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Hospitals, healthcare facilities urged to require staffs to get flu shots

February 3, 2012

Hospitals and healthcare facilities should require all employees to get an annual flu shot, a group representing many of the nation?s largest employers emphasized again at a press conference Wednesday in Washington, DC.

Ranbaxy accepts consent decree, permanent injunction

January 26, 2012

Indian drug giant Ranbaxy has accepted a consent decree filed by the U.S. Department of Justice on behalf of FDA. The decree, which must still be accepted by the U.S. District Court for the District of Maryland, requires Ranbaxy to fix long-standing manufacturing problems at plants in India as well as a plant in the United States.

FDA investigating death following first dose of MS drug

December 22, 2011

FDA announced that it is evaluating the case of a patient with multiple sclerosis who died 24 hours following administration of the first dose of fingolimod (Gilenya).

Almost half of new molecular entities approved in 2011 considered significant therapeutic advances

January 1, 2012

New molecular entities (NMEs) for calendar year 2011 number 30, considerably above the average of 23 during the past 10 years. Notably among this list are 8 drugs for cancer; 10 targeting orphan diseases; 2 each for hepatitis C and chronic obstructive pulmonary disease (COPD); and 3 anticoagulants.

Linaclotide: A guanylate cyclase type-C agonist for the treatment of constipation-predominant irritable bowel syndrome and chronic constipation

January 1, 2012

Constipation-predominant irritable bowel syndrome (IBS-C) and chronic constipation affect millions of Americans. Use of agents currently available for treatment is not supported by well-controlled clinical studies. A new drug application for linaclotide, an orally administered guanylate cyclase type-C receptor agonist for treatment of IBS-C and chronic constipation, was submitted to the US Food and Drug Administration (FDA) with a target action date of June 2012.

ACA "sunshine" rule increases transparency in healthcare

December 19, 2011

The Centers for Medicare & Medicaid Services announced a proposed rule that will increase public awareness of financial relationships between drug and device manufacturers and certain healthcare providers.

Focus on 2011: A year of novel pharmacologic agents in review

December 1, 2011

Throughout 2011, Formulary's "Focus on" articles have examined 10 newly approved or investigational drugs of interest to pharmacy and therapeutics (P&T) committee members. Because many readers have said they frequently refer to this column when making formulary decisions for hospitals, health systems, or managed care organizations, the editors have compiled this review of these agents, along with updates on the regulatory status of each.

Treatment of rheumatoid arthritis: A review of recommendations and emerging therapy

December 1, 2011

The etiology of rheumatoid arthritis is not fully understood, but environmental and genetic factors have been proposed as potential theories. Genetic predisposition results in the destructive nature of this autoimmune disease. The inheritance of certain genes in the major histocompatibility complex can increase the susceptibility of developing RA.

Crizotinib: A novel, targeted gene therapy for the treatment of non-small-cell lung cancer

November 1, 2011

Crizotinib is a new kinase inhibitor recently approved by FDA for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer who express the anaplastic lymphoma kinase gene.

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