Blog
RSS FeedPosted by Michael Wonder on 13 Jan 2021
Insights from the outcomes from the November 2020 PBAC meeting
14 January 2021 - What distinguishes an 'outcome' from an 'other matter?" ...
Posted by Michael Wonder on 13 Jan 2021
CADTH publishes initial recommendation for nivolumab for NSCLC
9 January 2021 - The pERC has conditionally recommended the reimbursement of nivolumab when used in combination with ipilimumab and ...
Posted by Michael Wonder on 13 Jan 2021
CADTH publishes initial pCODR recommendation for entrectinib
9 January 2021 - pERC has conditionally recommended the reimbursement of entrectinib for the first-line treatment of patients with ROS1 positive ...
Posted by Michael Wonder on 13 Jan 2021
Leading BioSciences announces FDA fast track designation granted to LB1148 for the treatment of post-operative gastro-intestinal dysfunction associated with paediatric cardiovascular surgery
13 January 2021 - LBS expects to initiate a pivotal trial in 2021. ...
Posted by Michael Wonder on 13 Jan 2021
Innovent announces NMPA acceptance of a supplemental new drug application for Tyvyt (sintilimab injection) in combination with Byvasda (bevacizumab injection) as first-line therapy in hepatocellular carcinoma
12 January 2021 - Innovent Biologics today announced that the National Medical Products Administration of China has accepted the supplemental ...
Posted by Michael Wonder on 13 Jan 2021
Regeneron announces U.S. Government agreement to purchase additional COVID-19 antibody cocktail doses
12 January 2021 - New agreement covers 1.25 million additional doses of the casirivimab and imdevimab antibody cocktail, bringing total potential ...
Posted by Michael Wonder on 13 Jan 2021
Chronocort marketing authorisation application submitted to the UK MHRA
12 January 2021 - Independent UK (MHRA) application to run in parallel with ongoing European (EMA) application, following end of Brexit ...
Posted by Michael Wonder on 13 Jan 2021
Health Canada approves Onureg (azacitidine tablets), first maintenance therapy for patients in remission from acute myeloid leukaemia
12 January 2021 - Onureg has shown clinically meaningful increase in overall survival for patients. ...
Posted by Michael Wonder on 13 Jan 2021
MorphoSys and Incyte announce acceptance by Health Canada of the new drug submission for tafasitamab
12 January 2021 - MorphoSys and Incyte today announced that Health Canada has accepted the new drug submission for tafasitamab, an ...
Posted by Michael Wonder on 13 Jan 2021
Health Canada approves Lundbeck's Vyepti (eptinezumab)--the first and only intravenous preventive treatment for migraine
12 January 2021 - Lundbeck is pleased to announce that Vyepti (eptinezumab) has been approved by Health Canada for the preventive ...
Posted by Michael Wonder on 12 Jan 2021
Middlemen sue to block a signature Trump drug pricing proposal
12 January 2021 - The Pharmaceutical Care Management Association, which represents drug middlemen in Washington, filed a lawsuit Tuesday to ...
Posted by Michael Wonder on 12 Jan 2021
U.S. FDA grants priority review to new drug application for finerenone to treat patients with chronic kidney disease and type 2 diabetes mellitus
12 January 2021 - Bayer announced today that the U.S. FDA has accepted its new drug application and granted priority review ...
Posted by Michael Wonder on 12 Jan 2021
ICER identifies most significant 2019 US drug price hikes — even after rebates — that were not supported by new clinical evidence
12 January 2021 - Out of 10 identified drugs that had substantial 2019 price increases on top of already high current ...
Posted by Michael Wonder on 12 Jan 2021
Janssen's ulcerative colitis treatment to receive reimbursement
12 January 2021 - Janssen Pharmaceutical said Tuesday that the Ministry of Health and Welfare would begin to reimburse Stelara, ...
Posted by Michael Wonder on 12 Jan 2021
Health Canada approves Bavencio for the maintenance treatment of patients with advanced bladder cancer
11 January 2021 - Bavencio is the first and only maintenance therapy for unresectable locally advanced or metastatic urothelial carcinoma ...