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RSS FeedPosted by Michael Wonder on 17 Jan 2017
CTD Holdings receives FDA fast track designation for development of Trappsol Cyclo to treat Niemann-Pick Disease Type C
17 January 2017 - CTD Holdings today announced that the U.S. FDA has granted fast track designation to Trappsol Cyclo for ...
Posted by Michael Wonder on 17 Jan 2017
Introducing IMEDS, a public-private resource for evidence generation
17 January 2017 - The FDA has been working to establish a national resource for FDA-approved medical products that can ...
Posted by Michael Wonder on 17 Jan 2017
Composite endpoints and the distortion of risk–benefit analysis
17 January 2017 - Evidence-based medicine is a reassuring phrase, but when we prescribe has the evidence for safety and efficacy ...
Posted by Michael Wonder on 17 Jan 2017
Drug makers manipulate orphan drug rules to create prized monopolies
17 January 2017 - More than 30 years ago, Congress overwhelmingly passed a landmark health bill aimed at motivating pharmaceutical ...
Posted by Michael Wonder on 13 Jan 2017
RedHill Biopharma announces QIDP fast track designation granted by FDA to RHB-104 for non-tuberculous Mycobacteria infections
11 January 2017 - RedHill Biopharma today announced that RHB-104 has been granted Qualified Infectious Disease Product designation by the ...
Posted by Michael Wonder on 13 Jan 2017
Two Silicon Valley insiders meet with Trump about heading FDA
12 January 2017 - Two critics of the FDA met with President-elect Donald Trump Thursday to discuss running the agency. ...
Posted by Michael Wonder on 13 Jan 2017
U.S. FDA extends review period for baricitinib
13 January 2017 - Eli Lilly and Incyte announced today that the U.S. FDA has extended the review period for ...
Posted by Michael Wonder on 13 Jan 2017
FDA finalises guidance on non-proprietary naming of biologics and biosimilars
12 January 2017 - In a departure from the way the WHO and Europe name biologics, the US FDA has ...
Posted by Michael Wonder on 13 Jan 2017
Heron announces submission of Cinvanti NDA for the prevention of chemotherapy-induced nausea and vomiting
12 January 2017 - If approved by the U.S. FDA, Cinvanti will strengthen Heron’s chemotherapy-induced nausea and vomiting franchise by ...
Posted by Michael Wonder on 13 Jan 2017
Interpretation of surrogate endpoints in the era of the 21st Century Cures Act
14 January 2017 - Surrogate endpoints are commonly used in clinical trials to get quicker results, but Kevin Knopf and ...
Posted by Michael Wonder on 13 Jan 2017
VivaGel BV granted QIDP and fast track designation by US FDA
12 January 2017 - Starpharma today announced it has been granted qualified infectious disease product and fast track designation for ...
Posted by Michael Wonder on 13 Jan 2017
Tesaro receives complete response letter for rolapitant IV from U.S. FDA
11 January 2017 - No concerns raised by FDA related to the rolapitant IV efficacy or safety profile and additional ...
Posted by Michael Wonder on 12 Jan 2017
What Trump gets wrong about drug companies
12 January 2017 - President-elect Donald Trump was hardly timid in declaring Wednesday that drug companies are “getting away with ...
Posted by Michael Wonder on 12 Jan 2017
Biopharma needs to stop getting blindsided by Donald Trump
11 January 2017 - The day after Donald Trump won the US presidential election, pharma and biotech investors seemed to ...
Posted by Michael Wonder on 11 Jan 2017
National Cancer Institute and drug companies aim to speed up clinical trials
11 January 2017 - The National Cancer Institute launched an effort Wednesday to speed up clinical trials by getting researchers ...