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RSS FeedPosted by Michael Wonder on 01 Nov 2017
Citius Pharmaceuticals receives fast track designation by FDA For Mino-Lok investigational trial
31 October 2017 - Citius Pharmaceuticals announced today it has received official notice from the U. S. FDA that the investigational ...
Posted by Michael Wonder on 01 Nov 2017
Institute for Clinical and Economic Review posts draft scoping document to guide review of tezacaftor and lumacaftor for cystic fibrosis
31 October 2017 - Document open to public comment until 20 November 2017. ...
Posted by Michael Wonder on 31 Oct 2017
Institute for Clinical and Economic Review announces new 13.9 million dollar grant from the Laura and John Arnold Foundation
31 October 2017 - Expanded funding enables ICER value assessments for all newly approved medicines in the US. ...
Posted by Michael Wonder on 31 Oct 2017
FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections
31 October 2017 - Agency completes eight capability assessments as part of the Mutual Recognition Agreement between the U.S. and European ...
Posted by Michael Wonder on 31 Oct 2017
EU-FDA mutual recognition of inspections of medicines manufacturers enters operational phase
31 October 2017 - Major milestone is a testimony to mutual trust. ...
Posted by Michael Wonder on 30 Oct 2017
A new team aims to slash drug development time — with help from the feds
27 October 2017 - A global pharma company is teaming up with federal research labs and academics in an ambitious ...
Posted by Michael Wonder on 30 Oct 2017
Bayer receives FDA approval for Xarelto 10 mg once daily for the extended treatment of venous thromboembolism
30 October 2017 - Rivaroxaban (Xarelto) 10 mg once daily significantly reduces the risk of recurrent venous thromboembolism compared with aspirin ...
Posted by Michael Wonder on 30 Oct 2017
The innovation health care really needs: help people manage their own health
30 October 2017 - Finally, health care, which has been largely immune to the forces of disruptive innovation, is beginning ...
Posted by Michael Wonder on 29 Oct 2017
Atara Biotherapeutics receives rare paediatric disease designation from FDA for ATA230 for treatment of congenital cytomegalovirus infection
26 October 2017 - Atara Biotherapeutics today announced that ATA230 was granted rare paediatric disease designation for the treatment of ...
Posted by Michael Wonder on 29 Oct 2017
Heron Therapeutics granted FDA fast track designation for HTX-011 to reduce post-operative pain and the need for opioid analgesics for 72 hours
26 October 2017 - Phase 3 studies for HTX-011 ongoing; NDA filing planned for 2018. ...
Posted by Michael Wonder on 28 Oct 2017
Achaogen submits plazomicin new drug application to the U.S. FDA for treatment of complicated urinary tract infections and bloodstream infections
26 October 2017 - Investigational drug has potential to treat certain multi-drug resistant gram-negative pathogens, including carbapenem-resistant Enterobacteriaceae. ...
Posted by Michael Wonder on 28 Oct 2017
FDA grants breakthrough therapy designation for BioMarin's valoctocogene roxaparvovec (formerly BMN 270), an investigational gene therapy for hemophilia A
26 October 2017 - Global phase 3 program to begin before year end. ...
Posted by Michael Wonder on 28 Oct 2017
Tracking the cost of gene therapy
24 October 2017 - Gene therapy, which introduces new genetic material into a person’s DNA, was developed as a revolutionary ...
Posted by Michael Wonder on 28 Oct 2017
AbbVie receives U.S. FDA priority review for investigational oral treatment elagolix for the management of endometriosis with associated pain
27 October 2017 - If approved, elagolix will be the first new oral medical management treatment option for endometriosis-associated pain ...
Posted by Michael Wonder on 27 Oct 2017
Prometic receives fast track designation for PBI-4050 in development for idiopathic pulmonary fibrosis
25 October 2017 - Fast track designation follows recent FDA approval of pivotal Phase 2/3 clinical trial in IPF. ...