Blog
RSS FeedPosted by Michael Wonder on 06 Feb 2025
Bayer files for approval of finerenone in heart failure in the EU
3 February 2025 - Regulatory submission is based on positive data from the Phase 3 FINEARTS-HF study presented at ESC Congress ...
Posted by Michael Wonder on 09 Mar 2025
Novo Nordisk to sell obesity drug Wegovy direct to patients at lower price
5 March 2025 - Move follows similar announcement by Eli Lilly, though Novo’s is broader. ...
Posted by Michael Wonder on 09 Mar 2025
Expanded reimbursement for Rinvoq enhances atopic dermatitis treatment options
7 March 2025 - Korean patients with moderate to severe atopic dermatitis now have greater flexibility in treatment as reimbursement ...
Posted by Michael Wonder on 08 Mar 2025
This immunotherapy drug helped me beat cancer - instead of $229k it now costs $31
8 March 2025 - When she was just 26-years-old, Bianca Tesoriero’s life changed in an instant, following a visit to her ...
Posted by Michael Wonder on 08 Mar 2025
Vertex announces UK MHRA approval of Alyftrek (deutivacaftor/tezacaftor/vanzacaftor), a once daily next in class CFTR modulator for the treatment of cystic fibrosis
7 March 2025 - In head to head clinical trials, deutivacaftor/tezacaftor/vanzacaftor was non-inferior on ppFEV1 and further decreased sweat chloride ...
Posted by Michael Wonder on 08 Mar 2025
FDA’s accelerated approval guidance gets pushback from industry
7 March 2025 - The pharmaceutical industry has some questions regarding the US FDA's recent guidance on its accelerated approval ...
Posted by Michael Wonder on 08 Mar 2025
Acarizax approved in Canada for treatment of young children
7 March 2025 - ALK today announced that Health Canada has approved ALK’s Acarizax tablet for use in children, aged ...
Posted by Michael Wonder on 07 Mar 2025
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma
7 March 2025 - Approval based on results of Phase 3 CheckMate-9DW clinical trial demonstrating a statistically significant and clinically ...
Posted by Michael Wonder on 07 Mar 2025
Lazertinib approved for use in combination with amivantamab for the treatment of adults with non-small cell lung cancer
6 March 2025 - The MHRA has today approved lazertinib (Lazcluze) for adults with non-small cell lung cancer that has spread ...
Posted by Michael Wonder on 07 Mar 2025
Public Summary Documents – November 2024 PBAC meeting
7 March 2025 - The Public Summary Documents (first time decisions not to recommend and deferrals) from the November 2024 PBAC ...
Posted by Michael Wonder on 07 Mar 2025
Amivantamab in combination with pemetrexed disodium heptahydrate and carboplatin for the treatment of patients with advanced EGFR exon 20 insertion mutation positive non-small-cell lung cancer
6 March 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 07 Mar 2025
Second consultation launched on NHS funding for Alzheimer's treatments
6 March 2025 - Cost and evidence gaps remain barriers to approving funding in the NHS for donanemab and lecanemab. ...
Posted by Michael Wonder on 07 Mar 2025
Ferring receives Health Canada approval for Rebyota (faecal microbiota, live)
6 March 2025 - A novel first in class microbiome restoration therapy for the prevention of recurrence of C. difficile infection. ...
Posted by Michael Wonder on 07 Mar 2025
scPharmaceuticals announces FDA approval of supplemental new drug application expanding the Furoscix indication to include the treatment of oedema in patients with chronic kidney disease
6 March 2025 - Furoscix is expected to be available for chronic kidney disease patients in April 2025. ...
Posted by Michael Wonder on 07 Mar 2025
Neurotech’s Encelto (revakinagene taroretcel-lwey) approved by the FDA for the treatment of macular telangiectasia type 2
6 March 2025 - Encelto is the first and only FDA approved treatment for macular telangiectasia type 2. ...
Posted by Michael Wonder on 06 Mar 2025
Cemiplimab in combination with platinum-based chemotherapy for the treatment of patients with advanced non-small-cell lung cancer
5 March 2025 - The Department of Health and Social Care has asked the NICE to produce guidance on the ...