Blog
RSS FeedPosted by Michael Wonder on 27 Jul 2024
US FDA approves Leqselvi (deuruxolitinib), an oral JAK inhibitor for the treatment of severe alopecia areata
25 July 2024 - Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials. ...
Posted by Michael Wonder on 27 Jul 2024
Leo Pharma receives positive CHMP opinion of Anzupgo (delgocitinib cream) for the treatment of adults with moderate to severe chronic hand eczema
26 July 2024 - The positive opinion is based on results from the DELTA phase 3 program, which includes the randomised, ...
Posted by Michael Wonder on 27 Jul 2024
Update on regulatory review of lecanemab for early Alzheimer’s disease in the European Union
26 July 2024 - Eisai and Biogen announced today that the CHMP of the EMA has adopted a negative opinion ...
Posted by Michael Wonder on 27 Jul 2024
Ipsen receives CHMP positive opinions for Iqirvo (elafibranor) in primary biliary cholangitis and Kayfanda (odevixibat) in Alagille syndrome, two rare cholestatic liver diseases
26 July 2024 - Ipsen announced today two positive opinions by the EMA's CHMP for two different rare cholestatic liver disease ...
Posted by Michael Wonder on 27 Jul 2024
Astellas receives positive CHMP opinion for zolbetuximab in combination with chemotherapy for treatment of advanced gastric and gastro-oesophageal junction cancer
26 July 2024 - If approved by the European Commission, zolbetuximab would become the first and only CLDN18.2 targeted therapy approved ...
Posted by Michael Wonder on 27 Jul 2024
Astellas receives positive CHMP opinion for Padcev (enfortumab vedotin) in combination with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer
26 July 2024 - Positive opinion is based on Phase 3 EV-302 clinical trial results which showed enfortumab vedotin in combination ...
Posted by Michael Wonder on 26 Jul 2024
EMA publishes agenda for 22-25 July 2024 CHMP meeting
22 July 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 25 Jul 2024
New clot busting drug recommended by NICE set to save NHS millions of pounds
24 July 2024 - Giving a new clot busting drug to people who have had a stroke could help save the ...
Posted by Michael Wonder on 24 Jul 2024
AbbVie's Epkinly receives first ever time-limited reimbursement recommendation by Canada's Drug Agency
23 July 2024 - AbbVie has successfully completed its negotiations with the pan-Canadian Pharmaceutical Alliance and a letter of intent ...
Posted by Michael Wonder on 19 Jul 2024
More than 40,000 people could benefit after NICE recommends new ‘take at home’ pill for advanced prostate cancer
19 July 2024 - A new pill to treat advanced hormone sensitive prostate cancer that could benefit just over 40,000 ...
Posted by Michael Wonder on 19 Jul 2024
Public Summary Documents (first time decisions not to recommend and deferrals) - March 2024 PBAC meeting
19 July 2024 - The Public Summary Documents (first time decisions not to recommend and deferrals) from the March 2024 ...
Posted by Michael Wonder on 18 Jul 2024
Rucaparib camsylate for maintenance treatment of advanced ovarian, fallopian tube and peritoneal cancer after response to first-line platinum-based chemotherapy
8 July 2024 - The Department of Health and Social Care has asked the NICE to produce guidance on the ...
Posted by Michael Wonder on 18 Jul 2024
Teclistamab for the treatment of patients with relapsed and refractory multiple myeloma after three or more treatments (review of previous guidance)
16 July 2024 - The Department of Health and Social Care has asked the NICE to review the guidance on ...
Posted by Michael Wonder on 17 Jul 2024
ICER releases draft evidence report on treatments for transthyretin amyloid cardiomyopathy
17 July 2024 - Public comment period now open until 13 August 2024; requests to make oral comment during public ...
Posted by Michael Wonder on 17 Jul 2024
CSL Behring announces positive reimbursement decision in Canada for Hemgenix (etranacogene dezaparvovec), the first gene therapy for haemophilia B
16 July 2024 - The positive decision from CADTH recognises the importance of this one-time, single dose innovative treatment for ...