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FDA APPROVALS

FDA Approves Olysio (simeprevir) in Combination with Sofosbuvir for Genotype 1 Chronic Hepatitis C Infection

FDA Approves Cyramza (ramucirumab) in Combination with Paclitaxel for Advanced Gastric Cancer after Prior Chemotherapy


Specialty Rx
SUMMARY OF TOP ARTICLES - NOVEMBER 13, 2014

Justices to Hear New Challenge to Health Law
New York Times - November 7, 2014
The Supreme Court on Friday agreed to hear a new challenge to the Affordable Care Act, potentially imperiling President Obama’s signature legislative achievement two years after it survived a different Supreme Court challenge by a single vote.

FDA Adds Warnings To Heartburn Meds, Three Years After a Request
Wall Street Journal - November 4, 2014
More than three years after a consumer advocacy group petitioned the FDA to strengthen the warnings on a group of medicines widely used to treat acid reflux and heartburn, the agency has decided to upgrade the language to reflect certain safety concerns.

Healthcare Reform Changes Likely Focus of GOP Senate
Healthcare Financial Management Association - November 5, 2014
The newly elected Republican Senate majority will target numerous provisions of the Affordable Care Act (ACA) when it takes office in January, including the individual mandate, the medical device tax, and a portion of the insurance mandate for full-time workers, according to its leader.

AFib Blood Thinner Has Higher GI Risk
University of Pittsburgh - November 3, 2014
Patients with atrial fibrillation who take the blood thinner dabigatran are at greater risk for major bleeding and gastrointestinal bleeding than those who take warfarin, according to a new study by researchers at the University of Pittsburgh Graduate School of Public Health.

HRSA Announces Inclusion of 340B Compliance Questions in Operational Site Visit
National Association of Community Health Centers - November 5, 2014
In its Primary Health Care Digest dated October 22, 2014, BPHC announced that Operational Site Visits (OSV) conducted on or after October 1, 2014 for health centers that participate in the 340B Discount Drug Pricing Program will include a “brief assessment of compliance with 340B requirements.”

Vaccine for Hepatitis C Inches Closer to Reality
HealthDay News - November 5, 2014
An initial study suggests that a potential vaccine against hepatitis C, a liver disease that affects at least 130 million people worldwide, is safe in people.

Cost and effect: Cheaper remedies should rule for diabetes nerve pain
ScienceDaily - November 5, 2014
Millions of people with diabetes take medicine to ease shooting, burning nerve pain, and new research suggests that many medicines can offer relief. But since some of those medicines cost nearly 10 times as much as others, cost should be a crucial factor in deciding which medicine to choose for diabetic neuropathy, say experts.

Think You're Allergic to Penicillin? Maybe Not
HealthDay News - November 7, 2014
Many Americans may check the box "allergic to penicillin" on medical forms, but new research suggests that most of them are mistaken.

OIG will increase audit activities for Medicare Advantage plans in 2015
Managed Healthcare Executive - November 07, 2014
Audits of Medicare Advantage (MA) plans and healthcare plans offering financial assistance as part of the Affordable Care Act (ACA) will be conducted by the Health and Human Services Office of Inspector General (OIG), according to the Center for Public Integrity.

Swing and a miss: Merck's ambitious 4-week hep C regimen fails
BioPharma Dive - November 11, 2014
Merck has designed a trial studying two of its drugs, grazoprevir and elbasvir, in combination with Sovaldi (sofosbuvir), in order to establish whether a mere 4-week regimen could provide a high level of cure in hepatitis C (HCV)-infected patients.

Certain Painkillers Tied to Raised Risk of Death After Stroke
HealthDay News - November 5, 2014
Arthritis pain relievers known as COX-2 inhibitors, including Celebrex and Lodine, are associated with an increased risk of dying within a month after a stroke, according to a new study.

Fewer than 10 million expected to enroll under health law in 2015
McClatchy Washington Bureau - November 10, 2014
The Obama administration expects fewer than 10 million people to enroll in marketplace health coverage next year, far below the 13 million people that the Congressional Budget Office has projected.

Encapsulating the problem? Machinery could save drugmakers up to $1m, says Capsugel
William Reed Business Media - November 6, 2014
Using encapsulation machinery that is well serviced and appropriate to the type of powder being used can save drugmakers hundreds of thousands of dollars, according to Capsugel.


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