Blog
RSS FeedPosted by Michael Wonder on 14 Jan 2018
Can your hip replacement kill you?
13 January 2018 - When Stephen Tower’s right hip gave out in 2006, he asked his surgeon to implant an ...
Posted by Michael Wonder on 14 Jan 2018
Drug makers see a pricing blueprint in an 850,000 dollar gene therapy
12 January 2018 - Global drug makers are looking to a tiny biotech’s $850,000 therapy for a rare type of blindness ...
Posted by Michael Wonder on 13 Jan 2018
Cour Pharmaceuticals receives FDA fast track designation for TIMP-GLIA
8 January 2018 - TIMP-GLIA is designed to enable patients to develop tolerance to gluten. ...
Posted by Michael Wonder on 13 Jan 2018
FDA grants fast track designation to Concert Pharmaceuticals' CTP-543 for the treatment of alopecia areata
12 January 2018 - CTP-543 is a novel JAK inhibitor in Phase 2 for alopecia areata as potential first-in-class treatment. ...
Posted by Michael Wonder on 13 Jan 2018
GSK receives FDA approval for expanded indication for Fluarix Quadrivalent (influenza vaccine) for persons 6 months and older
11 January 2018 - GSK announced today it has received approval from the US FDA's Center for Biologics Evaluation and Research ...
Posted by Michael Wonder on 13 Jan 2018
Institute for Clinical and Economic Review Report on voretigene neparvovec suggests substantial price discount needed to meet traditional cost-effectiveness standards
12 January 2018 - Special considerations include patient age, benefit durability, and rarity of condition. ...
Posted by Michael Wonder on 13 Jan 2018
Statement from FDA Commissioner on FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products
12 January 2018 - The FDA is committed to ensuring that we have the right policies and processes in place ...
Posted by Michael Wonder on 13 Jan 2018
FDA approves first treatment for breast cancer with a certain inherited genetic mutation
12 January 2018 - The U.S. FDA today expanded the approved use of Lynparza (olaparib) to include the treatment of patients ...
Posted by Michael Wonder on 11 Jan 2018
Institute for Clinical and Economic Review posts draft scoping document on elagolix for endometriosis
11 January 2018 - Document open to public comment until 1 February 2018. ...
Posted by Michael Wonder on 11 Jan 2018
Many “firsts” for CDER’s 2017 drug approvals reflect innovation and enhanced patient care
10 January 2018 - In 2017, FDA’s Center for Drug Evaluation and Research approved many new drugs never before marketed in ...
Posted by Michael Wonder on 11 Jan 2018
Middlemen are driving up the cost of life-saving drugs
10 January 2018 - History will record 2017 as a transformative year in medicine. ...
Posted by Michael Wonder on 11 Jan 2018
ObamaCare repeal fades from GOP priorities list in new year
10 January 2018 - The chances of repealing ObamaCare this year are fading further, with top Republicans saying they hardly ...
Posted by Michael Wonder on 11 Jan 2018
New guidance: When can the FDA refuse to file NDAs and BLAs?
10 January 2018 - According to US FDA regulations, the regulatory agency may refuse to file a new drug application ...
Posted by Michael Wonder on 10 Jan 2018
Trump likes drug price negotiations; his nominee for Health Secretary doesn’t
9 January 2018 - Alex M. Azar II, President Trump’s nominee for secretary of health and human services, said Tuesday ...
Posted by Michael Wonder on 10 Jan 2018
The health 202: This year's top 10 new drugs
9 January 2018 - Yes, overall spending on prescription drugs has slowed recently, but expect Democrats to pummel Alex Azar ...