Cancer

September 23, 2014 9:12 am | News | Comments

Navidea Biopharmaceuticals today announced the receipt of an initial notice of award for a Fast Track Small Business Innovation Research (SBIR) grant providing for up to $1.67 million from the National Cancer Institute (NCI), National Institutes of Health (NIH), to fund evaluation of Lymphoseek ® (technetium Tc 99m tilmanocept) Injection in women with cervical cancer.

WHO: 21,000 Ebola Cases by November if No Changes

September 23, 2014 8:29 am | News | Comments

New estimates from the World Health Organization warn the number of Ebola cases could hit 21,000 in six weeks unless efforts to curb the outbreak are ramped up, according to an analysis published online Tuesday by the New England Journal of Medicine.

MedImmune Receives FDA Fast Track Designation for Development of MEDI3902 for Prevention of Nosocomial Pneumonia

September 23, 2014 8:22 am | News | Comments

AstraZeneca announced today that its global biologics research and development arm, MedImmune, has received fast track designation from the FDA for its investigational monoclonal antibody (mAb) MEDI3902 for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa (P. aeruginosa), a highly drug-resistant bacterial pathogen.

Amgen Submits BLA for Investigational BiTE Immunotherapy Blinatumomab

September 22, 2014 2:20 pm | News | Comments

The BLA is for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow. BiTE antibody constructs represent an innovative immunotherapy approach that helps the body's immune system target cancer cells.

FDA Revises Food Safety Rules Due Next Year

September 22, 2014 8:16 am | by MARY CLARE JALONICK, Associated Press | News | Comments

The Food and Drug Administration on Friday revised sweeping food safety rules proposed last year after farmers complained that the regulations could hurt business. The new proposals would relax water quality standards and allow farmers to harvest crops sooner after using raw manure as fertilizer.

Soligenix Awarded $24.7M NIAID Contract to Develop Heat Stable RiVax Vaccine

September 19, 2014 8:11 am | News | Comments

The objectives of the contract are to advance the development of Soligenix's thermostabilization technology, ThermoVax, combined with the company's ricin toxin vaccine, Rivax, as a medical countermeasure (MCM) to prevent the effects of ricin exposure.

FDA Approves Eli Lilly's Injectable Diabetes Drug

September 18, 2014 4:46 pm | by The Associated Press | News | Comments

The Food and Drug Administration has approved a new injectable diabetes drug from Eli Lilly and Co. for adults with the most common form of the disease. The agency on Thursday cleared the drug, Trulicity, as a weekly injection to improve blood sugar control in patients with type 2 diabetes.

CDC Tells Healthy Adults Not to Forget Flu Vaccine

September 18, 2014 3:19 pm | by LAURAN NEERGAARD, AP Medical Writer | News | Comments

Think the flu's only a big threat to kids and seniors? Influenza hospitalized a surprisingly high number of young and middle-aged adults last winter — and this time around the government wants more of them vaccinated.      

Better Way to Diagnose Kidney Stones

September 18, 2014 9:02 am | Videos | Comments

A study in the New England Journal of Medicine found that the less expensive and radiation-free ultrasounds can detect kidney stones as well as the more expensive CT scans. Also, the FDA is investigating the increase in testosterone therapy by older men.

NIH: Ebola Unlikely to Become Airborne

September 18, 2014 8:55 am | by LAURAN NEERGAARD, AP Medical Writer | News | Comments

It's incredibly unlikely that Ebola would mutate to spread through the air, and the best way to make sure it doesn't is to stop the epidemic, a top government scientist told concerned lawmakers Wednesday.        

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