Blog
RSS FeedPosted by Michael Wonder on 04 Oct 2024
Blue Shield of California slashes cost of world's best selling drug
1 October 2024 - Non-profit health plan collaborates with Fresenius Kabi and Evio Pharmacy Solutions to purchase FDA approved Humira biosimilar ...
Posted by Michael Wonder on 21 Nov 2024
Arrowhead Pharmaceuticals submits new drug application to US FDA for plozasiran for the treatment of familial chylomicronemia syndrome
18 November 2024 - The new drug application is based on positive results from the Phase 3 PALISADE study. ...
Posted by Michael Wonder on 21 Nov 2024
ImmuneSensor Therapeutics receives orphan drug and rare paediatric disease designations from the US FDA for cGAS inhibitor drug candidate, IMSB301, for the treatment of Aicardi Goutières syndrome
20 November 2024 - ImmuneSensor Therapeutics announced that the US FDA has granted both orphan drug designation and rare paediatric disease ...
Posted by Michael Wonder on 19 Nov 2024
Zilucoplan sodium for the treatment of patients with antibody positive generalised myasthenia gravis (revised draft guidance)
14 November 2024 - NICE has produced updated guidance on the use of zilucoplan sodium in the NHS in England. ...
Posted by Michael Wonder on 19 Nov 2024
FDA grants breakthrough therapy designation to Huahui Health's libevitug (HH-003) for treatment of chronic hepatitis D virus infection
18 November 2024 - Huahui Health today announced that its investigational hepatitis D and B drug candidate, Libevitug (HH-003), an ...
Posted by Michael Wonder on 19 Nov 2024
Alkeus Pharmaceuticals receives FDA rare paediatric disease and fast track designations for gildeuretinol as a treatment for Stargardt disease
18 November 2024 - Alkeus Pharmaceuticals today announced that gildeuretinol (ALK-001), an investigational oral therapy, has received rare paediatric disease and ...
Posted by Michael Wonder on 18 Nov 2024
Vaderis receives FDA fast track designation for VAD044 for the treatment of hereditary haemorrhagic telangiectasia
18 November 2024 - Vaderis Therapeutics today announces that the US FDA has designated the allosteric AKT inhibitor VAD044 a fast ...
Posted by Michael Wonder on 18 Nov 2024
Alentis receives FDA fast track designation for ALE.P02 for the treatment of CLDN1 positive squamous solid tumours
18 November 2024 - ALE.P02 is a first in class antibody-drug conjugate targeting CLDN1. ...
Posted by Michael Wonder on 18 Nov 2024
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) plus chemotherapy as first-line treatment for adult patients with unresectable non-epithelioid malignant pleural mesothelioma
15 November 2024 - Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial. ...
Posted by Michael Wonder on 18 Nov 2024
Tagrisso recommended for approval in the EU by CHMP for patients with unresectable EGFR mutated lung cancer
18 November 2024 - Recommendation based on LAURA Phase 3 trial results which showed Tagrisso extended median progression-free survival to ...
Posted by Michael Wonder on 18 Nov 2024
AbbVie receives European Commission approval of Elahere (mirvetuximab soravtansine) for the treatment of platinum resistant ovarian cancer
18 November 2024 - VENTANA FOLR RxDx assay, the companion diagnostic to identify ovarian cancer patients eligible for Elahere, also ...
Posted by Michael Wonder on 17 Nov 2024
Azurity Pharmaceuticals announces FDA approval of Danziten (nilotinib) tablets, the first and only nilotinib with no mealtime restrictions
14 November 2024 - Azurity Pharmaceuticals announced today that the US FDA has approved Danziten, the first and only nilotinib with ...
Posted by Michael Wonder on 17 Nov 2024
Junshi Biosciences announces UK MHRA approval for marketing of toripalimab
16 November 2024 - Shanghai Junshi Biosciences announced that the UK MHRA has approved toripalimab (Loqtorzi) for the treatment of two ...
Posted by Michael Wonder on 17 Nov 2024
Establishing Genomics Australia
15 November 2024 - The Albanese Government is establishing a new national body to provide leadership, coordination and expertise so ...
Posted by Michael Wonder on 17 Nov 2024
MHRA approves adapted Nuvaxovid JN.1 COVID-19 vaccine for adults and children aged 12 plus
15 November 2024 - The MHRA has approved an adapted version of the Nuvaxovid COVID-19 vaccine that targets the Omicron JN.1 ...
Posted by Michael Wonder on 17 Nov 2024
Evidence of clinical benefit of cancer medicines considered for funding in Australia
14 November 2024 - The objective was to describe the type of evidence and the clinical benefit of cancer medicines ...