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 21 Jun 2021
Bayer submits regulatory applications for oncology treatment combination of copanlisib and rituximab in the U.S. and EU
21 June 2021 - Bayer today announced the submission of a supplemental new drug application to the U.S. FDA and a ...
Posted by Michael Wonder on 21 Jun 2021
FDA approves first oral blood thinning medication for children
21 June 2021 - Today, the U.S. FDA approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less ...
Posted by Michael Wonder on 21 Jun 2021
EMA publishes agenda for 21-24 June CHMP meeting
21 June 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 21 Jun 2021
Agios submits new drug application to FDA for mitapivat for treatment of adults with pyruvate kinase deficiency
21 June 2021 - Agios Pharmaceuticals today announced that it has submitted a new drug application for mitapivat to the U.S. ...
Posted by Michael Wonder on 21 Jun 2021
Medsafe approves Pfizer vaccine for New Zealand 12-15 year olds
21 June 2021 - Prime Minister Jacinda Ardern has welcomed Medsafe's "very carefully considered" provisional approval of the Pfizer/BioNTech vaccine ...
Posted by Michael Wonder on 21 Jun 2021
Sensome receives FDA breakthrough device designation for its AI powered stroke guidewire
21 June 2021 - Sensome announced today that it has been granted a Breakthrough Device designation by the Center of Devices ...
Posted by Michael Wonder on 21 Jun 2021
Novartis’ Cosentyx wins NICE backing for non-radiographic axial spondyloarthritis
18 June 2021 - Novartis’ Cosentyx has been recommended by NICE for the treatment of adults with non-radiographic axial spondyloarthritis. ...
Posted by Michael Wonder on 21 Jun 2021
Factors associated with generic drug uptake in the United States, 2012 to 2017
19 June 2021 - In the United States, brand-name prescription drugs remain expensive until market exclusivity ends and lower cost generics ...
Posted by Michael Wonder on 21 Jun 2021
Are drugs priced in accordance with value? A comparison of value based and net prices using Institute for Clinical and Economic Review reports
19 June 2021 - The Institute for Clinical and Economic Review is an independent organisation that reviews drugs and devices with ...
Posted by Michael Wonder on 21 Jun 2021
BeiGene announces China NMPA approval of Brukinsa (zanubrutinib) for the treatment of patients with relapsed or refractory Waldenström’s macroglobulinaemia
18 June 2021 - Third approval for Brukinsa in China and second approval in Waldenström’s macroglobulinaemia worldwide. ...
Posted by Michael Wonder on 21 Jun 2021
TGA not expecting Novavax quality data until September
20 June 2021 - Australian’s medicines regulator says it does not expect key data from the country’s third major COVID-19 ...
Posted by Michael Wonder on 21 Jun 2021
Cystic fibrosis life-altering drug nearing patient access across the country: Health Canada
20 June 2021 - For the cystic fibrosis community, persistence and constant belief are paying off. ...
Posted by Michael Wonder on 21 Jun 2021
Health equity and Medicaid transformation — operationalising President Biden’s agenda
19 June 2021 - President Biden has made reforms intended to “protect and strengthen Medicaid” a centrepiece of his health policy ...
Posted by Michael Wonder on 20 Jun 2021
AstraZeneca welcomes court ruling on supply of its COVID-19 vaccine to Europe
18 June 2021 - AstraZeneca today welcomed the ruling by the Court of First Instance in Brussels. The European Commission had ...
Posted by Michael Wonder on 20 Jun 2021
US plays catch-up with Europe over biosimilar patents
17 June 2021 - Moves to ease market access for generic drug makers are gaining momentum. ...