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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.

USDA Veterinarian: Bird Flu Outbreak Could be 'Devastating'

April 17, 2015 3:02 pm | by STEVE KARNOWSKI, Associated Press | News | Comments

The nation's poultry industry may have to live with a deadly bird flu strain for several years,...

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...

California Vaccine Bill Stalls; Will Cycle Back Next Week

April 16, 2015 10:47 am | by Judy Lin, Associated Press | News | Comments

A California vaccination bill that has generated intense debates and pitted personal rights...

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Ending Religious Waivers For Vaccines Back For Heated Debate

April 15, 2015 2:55 pm | by The Associated Press | News | Comments

California lawmakers are preparing for another round of heated talks Wednesday on whether the state should prevent parents from seeking vaccination exemptions for their children because of religious or personal beliefs.

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.

Actavis: No Apologies for Seeking Alzheimer's Drug Profits

April 14, 2015 10:45 am | by Larry Neumeister, Associated Press | News | Comments

A lawyer for Actavis urged a U.S. appeals court on Monday to let it replace a two-pill daily regimen with a single-dose version of the drug even if it cheats generic drugmakers of profits.

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Specialty, Generic Drug Costs Drive Medicaid Costs Up

April 13, 2015 4:01 pm | by MARIE FRENCH, Associated Press | News | Comments

The high cost of a drug used to treat Medicaid patients with hepatitis C drew scrutiny from lawmakers earlier this year, but other drugs are also driving up the state's costs and likely will continue to do so for several years, government data reveals.

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.

ND Measure Allows Patients to Try Experimental Treatments

April 13, 2015 3:17 pm | by The Associated Press | News | Comments

North Dakota's Legislature has passed a measure that gives patients the chance to try experimental drugs that haven't gotten final approval for general use from the U.S. Food and Drug Administration.

Survey: Nearly 9 in 10 U.S. Adults Now Have Health Insurance

April 13, 2015 1:25 pm | by Ricardo Alonso-Zaldivar, Associated Press | News | Comments

Underlining a change across the nation, nearly 9 out of 10 adults now say they have health insurance, according to an extensive survey released Monday.

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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FDA Panel Wary of Dropping Warnings From Tobacco Pouch

April 10, 2015 3:23 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

Government health advisers have serious reservations about a proposal by Swedish Match to market its smokeless tobacco pouches as less harmful than cigarettes and other tobacco products.

Suit Claims AIDS Foundation Scammed Medicare For $20M

April 9, 2015 1:59 pm | by KELLI KENNEDY, Associated Press | News | Comments

One of the nation's largest suppliers of HIV and AIDS medical care is accused of bilking Medicare and Medicaid in an elaborate $20 million dollar scam that spanned 12 states, according to a lawsuit filed in South Florida federal court.

Enrollment Doubles in Private Health Insurance

April 8, 2015 11:19 am | by Rebecca Rudolph, Surgical Products editor | News | Comments

The number of people who have enrolled for their 2015 employee benefits doubled in the last year from 3 million to 6 million people.

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.

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.

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Court: Arizona Probationers Can't Be Barred From Medical Pot

April 8, 2015 10:42 am | by Jacques Billeaud, Associated Press | News | Comments

Arizonans with medical marijuana cards cannot be barred from using the drug while on probation, the state Supreme Court concluded Tuesday in a ruling that will have ripple effects across the state.

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.

Mixed Feelings About HIV Prescriptions

April 7, 2015 4:08 pm | by Group Health Research Institute | News | Comments

Cost remains an issue as the only FDA-approved PrEP is Truvada, a combination of two anti-retroviral medications used to treat HIV: tenofovir and emtricitabine. Truvada costs $14,400/year, and lab costs for routine monitoring are $180/year, so total cost is around $40/day.

ReposiTrak Enters Pharma and Supplement Safety Market

April 7, 2015 1:00 pm | by Park City Group | News | Comments

Park City Group will expand into the pharma and dietary supplement channels using its food, drug & dietary supplement compliance management and traceability solution.

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.

Indiegogo Campaign to Develop Medical Cannabis in Ireland

April 2, 2015 1:28 pm | by GreenLight Health | News | Comments

An Irish healthcare company has launched a crowdfunding campaign on Indiegogo to raise funds to research and develop affordable medical cannabis.

Audit: Maryland Misallocated $28.4M for Health Exchange

March 30, 2015 1:19 pm | by Brian Witte, The Associated Press | News | Comments

Maryland misallocated $28.4 million in federal money for its flawed health care exchange and should pay the money back, according to a federal audit set to be released Friday.

GNC Reaches Deal With NY AG Over Herbal Plus Products

March 30, 2015 12:43 pm | by The Associated Press | News | Comments

GNC Holdings Inc. said Monday that it has reached a deal with New York Attorney General Eric Schneiderman over its Herbal Plus products.

Accelrys Acquires QUMAS

December 10, 2013 8:42 am | News | Comments

Accelrys, a provider of scientific innovation lifecycle management solutions, has acquired Ireland-based QUMAS, a global provider of Cloud-based and on-premises enterprise compliance software supporting regulatory and quality operations in life sciences and other highly regulated industries.

Pharmaceutical Processing's November/December 2013 Issue

December 2, 2013 11:52 am | Digital Editions | Comments

In the November/December issue of Pharmaceutical Processing we profile Metrics’ clinical trial materials manufacturing facility located in Greenville, North Carolina. This issue also includes our annual CMO/CSO reader survey and our directory of service providers. Two articles on pure water discuss compendial water system maintenance and monitoring considerations, and automated and continuous TOC monitoring of ultra-pure water cycles.

Biogen Idec Receives Notification from FDA of PDUFA Date Extension for ALPROLIX™

December 2, 2013 8:01 am | News | Comments

Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) has extended the initial Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics License Application (BLA) for ALPROLIX™, the company’s investigational long-lasting recombinant factor IX Fc fusion protein candidate for hemophilia B.

Zalviso New Drug Application Accepted for Filing by FDA

December 2, 2013 7:58 am | News | Comments

AcelRx Pharmaceuticals, Inc. has announced that the Zalviso New Drug Application (NDA) was accepted for filing by the FDA on November 26, 2013. The acceptance for filing of the NDA indicates the FDA has determined that the application is sufficiently complete to permit a substantive review.

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