Blog
RSS FeedPosted by Michael Wonder on 30 Sep 2016
AbbVie's investigational HCV regimen receives U.S. FDA breakthrough therapy designation
30 September 2016 - Breakthrough therapy designation granted based on Phase 2 clinical data for genotype 1 patients who failed previous ...
Posted by Michael Wonder on 29 Sep 2016
FDA eyes new diabetes outcome measures
29 September 2016 - A recent FDA workshop brought new diabetes outcome measures to the table, focusing on patient-oriented outcome measures. ...
Posted by Michael Wonder on 29 Sep 2016
U.S. FDA approves Orkambi (lumacaftor/ivacaftor) for use in children with cystic fibrosis ages 6 through 11 who have two copies of the F508del mutation
28 September 2016 - Approximately 2,400 children ages 6 through 11 have two copies of the F508del mutation in the U.S. ...
Posted by Michael Wonder on 27 Sep 2016
Axovant Sciences receives FDA fast track designation for intepirdine as an investigational treatment for dementia with Lewy bodies
26 September 2016 - Axovant Sciences today announced that the company has received fast track designation for its investigational new drug ...
Posted by Michael Wonder on 27 Sep 2016
A drug cartel at the FDA
26 September 2016 - A new rule will produce a lawsuit rush and raise prices for generics. ...
Posted by Michael Wonder on 27 Sep 2016
Innovation in medicine and device development, regulatory review, and use of clinical advances
26 September 2016 - Breakthrough advances in the understanding of fundamental biology and the dawn of an era of precision medicine ...
Posted by Michael Wonder on 27 Sep 2016
FDA approves Stelara (ustekinumab) for treatment of adults with moderately to severely active Crohn's disease
26 September 2016 - First biologic that targets interleukin-12 and interleukin-23 cytokines for the treatment of Crohn's disease. ...
Posted by Michael Wonder on 26 Sep 2016
Biogen completes rolling submission of new drug application to FDA for nusinersen as a treatment for spinal muscular atrophy
26 September 2016 - Submission of marketing authorization application to the EMA planned in the coming weeks. ...
Posted by Michael Wonder on 26 Sep 2016
Sanofi and Regeneron announce dupilumab biologics license application accepted for priority review by U.S. FDA
26 September 2016 - Sanofi and Regeneron Pharmaceuticals today announced that the U.S. FDA has accepted for priority review the biologics ...
Posted by Michael Wonder on 26 Sep 2016
AbbVie announces submission of a supplemental new drug application for Ibrutinib (imbruvica) for treatment of marginal zone lymphoma
26 September 2016 - If approved by the U.S. FDA, ibrutinib will be the first therapy specifically approved for patients with ...
Posted by Michael Wonder on 26 Sep 2016
US FDA approves labeling update of Rexulti (brexpiprazole) for maintenance treatment of schizophrenia
24 September 2016 - Labeling update includes clinical data on use of Rexulti in adult patients with schizophrenia in the maintenance ...
Posted by Michael Wonder on 26 Sep 2016
Janssen submits application seeking approval of sirukumab in United States for rheumatoid arthritis
23 September 2016 - Janssen announced today the submission of a biologics license application to the U.S. FDA seeking approval ...
Posted by Michael Wonder on 24 Sep 2016
FDA approves Amgen's Amjevita (adalimumab-atto) for treatment of seven inflammatory diseases
23 September 2016 - First biosimilar adalimumab approved by FDA. ...
Posted by Michael Wonder on 23 Sep 2016
FDA approves expanded indications for Ilaris for three rare diseases
23 September 2016 - The U.S. FDA today approved three new indications for Ilaris (canakinumab). ...
Posted by Michael Wonder on 22 Sep 2016
The FDA did the right thing by approving a novel drug for a disabling disease
22 September 2016 - The FDA’s leadership did the right thing, according to Elaine Schattner in Forbes magazine. ...