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 04 Feb 2025
CHMP recommends subcutaneous Rybrevant (amivantamab) for the treatment of patients with advanced EGFR mutated non-small cell lung cancer
3 February 2025 - Data from the Phase 3 PALOMA-3 study showed non-inferiority to intravenous administration meeting both co-primary pharmacokinetic endpoints, ...
Posted by Michael Wonder on 04 Feb 2025
Fondazione Telethon submits EU marketing authorisation application for etuvetidigene autotemcel gene therapy for the treatment of Wiskott-Aldrich syndrome
3 February 2025 - Fondazione Telethon announced that it has submitted the marketing authorisation application for the gene therapy - etuvetidigene ...
Posted by Michael Wonder on 04 Feb 2025
Comparison of clinical evidence submitted to the FDA and EMA for cell and gene therapies
3 February 2025 - Harmonisation in regulatory submissions across agencies may support timelier access to innovative treatments, including cell and gene ...
Posted by Michael Wonder on 04 Feb 2025
Durvalumab with tremelimumab for the first-line treatment of patients with advanced or unresectable hepatocellular carcinoma
4 February 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 04 Feb 2025
Insurer denies access to drugs granted accelerated approval by FDA
3 January 2025 - An insurer’s decision to delay reimbursement of drugs licensed under the FDA’s accelerated approval program has sparked ...
Posted by Michael Wonder on 03 Feb 2025
Imfinzi recommended for approval in the EU by CHMP as first and only immunotherapy for limited-stage small cell lung cancer
3 February 2025 - Recommendation based on ADRIATIC Phase 3 trial results which showed a 27% reduction in the risk ...
Posted by Michael Wonder on 03 Feb 2025
Roche receives FDA approval for the first companion diagnostic to identify patients with HER2 ultralow metastatic breast cancer eligible for Enhertu
31 January 2025 - The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2 low ...
Posted by Michael Wonder on 03 Feb 2025
US FDA accepts biologics license application for HLX11, biosimilar candidate of Perjeta (pertuzumab)
2 February 2025 - Shanghai Henlius Biotech announced that the US FDA has accepted the biologics license application for HLX11, ...
Posted by Michael Wonder on 03 Feb 2025
Proposal to fund a new oral contraceptive pill
3 February 2025 - PHARMAC is consulting on funding a new progestogen-only oral contraceptive pill called desogestrel (Cerazette) from 1 ...
Posted by Michael Wonder on 02 Feb 2025
Public consultation: draft 2025-26 cost recovery implementation statement for listing medicines on the PBS and designated vaccines on the NIP
31 January 2025 - Consultation on the draft 2025-26 cost recovery implementation statement for listing medicines on the PBS and ...
Posted by Michael Wonder on 02 Feb 2025
Life-saving lung cancer drug added to PBS, slashing price from $10,000 a month to $30 per script
1 February 2025 - Australians diagnosed with a rare form of lung cancer will now have access to a life-saving ...
Posted by Michael Wonder on 02 Feb 2025
Cheaper medicine for lung cancer patients
2 February 2025 - The Australian Government is listing Retevmo (selpercatinib) on the PBS for the first time to treat advanced ...
Posted by Michael Wonder on 02 Feb 2025
US FDA approves Celltrion's Avtozma (tocilizumab-anoh), a biosimilar to Actemra
30 January 2025 - Approval was received for multiple indications, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic ...
Posted by Michael Wonder on 02 Feb 2025
Cell and gene therapies - improving access and outcomes for Medicare and Medicaid beneficiaries
1 February 2025 - State Medicaid agencies can now apply to participate in a new model that supports voluntary, outcomes-based agreements ...
Posted by Michael Wonder on 01 Feb 2025
High quality evidence for the treatment of very rare diseases: IQWiG is involved in the EU project RealiseD
29 January 2025 - Developing clinical studies for good evidence on very rare diseases in order to arrive at effective therapies ...