Blog
RSS FeedPosted by Michael Wonder on 14 Feb 2018
FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint
14 February 2018 - The U.S. FDA today approved Erleada (apalutamide) for the treatment of patients with prostate cancer that ...
Posted by Michael Wonder on 13 Feb 2018
Statement from FDA Commissioner Scott Gottlieb on Administration’s request for new FDA funding to promote innovation and broaden patient access through competition
13 February 2018 - Additional resources will help advance initiatives to support novel medical technology and public health priorities such as ...
Posted by Michael Wonder on 13 Feb 2018
Legal challenges to state drug pricing laws
12 February 2018 - In recent years, growth in spending on prescription drugs has been fuelled by high prices of ...
Posted by Michael Wonder on 13 Feb 2018
Pharma gets the worst of both drug pricing worlds
14 February 2018 - Growth is slowing dramatically, but the political pressure isn't. ...
Posted by Michael Wonder on 13 Feb 2018
States look to lower drug costs, consider Canadian imports
11 February 2018 - Lawmakers in more than two-thirds of the states are considering ways to reduce prescription drug costs, ...
Posted by Michael Wonder on 13 Feb 2018
Icon Bioscience receives FDA approval for Dexycu, a potentially transformational drug therapy for treating inflammation associated with cataract surgery
12 February 2018 - Icon Bioscience today announced that the United States FDA has approved the company's new drug application for ...
Posted by Michael Wonder on 13 Feb 2018
Sandoz announces US FDA approval and launch of Glatopa 40 mg/mL three times-a-week generic option for relapsing forms of multiple sclerosis
13 February 2018 - Glatopa 40 mg/mL is a fully substitutable, AP-rated generic version of Copaxone (glatiramer acetate injection) 40 mg/mL. ...
Posted by Michael Wonder on 13 Feb 2018
U.S., EU and Japan health authorities accept regulatory submissions for review of Pfizer's third-generation ALK inhibitor lorlatinib
12 February 2018 - U.S. new drug application granted FDA priority review. ...
Posted by Michael Wonder on 13 Feb 2018
FDA approves Symdeko (tezacaftor/ivacaftor and ivacaftor) to treat the underlying cause of cystic fibrosis in people ages 12 and older with certain mutations in the CFTR gene
12 February 2018 - Symdeko to begin shipping to pharmacies this week. ...
Posted by Michael Wonder on 12 Feb 2018
Lower drug prices: new proposals carry lots of promises
9 February 2018 - The White House is considering a plan to lower out-of-pocket costs for people in Medicare drug ...
Posted by Michael Wonder on 12 Feb 2018
Adamis Pharmaceuticals announces FDA acceptance for review for the supplemental new drug application of its low dose Symjepi product candidate
12 February 2018 - Adamis Pharmaceuticals Corporation today announced that the U.S. FDA has accepted for review the company’s supplemental ...
Posted by Michael Wonder on 12 Feb 2018
U.S. FDA files new drug application under priority review for migalastat for treatment of Fabry disease
12 February 2018 - Six month PDUFA goal date is 13 August 2018. ...
Posted by Michael Wonder on 12 Feb 2018
McCain and Baldwin to Trump: hold pharma’s feet to the fire on drug prices
11 February 2018 - Frustrated by White House efforts to tackle rising drug prices, a pair of U.S. law makers ...
Posted by Michael Wonder on 12 Feb 2018
White House releases white paper on lowering drug prices
9 February 2018 - The White House released a 30 page white paper Friday morning that promotes easing government regulations ...
Posted by Michael Wonder on 11 Feb 2018
Salix provides update on FDA submission for Plenvu
9 February 2018 - Salix Pharmaceuticals and its partner Norgine have received notice that the U.S. FDA has extended the PDUFA ...