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 03 Aug 2022
Bupa patients worried Ramsay Health Care hospital dispute will leave them out of pocket
3 August 2022 - A funding dispute between one of Australia's largest private hospital operators and a major insurer could ...
Posted by Michael Wonder on 03 Aug 2022
U.S. prescription drug market lacks certain competitive features: case of biosimilars
3 August 2022 - In a legal ruling reported yesterday, a 7th Circuit Court Federal Judge, Frank Easterbrook, affirmed dismissal of ...
Posted by Michael Wonder on 03 Aug 2022
Fresenius Kabi’s biologics license application for biosimilar candidate tocilizumab accepted for review by the FDA
1 August 2022 - Fresenius Kabi announced today that the U.S. FDA has accepted for review the company’s 351(k) biologics ...
Posted by Michael Wonder on 03 Aug 2022
Amylyx Pharmaceuticals announces FDA Advisory Committee will reconvene to review new drug application for AMX0035 for the treatment of ALS
3 August 2022 - Amylyx Pharmaceuticals today announced that the U.S. FDA Peripheral and Central Nervous System Drugs Advisory Committee will ...
Posted by Michael Wonder on 03 Aug 2022
Supply a factor in restricting COVID vaccines for babies and toddlers
3 August 2022 - Most parents of babies and toddlers will not be able to access a COVID vaccine approved ...
Posted by Michael Wonder on 03 Aug 2022
AnHeart Therapeutics receives FDA breakthrough therapy designation for taletrectinib in ROS1 positive non-small-cell lung cancer
3 August 2022 - FDA breakthrough designation reinforces significant unmet need in the treatment of this highly aggressive cancer. ...
Posted by Michael Wonder on 03 Aug 2022
COVID-19 vaccination for children aged 6 months to under 5 years
3 August 2022 - The Albanese Government has accepted a recommendation from the Australian Technical Advisory Group on Immunisation to make ...
Posted by Michael Wonder on 03 Aug 2022
MediWound announces US FDA acceptance of biologics license application for NexoBrid for the treatment of severe thermal burns
3 August 2022 - Prescription Drug User Fee Act target date of 1 January 2023. ...
Posted by Michael Wonder on 03 Aug 2022
FDA approves Coherus’ Cimerli (ranibizumab-eqrn) as the first and only interchangeable biosimilar to Lucentis for all five indications, with 12 months of interchangeability exclusivity
2 August 2022 - First Cimerli product sales expected in October 2022. ...
Posted by Michael Wonder on 03 Aug 2022
PHARMAC tells MPs medicine buying agency undergoing 'substantial change'
3 August 2022 - PHARMAC has undergone “substantial change” in the past few years, even before a hard hitting review ...
Posted by Michael Wonder on 03 Aug 2022
Bupa, Ramsay fight puts pressure on customers and Health Minister Mark Butler
3 August 2022 - Mark Butler finds himself in an uncomfortable position after Australia’s biggest private hospital operator Ramsay terminated ...
Posted by Michael Wonder on 03 Aug 2022
COVID-19 vaccines undergoing evaluation (3 August 2022)
3 August 2022 - The TGA has published a list (table) of the COVID-19 vaccines currently under evaluation by the agency. ...
Posted by Michael Wonder on 03 Aug 2022
Pralsetinib for treating advanced RET fusion positive non-small-cell lung cancer
3 August 2022 - NICE has published evidence-based recommendations on the use of pralsetinib (Gavreto) for the treatment of adults ...
Posted by Michael Wonder on 03 Aug 2022
TGA commences evaluation of Pfizer's COVID-19 vaccine (Comirnaty) for children aged 6 months to less than 5 years
3 August 2022 - The TGA has commenced evaluation of an application from Pfizer to extend the use of its ...
Posted by Michael Wonder on 02 Aug 2022
Patient reported outcome measures in clinical research
2 August 2022 - Health conditions may cause patients to feel ill and have impaired functioning in their daily lives. Thus, ...