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RSS FeedPosted by Michael Wonder on 10 Oct 2016
Elbit Imaging announces that Gamida Cell has received FDA breakthrough therapy designation for Nicord
10 October 2016 - Elbit Imaging announced today that it was informed by Gamida Cell, an indirect associate of the ...
Posted by Michael Wonder on 10 Oct 2016
Anthem says will not cover Sarepta's approved Duchenne drug
7 October 2016 - Health insurer Anthem said it will not cover Sarepta Therapeutics Inc's medicine to treat patients with ...
Posted by Michael Wonder on 10 Oct 2016
U.S. FDA approves Carnexiv (carbamazepine) injection as intravenous replacement therapy for oral carbamazepine formulations
7 October 2016 - U.S. FDA approves Carnexiv (carbamazepine) injection as intravenous replacement therapy for oral carbamazepine formulations. ...
Posted by Michael Wonder on 09 Oct 2016
Teva and Celltrion announce exclusive biosimilar commercial partnership
6 October 2016 - Teva Pharmaceutical Industries Ltd and Celltrion Healthcare have announced that the companies have entered into an exclusive ...
Posted by Michael Wonder on 09 Oct 2016
Coherus Biosciences announces FDA acceptance of 351(K) biologics license application to U.S. FDA for CHS-1701 (pegfilgrastim biosimilar candidate)
6 October 2016 - Coherus BioSciences today announced that the U.S. FDA has accepted the filing of 351(k) biologics license ...
Posted 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 ...