Blog
RSS FeedPosted by Michael Wonder on 15 May 2017
Publication and reporting of the results of post-market studies for drugs required by the US FDA, 009 to 2013
15 May 2017 - Advancing scientific knowledge depends on the timely dissemination of research results, including those from medical product research ...
Posted by Michael Wonder on 15 May 2017
Price predicts Obamacare repeal passes Senate by August
12 May 2017 - Health and Human Services Secretary Tom Price on Friday said he expects the Senate to pass ...
Posted by Michael Wonder on 13 May 2017
The Health Care Bill’s insults to women
12 May 2017 - When Representative John Shimkus questioned, during a debate in March, why men have to pay for ...
Posted by Michael Wonder on 13 May 2017
Patients beg for pricey drugs on Facebook black market
11 May 2017 - Desperate patients are swapping pricey pharmaceutical drugs on Facebook. Doctors say it's dangerous. But when you ...
Posted by Michael Wonder on 13 May 2017
Institute for Clinical and Economic Review releases revised evidence report on dupilumab and crisaborole for treatment of atopic dermatitis
12 May 2017 - Limitations noted on the evidence for crisaborole; analyses find stronger evidence for dupilumab and suggest its price ...
Posted by Michael Wonder on 13 May 2017
FDA authorises use of new device to treat oesophageal birth defect in babies
12 May 2017 - The U.S. FDA today authorised use of the Flourish Pediatric Esophageal Atresia Anastomosis, a first-of-its-kind medical device ...
Posted by Michael Wonder on 12 May 2017
Oncolytics Biotech announces FDA fast track designation for Reolysin in metastatic breast cancer
8 May 2017 - Oncolytics Biotech announced today that the United States FDA has granted fast track designation for Reolysin, the ...
Posted by Michael Wonder on 12 May 2017
Vericel receives FDA regenerative medicine advanced therapy designation for ixmyelocel-T for the treatment of advanced heart failure due to ischaemic dilated cardiomyopathy
10 May 2017 - Ixmyelocel-T is the first therapy to receive the RMAT designation for the treatment of a serious ...
Posted by Michael Wonder on 12 May 2017
Proteon Therapeutics receives FDA breakthrough therapy designation for vonapanitase
10 May 2017 - Proteon Therapeutics today announced that its investigational treatment, vonapanitase, has received breakthrough therapy designation from the ...
Posted by Michael Wonder on 12 May 2017
SYN-004 (ribaxamase) receives breakthrough therapy designation from U.S. FDA for prevention of clostridium difficile infection
11 May 2017 - FDA action marks first breakthrough therapy designation for clinical program designed to prevent primary clostridium difficile infection. ...
Posted by Michael Wonder on 12 May 2017
Rhythm receives expanded FDA breakthrough therapy designation for setmelanotide for rare genetic disorders of obesity
11 May 2017 - Expands upon previous designation for POMC deficiency obesity. ...
Posted by Michael Wonder on 12 May 2017
FDA grants fast track designation for Celyad’s ischemic heart failure therapy, C-Cure
11 May 2017 - Designation granted on the strength of the evidence in the subset of patients that were responders ...
Posted by Michael Wonder on 11 May 2017
GSK escapes Advair hit for now as second generic bid fails
11 May 2017 - GlaxoSmithKline is likely to escape generic competition to its blockbuster lung drug Advair in the United ...
Posted by Michael Wonder on 11 May 2017
Aetna is the latest health insurer to quit Obamacare markets
10 May 2017 - Insurer had already pulled out of most ACA health exchanges. ...
Posted by Michael Wonder on 11 May 2017
Mylan disagrees with FDA over generic Advair delay
10 May 2017 - Generic drug maker Mylan on Wednesday said it disagrees with the reasoning behind the U.S. FDA's ...