Blog
RSS FeedPosted by Michael Wonder on 12 Aug 2017
Institute for Clinical and Economic Review to evaluate comparative clinical effectiveness and value of emicizumab for haemophilia A
11 August 2017 - Open input period now open until 6 September 2017. ...
Posted by Michael Wonder on 12 Aug 2017
Gilead announces US FDA priority review designation for fixed-dose combination of bictegravir, emtricitabine and tenofovir alafenamide for treatment of HIV
10 August 2017 - Final FDA Decision Anticipated by 12 February 2018. ...
Posted by Michael Wonder on 10 Aug 2017
Setting the record straight on FDA approvals in oncology
7 August 2017 - The Research Letter, “Quality of Life, Overall Survival and Costs of Cancer Drugs Approved Based on Surrogate ...
Posted by Michael Wonder on 10 Aug 2017
Trump takes issue with McConnell’s accusation that he had ‘excessive expectations’ for Congress
9 August 2017 - President Trump on Wednesday took a shot at Senate Majority Leader Mitch McConnell, pointedly asking on ...
Posted by Michael Wonder on 10 Aug 2017
To speed access to compassionate use, look beyond the FDA
10 August 2017 - In mid-July, the nonpartisan research arm of the federal government, the Government Accountability Office, released its long-awaited ...
Posted by Michael Wonder on 10 Aug 2017
The fix for American health care can be found in Europe
10 August 2017 - Policy makers should take a close look. ...
Posted by Michael Wonder on 10 Aug 2017
FDA issues a complete response letter on CCP-08 NDA
7 August 2017 - Vernalis announced today that the US FDA has issued a complete response letter regarding the new ...
Posted by Michael Wonder on 09 Aug 2017
FDA grants priority review and breakthrough therapy designation for Zelboraf (vemurafenib) in Erdheim-Chester disease with BRAF V600 mutation
7 August 2017 - There are currently no FDA-approved treatments for Erdheim-Chester disease, a rare blood disease. ...
Posted by Michael Wonder on 09 Aug 2017
Health insurance coverage and health — what the recent evidence tells us
9 August 2017 - The national debate over the Affordable Care Act has involved substantial discussion about what effects — if ...
Posted by Michael Wonder on 09 Aug 2017
Three ways President Trump can make good on his promise to bring down drug prices
9 August 2017 - A few months ago in Louisville, Kentucky, in one of his many attacks on drug prices. ...
Posted by Michael Wonder on 09 Aug 2017
Repeal, replace, repair, retreat — Republicans’ health care quagmire
9 August 2017 - For 7 years, Republicans vowed to repeal and replace the Affordable Care Act. ...
Posted by Michael Wonder on 09 Aug 2017
Valeant Pharmaceuticals receives complete response letter from the FDA for latanoprostene bunod ophthalmic solution, 0.024% NDA
7 August 2017 - Valeant Pharmaceuticals today announced it has received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 09 Aug 2017
Institute for Clinical and Economic Review posts draft scoping document on CAR-T therapies for public comment
9 August 2017 - Report expected to review axicabtagene ciloleucel and tisagenlecleucel-t, first CAR-T therapies submitted for FDA. ...
Posted by Michael Wonder on 08 Aug 2017
FDA approves Medicines360's sNDA for Liletta (levonorgestrel-releasing intrauterine system) 52 mg to prevent pregnancy for up to four years
7 August 2017 - Approval offers women additional flexibility for pregnancy prevention. ...
Posted by Michael Wonder on 07 Aug 2017
AbbVie wages HCV drug price war on Gilead
7 August 2017 - Pharma already leads the business world in unpredictability, with billions in sales potentially riding on a few ...