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FDA APPROVALS

FDA approves anti-clotting drug Savaysa

FDA Approves Rytary

FDA Approves Duopa


FDA NEWS

FDA Drug Safety Communication: FDA has reviewed possible risks of pain medicine use during pregnancy

US FDA launches overarching Office of Pharmaceutical Quality


2015 PBMI Conference
SUMMARY OF TOP ARTICLES - JANUARY 15, 2014

Biosimilars in 2015 - What Can We Expect?
Drugs.com - January 10, 2015
On Wednesday, January 7th, the FDA Oncologic Drugs Advisory Committee unanimously recommended approval of Sandoz’s EP2006, a biosimilar for filgrastim (Neupogen). EP2006 is a recombinant granulocyte colony-stimulating factor used to boost white blood cells after cancer treatments that deplete these necessary infection-fighting cells.

U.S. official urges use of antivirals to fight 'bad' flu season
Reuters - January 9, 2015
Influenza is widespread across the United States and this flu season is shaping up to be especially harsh, the director of the U.S. Centers for Disease Control and Prevention said on Friday.

NCPA Backs Generic Drug Payment Legislation
Pharmacy Times - January 12, 2015
Bipartisan legislation recently introduced, and endorsed today by the National Community Pharmacists Association (NCPA), would help prevent community pharmacists from being collateral damage as some generic drug prices spike dramatically but federal health plan reimbursements fail to keep pace.

More Than 1 in 10 Use Daily Aspirin Inappropriately
HealthDay News - January 12, 2015
For many users, the odds of heart attack, stroke are lower than the risk of serious bleeding, study says.

Doctors Question Wider Hepatitis C Screening Despite Cures
Bloomberg - January 14, 2015
Doctors should resist the urge to screen a wider group of patients for hepatitis C, a group of physicians said today in the British Medical Journal, despite the introduction of new drugs that can cure the liver disease.

House passes two bills affecting employer mandate, but veto is expected
Managed Healthcare Executive - January 09, 2015
The U.S. House of Representatives passed two bills this week affecting employer mandate reforms that are part of the Affordable Care Act (ACA), but one is headed for a veto if it clears the U.S. Senate.

FDA approved drug extends survival for patients with rare cancer
ScienceDaily - January 12, 2015
Sunitinib, an agent approved for use in several cancers, provides unprecedented antitumor activity in thymic carcinoma, a rare but aggressive tumor of the thymus gland, according to a phase II clinical trial.

Sanofi, Regeneron cholesterol drug also effective in monthly doses
Reuters - January 9, 2015
An experimental drug from Sanofi SA and Regeneron Pharmaceuticals was found to be effective in lowering "bad" cholesterol even when administered once every four weeks, instead of every two weeks.

FDA Label May Prevent Use of Metformin in Type 2 Diabetics
The University of Pennsylvania - January 7, 2015
Many patients with type 2 diabetes in the United States may be discouraged from taking metformin—a proven, oral diabetes medicine—because the U.S. Food and Drug Administration inappropriately labels the drug unsafe for some patients also suffering from kidney problems, researchers from Penn Medicine and Weill Cornell Medical College report this week in a research letter published in JAMA Internal Medicine.


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