Blog
RSS FeedPosted by Michael Wonder on 16 May 2024
It is time to reconsider the 3% discount rate
15 May 2024 - Health technology assessment guidance often recommends a 3% real annual discount rate, the appropriateness of which ...
Posted by Michael Wonder on 27 Apr 2024
A milestone in facilitating the development of safe and effective biosimilars
26 April 2024 - This week, the FDA approved the 50th biosimilar, reflecting the markedly increased availability of biosimilar products—products that ...
Posted by Michael Wonder on 27 Apr 2024
New hope for Aussies battling early stage breast cancer
28 April 2024 - For the first time in 15 years women with an invasive form of early breast cancer ...
Posted by Michael Wonder on 27 Apr 2024
Biogen receives positive CHMP opinion for Tofidence (tocilizumab), a biosimilar referencing RoActemra
25 April 2024 - CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing Tofidence ...
Posted by Michael Wonder on 27 Apr 2024
Pierre Fabre Laboratories receive positive CHMP opinion for Obgemsa (vibegron) in overactive bladder syndrome
26 April 2024 - Pierre Fabre Laboratories announced that the CHMP of the EMA has adopted a positive opinion recommending approval ...
Posted by Michael Wonder on 27 Apr 2024
Takeda receives positive CHMP opinion for fruquintinib in previously treated metastatic colorectal cancer
26 April 2024 - If approved in the European Union, fruquintinib will be the first novel targeted therapy for metastatic colorectal ...
Posted by Michael Wonder on 27 Apr 2024
Johnson & Johnson receives positive CHMP opinion for Rybrevant (amivantamab) in combination with chemotherapy for the first-line treatment of patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations
26 April 2024 - The recommendation is supported by data from the Phase 3 PAPILLON study, which showed amivantamab plus chemotherapy ...
Posted by Michael Wonder on 27 Apr 2024
CHMP adopts positive opinion recommending approval of Bristol Myers Squibb’s Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma
26 April 2024 - Recommendation based on results from CheckMate-901, the first Phase 3 trial with an immunotherapy-chemotherapy combination to demonstrate ...
Posted by Michael Wonder on 26 Apr 2024
Vertex announces European Commission approval for Kalydeco to treat infants with cystic fibrosis ages 1 month and older
26 April 2024 - Kalydeco is the first and only medicine approved in the EU in this age group to ...
Posted by Michael Wonder on 26 Apr 2024
US FDA approves Pfizer’s Beqvez (fidanacogene elaparvovec-dzkt), a one-time gene therapy for adults with hemophilia B
26 April 2024 - Pfizer announced today that the US FDA has approved Beqvez (fidanacogene elaparvovec-dzkt) for the treatment of adults ...
Posted by Michael Wonder on 26 Apr 2024
Recommendations made by the PBAC (March 2024)
26 April 2024 - Recommendations made by the PBAC in March 2024 relating to the listing of medicines on the PBS ...
Posted by Michael Wonder on 26 Apr 2024
FDA grants Medivir´s MIV-711 rare paediatric disease designation and orphan drug designation for the treatment of Legg-Calvé-Perthes Disease
25 April 2024 - Medivir announced today that its selective cathepsin K inhibitor, MIV-711, has been granted rare paediatric disease designation ...
Posted by Michael Wonder on 26 Apr 2024
Melphalan flufenamide hydrochloride in combination with dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma
25 April 2024 - NICE is unable to make a recommendation on the use of melphalan flufenamide hydrochloride (Pepaxti) in combination ...
Posted by Michael Wonder on 25 Apr 2024
Compass Therapeutics receives FDA fast track designation for the investigation of CTX-009 in combination with paclitaxel for the treatment of patients with metastatic or locally advanced biliary tract tumours that have been previously treated
25 April 2024 - Compass Therapeutics today announced that the US FDA has granted fast track designation to CTX-009, the Company’s ...
Posted by Michael Wonder on 25 Apr 2024
US FDA accepts for priority review GSK’s application for an expanded indication of Jemperli (dostarlimab) plus chemotherapy to include all adult patients with primary advanced or recurrent endometrial cancer
24 April 2024 - 23 August 2024 assigned as Prescription Drug User Fee Act action date for FDA decision. ...
Posted by Michael Wonder on 25 Apr 2024
Children and teenagers with an aggressive form of brain cancer set to benefit after NICE recommends new life-extending drug combination treatment
24 April 2024 - A new targeted drug combination treatment, described as a ‘step-change in care’ for children and young ...