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Glaxo Recalls Flu Vaccine Due to Potency Problem

April 17, 2015 3:37 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

The company alerted U.S. customers Tuesday that the vaccine can lose potency and fail to adequately protect against some strains of the flu.

Survey: More Than Half of Older Adults in The US Now Taking Aspirin

April 17, 2015 3:05 pm | by Oregon State University | News | Comments

More than half of the older adults in the United States are now taking a daily dose of aspirin,...

Merck CEO Frazier Becomes PhRMA Board Chairman

April 17, 2015 12:25 pm | News | Comments

Kenneth C. Frazier, chairman and CEO of Merck & Co., Inc., was elected chairman of the Board...

FDA Approves First Generic To Treat MS

April 17, 2015 12:16 pm | by FDA | News | Comments

The U.S. Food and Drug Administration today approved the first generic version of Copaxone (...

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PhRMA Applauds 2015 We Work For Health Award Winners

April 17, 2015 12:03 pm | by Pharmaceutical Research and Manufacturers of America (PhRMA) | News | Comments

PhRMA honored 13 employees from 12 biopharmaceutical companies as “We Work For Health Champions” for their extraordinary efforts in policy advocacy and community service.

U.S. Marshals Seize Unapproved Drugs From Florida Distributor

April 16, 2015 3:31 pm | by FDA.gov | News | Comments

Stratus Pharmaceuticals marketed and distributed unapproved prescription drug products that were manufactured by Sonar Products, Inc., of Carlstadt, New Jersey.

OriGen Biomedical Issues Nationwide Recall

April 16, 2015 11:20 am | by OriGen Biomedical | News | Comments

OriGen Biomedical initiated a nationwide recall for one lot of Reinforced Dual Lumen ECMO catheters.

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Disney-Linked Measles Outbreak Soon To Be Over In California

April 16, 2015 10:44 am | by Alicia Chang, AP Science Writer | News | Comments

A measles outbreak that began at Disneyland and reignited debate about vaccinations is nearing an end.

FDA Warns of Liver Injury From Muscle-Building Supplement

April 14, 2015 2:05 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

The Food and Drug Administration is warning consumers to avoid dietary supplements sold by a Las Vegas company because they may contain anabolic steroids that can cause liver damage.

Norovirus Sickens 200 on Cruise Ships

April 14, 2015 10:49 am | by The Associated Press | News | Comments

Federal health officials say about 200 people have come down with vomiting and diarrhea aboard two San Diego-bound cruise ships.

FDA Confirms Change of Ownership of 23 US Generic Drugs

April 13, 2015 3:54 pm | by PR Newswire | News | Comments

IDT Australia Limited announced that the U.S. Food and Drug Administration (FDA) has confirmed receipt of the change of ownership letters formally transferring ownership of the 23 generic drug products to IDT.

Big Retailers Pull Sales of Weight-Loss Supplements With Dangerous Chemical

April 10, 2015 3:30 pm | by Meagan Parrish, Editor, Chem.Info | News | Comments

The issue also intensified criticisms of the FDA.

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Tekmira to Resume Ebola Drug Trials

April 10, 2015 12:00 pm | by Tekmira Pharmaceuticals | News | Comments

The FDA has notified Tekmira that the partial clinical hold on TKM-Ebola has been modified. Tekmira plans to resume the TKM-Ebola Phase I clinical trial in the coming weeks.

Botox Death Prompts Lawsuit

April 10, 2015 11:48 am | by Ray Chester, McGinnis Lochridge LLP | News | Comments

Parents of Melinda Ann "Mandy" Fortuna filed suit yesterday against Allergan, Inc., alleging that a series of off-label Botox overdoses were responsible for their daughter's death.

Baxter Recalls IV Solutions

April 10, 2015 11:42 am | by Baxter International | News | Comments

Baxter International Inc. announced today it is voluntarily recalling select lots of IV solutions to the hospital/user level due to the potential presence of particulate matter.

Fast Track for BioBlast Pharma

April 9, 2015 11:53 am | by BioBlast Pharma | News | Comments

The FDA has granted Fast Track designation to BioBlast's Cabaletta for the treatment of patients with Oculopharyngeal Muscular Dystrophy (OPMD).

