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 Sep 2022
Mallinckrodt receives US FDA approval for Terlivaz (terlipressin) for injection for the treatment of hepatorenal syndrome
14 September 2022 - Terlivaz is the first and only FDA approved treatment for adults with hepatorenal syndrome involving rapid ...
Posted by Michael Wonder on 15 Sep 2022
Progesterone to be fully funded for all who need it
15 September 2022 - PHARMAC has today confirmed that it is removing all funding restrictions from progesterone, with tens of thousands ...
Posted by Michael Wonder on 14 Sep 2022
Dexamethasone intravitreal implant for treating diabetic macular oedema
14 September 2022 - NICE has published evidence-based recommendations on the use of dexamethasone intravitreal implant for the treatment of ...
Posted by Michael Wonder on 14 Sep 2022
Improving dose optimisation processes used in oncology drug development to minimise toxicity and maximise benefit to patients
12 September 2022 - We reviewed US FDA initial approvals (2019-2021) of small molecules and antibody-drug conjugates for oncologic indications. ...
Posted by Michael Wonder on 14 Sep 2022
Minoryx‘s marketing authorisation application for its lead candidate leriglitazone validated by EMA for orphan indication X-linked adrenoleukodystrophy
14 September 2022 - 4, 2022 - Minoryx Therapeutics today announces that it has filed a marketing authorisation application for its ...
Posted by Michael Wonder on 14 Sep 2022
Is drug price negotiation a concept whose time has come?
14 September 2022 - The US Congress has just approved the Inflation Reduction Act of 2022, which includes a provision ...
Posted by Michael Wonder on 14 Sep 2022
Has there actually been early resolution for early resolution resubmissions?
15 September 2022 - Following on from this week's article on early re-entry resubmissions, today we took a close look ...
Posted by Michael Wonder on 14 Sep 2022
Growing financial burden from high-cost targeted oral anti-cancer medicines among Medicare beneficiaries with cancer
13 September 2022 - The rapidly rising costs of targeted oral anti-cancer medicines raise concerns over their affordability. ...
Posted by Michael Wonder on 14 Sep 2022
TRACON Pharmaceuticals announces fast track designation by the FDA for envafolimab for the treatment of the soft tissue sarcoma subtypes of UPS and MFS
14 September 2022 - TRACON Pharmaceuticals announced today that the US FDA has granted fast track designation for the development of ...
Posted by Michael Wonder on 14 Sep 2022
Jazz Pharmaceuticals receives SMC approval for reimbursement of Sativex
14 September 2022 - Therapy is for the treatment of spasticity due to multiple sclerosis. ...
Posted by Michael Wonder on 14 Sep 2022
NICE inks another early full stop on the appraisal of a cancer medicine
14 September 2022 - Once again, the sponsor decided not to provide an evidence submission. ...
Posted by Michael Wonder on 14 Sep 2022
Potrero Medical receives FDA breakthrough device designation for Accuryn AKI predict algorithm
13 September 2022 - Potrero Medical announced today that the FDA granted breakthrough device designation for their AKI Predict machine learning ...
Posted by Michael Wonder on 14 Sep 2022
ATAGI update following COVID-19 meeting (7 September 2022)
14 September 2022 - An update from the Australian Technical Advisory Group on Immunisation following their meeting on 7 September 2022. ...
Posted by Michael Wonder on 14 Sep 2022
Lupin receives Health Canada approval for Rymti (biosimilar etanercept)
13 September 2022 - Rymti is Lupin’s biosimilar etanercept approved for all indications of the reference product. ...
Posted by Michael Wonder on 14 Sep 2022
Health Canada approves Keytruda (pembrolizumab) as adjuvant treatment for adults and children with stage IIB or IIC melanoma following complete resection
13 September 2022 - Approval is based on the Phase 3 KEYNOTE-716 trial. ...