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The Lead

Serialization: Don’t Wait Until the Last Minute

October 30, 2014 11:11 am | by Kevin Swartz, Senior Engineer, IPS; Tina Gushue, Process Engineer, IPS | Blogs | Comments

A reminder to pharma manufacturers, the Drug Supply Chain Security Act (DSCSA) deadlines are quickly approaching. Have you planned for the implementation of Transaction Documents for your packaged products and how to introduce them into your supply chain? Have you developed a strategy for implementing packaging serialized data and infrastructure?

FDA Approves Once-Daily XIGDUO™ XR Tablets for Adults with Type 2 Diabetes

October 30, 2014 8:04 am | News | Comments

AstraZeneca today announced that the FDA has approved once-daily XIGDUO™ XR (dapagliflozin and...

FDA Grants Accelerated Approval to Pfizer’s TRUMENBA®

October 29, 2014 3:22 pm | News | Comments

Pfizer announced that the FDA has granted accelerated approval of TRUMENBA ® (meningococcal...

North Dakota Court Bans Use of Drug in Abortions

October 29, 2014 8:44 am | by JAMES MacPHERSON, Associated Press | News | Comments

The North Dakota Supreme Court on Tuesday upheld a state law that limits the use of drugs to...

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States Ask Congress to Intervene on Drug Prices

October 29, 2014 8:24 am | News | Comments

In a letter Tuesday to key congressional committees, the National Association of Medicaid Directors said lawmakers should consider everything from outright price controls on manufacturers to federal help for states trying to pay for the new medications.

New Warning for Dietary Supplement Users

October 23, 2014 10:46 am | Videos | Comments

Researchers at Harvard found that two-thirds of dietary supplements that have previously been recalled still contain banned ingredients. Also, smoking may get in the way of recovering alcoholics.         

HealthCare.gov's EZ Form Not for Legal Immigrants

October 23, 2014 8:26 am | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

HealthCare.gov's new EZ application for coverage can't be used by legal immigrants or naturalized U.S. citizens, prompting concern that many Hispanics and Asians will go right back into long enrollment queues this year.      

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Study Finds Drugs Still in Recalled Supplements

October 22, 2014 8:58 am | by LINDSEY TANNER, AP Medical Writer | News | Comments

Dietary supplements containing potentially dangerous prescription drug ingredients may still be for sale even years after safety recalls, a study found. In supplements bought online, researchers detected hidden steroids, similar ingredients to Viagra and Prozac and a weight loss drug linked with heart attacks.

Packaging Error Prompts Recall of Naproxen Pills

October 21, 2014 11:48 am | News | Comments

A North Carolina company is recalling nearly 12,000 boxes of pain relief tablets sold at Dollar Tree stores because some cartons contain a different medication that could cause allergic reactions.         

Halozyme Receives FDA Approval for Additional Manufacturing Facilities For Hylenex Recombinant

October 20, 2014 9:02 am | News | Comments

The FDA approved the use of the Cook Pharmica manufacturing facility in Bloomington, Indiana for the production of bulk rHuPH20, the active ingredient used in Hylenex, and the Patheon facility in Greenville, North Carolina, for production of finished Hylenex product.

FDA Panel Votes to Keep Boxed Warning on Chantix

October 16, 2014 4:36 pm | by The Associated Press | News | Comments

Federal health advisers say a bold-letter warning about suicide risks with Pfizer's Chantix should remain on the anti-smoking drug until it can reevaluated based on new, rigorous study information. Eleven advisers to the Food and Drug Administration voted to retain the so-called black box warning.

FDA Approves Esbriet to Treat Idiopathic Pulmonary Fibrosis

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

Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities.  

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Mylan Recalls Some Lots of Nitroglycerin Spray Used to Treat Angina

October 15, 2014 2:14 pm | by The Canadian Press | News | Comments

Some lots of the product, called Mylan-Nitro Sublingual Spray 0.4 mg Per Metered Dose, are potentially missing the dip tube, a part of the pump component. A missing dip tube could pose a problem with delivery of nitroglycerin to the patient.  

Hospira Announces Voluntary Nationwide Recall of Certain Lots of Several Lifecare Products

October 15, 2014 8:44 am | News | Comments

Hospira has announced the voluntary recall of certain lots of several products in its LifeCare™ line of flexible intravenous solutions due to the potential for leakage.              

How the New HealthCare.gov Stacks Up With the Old

October 14, 2014 8:23 am | by RICARDO ALONSO-ZALDIVAR, Associated Press; CALVIN WOODWARD, Associated Press | News | Comments

HealthCare.gov, the website for health insurance under President Barack Obama's health care law, has been revamped as its second enrollment season approaches. But things are still complicated, since other major provisions of the Affordable Care Act are taking effect for the first time. A look at website and program changes just ahead.

