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 05 Jul 2021
Medical devices reforms: enhancements to post-market monitoring
5 July 2021 - This project has been established to enhance the adverse event reporting processes. ...
Posted by Michael Wonder on 04 Jul 2021
Solasia announces submission of new drug application for anti-cancer drug darinaparsin for peripheral T-cell lymphoma in Japan
30 June 2021 - New drug application filed in Japan ahead of anywhere else in the world. ...
Posted by Michael Wonder on 04 Jul 2021
COVID-19 indemnity scheme to protect health professionals and patients
2 July 2021 - The Australian Government is establishing a COVID-19 Vaccine Claim Scheme to provide further assurance and confidence to ...
Posted by Michael Wonder on 04 Jul 2021
Medicare ‘coverage with evidence development’ for aducanumab? How might it work?
30 June 2021 - In the wake of the FDA’s controversial decision to approve aducanumab for Alzheimer’s disease, how will, and ...
Posted by Michael Wonder on 04 Jul 2021
Sonic Healthcare USA to offer assay to aid in the selection of Jemperli (dostarlimab-gxly) therapy in endometrial cancer
2 July 2021 - LMC Pathology Services, a Sonic Healthcare USA Anatomic Pathology Practice, is the first reference laboratory in ...
Posted by Michael Wonder on 04 Jul 2021
Galderma receives FDA approval for Restylane Contour for cheek augmentation and correction of midface contour deficiencies
29 June 2021 - Galderma's first and only product in the U.S. to use proprietary XpresHAn Technology for the cheeks. ...
Posted by Michael Wonder on 04 Jul 2021
ICER to test principle of fair access to fairly priced pharmaceuticals
2 July 2021 - The controversial approval last month by the FDA of Aduhelm (aducanumab) for patients with early-stage Alzheimer’s disease ...
Posted by Michael Wonder on 03 Jul 2021
Iterum Therapeutics provides regulatory update
1 July 2021 - Iterum Therapeutics today announced that the Company received a letter from the U.S.FDA stating that, as ...
Posted by Michael Wonder on 02 Jul 2021
Formycon and Bioeq announce submission of the marketing authorisation application for FYB201, a biosimilar candidate to Lucentis (ranibizumab) to the EMA
29 June 2021 - Formycon and its license partner Bioeq AG announce that the marketing authorisation application for FYB201, Formycon’s ...
Posted by Michael Wonder on 02 Jul 2021
PBAC Public Summary Documents – March 2021 meeting
2 July 2021 - The Public Summary Documents (positive recommendations and subsequent decisions not to recommend) from the March 2021 PBAC ...
Posted by Michael Wonder on 02 Jul 2021
Bevacizumab on the PBS
2 July 2021 - Mvasi, a biosimilar brand of bevacizumab, was listed on the PBS from 1 June 2021, as ...
Posted by Michael Wonder on 01 Jul 2021
2021's first forecast of savings from side agreements
28 June 2021 - In a new report to the government, TLV forecasts that the pharmaceutical companies will pay approximately ...
Posted by Michael Wonder on 01 Jul 2021
Lupin announces FDA approval of supplemental new drug application for Solosec (secnidazole) for the treatment of trichomoniasis
1 July 2021 - Solosec demonstrated a 92.2% clinically and statistically significant cure rate for patients with trichomoniasis based on ...
Posted by Michael Wonder on 01 Jul 2021
WHO calls for lower prices on Gilead drug for COVID linked black fungus
1 July 2021 - The World Health Organization has called for prices of a Gilead Sciences drug to treat black ...
Posted by Michael Wonder on 01 Jul 2021
Analysis of launch and post-approval cancer drug pricing, clinical benefit, and policy implications in the US and Europe
1 June 2021 - In this economic evaluation of the US compared with 3 European countries, launch prices of cancer drugs ...