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 21 Jan 2023
Stop blaming Biogen for putting profit at the expense of patients. Blame the systems that enabled it.
17 January 2023 - Two congressional committees recently released damning results of an 18 month investigation into the FDA’s approval of ...
Posted by Michael Wonder on 21 Jan 2023
MedPacto receives US FDA fast track designation for vactosertib for the treatment of metastatic osteosarcoma
17 January 2023 - MedPacto announced that the US FDA has granted fast track designation to vactosertib as a monotherapy ...
Posted by Michael Wonder on 20 Jan 2023
US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease
20 January 2023 - The supplemental new drug application is based on results from the landmark EMPA-KIDNEY Phase 3 trial, which ...
Posted by Michael Wonder on 20 Jan 2023
Opiant Pharmaceuticals announces FDA acceptance and priority review of NDA for OPNT003, nasal nalmefene, for opioid overdose
19 January 2023 - FDA sets PDUFA date of 22 May 2023. ...
Posted by Michael Wonder on 20 Jan 2023
UK's voluntary scheme for branded medicines, pricing and access (VPAS) faces a potential crisis
19 January 2023 - The UK has a “voluntary scheme for branded medicines, pricing, and access” or VPAS, which sets a ...
Posted by Michael Wonder on 20 Jan 2023
FDA approves zanubrutinib for chronic lymphocytic leukaemia or small lymphocytic lymphoma
19 January 2023 - Today the FDA approved zanubrutinib (Brukinsa, BeiGene) for chronic lymphocytic leukaemia or small lymphocytic lymphoma. ...
Posted by Michael Wonder on 20 Jan 2023
US FDA issues complete response letter for accelerated approval of donanemab
19 January 2023 - Complete response letter based on limited number of patients with 12 month drug exposure data in the ...
Posted by Michael Wonder on 20 Jan 2023
Consultation on the revised PBS post-market review framework – publication of responses
20 January 2023 - Consultation on a revised draft of the PBS post-market review framework was open from 20 October ...
Posted by Michael Wonder on 19 Jan 2023
Scottish Medicines Consortium recommends Merck’s Tepmetko
18 January 2023 - Therapy is the first oral MET inhibitor treatment option for certain advanced NSCLC adult patients ...
Posted by Michael Wonder on 19 Jan 2023
Seagen announces FDA accelerated approval of Tukysa (tucatinib) in combination with trastuzumab for people with previously treated RAS wild type, HER2 positive metastatic colorectal cancer
19 January 2023 - First FDA approved treatment in HER2 positive metastatic colorectal cancer. ...
Posted by Michael Wonder on 19 Jan 2023
NICE backs Alnylam’s Amvuttra for rare form of amyloidosis
19 January 2023 - Alnylam’s gene-silencing drug Amvuttra has been recommended as a treatment for hereditary transthyretin-related amyloidosis by NICE, ...
Posted by Michael Wonder on 19 Jan 2023
Radicava (edarvarone) oral suspension receives positive recommendation from CADTH for the treatment of patients with ALS
18 January 2023 - Mitsubishi Tanabe Pharma Canada is pleased to announce a positive recommendation from the CADTH Canadian Drug Expert ...
Posted by Michael Wonder on 19 Jan 2023
NICE recommends reimbursement for Translarna
19 January 2023 - Only approved treatment for the underlying cause of nonsense mutation Duchenne muscular dystrophy. ...
Posted by Michael Wonder on 19 Jan 2023
The battle over European drug pricing
19 January 2023 - UK and EU must balance health cost control with plans to grow life sciences. ...
Posted by Michael Wonder on 19 Jan 2023
Drugs added to reimbursement list
19 January 2023 - China will add 111 drugs to its national medical reimbursement list this year, with a focus ...