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 04 Apr 2022
FDA shuts out its own experts in authorising another vaccine booster
3 April 2022 - Decisions like this only reinforce the perception that Covid policy is driven by groupthink and politics. ...
Posted by Michael Wonder on 04 Apr 2022
Upper Hutt dad's plea to PHARMAC to cover family's $5,200 a year bill for 'life changing' diabetes devices
2 April 2022 - A Kiwi teacher is calling for public funding for "life changing" diabetes devices after being forced ...
Posted by Michael Wonder on 04 Apr 2022
Novartis announces European Commission approval of Beovu for people living with diabetic macular oedema
31 March 2022 - Approval is based on year one data from the Phase 3 KESTREL and KITE trials investigating Beovu ...
Posted by Michael Wonder on 04 Apr 2022
Digital Medicine Society launches toolkit to support reimbursement for new drugs developed using digital outcomes
4 April 2022 - New essential resources ensure that patients will benefit without delay following regulatory acceptance of digital outcomes. ...
Posted by Michael Wonder on 04 Apr 2022
Mystery solved over Hansard change to hide budget’s missing $10 drug price cut
4 April 2022 - Financial Services Minister Jane Hume’s office asked Hansard staff to delete references to a planned $10 ...
Posted by Michael Wonder on 04 Apr 2022
Precigen receives fast track designation for PRGN-3006 UltraCAR-T in patients with relapsed or refractory acute myeloid leukaemia
4 April 2022 - PRGN-3006 UltraCAR-T previously received orphan drug designation in patients with acute myeloid leukaemia by the US FDA. ...
Posted by Michael Wonder on 04 Apr 2022
FDA approves Nobelpharma's Hyftor (sirolimus 0.2% topical gel)
4 April 2022 - Hyftor is the first topical treatment approved by the FDA for facial angiofibroma in individuals with tuberous ...
Posted by Michael Wonder on 04 Apr 2022
Alnylam announces three month extension of review period for new drug application for vutrisiran
4 April 2022 - New PDUFA goal date scheduled for 14 July 2022. ...
Posted by Michael Wonder on 04 Apr 2022
Acer Therapeutics’ Edsivo (celiprolol) granted FDA breakthrough therapy designation for vascular Ehlers-Danlos syndrome
4 April 2022 - Discussions on-going with FDA through special protocol assessment seeking agreement on planned pivotal Phase 3 DiSCOVER trial ...
Posted by Michael Wonder on 04 Apr 2022
Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion
1 April 2022 - Celerity Pharmaceuticals Uses Biocon Biologics’ Insulin Drug Substance to Develop the Product. ...
Posted by Michael Wonder on 04 Apr 2022
U.S. FDA grants priority review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults
4 April 2022 - If approved, Actemra/RoActemra would be the first U.S. FDA approved immunomodulator for the treatment of COVID-19 in ...
Posted by Michael Wonder on 04 Apr 2022
FDA accepts Dupixent (dupilumab) for priority review in patients aged 12 years and older with eosinophilic oesophagitis
4 April 2022 - If approved, Dupixent would be the first medicine available in the U.S. indicated to treat eosinophilic esophagitis. ...
Posted by Michael Wonder on 04 Apr 2022
JW Therapeutics announces receipt of breakthrough therapy designation for Carteyva in mantle cell lymphoma in China
3 April 2022 - JW Therapeutics announced that the Center for Drug Evaluation of the National Medical Products Administration of China ...
Posted by Michael Wonder on 04 Apr 2022
Bluebird Bio has serious cash flow concerns; inability to strike reimbursement deals in Europe partly to blame
3 April 2022 - Bluebird bio is a highly innovative biotechnology company which develops gene therapies for several rare genetic ...
Posted by Michael Wonder on 04 Apr 2022
Here comes yet another new medicine for patients with MS
4 April 2022 - The TGA has approved Vumerity (diroximel fumarate). ...