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Michigan Man Among First in US to Get 'Bionic Eye'

April 23, 2014 8:20 am | by MIKE HOUSEHOLDER, Associated Press | News | Comments

Diagnosed with retinitis pigmentosa as a teenager, Pontz has been almost completely blind for years. Now, thanks to a high-tech procedure that involved the surgical implantation of a "bionic eye," he's regained enough of his eyesight to catch small glimpses of his wife, grandson and cat.

E-cig Industry Awaits Looming FDA Regulation

April 22, 2014 8:14 am | by MICHAEL FELBERBAUM, AP Tobacco Writer | News | Comments

Smokers are increasingly turning to battery-powered electronic cigarettes to get their nicotine...

FDA Accepts Gilead's NDAs for Cobicistat and Elvitegravir for HIV Therapy

April 22, 2014 8:09 am | News | Comments

Gilead Sciences announced that the FDA has accepted the company’s refiling of two New Drug...

FDA Approves Cyramza for Stomach Cancer

April 22, 2014 8:05 am | News | Comments

The FDA has approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or...

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Second Wave of Milder Flu Hitting Northeast

April 21, 2014 8:17 am | by MIKE STOBBE, AP Medical Writer | News | Comments

A second, milder wave of flu is hitting the Northeast. Months ago, the flu season seemed to be winding down. But health officials on Friday reported widespread flu-like illnesses in six states.          

Kids Get Codeine in ER Despite Risks, Guidelines

April 21, 2014 8:14 am | by LINDSEY TANNER, AP Medical Writer | News | Comments

Despite recommended limits on codeine use in children, the potent painkiller is prescribed for children in at least half a million emergency room visits each year, a study suggests.             

Hospira Recalls Seven Lots of Propofol Injectable Emulsion

April 18, 2014 2:36 pm | News | Comments

Hospira announced today that on April 2, 2014, it informed customers of a nationwide recall of seven lots of Propofol Injectable Emulsion, USP, to the user level due to a glass defect located on the interior neck of the vial, which was identified during a retain sample inspection where the glass vial contained visible embedded metal particulate. Free-floating metal particulates were also identified in vials upon further analysis

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FDA Warns of Cancer Risk with Fibroid Procedure

April 18, 2014 8:45 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

The agency is discouraging doctors from performing the procedure, which uses an electronic device to grind and shred uterine tissue so it can be removed through a small incision in the abdomen. Known as laparoscopic power morcellation, the technique is widely used to treat painful fibroids, either by removing the noncancerous growths themselves or the entire uterus.

EMA Provides Update on Stolen Vials of Herceptin

April 18, 2014 8:26 am | News | Comments

Italian law enforcement authorities are currently investing the theft. However, the situation goes beyond EU and national current practices for handling quality or product defects; these are extraordinary circumstances driven by criminal activities that require special measures and strong collaboration from authorities across the EU.

FDA Approves Arzerra for Chronic Lymphocytic Leukemia

April 18, 2014 8:05 am | News | Comments

GlaxoSmithKline and Genmab A/S announced that the FDA has approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra, a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia for whom fludarabine-based therapy is considered inappropriate.

FDA Approves Merck Tablet to Reduce Ragweed Allergies

April 17, 2014 4:41 pm | by The Associated Press | News | Comments

U.S. regulators have again approved a Merck & Co. tablet for gradually reducing seasonal allergies, this time for ragweed pollen. Ragwitek tablets dissolve quickly under the tongue. Patients are to take one daily for a few years, starting three months before ragweed season begins in late summer.

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.         

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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 than 60 percent, a new federal study shows. The research also confirms earlier reports of drastic declines in diabetes-related kidney failure and amputations.

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 Herceptin (trastuzumab), thought to have been stolen in Italy, including from hospitals, have been tampered with and re-introduced under false credentials into the supply chain in some countries.

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 diabetes. The agency cleared the company's drug, Tanzeum, to help patients control their blood sugar levels, in combination with diet and exercise.  

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.

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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.     

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.      

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.                      

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.      

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