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RSS FeedPosted 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 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
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. ...
Posted by Michael Wonder on 27 Oct 2017
FDA accepts Genentech’s supplemental biologics license application for Avastin as a front-line treatment for women with advanced ovarian cancer
25 October 2017 - Genentech announced today that the U.S. FDA has accepted the company's supplemental biologics license application for ...
Posted by Michael Wonder on 27 Oct 2017
MorphoSys receives FDA breakthrough therapy designation for its antibody MOR208 in relapsed/refractory DLBCL
23 October 2017 - Designation is intended to expedite development of MorphoSys's most advanced blood cancer drug candidate MOR208 in ...
Posted by Michael Wonder on 26 Oct 2017
New shingles vaccine endorsed over competitor by expert panel, a boost for GSK
25 October 2017 - The expert panel that helps guide U.S. vaccination policy has voted to give a preferential recommendation ...
Posted by Michael Wonder on 26 Oct 2017
PTC Therapeutics receives complete response letter for ataluren's NDA
25 October 2017 - PTC Therapeutics today announced that the Office of Drug Evaluation I of the U.S. FDA has ...
Posted by Michael Wonder on 26 Oct 2017
Tesaro announces U.S. FDA approval of Varubi IV for delayed nausea and vomiting associated with cancer chemotherapy
25 October 2017 - Availability of new formulation offers healthcare providers the flexibility to choose oral or IV administration. ...
Posted by Michael Wonder on 25 Oct 2017
Medivir receives FDA fast track designation for MIV-711 for the treatment of osteoarthritis
24 October 2017 - Medivir today announced that the U.S. FDA has granted fast track designation for the company´s product ...
Posted by Michael Wonder on 24 Oct 2017
FDA grants fast track designation to Alzheon’s ALZ-801 development program for the treatment of Alzheimer’s disease
24 October 2017 - Company’s phase 3 clinical program pioneers a precision medicine approach in Alzheimer’s disease. ...