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RSS FeedPosted by Michael Wonder on 13 Mar 2017
Enhancing transparency at the US FDA: moving beyond the 21st Century Cures Act
13 March 2017 - The US FDA has primary responsibility for oversight of every drug, biologic, and medical device sold ...
Posted by Michael Wonder on 13 Mar 2017
How Republicans want to change Medicaid
9 March 2017 - One of the crucial ingredients of the Affordable Care Act, better known as Obamacare, was an expansion ...
Posted by Michael Wonder on 13 Mar 2017
Novartis Kisqali (ribociclib, LEE011) receives FDA approval as first-line treatment for HR+/HER2- metastatic breast cancer in combination with any aromatase inhibitor
13 March 2017 - Approved based on a first-line Phase III trial that met its primary endpoint of progression-free survival ...
Posted by Michael Wonder on 13 Mar 2017
G.O.P. desire to keep party feuds private breaks down over health care
12 March 2017 - Top Republicans never like to see their internal party quarrels messily spilled out in public for ...
Posted by Michael Wonder on 13 Mar 2017
Rare diseases patients need more than miracles and Trumpcare
11 March 2017 - Never one to miss an opportunity, Trump cheapened Rare Disease Week by exploiting a young woman, Megan ...
Posted by Michael Wonder on 12 Mar 2017
The G.O.P.’s high-risk strategy for health law repeal
11 March 2017 - President Trump and House Republicans are pressing forward with a high-risk strategy to repeal and replace ...
Posted by Michael Wonder on 11 Mar 2017
Radius Health receives notification of PDUFA extension for abaloparatide
10 March 2017 - PDUFA goal date extended by standard extension period of three months to 30 June 2017. ...
Posted by Michael Wonder on 11 Mar 2017
Trump picks Scott Gottlieb to serve as FDA Commissioner
11 March 2017 - Nominee was senior FDA executive under George W. Bush. ...
Posted by Michael Wonder on 11 Mar 2017
Institute for Clinical and Economic Review releases revised report on targeted immune modulators for treatment of rheumatoid arthritis
10 March 2017 - Analyses of evidence on comparative effectiveness raise questions about current step therapy protocols, while net prices for ...
Posted by Michael Wonder on 10 Mar 2017
John Kasich: end the partisan warfare on health care
10 March 2017 - Americans are relying on leaders in Washington to fix health care, not engage in yet another ...
Posted by Michael Wonder on 10 Mar 2017
R&D costs for pharmaceutical companies do not explain elevated US drug prices
7 March 2017 - That pharmaceutical companies charge much more for their drugs in the US than they do in ...
Posted by Michael Wonder on 10 Mar 2017
After halting start, Trump plunges into effort to repeal health law
9 March 2017 - President Trump, after a halting start, is now marshalling the full power of his office to ...
Posted by Michael Wonder on 10 Mar 2017
Regeneron CEO on drug prices: ‘a few bad actors are not the problem’
9 March 2017 - Len Schleifer made something of a splash at an industry conference last December. ...
Posted by Michael Wonder on 10 Mar 2017
Keryx Biopharmaceuticals announces U.S. FDA filing acceptance of supplemental new drug application for Auryxia (ferric citrate) tablets
8 March 2017 - Keryx Biopharmaceuticals today announced that the U.S. FDA has accepted for review the supplemental new drug ...
Posted by Michael Wonder on 10 Mar 2017
Nicox resubmits AC-170 (Zerviate) NDA to the U.S. FDA
9 March 2017 - CGMP issues at the API manufacturer have been resolved. ...