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RSS FeedPosted by Michael Wonder on 17 Dec 2016
Grünenthal receives breakthrough therapy designation from U.S. FDA for neridronic acid for the treatment of complex regional pain syndrome, a debilitating orphan disease with high medical need
16 December 2016 - Neridronic acid is the first investigational medicine to receive breakthrough therapy designation for the treatment of ...
Posted by Michael Wonder on 16 Dec 2016
Why did new drug approvals in the U.S. plunge this year?
15 December 2016 - New drug approvals dropped more than 50% this year. ...
Posted by Michael Wonder on 16 Dec 2016
Trump's FDA chief may implement progressive approval for drugs
15 December 2016 - The first potential FDA chief appointee leaked by the Trump transition team is Jim O’Neill. ...
Posted by Michael Wonder on 15 Dec 2016
US states sue Mylan, Teva, others for allegedly fixing drug prices
15 December 2016 - One day after federal prosecutors unsealed a criminal information against the former CEO of Heritage Pharmaceuticals, ...
Posted by Michael Wonder on 14 Dec 2016
The 21st Century Cures Act — a view from the NIH
14 December 2016 - The Cures Act, formally known as H.R. 34 or the 21st Century Cures Act, passed overwhelmingly in ...
Posted by Michael Wonder on 14 Dec 2016
FDA approves Eucrisa for eczema
14 December 2016 - The U.S. FDA today approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in ...
Posted by Michael Wonder on 14 Dec 2016
Obama signs $6.3 billion law for cancer research, drug treatment
14 December 2016 - President Barack Obama has signed into law legislation that makes new investments in cancer research and battling ...
Posted by Michael Wonder on 14 Dec 2016
Two executives charged in generic drug price-fixing federal investigation
14 December 2016 - The U.S. filed its first charges in a generic drug price-fixing probe on Wednesday. ...
Posted by Michael Wonder on 13 Dec 2016
FDA approves first autologous cellularized scaffold for the repair of cartilage defects of the knee
14 December 2016 - The U.S. FDA today approved Maci (autologous cultured chondrocytes on porcine collagen membrane) for the repair of ...
Posted 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 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 ...