Oregon Compounding Centers Recalls Unexpired Sterile Products Due to Lack of Sterility Assurance

October 10, 2014 8:16 am | News | Comments

The company has not received any reports of product contamination or adverse events to date, but is issuing this voluntary recall out of an abundance of caution following a recent inspection which identified an issue with sterility assurance.  

FDA Approves VELCADE® for Injection for Previously Untreated Patients with Mantle Cell Lymphoma

October 9, 2014 1:48 pm | News | Comments

Millennium: The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited, today announced that the FDA has approved VELCADE® for injection for use in previously untreated patients with mantle cell lymphoma. VELCADE is the first treatment in the United States to be approved for use in previously untreated patients with MCL.

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Next Edition of HealthCare.gov is Unveiled

October 9, 2014 8:41 am | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

The Obama administration unveiled a new version of HealthCare.gov on Wednesday, with some improvements as well as at least one early mistake and a new challenge. Officials also said that HealthCare.gov won't display premiums for 2015 until the second week of November. Open enrollment season runs Nov. 15 through Feb. 15. Coverage can start as early as Jan. 1.

Health Law Waivers: Too Complicated to Claim?

October 8, 2014 9:01 am | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

Millions of Americans may qualify for waivers from the most unpopular part of President Barack Obama's health care overhaul. But getting that exemption could be an ordeal. Community groups are concerned about a convoluted process for waivers from the law's tax penalty on people who remain uninsured.

VA Moves to Ax Four Senior Execs in Scandal Response

October 7, 2014 8:20 am | by MATTHEW DALY, Associated Press | News | Comments

The Veterans Affairs Department said it is firing four senior executives as officials move to crack down on wrongdoing following a nationwide scandal over long wait times for veterans seeking medical care, and falsified records covering up the delays.

FDA Approves AbbVie's HUMIRA for Patients Ages Two and Older

October 6, 2014 8:20 am | News | Comments

AbbVie has announced that the FDA has approved the extension of the HUMIRA indication for moderately to severely active polyarticular juvenile idiopathic arthritis to reducing signs and symptoms in patients ages 2 and older. HUMIRA was approved in the United States in 2008 for polyarticular juvenile idiopathic arthritis in patients ages 4 and older.

Senators: Widen Medicaid Program for Frail Seniors

September 29, 2014 12:16 pm | by HOPE YEN, Associated Press | News | Comments

More than a dozen U.S. senators from both parties are calling on the Obama administration to broaden a Medicaid program for the nation's frailest seniors, calling it a proven alternative to pricier nursing home care as states seek to limit long-term medical costs.

FDA Approves Revised Indication for Allergan's OZURDEX®

September 29, 2014 10:06 am | News | Comments

Allergan announced today that the U.S. Food and Drug Administration (FDA) has approved OZURDEX® (dexamethasone intravitreal implant) 0.7 mg, a sustained-release biodegradable steroid implant, for the treatment of diabetic macular edema (DME).  

Alimera, pSivida say FDA Clears Eye Implant

September 26, 2014 5:45 pm | by The Associated Press | News | Comments

Alimera Sciences and pSivida said Friday the FDA approved their eye disease implant Iluvien. Iluvien is an implant delivered by injection that is intended to treat diabetic macular edema, a condition that can cause blurred vision and blindness. 

AbbVie Gets Approval For Humira

September 26, 2014 10:48 am | News | Comments

The FDA cleared Humira as a treatment for moderate to severe Crohn's disease in children ages six and older when those children haven't been helped by other treatments, AbbVie said. Humira can be administered at home, unlike similar drugs used to treat the condition.

WHO: Ebola Vaccine On The Way

September 26, 2014 10:12 am | News | Comments

The World Health Organization says there should be thousands of doses of experimental Ebola vaccines available in the coming months and they could eventually be given to health care workers and other people who have had contact with the sick.

Limits on Overseas Mergers Prompt Renewed Debate

September 23, 2014 8:05 am | by JOSH LEDERMAN, Associated Press; JIM KUHNHENN, Associated Press | News | Comments

The Obama administration's decision to curb the ability of U.S. corporations to skirt taxes by merging with foreign companies kicked off an immediate election-season debate over when and how to tackle the nation's complex corporate tax code.  

FDA Revises Food Safety Rules Due Next Year

September 22, 2014 8:16 am | by MARY CLARE JALONICK, Associated Press | News | Comments

The Food and Drug Administration on Friday revised sweeping food safety rules proposed last year after farmers complained that the regulations could hurt business. The new proposals would relax water quality standards and allow farmers to harvest crops sooner after using raw manure as fertilizer.

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 Co. for adults with the most common form of the disease. The agency on Thursday cleared the drug, Trulicity, as a weekly injection to improve blood sugar control in patients with type 2 diabetes.

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