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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...

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...

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...

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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.        

FDA OKs Faster-Acting Label for Stendra

September 18, 2014 8:37 am | by The Associated Press | News | Comments

Federal regulators have approved a new label for Vivus' impotence drug, stating that it becomes effective in half the time that the previous label had stated.                

Experts Want Restrictions on Testosterone Drug Use

September 17, 2014 6:44 pm | by Matthew Perrone - AP Health Writer - Associated Press | News | Comments

Federal health experts said Wednesday there is little evidence that testosterone-boosting drugs are effective for treating common signs of aging in men and that their use should be narrowed to exclude millions of Americans currently taking them. The panel of Food and Drug Administration advisers...

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Baxter Recalls One Lot of Potassium Chloride Injection

September 17, 2014 3:00 pm | News | Comments

Baxter International Inc. announced today it is voluntarily recalling one lot of Potassium Chloride Injection 10mEq per 100mL, product code 2B0826 to the hospital/pharmacy/nurse level. The recall is being initiated due to a labeling error on the shipping cartons in a single lot, which was identified by three customers.

First UK Volunteer Gets Experimental Ebola Vaccine

September 17, 2014 12:51 pm | by The Associated Press | News | Comments

British scientists say a former nurse has become the first person in the country to receive an experimental Ebola vaccine in an early trial to test its safety. Ruth Atkins, 48, got the injection on Wednesday in Oxford, the first of 60 healthy volunteers in the U.K. who will receive the vaccine.

UN: Nearly $1B Needed Now to Stop Ebola

September 17, 2014 8:34 am | by JOHN HEILPRIN, Associated Press; KRISTA LARSON, Associated Press | News | Comments

The number of Ebola cases could start doubling every three weeks in West Africa, the World Health Organization said Tuesday, warning that the outbreak will cost nearly $1 billion to contain so it does not turn into a "human catastrophe."   

CDC Study: Americans' Bellies Are Expanding Fast

September 17, 2014 8:23 am | by LINDSEY TANNER, AP Medical Writer | News | Comments

The number of American men and women with big-bellied, apple-shaped figures — the most dangerous kind of obesity — has climbed at a startling rate over the past decade, according to a government study.        

FDA Clears Constipation Drug Movantik

September 16, 2014 3:16 pm | News | Comments

Movantik, or naloxegol, is approved for adults who have chronic pain that is not caused by cancer. British drugmaker AstraZeneca PLC will market the drug, and it has also filed for regulatory approval in the European Union and Canada.   

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EYLEA Injection Receives FDA Breakthrough Therapy Designation

September 16, 2014 9:03 am | News | Comments

Regeneron Pharmaceuticals today announced that the FDA has granted EYLEA (aflibercept) Injection Breakthrough Therapy designation for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME).      

Skin Shocks Used at Massachusetts School Draw FDA Scrutiny

September 15, 2014 8:44 am | by JENNIFER C. KERR, Associated Press; LAURAN NEERGAARD, Associated Press | News | Comments

The Food and Drug Administration is considering whether to ban devices used by the Judge Rotenberg Educational Center in Canton, Massachusetts, the only place in the country known to use skin shocks as aversive conditioning for aggressive patients.

FDA Approves Baxter’s HYQVIA for Treatment of Adults with Primary Immunodeficiency

September 15, 2014 8:31 am | News | Comments

Baxter International and Halozyme Therapeutics announced that the FDA approved Baxter’s subcutaneous treatment for adult patients with primary immunodeficiency (PI), HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase].

U.S. Government, WHO Seek Ways to Expand Production of Ebola Drugs, Vaccines

September 15, 2014 8:20 am | by Helen Branswell, The Canadian Press | News | Comments

High level efforts are underway to find ways to substantially ramp up production of experimental Ebola vaccines and drugs, officials at the World Health Organization and within the U.S. government say.         

FDA Accepts Tuzistra XR NDA for Full Review

September 15, 2014 8:12 am | News | Comments

Vernalis and Tris Pharma announced that the FDA has confirmed that the New Drug Application for Tuzistra XR has been accepted for full review. This triggers a milestone payment from Vernalis to Tris.        

