Blog
RSS FeedPosted by Michael Wonder on 15 Jul 2025
New cystic fibrosis drug fast tracked for NHS use
15 July 2025 - Some people with cystic fibrosis are set to benefit from a new once daily triple therapy treatment, ...
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
Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) accepted for priority review by US FDA in fifth cancer type for relapsed or refractory marginal zone lymphoma
4 August 2025 - Bristol Myers Squibb today announced that the US FDA has accepted the supplemental biologics license application ...
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 04 Aug 2025
PHARMAC expands access to meningococcal B vaccine for children under 5
31 July 2025 - PHARMAC is extending access to the meningococcal B vaccine (Bexsero), with up to 77,000 more children ...
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 ...
Posted by Michael Wonder on 01 Aug 2025
FDA approves Alhemo as once daily prophylactic treatment to prevent or reduce the frequency of bleeding episodes for adults and children 12 years of age and older with haemophilia A or B without inhibitors
31 July 2025 - FDA approval is based on phase 3 trial data (explorer8), which established the safety and efficacy of ...
Posted by Michael Wonder on 01 Aug 2025
Serplulimab in combination with carboplatin and etoposide phosphate for the first-line treatment of patients with extensive-stage small-cell lung cancer
30 July 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 01 Aug 2025
BeOne Medicines receives PRIME designation from the EMA for BGB-16673 in Waldenström’s macroglobulinaemia
31 July 2025 - Decision highlights the promise of BGB-16673, an investigational and potentially first in class BTK degrader designed ...
Posted by Michael Wonder on 01 Aug 2025
Reimbursement for oral Fabry disease drug Galafold expanded to first-line treatment
1 August 2025 - Handok's Fabry disease treatment, Galafold (migalastat), will have its insurance coverage criteria expanded to include first-line ...