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 11 Apr 2022
UK patients granted early access for radioligand therapy in advanced prostate cancer
8 April 2022 - Advanced Accelerator Applications has announced that eligible patients in the UK have been granted early access ...
Posted by Michael Wonder on 11 Apr 2022
Pfizer’s ALK targeted therapy Lorviqua passes reimbursement review
8 April 2022 - Pfizer’s Lorviqua (lorlatinib), a third generation anaplastic lymphoma kinase (ALK) targeted therapy, passed the review for ...
Posted by Michael Wonder on 11 Apr 2022
Orchard Therapeutics announces reimbursement agreement making Libmeldy available for all eligible MLD patients in Italy
11 April 2022 - Orchard Therapeutics today announced it has reached another historic reimbursement agreement with the Italian Medicines Agency, also ...
Posted by Michael Wonder on 11 Apr 2022
Spectrum Pharmaceuticals announces FDA acceptance of BLA resubmission for eflapegrastim
11 April 2022 - FDA has assigned 9 September 2022 as the PDUFA date. ...
Posted by Michael Wonder on 11 Apr 2022
Hugel says FDA’s complete response letter will not affect Letybo approval
11 April 2022 - Hugel said a complete response letter from the U.S. FDA on botulinum toxin Letybo requires supplementary ...
Posted by Michael Wonder on 11 Apr 2022
Alzheimer's drug makers seek accelerated FDA review despite U.S. coverage decision
8 April 2022 - Eisai and Eli Lilly on Friday said they still plan to seek accelerated U.S. approval for ...
Posted by Michael Wonder on 11 Apr 2022
8,700 more Pacific peoples need treatment to prevent gout each year to achieve equity
11 April 2022 - PHARMAC has released the Pacific peoples health – Gout data insights report today. ...
Posted by Michael Wonder on 11 Apr 2022
Drug makers pledge speedier European market launches to avert stricter regulation
11 April 2022 - Drug makers on Monday pledged to speed up the market launch of new drugs in underserved ...
Posted by Michael Wonder on 11 Apr 2022
New COVID-19 oral treatment on PBS
11 April 2022 - Greg Hunt's swan song press release. ...
Posted by Michael Wonder on 10 Apr 2022
Amphastar receives FDA approval for ganirelix acetate injection
8 April 2022 - Amphastar Pharmaceuticals announced that the U.S. FDA has approved the Company's abbreviated new drug application for ganirelix ...
Posted by Michael Wonder on 10 Apr 2022
‘Precedents are important’: Aduhelm coverage restrictions could shape the future of accelerated approval
9 April 2022 - Whither accelerated approval? ...
Posted by Michael Wonder on 10 Apr 2022
Faster patient access to new medicines must be a priority for next Government
10 April 2022 - With the Federal Election campaign now formally underway, Medicines Australia is reminding the major parties of ...
Posted by Michael Wonder on 10 Apr 2022
CMS made the wrong decision on Aduhelm. But there might be a silver lining.
9 April 2022 - CMS issued on Thursday its hotly debated final decision on whether to cover aducanumab (Aduhelm), the ...
Posted by Michael Wonder on 10 Apr 2022
Health Technology Assessment Review Reference Committee will drive reform to support Australian patients
10 April 2022 - The Health Technology Assessment Review Reference Committee announced (via the Department of Health website) is tasked ...
Posted by Michael Wonder on 09 Apr 2022
ATAGI statement on use of booster doses in adolescents aged 12-15 years
8 April 2022 - A statement from the ATAGI on booster doses in adolescents aged 12-15 years. ...