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 16 Nov 2021
CARsgen announces CAR T-cell product candidate CT041 granted PRIME eligibility by the EMA
15 November 2021 - CARsgen Therapeutics today announced that the EMA has granted Priority Medicines (PRIME) eligibility to CT041 for the ...
Posted by Michael Wonder on 15 Nov 2021
New WHO report maps barriers to insulin availability and suggests actions to promote universal access
12 November 2021 - 100 years after its discovery, insulin still out of reach for many living with diabetes. ...
Posted by Michael Wonder on 15 Nov 2021
Competing with, and learning from, China in the global pharmaceutical innovation race
15 November 2021 - President Joe Biden has promoted investment in technology based industries, including the life sciences, as a strategic ...
Posted by Michael Wonder on 15 Nov 2021
When insurers choose, patients lose - campaign launched to protect patient choice
15 November 2021 - A new public health campaign to protect Australians’ access to life-saving therapies and medical technologies has ...
Posted by Michael Wonder on 15 Nov 2021
Celltrion’s monoclonal antibody treatment regdanvimab, approved by the European Commission for the treatment of COVID-19
14 November 2021 - The European Commission granted marketing authorisation for Celltrion’s regdanvimab following positive opinion by the EMA's CHMP last ...
Posted by Michael Wonder on 15 Nov 2021
New FDA chief will face COVID woes and calls for drug approval reform
12 November 2021 - After long delay, US President Joe Biden picks Robert Califf to once again head the US FDA. ...
Posted by Michael Wonder on 15 Nov 2021
It's time for Congress to get Medicare drug pricing reform right
15 November 2021 - After a three-year debate and delay in delivering patients much-needed relief from high out-of-pocket prescription drug costs, ...
Posted by Michael Wonder on 15 Nov 2021
Califf has lots of unfinished FDA business
15 November 2021 - Robert Califf, whom President Biden picked to lead the US. FDA, does not have much to show ...
Posted by Michael Wonder on 15 Nov 2021
Rhythm Pharmaceuticals announces FDA acceptance for filing and priority review of supplemental new drug application for Imcivree (setmelanotide) for patients with Bardet-Biedl syndrome and Alström syndrome
15 November 2021 - FDA sets PDUFA goal date of 16 March 2022. ...
Posted by Michael Wonder on 15 Nov 2021
NICE recommends cenobamate for treatment of adult epilepsy patients in UK
15 November 2021 - NICE has issued a positive recommendation for Arvelle Therapeutics’ cenobamate (Ontozry), for the treatment of focal-onset ...
Posted by Michael Wonder on 15 Nov 2021
Horizon Therapeutics receives CHMP positive opinion for Uplinza (inebilizumab) as a monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorder
12 November 2021 - CHMP recommendation based on positive results from N-MOmentum, the largest clinical trial ever conducted in NMOSD to ...
Posted by Michael Wonder on 15 Nov 2021
Ozempic 2 mg recommended for approval for the treatment of type 2 diabetes by the European Medicines Agency
12 November 2021 - Novo Nordisk today announced that the EMA's CHMP has adopted a positive opinion recommending a label ...
Posted by Michael Wonder on 15 Nov 2021
Medicare premiums to jump in part due to pricey Alzheimer's drug
12 November 2021 - Seniors on Medicare will have to pay more than $20 more per month extra in premiums ...
Posted by Michael Wonder on 15 Nov 2021
Wegovy recommended for approval for the treatment of obesity by the European regulatory authorities
11 November 2021 - Novo Nordisk today announced that the European Medicines Agency’s CHMP has adopted a positive opinion, recommending ...
Posted by Michael Wonder on 15 Nov 2021
Supporting Australians with rare stomach and bowel cancer
15 November 2021 - The Morrison Government will list Qinlock (ripretinib) on the PBS for the treatment of advanced gastro-intestinal stromal ...