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RSS FeedPosted by Michael Wonder on 05 Sep 2019
European Commission approves Merck’s Keytruda (pembrolizumab) in combination with Inlyta (axitinib) as first-line treatment for patients with advanced renal cell carcinoma
4 September 2019 - European approval based on KEYNOTE-426 trial results demonstrating significant improvement in overall survival with Keytruda in combination ...
Posted by Michael Wonder on 05 Sep 2019
$32 million available to support vital translational health
5 September 2019 - The Australian Government is opening the door for Australian researchers through a $32 million investment that will ...
Posted by Michael Wonder on 05 Sep 2019
European Commission approves expanded use of Janssen’s Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis in the European Union
4 September 2019 - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission has approved the ...
Posted by Michael Wonder on 05 Sep 2019
Tricida announces submission of new drug application for veverimer for the treatment of metabolic acidosis in patients with chronic kidney disease
4 September 2019 - New drug application submitted under the FDA’s accelerated approval program. ...
Posted by Michael Wonder on 04 Sep 2019
Magenta Therapeutics announces FDA regenerative medicine advanced therapy designation granted to MGTA-456 for the treatment of inherited metabolic disorders
4 September 2019 - Magenta Therapeutics today announced that the U.S. FDA granted regenerative medicine advanced therapy designation for MGTA-456, ...
Posted by Michael Wonder on 04 Sep 2019
Health Canada updates its biosimilar fact sheet
4 September 2019 - Health Canada recently updated its fact sheet on biosimilars, including new or clarified information about key ...
Posted by Michael Wonder on 04 Sep 2019
Releasing the potential of real world evidence
4 September 2019 - Janssen believes RWE could realise an efficient, personalised and truly patient-centric health care system. ...
Posted by Michael Wonder on 04 Sep 2019
Forty Seven granted fast track designation for magrolimab for the treatment of myelodysplastic syndrome and acute myeloid leukaemia
3 September 2019 - Forty Seven today announced that the U.S. FDA has granted fast track designation to magrolimab (formerly known ...
Posted by Michael Wonder on 04 Sep 2019
GeneTx and Ultragenyx announce orphan drug designation and rare paediatric disease designation for GTX-102
3 September 2019 - GeneTx Biotherapeutics and Ultragenyx today announced that the U.S. FDA has granted orphan drug designation and rare ...
Posted by Michael Wonder on 04 Sep 2019
Inotrem announces fast track designation granted by U.S. FDA to nangibotide development program for the treatment of septic shock
4 September 2019 - Inotrem announced today that the U.S. FDA has granted fast track designation to nangibotide development program for ...
Posted by Michael Wonder on 03 Sep 2019
Mylan and Biocon get a second complete response letter for insulin glargine follow-on
3 September 2019 - Over the weekend, drug maker Biocon disclosed that it and partner Mylan have been issued a second ...
Posted by Michael Wonder on 03 Sep 2019
Janssen announces U.S. FDA breakthrough therapy designation for investigational prophylactic vaccine for the prevention of respiratory syncytial virus in older adults
3 September 2019 - Janssen announced today that the U.S. FDA has granted breakthrough therapy designation for the Company's investigational ...
Posted by Michael Wonder on 03 Sep 2019
The FDA and Sarepta: a window into the real world of drug regulation
3 September 2019 - It is hard to discern the true state of drug regulation from the outside, but two ...
Posted by Michael Wonder on 03 Sep 2019
Added therapeutic benefit and drug licensing
3 September 2019 - One aspect of the ongoing debate about drug pricing is the added therapeutic benefit of new drugs ...
Posted by Michael Wonder on 03 Sep 2019
The TGA launches new tool to help sponsors find information on registering prescription medicines
3 September 2019 - Today the Therapeutic Goods Administration launched a new tool to assist users with finding information within ...