Blog
RSS FeedPosted by Michael Wonder on 08 Dec 2017
Concentric Analgesics receives FDA fast track designation for CA-008 for post-surgical pain
7 December 2017 - Novel pro-drug with unique mechanism of action takes on the opioid crisis. ...
Posted by Michael Wonder on 08 Dec 2017
Acorda resubmits new drug application for Inbrija (CVT-301, levodopa inhalation powder)
7 December 2017 - Acorda Therapeutics announced the resubmission of its new drug application for Inbrija to the U.S. FDA. ...
Posted by Michael Wonder on 07 Dec 2017
Other countries control drug prices the US could, too
7 December 2017 - Public opinion surveys show that most Americans are deeply concerned about rising drug prices. ...
Posted by Michael Wonder on 07 Dec 2017
How to reduce medical drug prices at a stroke
6 December 2017 - From penicillin to vaccines to biologics, pharmaceutical innovation has blessed us with better ways to treat, ...
Posted by Michael Wonder on 07 Dec 2017
FDA required studies of approved drugs make a big difference for public health
7 December 2017 - Drugs are approved by FDA based upon substantial evidence from clinical trials that the medicine will be ...
Posted by Michael Wonder on 07 Dec 2017
FDA seeks to speed approvals of generic drug-device combos
5 December 2017 - New FDA guidance will make it easier for generic companies to get drug-device combination products approved. ...
Posted by Michael Wonder on 07 Dec 2017
Out-of-pocket health spending in 2016 increased at the fastest rate in a decade
6 December 2017 - U.S. health care spending increased to $3.3 trillion in 2016, with out-of-pocket health care costs borne ...
Posted by Michael Wonder on 07 Dec 2017
The prospect of Amazon’s entry is a spur to a massive deal in health care
7 December 2017 - CVS Health’s $69bn purchase of Aetna is partly about the e-commerce giant’s rumoured plans to transform the ...
Posted by Michael Wonder on 07 Dec 2017
Sunovion receives FDA approval for Lonhala Magnair inhalation solution to treat COPD
5 December 2017 - Lonhala Magnair is the first nebulised long-acting muscarinic antagonist approved for the treatment of COPD in the ...
Posted by Michael Wonder on 07 Dec 2017
Speed, safety, and industry funding - from PDUFA I to PDUFA VI
7 December 2017 - The FDA Reauthorization Act of 2017 includes the sixth version of the Prescription Drug User Fee Act. ...
Posted by Michael Wonder on 06 Dec 2017
What the CVS-Aetna deal means for the future of health care
5 December 2017 - When drug company chief executive Heather Bresch was hauled in front of Congress last year to ...
Posted by Michael Wonder on 06 Dec 2017
FDA accepts new drug application for buprenorphine sublingual spray from INSYS Therapeutics
6 December 2017 - Novel formulation of partial opioid offers potential benefits compared to current alternatives. ...
Posted by Michael Wonder on 06 Dec 2017
Clovis announces priority review designation for rucaparib supplemental new drug application
5 December 2017 - Priority review granted based on positive data from phase 3 ARIEL3 clinical trial in which rucaparib significantly ...
Posted by Michael Wonder on 06 Dec 2017
FDA grants Genentech’s Avastin full approval for most aggressive form of brain cancer
5 December 2017 - Genentech announced today that the U.S. FDA has granted full approval for Avastin (bevacizumab) for the ...
Posted by Michael Wonder on 06 Dec 2017
Ozempic (semaglutide) approved in the US
5 December 2017 - Novo Nordisk today announced that the US FDA has approved Ozempic (semaglutide injection). ...