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 14 Nov 2023
FDA grants fast track designation to SonALAsense’s Sonala-001 in combination with the Insightec transcranial ultrasound device for sonodynamic therapy of DIPG, a rare paediatric brain cancer
14 November 2023 - SonALAsense today announced that the US FDA has granted fast track designation to the development program of ...
Posted by Michael Wonder on 14 Nov 2023
Atsena Therapeutics receives FDA regenerative medicine advanced therapy designation for ATSN-101 gene therapy for GUCY2D associated Leber congenital amaurosis
14 November 2023 - ATSN-101 has demonstrated clinically meaningful improvements in vision at the highest dose with no drug-related serious ...
Posted by Michael Wonder on 14 Nov 2023
Biocon Biologics receives UK (MHRA) approval for Yesafili, biosimilar aflibercept
13 November 2023 - Biocon Biologics has announced that MHRA in the UK has granted marketing authorisation for Yesafili, a biosimilar ...
Posted by Michael Wonder on 14 Nov 2023
Inequitable conduct and invalidation of patents related to FDA regulated products
13 November 2023 - Median brand name drug launch prices increased from $2,115 in 2008 to $180,007 in 2021. ...
Posted by Michael Wonder on 14 Nov 2023
DUSC utilisation analysis public release documents (June 2023)
14 November 2023 - The utilisation analysis public release documents from the June 2023 DUSC meeting are now available. ...
Posted by Michael Wonder on 14 Nov 2023
Ancillary product patents to extend biologic patent life
13 November 2023 - In 2021, 46% ($260 billion) of all gross prescription drug spending in the US was on biologic ...
Posted by Michael Wonder on 14 Nov 2023
Imfinzi plus chemotherapy approved in China as first immunotherapy regimen for patients with locally advanced or metastatic biliary tract cancer
14 November 2023 - Approval based on results from TOPAZ-1 global Phase 3 trial and a Chinese patient cohort which ...
Posted by Michael Wonder on 14 Nov 2023
Ipsen and Medison Pharma announce Health Canada approval of Bylvay (odevixibat) for the treatment of pruritus due to progressive familial intrahepatic cholestasis
13 November 2023 - Bylvay (odevixibat) is the first and only oral treatment available in Canada for the treatment of ...
Posted by Michael Wonder on 13 Nov 2023
Informing real-time decisions with post-market drug evidence
10 November 2023 - It’s been one year since CADTH launched the Post-Market Drug Evaluation (PMDE) Program to provide decision-makers with ...
Posted by Michael Wonder on 13 Nov 2023
MediWound receives positive CHMP opinion recommending approval for NexoBrid to treat paediatric patients
13 November 2023 - The label expansion will solidify NexoBrid’s position in the EU as a safe and effective non-surgical treatment ...
Posted by Michael Wonder on 13 Nov 2023
SMC - November 2023 decisions
13 November 2023 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 13 Nov 2023
GSK receives positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia
13 November 2023 - If approved, momelotinib will become the first and only treatment in the EU specifically indicated for myelofibrosis ...
Posted by Michael Wonder on 13 Nov 2023
In shocking reversal, CMS wants to allow Medicare Part D plan sponsors to substitute non-interchangeable biosimilars
10 November 2023 - On November 6, 2023, CMS announced a proposed Rule that would permit Medicare Part D plan sponsors ...
Posted by Michael Wonder on 13 Nov 2023
Outcome statement - September 2023 DUSC meeting
13 November 2023 - The Outcome Statement from the September 2023 DUSC meeting is now available. ...
Posted by Michael Wonder on 13 Nov 2023
PHARMAC calls for applications for medicines for rare disorders
13 November 2023 - PHARMAC is calling for applications for medicines to treat rare disorders. ...