Blog
RSS FeedPosted by Michael Wonder on 11 Sep 2017
A much needed corrective on drug development costs
11 September 2017 - Contemporary pharmaceutical industry pricing practices are threatening to undermine the health care industry’s and policymakers’ efforts at ...
Posted by Michael Wonder on 11 Sep 2017
Research and development spending to bring a single cancer drug to market and revenues after approval
11 September 2017 - Prasad & Mailankody have estimated research and development spending for developing a new cancer drug. ...
Posted by Michael Wonder on 11 Sep 2017
New (very high) prices on old drugs
11 September 2017 - H. P. Acthar gel, or repository corticotropin (rACTH), was approved by the US FDA in 1952 and ...
Posted by Michael Wonder on 10 Sep 2017
Sobi receives approval from the FDA for once-daily dosing frequency of Orfadin for the treatment of HT-1
5 September 2017 - Sobi has received approval from the U.S. FDA for a reduced dosing frequency for Orfadin (nitisinone) ...
Posted by Michael Wonder on 09 Sep 2017
Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study
7 September 2017 - Mostaghim et al. set out to determine if drugs approved through the FDA’s expedited development and review ...
Posted by Michael Wonder on 09 Sep 2017
Should value frameworks take a ‘societal perspective’?
6 September 2017 - In 1996, the U.S. Panel on Cost-Effectiveness in Health and Medicine recommended that analysts conducting cost-effectiveness ...
Posted by Michael Wonder on 09 Sep 2017
Can a new value framework help ease friction over orphan drug prices?
7 September 2017 - America’s healthcare debate has stalled in Congress, but constructive dialogue and innovation are thriving in specialised ...
Posted by Michael Wonder on 09 Sep 2017
Sanofi and Regeneron announce that cemiplimab (REGN2810) has received FDA breakthrough therapy designation for advanced cutaneous squamous cell carcinoma
8 September 2017 - Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the U.S. FDA has granted breakthrough therapy designation ...
Posted by Michael Wonder on 07 Sep 2017
A GOP Senate leader calls for bipartisan compromise on ACA marketplaces
6 September 2017 - A bipartisan group of state insurance commissioners on Wednesday sketched out possible common ground where Congress ...
Posted by Michael Wonder on 07 Sep 2017
Statement from FDA Commissioner Scott Gottlieb on a new qualified health claim advising that early introduction of peanuts to certain high-risk infants may reduce risk of peanut allergy
7 September 2017 - As the science governing allergies and diets continues to evolve, so do expert recommendations around how best ...
Posted by Michael Wonder on 07 Sep 2017
FDA’s plan to engage the public in the agency’s new effort to strengthen and modernise FDA’s regulatory framework
7 September 2017 - We’re at a moment of extraordinary opportunity to improve the public health. New innovations are giving us ...
Posted by Michael Wonder on 07 Sep 2017
From last to first - could the U.S. health care system become the best in the world?
7 September 2017 - Many Americans believe that the United States has the best health care system in the world, ...
Posted by Michael Wonder on 07 Sep 2017
NeuroRx awarded FDA fast track designation for first drug regimen targeting suicide in bipolar depression
6 September 2017 - NeuroRx has been granted fast track status by the US FDA for its sequential therapy of NRX-100 ...
Posted by Michael Wonder on 07 Sep 2017
Novimmune receives rare paediatric disease designation from the FDA for its lead drug emapalumab
5 September 2017 - Providing eligibility is confirmed at the time of approval of emapalumab for the treatment of primary haemophagocytic ...
Posted by Michael Wonder on 07 Sep 2017
Enzyvant receives FDA rare paediatric disease designation for investigational therapy RVT-802
5 September 2017 - RVT-802 has also received breakthrough therapy designation, regenerative medicine advanced therapy designation, and orphan drug designation from ...