Blog
RSS FeedPosted by Michael Wonder on 16 May 2024
It is time to reconsider the 3% discount rate
15 May 2024 - Health technology assessment guidance often recommends a 3% real annual discount rate, the appropriateness of which ...
Posted by Michael Wonder on 09 Apr 2024
Using effect scores to characterise heterogeneity of treatment effects
9 April 2024 - It is common for treatments to yield different outcomes in different patients. If patient characteristics that predict ...
Posted by Michael Wonder on 09 Apr 2024
ICER publishes 2024 research protocol for assessing unsupported price increases on prescription drugs
9 April 2024 - Input period now open until 13 May 2024. ...
Posted by Michael Wonder on 09 Apr 2024
ViiV Healthcare announces US FDA approval of Dovato (dolutegravir/lamivudine) for adolescents living with HIV
8 April 2024 - Dovato is now the first and only oral, two drug, single-tablet regimen available for people aged 12 ...
Posted by Michael Wonder on 09 Apr 2024
Shorla Oncology announces FDA filing acceptance of new drug application to treat certain forms of leukaemia and other cancers
8 April 2024 - Second FDA acceptance for an NDA filing by Shorla Oncology announced in 2024. ...
Posted by Michael Wonder on 09 Apr 2024
Supernus provides regulatory update for SPN-830
8 April 2024 - Supernus Pharmaceuticals today announced a regulatory update for SPN-830. ...
Posted by Michael Wonder on 08 Apr 2024
SMC - April 2024 decisions
8 April 2024 - The SMC has today published advice on seven medicines. ...
Posted by Michael Wonder on 08 Apr 2024
Stealth BioTherapeutics announces FDA acceptance of new drug application for elamipretide for the treatment of Barth syndrome
8 April 2024 - If approved, elamipretide would become the first approved therapy for Barth syndrome. ...
Posted by Michael Wonder on 08 Apr 2024
Phanes Therapeutics' PT217 granted fast track designation by the FDA
8 April 2024 - Phanes Therapeutics announced today that the US FDA has granted fast track designation to PT217 for the ...
Posted by Michael Wonder on 08 Apr 2024
ARS Pharmaceuticals submits response to FDA complete response letter for neffy (epinephrine nasal spray)
3 April 2024 - Submission of complete response letter response triggers up to six month review period by the FDA. ...
Posted by Michael Wonder on 08 Apr 2024
Australians benefit from cheaper medicines on the PBS
8 April 2024 - Australians with high cholesterol, chronic kidney disease and ovarian cancer now have access to cheaper medicines under ...
Posted by Michael Wonder on 08 Apr 2024
EMA says it will consider conditional approval for NASH drugs using intermediate outcomes
5 April 2024 - The EMA said in a new reflection paper that it will consider granting conditional marketing approval ...
Posted by Michael Wonder on 08 Apr 2024
All women go through menopause. So why is treatment so expensive?
8 April 2024 - Hormone therapies for women experiencing menopause are too expensive and inaccessible, and doctors aren’t confident managing ...
Posted by Michael Wonder on 08 Apr 2024
Carvykti is the first and only BCMA targeted treatment approved by the US FDA for patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy
5 April 2024 - Approval is based on results from the Phase 3 CARTITUDE-4 study, in which treatment with Carvykti ...
Posted by Michael Wonder on 07 Apr 2024
FDA grants breakthrough therapy designation to sunvozertinib for the first-line treatment of patients with advanced non-small cell lung cancer harboring EGFR exon 20 insertion mutations
7 April 2024 - Dizal today announced that the US FDA has granted breakthrough therapy designation to its sunvozertinib as ...
Posted by Michael Wonder on 06 Apr 2024
Nurtec ODT is now available in Canada for the treatment of acute migraine
4 April 2024 - More than one billion people worldwide live with migraine, and the World Health Organization classifies migraine ...