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RSS FeedPosted by Michael Wonder on 13 Dec 2016
We need to tame the price of new cancer drugs
13 December 2016 - Last week Dr. Peter Bach, a physician and cancer drug pricing theorist, gave a plenary lecture ...
Posted by Michael Wonder on 13 Dec 2016
Approving a problematic muscular dystrophy drug: implications for FDA policy
13 December 2016 - In September 2016, the US FDA approved eteplirsen (Exondys 51), a new drug for Duchenne muscular ...
Posted by Michael Wonder on 13 Dec 2016
Faster information from FDA means improved drug safety for patients
12 December 2016 - The FDA is now making it easier and faster for health care professionals and patients to ...
Posted by Michael Wonder on 12 Dec 2016
Flexion Therapeutics submits new drug application for Zilretta to treat knee osteoarthritis pain
12 December 2016 - Flexion Therapeutics today announced it has submitted a new drug application to the U.S. FDA for its ...
Posted by Michael Wonder on 12 Dec 2016
U.S. FDA approves Synjardy XR (empagliflozin/metformin hydrochloride extended-release) tablets for adults with type 2 diabetes
12 December 2016 - New once-a-day formulation indicated to improve blood sugar when used along with diet and exercise ...
Posted by Michael Wonder on 11 Dec 2016
Cardiorentis’ ularitide receives FDA fast track designation for the treatment of acute decompensated heart failure
11 December 2015 - TRUE-AHF phase III top line results anticipated in spring 2016. ...
Posted by Michael Wonder on 11 Dec 2016
ARCA Biopharma receives FDA fast track designation for Gencaro atrial fibrillation development in a genetically targeted heart failure population
13 April 2015 - ARCA Biopharma today announced that the U.S. FDA has designated as a fast track development program the ...
Posted by Michael Wonder on 11 Dec 2016
Gilead submits new drug application to U.S. FDA for the investigational single tablet regimen sofosbuvir/velpatasvir/voxilaprevir
8 December 2016 - If approved, SOF/VEL/VOX would be the first once daily single tablet regimen available as a salvage ...
Posted by Michael Wonder on 10 Dec 2016
Big price hikes seen in drug that prevents overdose deaths
9 December 2016 - Two of the largest suppliers of the life-saving drug naloxone have dramatically increased their prices in ...
Posted by Michael Wonder on 10 Dec 2016
New diabetes guidelines imminent, Jardiance sales may surge
9 December 2016 - Two leading U.S. medical societies are poised in the coming weeks to issue new diabetes treatment ...
Posted by Michael Wonder on 09 Dec 2016
US FDA accepts first biologics license application for AstraZeneca’s durvalumab in bladder cancer
9 December 2016 - FDA grants priority review status with PDUFA set for Q2 2017. ...
Posted by Michael Wonder on 09 Dec 2016
Cipla receives final FDA approval for generic Baraclude tablets
8 December 2016 - Cipla has received final approval for its abbreviated new drug application for entecavir 0.5 mg and ...
Posted by Michael Wonder on 09 Dec 2016
US Solicitor General calls on Supreme Court to review six-month delays to biosimilar launches
8 December 2016 - With the timing of all future US launches of biosimilars at stake, the US Solicitor General ...
Posted by Michael Wonder on 08 Dec 2016
Interpreting geographic variations in results of randomised, controlled trials
7 December 2016 - Clinical triallists generally accept the premise that surprising results in subgroups of a randomised, controlled trial most ...
Posted by Michael Wonder on 08 Dec 2016
Real world evidence — what is it and what can it tell us?
7 December 2016 - The FDA is developing guidance on the use of “real-world evidence” — health care information from atypical ...