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RSS FeedPosted 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 11 Jan 2017
Merck receives FDA acceptance of supplemental biologics license application for Keytruda (pembrolizumab) in combination with chemotherapy for first-line treatment of metastatic non-squamous non-small cell lung cancer
10 January 2017 - Submission based on data from KEYNOTE-021 trial, cohort G, which enrolled patients regardless of PD-L1 expression. ...
Posted by Michael Wonder on 11 Jan 2017
ViraCyte granted U.S. FDA fast track designation for Viralym-C
10 January 2017 - ViraCyte today announced that the U.S. FDA has granted fast track designation for Viralym-C, ViraCyte’s T cell ...
Posted by Michael Wonder on 10 Jan 2017
Egalet receives FDA approval for Arymo ER (morphine sulphate) C-II, an extended release morphine product formulated with abuse deterrent properties for treatment of chronic pain
9 January 2017 - Egalet Corporation today announced that the U.S. FDA has approved Arymo ER (morphine sulphate) extended-release (ER) tablets ...
Posted by Michael Wonder on 09 Jan 2017
FDA grants Roche’s cancer immunotherapy Tecentriq (atezolizumab) priority review in additional type of advanced bladder cancer
9 January 2017 - Second priority review granted for Tecentriq in advanced bladder cancer. ...
Posted by Michael Wonder on 08 Jan 2017
Don’t thank big government for medical breakthroughs
5 January 2017 - New cures come from private research, not cash dumped into the National Institutes of Health. ...
Posted by Michael Wonder on 06 Jan 2017
2016 financial year report from the Director
5 January 2017 - This letter is the Director's first annual report to various stakeholders. It summarises what Center have ...