Blog
RSS FeedPosted by Michael Wonder on 30 Aug 2022
TGA launches new look website
30 August 2022 - The new look website has gone live this evening. ...
Posted by Michael Wonder on 30 Aug 2022
EMA announces withdrawal of two submissions for cancer medicines
30 August 2022 - The information is somewhat buried on the EMA website. ...
Posted by Michael Wonder on 30 Aug 2022
Novartis Scemblix, with novel mechanism of action, approved by the European Commission for adult patients with chronic myeloid leukaemia
29 August 2022 - Approval based on results from pivotal Phase 3 ASCEMBL trial, in which Scemblix (asciminib) nearly doubled the ...
Posted by Michael Wonder on 30 Aug 2022
Quizartinib supplemental new drug application submitted in Japan for patients with newly diagnosed FLT3-ITD positive acute myeloid leukaemia
30 August 2022 - Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy ...
Posted by Michael Wonder on 30 Aug 2022
FDA grants priority review to efanesoctocog alfa for people with haemophilia A
30 August 2022 - Priority review based on pivotal data from the XTEND-1 Phase 3 study. ...
Posted by Michael Wonder on 30 Aug 2022
Yukon woman paid $7,000 for private ketamine treatment, only to learn that the Yukon Government covers it
29 August 2022 - Evelyn Larson visited a private clinic in Saskatoon only to find the Yukon did cover the treatment ...
Posted by Michael Wonder on 29 Aug 2022
FDA boldly bows to big pharma at Americans’ expense
29 August 2022 - A Wall Street Journal headline went this way: “Latest Covid Boosters Are Set to Roll Out ...
Posted by Michael Wonder on 29 Aug 2022
European Commission approves Ranivisio (ranibizumab), a biosimilar to Lucentis
29 August 2022 - Formycon, Polpharma Biologics and Bioeq jointly announce that the European Commission has granted marketing authorisation for ...
Posted by Michael Wonder on 28 Aug 2022
Ovarian cancer drug that costs up to $130k will soon be affordable for hundreds of patients
28 August 2022 - A drug that works to prolong survival for some patients with advanced ovarian cancer is being ...
Posted by Michael Wonder on 26 Aug 2022
Patient registries: EMA officials highlight opportunities in orphan drug development
25 August 2022 - Officials from the EMA tout the benefits of patient registries to support regulatory decision making for ...
Posted by Michael Wonder on 26 Aug 2022
Stakeholders ask FDA to be more flexible on rescinding breakthrough drug designations
26 August 2022 - Pharmaceutical stakeholders want the US FDA to be more flexible when revoking breakthrough therapy designations. ...
Posted by Michael Wonder on 26 Aug 2022
Incyte announces FDA approval of Pemazyre (pemigatinib) as the first and only targeted treatment for myeloid/lymphoid neoplasms with FGFR1 rearrangement
26 August 2022 - Pemazyre is the only FGFR inhibitor with multiple indications ...
Posted by Michael Wonder on 26 Aug 2022
Agenda for the September 2022 PBAC intracycle meeting
26 August 2022 - The agenda for the September 2022 PBAC intracycle meeting is now available.
...
Posted by Michael Wonder on 26 Aug 2022
Government secures monkeypox medicine, PHARMAC working on getting vaccines
26 August 2022 - The Government has secured monkeypox medicine which is expected to be available in New Zealand from ...
Posted by Michael Wonder on 26 Aug 2022
PBAC Public Summary Documents – May 2022 meeting
26 August 2022 - The Public Summary Documents (positive recommendations and subsequent decisions not to recommend) from the May 2022 PBAC ...