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 01 Jul 2024
CHMP recommends EU approval of Roche’s PiaSky for people with PNH, a rare, life-threatening blood condition
28 June 2024 - The recommendation is based on the COMMODORE 2 study results, where SC PiaSky given every month demonstrated ...
Posted by Michael Wonder on 01 Jul 2024
Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention
1 July 2024 - Submission based on positive SUPERNOVA Phase 3 trial data which demonstrated a statistically significant reduction in ...
Posted by Michael Wonder on 01 Jul 2024
Lynparza and Imfinzi combination recommended for approval in the EU by CHMP for patients with mismatch repair proficient advanced or recurrent endometrial cancer
1 July 2024 - Recommendation based on DUO-E Phase 3 results, which showed both regimens demonstrated statistically significant and clinically ...
Posted by Michael Wonder on 01 Jul 2024
DoH publishes revised agenda for July 2024 PBAC meeting (1 July 2024)
1 July 2024 - Version 5 of the agenda for the July 2024 PBAC meeting is now available; one major change. ...
Posted by Michael Wonder on 01 Jul 2024
FDA opens doors for more treatments for rare diseases through the new START Pilot Program
27 June 2024 - We are at a turning point in understanding the science that is opening doors to rare disease ...
Posted by Michael Wonder on 01 Jul 2024
Real world evidence submissions to the Center for Biologics Evaluation and Research
26 June 2024 - As part of the reauthorisation of the Prescription Drug User Fee Act (PDUFA VII), FDA committed ...
Posted by Michael Wonder on 01 Jul 2024
FDA grants approval for Eylea biosimilar FYB203/Azhantive (aflibercept-mrbb)
28 June 2024 - Formycon and its licensing partner Klinge Biopharma announce that the US FDA today approved FYB203/Azhantive (aflibercept-mrbb), ...
Posted by Michael Wonder on 01 Jul 2024
FDA approves biosimilar Pyzchiva (ustekinumab-ttwe), to be commercialised by Sandoz in US
1 July 2024 - FDA granted provisional determination for interchangeability designation for Pyzchiva. ...
Posted by Michael Wonder on 01 Jul 2024
Leqembi (lecanemab) for the treatment of Alzheimer’s disease launched in China
27 June 2024 - China is the third country to launch Leqembi following the United States and Japan. ...
Posted by Michael Wonder on 30 Jun 2024
Roche’s Vabysmo gets CHMP recommendation for third indication retinal vein occlusion
28 June 2024 - Positive recommendation is based on two Phase 3 studies. In addition to robust retinal drying with Vabysmo, ...
Posted by Michael Wonder on 30 Jun 2024
New Zealand Pharmaceutical Schedule - 1 July 2024
1 July 2024 - July 2024 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 30 Jun 2024
Schedule of Pharmaceutical Benefits - 1 July 2024
1 July 2024 - The July 2024 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 29 Jun 2024
Highlights from the 24-27 June 2024 CHMP meeting
28 June 2024 - The EMA’s CHMP recommended ten medicines for approval at its June 2024 meeting. ...
Posted by Michael Wonder on 29 Jun 2024
Tubulis receives FDA fast track designation for antibody drug conjugate candidate TUB-040 in platinum-resistant ovarian cancer
27 June 2024 - Designation for TUB-040 in platinum-resistant ovarian cancer is based on preclinical data in a range of models, ...
Posted by Michael Wonder on 29 Jun 2024
Abdera Therapeutics announces FDA fast track designation for ABD-147, a next generation precision radiopharmaceutical therapy, for the treatment of patients with extensive-stage small cell lung cancer
27 June 2024 - Abdera Therapeutics today announced that the US FDA has granted fast track designation to ABD-147 for the ...