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Ebola Virus in Africa Outbreak is a New Strain

April 17, 2014 8:27 am | by MARILYNN MARCHIONE, AP Chief Medical Writer | News | Comments

The Ebola virus that has killed scores of people in Guinea this year is a new strain — evidence that the disease did not spread there from outbreaks in some other African nations, scientists report.         

Study: Diabetic Heart Attacks and Strokes Falling

April 17, 2014 8:20 am | by MIKE STOBBE, AP Medical Writer | News | Comments

Over the last two decades, the rates of heart attacks and strokes among diabetics fell by more...

EMA Reports Vials of Falsified Herceptin Identified

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

The European Medicines Agency (EMA) has been informed that vials of the cancer medicine...

FDA Approves Injectable Diabetes Drug from Glaxo

April 15, 2014 5:32 pm | by The Associated Press | News | Comments

The FDA has approved a new injectable drug from GlaxoSmithKline plc for adults with Type 2...

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DNA Alternative to Pap Smear Sparks Medical Debate

April 15, 2014 1:41 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

A high-tech screening tool for cervical cancer is facing pushback from more than a dozen U.S. patient groups, who warn that the genetic test could displace a simpler, cheaper and more established mainstay of women's health: the Pap smear.  

FDA Approves Merck’s Allergy Treatment

April 15, 2014 8:04 am | News | Comments

Merck has announced that FDA has approved GRASTEK ® (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use [2800 Bioequivalent Allergy Units (BAU)]. GRASTEK is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis.

DesignMedix Awarded $3M to Develop Low-Cost, Safe Malaria Drug

April 15, 2014 8:00 am | News | Comments

DesignMedix, Inc., a biotech startup with ties to Portland State University, received a grant for almost $3 million from the National Institutes of Health to continue development and manufacture of a new anti-malarial drug.     

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FDA Extends Market Exclusivity of KUVAN Powder for Oral Solution and Tablets

April 14, 2014 8:22 am | News | Comments

BioMarin Pharmaceutical today announced that the FDA granted KUVAN(R) (sapropterin dihydrochloride) Powder for Oral Solution and Tablets a six-month pediatric exclusivity extension. The FDA action extends KUVAN's market exclusivity to June 2015 and is based on studies submitted in response to a written request by the FDA to investigate the use of KUVAN in pediatric patients from birth to age 6

BMS Submits NDA for a Fixed-Dose Combination Tablet of Atazanavir Sulfate with Cobicistat for HIV-1

April 14, 2014 8:18 am | News | Comments

Bristol-Myers Squibb Company announced today the submission of a new drug application (NDA) on April 4, 2014 to the FDA for a fixed-dose combination of atazanavir sulfate, a protease inhibitor marketed as Reyataz®, and cobicistat, an investigational pharmacokinetic enhancer, or boosting agent, that can increase the level of certain HIV-1 medicines in the blood and make them more effective.

Iraq Scrambles to Fight Polio Surge Amid Conflict

April 14, 2014 8:14 am | by SINAN SALAHEDDIN, Associated Press | News | Comments

Across parts of Iraq, medical teams in white coats and gloves again roam the streets giving children polio vaccines and marking the walls of their homes, fighting a resurgent virus once more taking advantage of the country's turmoil.   

Pfizer’s Ian Read Becomes PhRMA Board Chairman; Ken Frazier, George Scangos Assume New Posts

April 14, 2014 8:02 am | News | Comments

Ian C. Read, chairman and CEO of Pfizer, Inc, was elected chairman of the Pharmaceutical Research and Manufacturers of America (PhRMA) at the trade association’s annual meeting. Also elected were Kenneth C. Frazier, chairman, president and CEO of Merck & Co, Inc., as chairman-elect of the PhRMA Board of Directors, and George A. Scangos, Ph.D., CEO of Biogen Idec, as Board treasurer.

Congressional Report Presses for E-cigarette Rules

April 14, 2014 7:52 am | by MICHAEL FELBERBAUM, AP Tobacco Writer | News | Comments

Concerns about electronic cigarettes, including flavors and marketing that could appeal to young people, underscore the need to regulate the fast-growing industry, according to a Congressional report released Monday.      

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FDA Approves Lipiodol Injection For Tumor Imaging

April 11, 2014 11:12 am | News | Comments

Guerbet announced that Lipiodol® was approved by the US Food and Drug Administration pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act indicated for selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC). 

FDA Places Clinical Hold on Halozyme’s PEGPH20 Pancreatic Cancer Trial

April 10, 2014 8:58 am | News | Comments

Halozyme Therapeutics, Inc. has announced that the  FDA has  informed the company that a clinical hold has been placed on patient enrollment and dosing of PEGPH20 in an ongoing Phase 2 trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer.