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Controlling Blood Sugar May Not Prevent Diabetes, Study Finds

September 12, 2014 8:29 am | Videos | Comments

Research from the American Heart Association found that controlling blood sugar levels may not be enough to avoid heart disease and diabetes. Plus, doctors are calling on wealthier countries to help fight the Ebola virus outbreak.    

FDA Backs Novo Nordisk Injection for Obesity

September 11, 2014 5:47 pm | by The Associated Press | News | Comments

Federal health experts say a diabetes drug from Novo Nordisk should be approved for a new use in treating obesity. The panel of Food and Drug Administration advisers voted 14-1 that the injectable drug's benefits outweigh it risks for patients who are obese or dangerously overweight.

Silicon Valley Struggles to Speak FDA's Language

September 11, 2014 10:26 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

From Apple's new smartwatch that tracks heartbeats to contact lenses that measure blood sugar — Silicon Valley is pouring billions into gadgets and apps designed to transform health care. But the tech giants that have famously disrupted so many industries are now facing their own unexpected disruption: regulation.

Rare Respiratory Virus Spreading Rapidly

September 11, 2014 9:08 am | Videos | Comments

The CDC is tracking the disease that is currently affecting twelve states.                               

FDA Approves New Indication for the Use of XTANDI Capsules

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

Astellas Pharma and Medivation announced today that the FDA approved a new indication for the use of XTANDI (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer (CRPC).          

FDA Approves Weight-Loss Drug Contrave

September 11, 2014 8:13 am | News | Comments

The drug is approved for use by people who have a body mass index of 30 or higher, which is the level at which people are considered to be obese. It is also approved for use by people with a BMI of 27 or higher who also have a weight-related medical condition such as diabetes.

Gates Foundation to Spend $50M on Ebola Response

September 10, 2014 2:49 pm | by DONNA GORDON BLANKINSHIP, Associated Press | News | Comments

The Seattle-based foundation said the money will go to the United Nations, the World Health Organization, the U.S. Centers for Disease Control and Prevention and international organizations involved in fighting transmission of the virus.  

Study: Many Hospitals Use Too Many Antibiotics

September 10, 2014 2:44 pm | by MIKE STOBBE, AP Medical Writer | News | Comments

A new study suggests that doctors in many hospitals are unnecessarily prescribing multiple antibiotics for several days when just one would do the job. Health officials say overuse of antibiotics is helping to breed dangerous bacteria that are increasingly resistant to treatment.

Lilly Receives European Marketing OK for Insulin

September 10, 2014 10:58 am | News | Comments

European regulators have approved a long-lasting insulin from Eli Lilly and Co. and German drugmaker Boehringer Ingelheim that is the subject of patent infringement litigation with French rival Sanofi.        

PharmAthene Awarded Contract Of Up To $28.1M to Develop Next Generation Thermostable Anthrax Vaccine

September 10, 2014 9:12 am | News | Comments

PharmAthene announced today that the National Institute of Allergy and Infectious Diseases (NIAID) has awarded the company a contract, valued at up to $28.1M if all contract options are exercised, for the development of a next generation anthrax vaccine based on the company's proprietary rPA anthrax vaccine technology platform.

FDA Advisory Committee Recommends Against Approval of Actavis' Hypertension Treatment

September 10, 2014 8:20 am | News | Comments

Actavis has confirmed that the FDA's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted to recommend against approval of Actavis' New Drug Application (NDA) for the fixed-dose combination of nebivolol and valsartan for the treatment of hypertension.

Fourth American with Ebola to be Flown to US for Care

September 9, 2014 8:16 am | by KATE BRUMBACK, Associated Press; JOSH FUNK, Associated Press | News | Comments

A fourth American who contracted Ebola in West Africa was expected to arrive in the U.S. for care today and will be treated at an Atlanta hospital where two other aid workers successfully recovered from the disease.      

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