Blog
RSS FeedPosted by Michael Wonder on 19 Dec 2016
AbbVie submits new drug application to U.S. FDA for its investigational regimen of glecaprevir/pibrentasvir for the treatment of all major genotypes of chronic hepatitis C
19 December 2016 - AbbVie's investigational regimen was granted breakthrough therapy designation by the FDA for genotype 1 patients not ...
Posted by Michael Wonder on 19 Dec 2016
FDA grants accelerated approval to new treatment for advanced ovarian cancer
19 December 2016 - The U.S. FDA today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain ...
Posted by Michael Wonder on 19 Dec 2016
Boehringer Ingelheim and Lilly welcome new recommendation for Jardiance (empagliflozin) tablets in updated American Diabetes Association's 2017 standards
16 December 2016 - Guidelines include new recommendation to consider the use of Jardiance in people with type 2 diabetes ...
Posted by Michael Wonder on 19 Dec 2016
The most expensive drugs of 2016
16 December 2016 - Prescription drug prices have gotten out of control for many Americans and many insurers. ...
Posted by Michael Wonder on 18 Dec 2016
Janssen submits application seeking FDA approval of Stelara (ustekinumab) for the treatment of adolescents with moderate to severe plaque psoriasis
16 December 2016 - Janssen Biotech announced today the submission of a supplemental biologics license application to the U.S. FDA seeking ...
Posted 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 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 ...