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3:03 PM, Jul 23, 2018  |  BioCentury | Politics, Policy & Law

Azar’s political play with drug importation

The drug importation policy announced by Alex Azar last week is a political stunt, aimed at generating headlines at a time when the HHS secretary seems desperate to demonstrate to Donald Trump and the media...
7:33 PM, Jul 20, 2018  |  BioCentury | Politics, Policy & Law

Getting serious

HHS Secretary Alex Azar isn’t waiting for the ink to dry on the department’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, or for his staff to digest tens of thousands of pages of...
10:25 AM, Jun 02, 2018  |  BioCentury | Politics, Policy & Law

Getting flatter

Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, brought the center’s entire staff of about 5,000 people together in the agency’s Great Room on June 1 for a town hall meeting to...
5:03 PM, May 18, 2018  |  BioCentury | Politics, Policy & Law

Shifting parts

HHS Secretary Alex Azar is convinced that the way Medicare Part B spends money for drugs makes no sense, costs the taxpayers too much and isn’t good for patients. He says he’s open to suggestions...
5:25 PM, May 11, 2018  |  BioCentury | Politics, Policy & Law

Getting reorganized

FDA is reorganizing the Office of New Drugs in its Center for Drug Evaluation and Research, seeking to make review oversight more consistent while encouraging senior staff to become thought leaders. The changes at OND...
10:57 AM, May 04, 2018  |  BioCentury | Politics, Policy & Law

A Remembrance: An exceptional responder

Jane Reese-Coulbourne was an exceptional responder. In 1990, faced with a diagnosis of advanced breast cancer, she enrolled in a clinical trial at the National Cancer Institute, enduring a grueling regimen of high doses of...
3:50 PM, Apr 27, 2018  |  BioCentury | Politics, Policy & Law

New hopes in IPR

The U.S. Supreme Court dashed biopharma’s hopes that the inter partes review system will quickly disappear, and threw a monkey wrench into the U.S. Patent and Trademark Office’s procedures for streamlining the adjudication of IPR...
7:56 AM, Apr 06, 2018  |  BioCentury | Politics, Policy & Law

Part D sour spot

A law that comes into effect next year will squeeze profits from moderately priced drugs that treat common, chronic conditions afflicting older Americans, and increase economic incentives to develop high-priced medicines for rare or acute,...
12:51 PM, Mar 29, 2018  |  BioCentury | Politics, Policy & Law

Progress preserved

The drug pricing reforms from Japan’s Ministry of Health, Labour and Welfare, set to take effect on April 1, largely preserve the regulatory innovations put in place by PMDA. But changes to the price maintenance...
3:03 PM, Mar 23, 2018  |  BioCentury | Politics, Policy & Law

Predicting the pricing plan

A plan for reducing prescription drug prices slated for release at a White House event next month will highlight HHS Secretary Alex Azar’s aspirations to narrow the gap between net and list prices. It also...

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