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 Aug 2021
Interoperability of track and trace systems: key to public health protection
6 August 2021 - EMA has endorsed recommendations developed by the International Coalition of Medicines Regulatory Authorities to facilitate the use ...
Posted by Michael Wonder on 06 Aug 2021
Formycon and Bioeq announce submission of the biologics license application for FYB201, a biosimilar candidate to Lucentis (ranibizumab) to the U.S. FDA
5 August 2021 - Formycon and its license partner Bioeq announce that the biologics license application for FYB201, Formycon’s biosimilar ...
Posted by Michael Wonder on 06 Aug 2021
Updated financial estimates workbook
6 August 2021 - An updated version of the Utilisation and Cost Model workbook is now available to support PBAC submissions. ...
Posted by Michael Wonder on 06 Aug 2021
Altoida awarded FDA breakthrough designation for development of world’s first precision neurology device for prediction of Alzheimer's disease
5 August 2021 - Breakthrough designation will advance the development of industry’s first predictive diagnostic device for conversion to Alzheimer’s disease, ...
Posted by Michael Wonder on 05 Aug 2021
Canadian agency loses a battle in effort to force a drug maker to lower ‘excessive’ pricing
4 August 2021 - In a withering ruling, a Canadian appeals court overturned a controversial decision issued four years ago ...
Posted by Michael Wonder on 05 Aug 2021
U.S. health care system ranks last among 11 high income countries, researchers say
5 August 2021 - The United States has the worst health care system overall among 11 high income countries, even ...
Posted by Michael Wonder on 05 Aug 2021
Pfizer epilepsy drug prices were 'unfairly high,' UK review finds
5 August 2021 - Britain's competition watchdog is sticking with its view that Pfizer and Flynn Pharma broke the law ...
Posted by Michael Wonder on 05 Aug 2021
Exelixis announces U.S. FDA accepts for priority review the supplemental new drug application for Cabometyx (cabozantinib) for patients with previously treated radioactive iodine refractory differentiated thyroid cancer
5 August 2021 - U.S. Food and Drug Administration assigned a Prescription Drug User Fee Act action date of 4 December ...
Posted by Michael Wonder on 05 Aug 2021
Pillar Biosciences receives premarket approval from FDA for its oncoReveal Dx lung and colon cancer assay
5 August 2021 - Pillar Biosciences today announced the U.S. FDA has given premarket approval to its oncoReveal Dx Lung ...
Posted by Michael Wonder on 05 Aug 2021
Eiger announces FDA breakthrough therapy designation for avexitide for treatment of congenital hyperinsulinism
5 August 2021 - All five orphan programs now have breakthrough therapy designation. ...
Posted by Michael Wonder on 05 Aug 2021
ICER publishes final evidence report and policy recommendations on aducanumab for Alzheimer’s disease
5 August 2021 - Independent appraisal committee unanimously determined the evidence is not adequate to demonstrate that aducanumab provides a net ...
Posted by Michael Wonder on 05 Aug 2021
Treasury wanted Labour to break all health election promises bar one
5 August 2021 - Treasury told the Government to kick its election promises like funding for PHARMAC, cochlear implants, and ...
Posted by Michael Wonder on 05 Aug 2021
New drug application for penpulimab monoclonal antibody (PD-1) for third-line treatment of metastatic nasopharyngeal carcinoma accepted by NMPA
5 August 2021 - Akeso announced that the new drug application of penpulimab (AK105) for third-line treatment of metastatic nasopharyngeal ...
Posted by Michael Wonder on 05 Aug 2021
From Our Perspective: FDA approval demonstrates the role of real world evidence in regulatory decision-making on drug effectiveness
4 August 2021 - In this CDER From Our Perspective, experts discuss the recent FDA approval of Prograf (tacrolimus) in combination ...
Posted by Michael Wonder on 05 Aug 2021
G1 Therapeutics granted new technology add-on payment for Cosela (trilaciclib) by CMS
4 August 2021 - G1 Therapeutics today announced that CMS has granted a new technology add-on payment for Cosela (trilaciclib ...