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 Jun 2022
Rhythm Pharmaceuticals announces FDA approval of Imcivree (setmelanotide) for use in patients with Bardet-Biedl syndrome
16 June 2022 - Approval based on Phase 3 trial results that demonstrated statistically significant reductions in weight and hunger in ...
Posted by Michael Wonder on 16 Jun 2022
Former FDA officials call for more transparency for drug approvals
15 June 2022 - The US FDA needs to take a more proactive approach in combatting misinformation and communicating decisions to ...
Posted by Michael Wonder on 16 Jun 2022
Novartis receives GB licence for Scemblix (asciminib), the first STAMP inhibitor for patients with chronic myeloid leukaemia
16 June 2022 - Asciminib is the first treatment in its class to be authorised in Great Britain. ...
Posted by Michael Wonder on 16 Jun 2022
New treatment to increase the chances of a successful kidney transplant recommended by NICE
16 June 2022 - A new treatment that increases the chance of a successful kidney transplant has been recommended by ...
Posted by Michael Wonder on 16 Jun 2022
Pharmaceutical Benefits Scheme Safety Net threshold reduction from 1 July 2022
16 June 2022 - As a cost of living measure, the Australian Government is lowering the PBS Safety Net thresholds ...
Posted by Michael Wonder on 16 Jun 2022
New PHARMAC funded cancer drugs already 'old and cheap', patient advocate Malcolm Mulholland says
16 June 2022 - New cancer drugs that will now be funded by the Government drug buying agency are already ...
Posted by Michael Wonder on 16 Jun 2022
Kintara Therapeutics granted fast track designation from the FDA for VAL-083 for newly diagnosed glioblastoma
15 June 2022 - swire/ -- Kintara Therapeutics today announced that the United States FDA has granted fast track designation to ...
Posted by Michael Wonder on 15 Jun 2022
EFPIA-EURORDIS joint statement on patient access to medicines for rare diseases
15 June 2022 - Today marks the publication of the EFPIA-EURORDIS joint statement on patient access to medicines for rare diseases. ...
Posted by Michael Wonder on 15 Jun 2022
A ‘safe space’ for addressing complex health technology assessment challenges
15 June 2022 - Innovative medicines, medical devices and diagnostics are arriving at an unprecedented pace. ...
Posted by Michael Wonder on 15 Jun 2022
A first step towards best practice recommendations for the design and statistical analyses of pragmatic clinical trials: a modified Delphi approach
15 June 2022 - Pragmatic clinical trials are randomised trials implemented through routine clinical practice, where design parameters of traditional randomised ...
Posted by Michael Wonder on 15 Jun 2022
Effective biomedical public-private partnerships are about innovation, not lower drug prices
15 June 2022 - There is fascination of late with the prospect of exercising Bayh-Dole Act “march-in rights,” primarily as a ...
Posted by Michael Wonder on 15 Jun 2022
Shionogi signs agreement with NHS England to begin an innovative subscription payment model for reimbursement of its antibiotic, Fetcroja (cefiderocol)
15 June 2022 - Shionogi recognises the UK’s leadership role in introducing the world’s first fully ‘delinked’ pilot reimbursement model; pull ...
Posted by Michael Wonder on 15 Jun 2022
Start of rolling review for adapted Comirnaty COVID-19 vaccine
15 June 2022 - EMA has started a rolling review for a version of Comirnaty adapted to provide better protection ...
Posted by Michael Wonder on 15 Jun 2022
England’s Innovative Medicines Fund hits another milestone
15 June 2022 - Just like the Cancer Drugs Fund, the time-limited fund for the most promising cancer drugs introduced ...
Posted by Michael Wonder on 15 Jun 2022
NICE’s early value assessment for medtech: panning for nuggets of innovation gold
15 June 2022 - The explosion in digital health products has left NHS commissioners wondering how they can possibly sift out ...