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 09 Jul 2024
Pharmacy middlemen appear to be inflating drug prices, FTC says
9 July 2024 - The Federal Trade Commission released a critical report detailing how pharmacy benefit managers—like CVS Health’s Caremark, Cigna’s ...
Posted by Michael Wonder on 09 Jul 2024
A new gene therapy, transformative cystic fibrosis medicines and an obesity jab included in guidance recommended during pre-election period
8 July 2024 - More than 20 pieces of draft and final guidance on a range of medicines and medical conditions ...
Posted by Michael Wonder on 09 Jul 2024
Adicet Bio receives FDA fast track designation for ADI-270 in metastatic/advanced clear cell renal cell carcinoma
8 July 2024 - Adicet Bio today announced the US FDA has granted fast track designation to ADI-270 for the ...
Posted by Michael Wonder on 09 Jul 2024
Insurers pocketed $50 billion from Medicare for diseases no doctor treated
8 July 2024 - Questionable diagnoses of HIV and other maladies triggered extra Medicare Advantage payments; ‘It’s anatomically impossible’. ...
Posted by Michael Wonder on 09 Jul 2024
Mesoblast resubmits biologics license application with US FDA for approval of Ryoncil in children with steroid-refractory acute graft versus host disease
8 July 2024 - Mesoblast announced today it has resubmitted its BLA for approval of Ryoncil (remestemcel-L) in the treatment ...
Posted by Michael Wonder on 08 Jul 2024
Besremi retries for insurance coverage promising a potential operational cure
8 July 2024 - Besremi (rofeginterferon alfa-2b), which has recently set a new standard in treating polycythemia vera by offering ...
Posted by Michael Wonder on 08 Jul 2024
Post-market review workplan (May 2024)
8 July 2024 - The post-market review workplan was considered by the PBAC at its intracycle meeting in May 2024. ...
Posted by Michael Wonder on 08 Jul 2024
Xpovio (selinexor) approved for new indication in DLBCL in China, bringing a new treatment option to patients in the country
5 July 2024 - Results from the registrational SEARCH study in China showed that the overall response rate among the ...
Posted by Michael Wonder on 07 Jul 2024
FDA approves Genentech’s Vabysmo pre-filled syringe for three leading causes of vision loss
4 July 2024 - Vabysmo PFS is the first and only syringe pre-filled with an FDA approved bi-specific antibody to treat ...
Posted by Michael Wonder on 06 Jul 2024
Four decades of orphan drugs and priorities for the future
6 July 2024 - The Orphan Drug Act was enacted in the United States in 1983 in response to growing awareness ...
Posted by Michael Wonder on 06 Jul 2024
Summary of consultation to widen access to cancer medicines and treatments to prevent fungal infections
5 July 2024 - PHARMAC is proposing to widen access to two medicines for cancer and two medicines for prevention ...
Posted by Michael Wonder on 06 Jul 2024
Judge rules against Boehringer Ingelheim in pharma’s latest legal loss on Medicare negotiation
5 July 2024 - A federal judge ruled against Boehringer Ingelheim’s challenge to the new Medicare drug price negotiation program, ...
Posted by Michael Wonder on 06 Jul 2024
Submission of Nidlegy marketing authorisation application validated by EMA
4 July 2024 - The assessment period of the dossier by the authorities has started on 20 June. ...
Posted by Michael Wonder on 05 Jul 2024
Hinova Pharmaceuticals receives FDA fast track designation for HP518 for treatment of androgen receptor triple-negative breast cancer
5 July 2024 - Hinova Pharmaceuticals today announced that the US FDA has granted fast track designation for HP518, an investigational ...
Posted by Michael Wonder on 05 Jul 2024
Public Summary Documents – March 2024 PBAC meeting (round 1)
5 July 2024 - The Public Summary Documents (positive recommendations and subsequent decisions not to recommend) from the March 2024 PBAC ...