Prolong Flagship Product Granted Orphan Drug Designation

April 8, 2015 10:57 am | by Prolong Pharmaceuticals | News | Comments

Prolong Pharmaceuticals, LLC, a biopharmaceutical company, announced that the FDA has granted Orphan Drug Designation for its Sickle Cell Disease (SCD) treatment.

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FDA Questions Evidence for Lower-Risk Tobacco Product

April 8, 2015 10:48 am | by Matthew Perrone, AP Health Writer | News | Comments

U.S. health regulators have questions about tobacco maker Swedish Match's bid to become the first to market a smokeless tobacco product as less harmful than cigarettes.

Hospira gets FDA Warning

April 7, 2015 4:17 pm | by AP | News | Comments

Drug and medical device maker Hospira said that it received a warning letter from the FDA following an Italian factory inspection. The agency said it found problems with procedures that are supposed to prevent sterile products from being contaminated, and found fault with Hospira's inspections procedures. It also said the company should have better security protecting data generated during its manufacturing process.

American with Ebola is Improving

April 7, 2015 4:12 pm | by AP | News | Comments

Officials say an American healthcare worker who contracted Ebola while volunteering in Sierra Leone has improved to good condition at a federal hospital. He is being treated at the NIH hospital in Bethesda, Maryland.

GE Ventures Leader Joins U.S. Precision Medicine Program

April 6, 2015 4:00 pm | by GE Reports | News | Comments

“Precision” drugs are tailored to a cancer’s or a patient’s genetic makeup. Such “precision medicine” is now the focus of a new $215 million research initiative launched this year by U.S. President Barack Obama.

Asia Agencies Purchase U.S. Simulation Software

April 6, 2015 12:01 pm | by Simulations Plus | News | Comments

Simulations Plus announced that several regulatory agencies around the world have added licenses of software for pharmaceutical discovery and development within the past three months.

In Alzheimer's Mice, Memory Restored With Cancer Drug

April 1, 2015 1:01 pm | by Yale University | News | Comments

Memory and as well as connections between brain cells were restored in mice with a model of Alzheimer's given an experimental cancer drug.

HHS Contracts to Develop New Ebola Drug

March 31, 2015 11:54 am | by U.S. Department of Health & Human Services | News | Comments

HHS awarded approximately $12 million today to BioCryst Pharmaceuticals of Durham, North Carolina, for the advanced development of a promising experimental drug for Ebola, including preparing for large-scale manufacturing of the drug and conducting related studies.

Pharmacist Group Says Members Shouldn't Aid in Executions

March 31, 2015 11:17 am | by Julie Watson, The Associated Press | News | Comments

In a move that could heighten the hurdles faced by states attempting to execute prisoners, a leading association for U.S. pharmacists has officially discouraged its members from providing drugs for use in lethal injections.

FDA to Scrutinize Unproven Alternative Remedies

March 26, 2015 3:23 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

Federal officials plan to review the safety and evidence behind alternative remedies like Zicam and Cold-Eeze, products that are protected by federal law, but not accepted by mainstream medicine.

Orexigen's Mysimba Approved in Europe for the Treatment of Obesity

March 26, 2015 3:17 pm | News | Comments

Orexigen Therapeutics has announced that the European Commission has granted marketing authorization for Mysimba (naltrexone HCl / bupropion HCl prolonged release) as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients.

Science, Patients Driving Rare Disease Drug Research Surge

March 25, 2015 2:24 pm | by LINDA A. JOHNSON, AP Business Writer | News | Comments

The global pharmaceutical industry is pouring billions of dollars into developing treatments for rare diseases, which once drew little interest from major drugmakers but now point the way toward a new era of innovative therapies and big profits.

FDA Approves Sanofi Pasteur’s Quadracel DTaP-IPV Vaccine for Children

March 25, 2015 12:24 pm | News | Comments

Sanofi Pasteur, the vaccines division of Sanofi announced that FDAhas approved use of Quadracel vaccine for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children 4 through 6 years of age.

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