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 15 Dec 2021
TGA approves new medicine for paediatric cancer
15 December 2021 - Another new cancer medicine from AstraZeneca. ...
Posted by Michael Wonder on 15 Dec 2021
Alnylam submits regulatory applications to the U.S. FDA and EMA to support label expansion for Oxlumo for the treatment of advanced primary hyperoxaluria type 1
14 December 2021 - Findings from the ILLUMINATE-C Phase 3 study showed substantial reductions in plasma oxalate in PH1 patients with ...
Posted by Michael Wonder on 15 Dec 2021
Incyte announces acceptance and priority review of sNDA for ruxolitinib cream (Opzelura) as a treatment for patients with vitiligo
14 December 2021 - Incyte today announced that the U.S. FDA has accepted for priority review the supplemental new drug application ...
Posted by Michael Wonder on 15 Dec 2021
U.S. FDA approves Pfizer’s Xeljanz (tofacitinib) for the treatment of active ankylosing spondylitis
14 December 2021 - Pfizer announced today that the U.S. FDA has approved the supplemental new drug application for Xeljanz/Xeljanz XR ...
Posted by Michael Wonder on 15 Dec 2021
Rinvoq (upadacitinib) receives U.S. FDA approval for active psoriatic arthritis
14 December 2021 - Milestone marks the second FDA approved indication for Rinvoq following rheumatoid arthritis in 2019. ...
Posted by Michael Wonder on 14 Dec 2021
Heterogeneity of treatment effect; estimating how the effects of interventions vary across individuals
14 December 2021 - ...
Posted by Michael Wonder on 14 Dec 2021
Health technology assessment: European Commission welcomes the adoption of new rules to improve access to innovative technologies
13 December 2021 - Today, the Regulation on Health Technology Assessment, a deliverable of the EU Pharmaceutical Strategy, has been adopted. ...
Posted by Michael Wonder on 14 Dec 2021
PHARMAC still stalled on lung cancer drug
14 December 2021 - Lung cancer sufferers are still waiting on PHARMAC to reverse a decision made more than a ...
Posted by Michael Wonder on 14 Dec 2021
FTC takes 'Pharma Bro' Martin Shkreli to trial over drug price hike
14 December 2021 - Shkreli is accused of masterminding an illegal scheme to jack up prices of the lifesaving drug Daraprim ...
Posted by Michael Wonder on 14 Dec 2021
TG Therapeutics announces FDA acceptance of biologics license application for ublituximab as a treatment for patients with relapsing forms of multiple sclerosis
14 December 2021 - Prescription Drug User Fee Act goal date of 28 September 2022. ...
Posted by Michael Wonder on 14 Dec 2021
EU regulation passed: G-BA works on European HTA assessment
14 December 2021 - Today the EU Parliament passed the EU-HTA regulation for a joint health technology assessment, which includes, ...
Posted by Michael Wonder on 14 Dec 2021
Trastuzumab deruxtecan supplemental new drug application submitted in Japan for treatment of patients with HER2 positive metastatic breast cancer
14 December 2021 - Submission based on groundbreaking DESTINY-Breast03 phase 3 trial, in which trastuzumab deruxtecan demonstrated a 72% reduction in ...
Posted by Michael Wonder on 14 Dec 2021
SMC approves first immunotherapy combination for advanced bowel cancer patients with rare mutation
14 December 2021 - Nivolumab plus ipilmumab has been accepted as a treatment option for adult patients by NHS Scotland ...
Posted by Michael Wonder on 14 Dec 2021
EMA reviewing new data on effectiveness of Lagevrio (molnupiravir) for the treatment of COVID-19
14 December 2021 - Following EMA’s interim recommendations to support national authorities who may decide on early use of Lagevrio ...
Posted by Michael Wonder on 14 Dec 2021
Private health pushes back on rates rise queries from Greg Hunt
14 December 2021 - Private health insurers are pushing back at Morrison government calls to reconsider a rise in their ...