Blog
RSS FeedPosted by Michael Wonder on 06 Aug 2025
The US FDA granted fast track designation to Dizal's birelentinib for relapsed/refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma
6 August 2025 - Supporting data from a pooled analysis of Phase I/II studies of birelentinib showed an objective response ...
Posted by Michael Wonder on 06 Aug 2025
NICE approves first immunotherapy combination for endometrial cancer
6 August 2025 - Around 2,100 people with advanced womb cancer are set to benefit from a groundbreaking new treatment option, ...
Posted by Michael Wonder on 06 Aug 2025
FDA grants accelerated approval to dordaviprone for diffuse midline glioma
6 August 2025 -Today, the FDA granted accelerated approval to dordaviprone (Modeyso, Jazz Pharmaceuticals), a protease activator, for adult and ...
Posted by Michael Wonder on 06 Aug 2025
Patients to receive medicines 3 to 6 months faster under 10 year health plan
6 August 2025 - NICE and the MHRA have described how the 10 year health plan will lead to faster medicines ...
Posted by Michael Wonder on 06 Aug 2025
How Australia is getting tangled in Trump’s fight with big pharma
6 August 2025 - The US president is angry Americans pay more for their medicines. Will he want the PBS – ...
Posted by Michael Wonder on 06 Aug 2025
Kye Pharmaceuticals announces the approval of Dynavel XR (amphetamine extended release) tablets and oral suspension for the treatment of adults and children with ADHD
5 August 2025 - Kye Pharmaceuticals is pleased to announce the Health Canada approval (notice of compliance) for Dyanavel XR ...
Posted by Michael Wonder on 05 Aug 2025
Health technology assessment, again: a transparent, evidence-based approach for CMS drug price negotiations
4 August 2025 - The CMS can now negotiate the prices of a set of drugs that represent significant Medicare expenditures. ...
Posted by Michael Wonder on 04 Aug 2025
Clarametyx Biosciences announces FDA grant of fast track and qualified infectious disease product designations for CMTX-101
4 August 2025 - Clarametyx Biosciences today announced that the US FDA has granted fast track and qualified infectious disease ...
Posted by Michael Wonder on 04 Aug 2025
Dyne Therapeutics announces FDA breakthrough therapy designation for DYNE-251 in Duchenne muscular dystrophy
4 August 2025 - Dyne Therapeutics today announced that the US FDA has granted breakthrough therapy designation to DYNE-251 for ...
Posted by Michael Wonder on 04 Aug 2025
Update from the PBAC (July 2025)
4 August 2025 - The PBAC update following the July 2025 PBAC meeting is now available. ...
Posted by Michael Wonder on 04 Aug 2025
Why drug prices for some big medicines will remain high for a longer time
3 August 2025 - Little known provisions in the Big Beautiful Bill lobbied by industry will cost Medicare billions in missed ...
Posted by Michael Wonder on 04 Aug 2025
PBS listing of Parkinson's drug a life-changing move for father of two Craig Gillespie
4 August 2025 - The price of a revolutionary treatment has plummeted from $130,000 a year to just $31.60 a script, ...
Posted by Michael Wonder on 04 Aug 2025
Australians now take drastic steps to pay for vital medicines not on the PBS
4 August 2025 - Many Australians struggling to pay bills have had to borrow money, fundraise or take on extra work ...
Posted by Michael Wonder on 02 Aug 2025
Update on US regulatory review of supplemental biologics license application
1 August 2025 - The US FDA issued a complete response letter for the supplemental biologics license application for Darzalex ...
Posted by Michael Wonder on 02 Aug 2025
Seladelpar lysine dihydrate for the treatment of patients with primary biliary cholangitis
30 July 2025 - The Department of Health and Social Care has asked the NICE to produce guidance on the ...