Blog
RSS FeedPosted by Michael Wonder on 14 Feb 2017
An open letter to the Duchenne community
13 February 2017 - We are pausing our commercialisation efforts in order to meet with Duchenne community leaders and explain our ...
Posted by Michael Wonder on 13 Feb 2017
Grassley launches inquiry into orphan drugs after KHN investigation
10 February 2017 - Republican Sen. Chuck Grassley, chairman of the Senate Judiciary Committee, has opened an inquiry into potential ...
Posted by Michael Wonder on 12 Feb 2017
Marathon dystrophy drug’s approval sends cost sky high
13 February 2017 - A drug to treat muscular dystrophy will hit the US market with a price tag of ...
Posted by Michael Wonder on 11 Feb 2017
A Ted Cruz proposal to speed FDA approvals may have limited impact
9 February 2017 - In late 2015, Senator Ted Cruz introduced a bill to make more drugs available to Americans ...
Posted by Michael Wonder on 10 Feb 2017
An old drug gets a new price to fight a rare disease: $89,000 a year
10 February 2017 - An old steroid treatment, long available outside the United States, received approval this week for a ...
Posted by Michael Wonder on 09 Feb 2017
Amid flurry of new cancer drugs, how many offer real benefits?
9 February 2017 - Marlene McCarthy's breast cancer has grown relentlessly over the past seven years, spreading painfully through her ...
Posted by Michael Wonder on 09 Feb 2017
FDA approves drug to treat Duchenne muscular dystrophy
9 February 2017 - The U.S. FDA today approved Emflaza (deflazacort) tablets and oral suspension to treat patients age 5 ...
Posted by Michael Wonder on 09 Feb 2017
FDA approves Bio Products Laboratory's Gammaplex 10% for treatment of primary immunodeficiency and chronic immune thrombocytopenic purpura
8 February 2017 - Bio Products Laboratory today announced that the U.S. FDA has approved Gammaplex 10% (immune globulin intravenous ...
Posted by Michael Wonder on 08 Feb 2017
Lilly's Trulicity (dulaglutide) label updated to include use in combination with basal insulin for adults with type 2 diabetes
8 February 2017 - The label for Eli Lilly and Company's once-weekly Trulicity (dulaglutide) is now updated to include use ...
Posted by Michael Wonder on 08 Feb 2017
FDA approves Amgen's Parsabiv (etelcalcetide), first new treatment in more than a decade for secondary hyperparathyroidism in adult patients on hemodialysis
7 February 2017 - Intravenous administration puts delivery in hands of health care provider. ...
Posted by Michael Wonder on 08 Feb 2017
FDA grants fast track designation to Angionetics' Generx product candidate, a one-time gene therapy for coronary heart disease
7 February 2017 - Angionetics today reported that the FDA has granted fast track designation for the Phase 3 clinical ...
Posted by Michael Wonder on 08 Feb 2017
Flexion Therapeutics announces new drug application for Zilretta (FX006) accepted by U.S. Food and Drug Administration
7 February 2017 - FDA reviewing Zilretta as potential new treatment for osteoarthritis of the knee. ...
Posted by Michael Wonder on 07 Feb 2017
Promotion of drugs for off-label uses: the US Food and Drug Administration at a crossroads
7 February 2017 - Since 1962, the US FDA has required companies to establish, with adequate and well-controlled clinical trials, ...
Posted by Michael Wonder on 07 Feb 2017
Perrigo confirms patent challenge for generic version of Onexton Gel
7 February 2017 - Perrigo announced that it has filed an abbreviated new drug application with the U.S. FDA for clindamycin, ...
Posted by Michael Wonder on 06 Feb 2017
Trump’s F.D.A. pick could undo decades of drug safeguards
5 February 2017 - President Trump’s vow to overhaul the Food and Drug Administration could bring major changes in policy, ...