Blog
RSS FeedPosted by Michael Wonder on 09 Oct 2016
Muscular dystrophy drug looks set for commercial success despite clinical doubts
3 October 2016 - A newly approved drug to treat Duchenne muscular dystrophy seems likely to be used by most ...
Posted by Michael Wonder on 06 Oct 2016
FDA grants breakthrough therapy designation for Roche’s Actemra/RoActemra in giant cell arteritis, a form of vasculitis
5 October 2016 - Fourteenth breakthrough therapy designation for Roche medicines. ...
Posted by Michael Wonder on 05 Oct 2016
Xenoscope, the revolutionary cost-effective laparoscope, wins FDA fast track clearance
4 October 2016 - Xenocor announced today that its first product, the Xenoscope, was 510(k) cleared by the U.S. FDA for ...
Posted by Michael Wonder on 04 Oct 2016
US FDA grants breakthrough therapy designation for Roche's Alecensa (alectinib) for first-line treatment of people with ALK-positive NSCLC
4 October 2016 - This second Alecensa breakthrough therapy designation granted is based on phase 3 J-ALEX study. ...
Posted by Michael Wonder on 03 Oct 2016
A golden ticket that fast tracks a medicine through the FDA
29 September 2016 - Sarepta Therapeutics won a big victory when its $300,000 muscular dystrophy drug was recently approved, but the ...
Posted by Michael Wonder on 03 Oct 2016
Obama extends controversial program for rare pediatric drugs
30 September 2016 - Despite objections from his own regulators, President Barack Obama signed into law a bill on Friday ...
Posted 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 28 Sep 2016
FDA approves first automated insulin delivery device for type 1 diabetes
28 September 2016 - The U.S. FDA today approved Medtronic’s MiniMed 670G hybrid closed looped system, the first FDA-approved device that ...
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. ...