Blog
RSS FeedPosted by Michael Wonder on 25 Jun 2024
AbbVie provides US regulatory update on ABBV-951 (foscarbidopa/foslevodopa)
25 June 2024 - AbbVie continues to work with the FDA to bring ABBV-951 to patients in the US as ...
Posted by Michael Wonder on 25 Jun 2024
DoH publishes revised agenda for July 2024 PBAC meeting (21 June 2024)
21 June 2024 - Version 4 of the agenda for the July 2024 PBAC meeting is now available; four minor ...
Posted by Michael Wonder on 25 Jun 2024
EMA publishes agenda for June 24-27 2024 CHMP meeting
24 June 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 25 Jun 2024
Ezharmia approved in Japan as first dual EZH1 and EZH2 inhibitor therapy for patients with peripheral T-cell lymphoma
24 June 2024 - Approval based on VALENTINE-PTCL01 results showing a clinically meaningful objective response rate of 43.7% in patients ...
Posted by Michael Wonder on 25 Jun 2024
Oncoinvent receives FDA fast track designation for Radspherin as treatment for peritoneal carcinomatosis from ovarian cancer
24 June 2024 - Phase 2b trial of Radspherin to treat ovarian cancer patients expected to initiate imminently. ...
Posted by Michael Wonder on 25 Jun 2024
BioNTech and DualityBio receive FDA fast track designation for antibody-drug conjugate candidate BNT324/DB-1311 in prostate cancer
24 June 2024 - Designation is based on pre-clinical data and data from an ongoing Phase 1/2 trial for BNT324/DB-1311, with ...
Posted by Michael Wonder on 25 Jun 2024
Tagrisso with the addition of chemotherapy approved in Japan as new first-line treatment for patients with EGFR mutated advanced lung cancer
25 June 2024 - Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly ...
Posted by Michael Wonder on 25 Jun 2024
Jemperli (dostarlimab) plus chemotherapy application accepted for review by the EMA to expand use to all patients with primary advanced or recurrent endometrial cancer
24 June 2024 - Regulatory submission supported by statistically significant and clinically meaningful progression-free and overall survival data from Part 1 ...
Posted by Michael Wonder on 25 Jun 2024
Update from the PBAC (June 2024)
25 June 2024 - As newly appointed Chair of the PBAC, I would like to take the opportunity to establish ...
Posted by Michael Wonder on 25 Jun 2024
Sellas announces US FDA rare paediatric disease designation granted to SLS009 for the treatment of paediatric acute lymphoblastic leukaemia
24 June 2024 - Sellas Life Sciences today announced that the US FDA has granted rare paediatric disease designation to SLS009, ...
Posted by Michael Wonder on 25 Jun 2024
Will Trodelvy get innovative new drug status backed by 100,000 petitions?
24 June 2024 - As the government will likely reflect innovative new drug values on its reimbursement criteria this year, ...
Posted by Michael Wonder on 25 Jun 2024
Takeda announces approval of Livtencity (maribavir) in Japan for post-transplant cytomegalovirus (CMV) infection/disease that is refractory to existing anti-CMV therapies
24 June 2024 - Livtencity is the first and only post-transplant anti-CMV treatment approved in Japan that targets/inhibits UL97 protein kinase. ...
Posted by Michael Wonder on 24 Jun 2024
Funding boost means more medicines for more New Zealanders
24 June 2024 - PHARMAC welcomes the Government’s funding boost which will see about 175,000 more people receiving the medicines they ...
Posted by Michael Wonder on 24 Jun 2024
argenx announces FDA approval of Vyvgart Hytrulo for chronic inflammatory demyelinating polyneuropathy
21 June 2024 - Third approved indication for Vyvgart and Vyvgart Hytrulo franchise. ...
Posted by Michael Wonder on 24 Jun 2024
Expanded PBS listings for lung cancer and a chronic skin disease
24 June 2024 - Australians with non-small cell lung cancer and the chronic skin disease hidradenitis suppurativa, now have access to ...