Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 06 Jul 2022
Regulatory submission for GSK's daprodustat accepted into Health Canada review
6 July 2022 - Canadian regulatory submission acceptance follows that of the US FDA and the EMA as well as ...
Posted by Michael Wonder on 06 Jul 2022
Health Canada approves HyQvia, a new treatment for Canadians with immune deficiencies
6 July 2022 - New immunoglobulin treatment offers Canadian patients option of subcutaneous once-monthly (every three or four weeks) dosing. ...
Posted by Michael Wonder on 06 Jul 2022
InflaRx receives FDA fast track designation for treatment of ulcerative pyoderma gangrenosum
6 July 2022 - Fast track follows recently reported orphan drug designation by both US FDA and EMA ...
Posted by Michael Wonder on 06 Jul 2022
Junshi Biosciences and Coherus announce FDA acceptance of resubmission of BLA for toripalimab for the treatment of nasopharyngeal carcinoma
6 July 2022 - The FDA has set a target action date of 23 December 2022 for the toripalimab BLA. ...
Posted by Michael Wonder on 06 Jul 2022
Australian Technical Advisory Group on Immunisation makes call on fourth Covid vaccine dose
6 July 2022 - Australians as young as 30 will be eligible to get a fourth dose of the Covid jab ...
Posted by Michael Wonder on 06 Jul 2022
TGA grants provisional determinations to Pfizer for COVID-19 vaccines to target Omicron variant
6 July 2022 - On 5 July 2022, the TGA granted two provisional determinations to Pfizer in relation to COVID-19 ...
Posted by Michael Wonder on 06 Jul 2022
Setmelanotide for the treatment of patients with obesity caused by LEPR or POMC deficiency
6 July 2022 - NICE has issued fvidence-based recommendations on setmelanotide (Imcivree) for treating obesity caused by LEPR or POMC ...
Posted by Michael Wonder on 06 Jul 2022
PHARMAC opens door to funding Keytruda in 'biggest step forward in treatment of lung cancer'
6 July 2022 - Keytruda has been called a 'miracle' drug, and there's a glimmer of hope now for those ...
Posted by Michael Wonder on 06 Jul 2022
FDA grants priority review to Genentech’s mosunetuzumab for people with relapsed or refractory follicular lymphoma
6 July 2022 - Application is based on results from the pivotal Phase I/II study showing mosunetuzumab induced high and durable ...
Posted by Michael Wonder on 06 Jul 2022
The U.S. FDA accepts and grants priority review for Eisai's biologics license application of lecanemab for early Alzheimer's disease under the accelerated approval pathway
6 July 2022 - Eisai and Biogen announced today that the U.S. FDA has accepted the biologics license application under the ...
Posted by Michael Wonder on 06 Jul 2022
Agenda for July 2022 PBAC meeting (version 3)
6 July 2022 - It is actually version 4. ...
Posted by Michael Wonder on 06 Jul 2022
PHARMAC considering funding new medicines for lung cancer
6 July 2022 - PHARMAC is seeking proposals from pharmaceutical suppliers for medicines that could treat New Zealanders with lung ...
Posted by Michael Wonder on 05 Jul 2022
Government drug price negotiations offer a false promise
5 July 2022 - With inflation rising and midterm elections just months away, Democrats are desperate for something they can ...
Posted by Michael Wonder on 05 Jul 2022
Sandoz Canada expands its generics portfolio with three new products
5 July 2022 - Generic medicines like these three products help make effective medicine more affordable and accessible for Canadians and ...
Posted by Michael Wonder on 05 Jul 2022
ATAGI update following weekly COVID-19 meeting (29 June 2022)
5 July 2022 - An update from the Australian Technical Advisory Group on Immunisation (ATAGI) following their weekly meeting on 29 ...