Saudi Arabia Reports Two More Deaths from MERS

April 10, 2014 8:38 am | by ADAM SCHRECK, Associated Press | News | Comments

Saudi health authorities said Wednesday that 11 people in the western city of Jiddah have contracted the Middle East respiratory syndrome, resulting in two recent deaths and prompting officials to temporarily shutter the emergency unit at one of the city's biggest hospitals.

FDA Approves Pradaxa For Deep Vein Thrombosis & Pulmonary Embolism

April 8, 2014 11:44 am | by Associated Press | News | Comments

Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved Pradaxa ® (dabigatran etexilate) for the treatment of DVT and PE in patients who have been treated with a parenteral (injectable) anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.

FDA Approves Handheld Opiate Antidote

April 4, 2014 8:53 am | Videos | Comments

One person dies every 36 minutes from an opioid overdose from painkillers. A recently approved drug aims to reverse that trend.                      

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FDA Approves EVZIO for the Emergency Treatment of Opioid Overdose

April 3, 2014 11:01 am | News | Comments

Kaleo announced that the FDA has approved EVZIO (naloxone hydrochloride injection) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.      

FDA Accepts Biologic License Application for Fibrocaps Hemostatic Agent

April 3, 2014 8:00 am | News | Comments

The Medicines Company has announced that the FDA has accepted the filing of a biologic license application (BLA) for the investigational hemostatic agent Fibrocaps, a dry powder formulation of fibrinogen and thrombin being developed to aid in hemostasis during surgery, where control of mild or moderate bleeding by conventional means is ineffective or impractical.

FDA OKs First Hay Fever Allergy Immunotherapy Tablet

April 2, 2014 11:28 am | by The Associated Press | News | Comments

The U.S. Food and Drug Administration has approved the first tablet for gradually reducing hay fever allergy symptoms, an alternative to uncomfortable allergy-desensitizing shots.            

FDA Fast Tracks IV and Oral Formulations of Eravacycline

April 2, 2014 8:43 am | News | Comments

Tetraphase Pharmaceuticals today announced that the FDA has granted Fast Track designations for both the intravenous (IV) and oral formulations of the company’s lead antibiotic candidate, eravacycline.        

FDA Committee Recommends Approval of AFREZZA

April 2, 2014 8:16 am | News | Comments

MannKind Corporation announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA voted 13 to 1 to recommend that AFREZZA® (insulin human [rDNA origin]) Inhalation Powder be granted marketing approval by the FDA.   

Beer Brewers in Uproar Over New Proposed FDA Rule

March 31, 2014 3:22 pm | News | Comments

A proposed federal rule that would make it harder for beer breweries to sell leftover grains as animal feed has brewers' blood boiling. Beer makers complain that the new rules, if adopted, would force them to dump millions of tons of "spent grains," which are left over after barley, wheat and other grains are steeped in hot water.

FDA Advisory Committee Recommends Approval of Cubist’s SIVEXTRO™

March 31, 2014 3:20 pm | News | Comments

Cubist Pharmaceuticals has announced today that the FDA Anti-Infective Drugs Advisory Committee (AIDAC) voted to recommend approval of Cubist’s investigational antibiotic SIVEXTRO™ (tedizolid phosphate).        

FDA Approves Topamax for Migraine Prevention in Adolescents

March 31, 2014 8:42 am | News | Comments

The FDA has approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group.       

FDA Approves Biogen Idec’s ALPROLIX™

March 31, 2014 8:21 am | News | Comments

Biogen Idec has announced that the FDA has approved ALPROLIX™ [Coagulation Factor IX (Recombinant), Fc Fusion Protein], the first recombinant, DNA derived hemophilia B therapy with prolonged circulation in the body.      

Studies Find New Drugs Greatly Lower Cholesterol

March 29, 2014 3:31 pm | by Marilynn Marchione - AP Chief Medical Writer - Associated Press | News | Comments

A new class of experimental medicines can dramatically lower cholesterol, raising hopes of a fresh option for people who can't tolerate or don't get enough help from Lipitor and other statin drugs that have been in use for decades.  

Judge Won't Dismiss 'Pink Slime' Defamation Suit

March 28, 2014 8:35 am | News | Comments

A South Dakota judge on Thursday refused to throw out a defamation lawsuit against ABC related to its coverage of a meat product called lean, finely textured beef, which critics have dubbed "pink slime."        

US Autism Estimate Rises to 1 in 68 Children

March 28, 2014 8:12 am | by MIKE STOBBE, AP Medical Writer | News | Comments

The government's estimate of autism has moved up again to 1 in 68 U.S. children, a 30 percent increase in two years. But health officials say the new number may not mean autism is more common.          

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