Blog
RSS FeedPosted by Michael Wonder on 06 Apr 2023
Trastuzumab deruxtecan for the treatment of patients with HER2 positive unresectable or metastatic gastric or gastro-oesophageal junction cancer after anti-HER2 treatment
6 April 2023 - NICE is unable to make a recommendation on the use of trastuzumab deruxtecan (Enhertu) for the treatment ...
Posted by Michael Wonder on 06 Apr 2023
Public summary documents – December 2022 PBAC meeting
6 April 2023 - The public summary documents (positive recommendations and subsequent decisions not to recommend) from the December 2022 PBAC ...
Posted by Michael Wonder on 05 Apr 2023
Ipsen reacts to NICE’s Cabometyx verdict
5 April 2023 - Company disappointed by institute’s failure to recommend thyroid cancer therapy for specific patient group ...
Posted by Michael Wonder on 04 Apr 2023
TLV reconsiders the subsidy of Lumykras (sotorasib)
4 April 2023 - TLV has started a review of Lumykras (sotorasib). Lumykras (sotorasib) has already been included in the high-cost ...
Posted by Michael Wonder on 04 Apr 2023
Daridorexant for the treatment of patients with insomnia disorder
3 April 2023 - The Department of Health and Social Care has asked the NICE to produce guidance on the ...
Posted by Michael Wonder on 03 Apr 2023
Ultomiris recommended for approval in the EU by CHMP for the treatment of adults with neuromyelitis optica spectrum disorder
3 April 2023 - No relapses observed in pivotal trial of first and only long-acting C5 inhibitor, indicating potential to ...
Posted by Michael Wonder on 02 Apr 2023
Samsung Bioepis receives positive CHMP opinion for eculizumab biosimilar, Epysqli
31 March 2023 - Epysqli, a biosimilar referencing Soliris (eculizumab), is Samsung Bioepis’ first biosimilar in haematology to be recommended for ...
Posted by Michael Wonder on 02 Apr 2023
TG Therapeutics announces positive CHMP opinion for Briumvi (ublituximab-xiiy) for the treatment of relapsing forms of multiple sclerosis in adults
31 March 2023 - TG Therapeutics today announced that the CHMP of the EMA has issued a positive opinion recommending ...
Posted by Michael Wonder on 02 Apr 2023
Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for relapsed or refractory large B-cell lymphoma after one prior therapy
31 March 2023 - Recommendation for approval based on Phase 3 TRANSFORM study, supporting the potential of Breyanzi in earlier ...
Posted by Michael Wonder on 02 Apr 2023
Novartis Entresto receives positive CHMP opinion for a heart failure
31 March 2023 - The positive opinion is based on final data from the 52 week Phase 3 PANORAMA-HF trial, the ...
Posted by Michael Wonder on 01 Apr 2023
Highlights from the 27 - 30 March 2023 CHMP meeting
31 March 2023 - The EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its March 2023 meeting. ...
Posted by Michael Wonder on 29 Mar 2023
MSAC Secretariat publishes agenda for July 2023 MSAC meeting
29 March 2023 - The MSAC Secretariat has published a list of applications scheduled to be considered by the MSAC ...
Posted by Michael Wonder on 29 Mar 2023
Hundreds of people are set to receive the first immunotherapy drug for advanced cervical cancer through the Cancer Drugs Fund
29 March 2023 - It is estimated that around 400 people with advanced cervical cancer will be eligible for pembrolizumab ...
Posted by Michael Wonder on 29 Mar 2023
Agenda for the July 2023 PBAC meeting
29 March 2023 - The agenda for the July 2023 PBAC meeting is now available. ...
Posted by Michael Wonder on 27 Mar 2023
Finerenone for the treatment of chronic kidney disease in patients with type 2 diabetes
23 March 2023 - NICE has issued evidence-based recommendations on the use of finerenone (Kerendia) for the treatment of adults ...