Blog
RSS FeedPosted by Michael Wonder on 04 Oct 2024
Blue Shield of California slashes cost of world's best selling drug
1 October 2024 - Non-profit health plan collaborates with Fresenius Kabi and Evio Pharmacy Solutions to purchase FDA approved Humira biosimilar ...
Posted by Michael Wonder on 18 Oct 2024
Alhemo recommended for European approval as first once daily subcutaneous prophylactic treatment for people living with haemophilia A or B with inhibitors
18 October 2024 - Novo Nordisk today announced that the EMA's CHMP has adopted a positive opinion, recommending approval of ...
Posted by Michael Wonder on 18 Oct 2024
Novartis receives positive CHMP opinion for Kisqali to help reduce risk of recurrence in people with HR+/HER2- early breast cancer
18 October 2024 - Recommendation is based on the Phase 3 NATALEE trial, where Kisqali added to endocrine therapy significantly reduced ...
Posted by Michael Wonder on 18 Oct 2024
Outcomes of the September 2024 PBAC intracycle meeting
18 October 2024 - The outcomes from the September 2024 PBAC intracycle meeting are now available. ...
Posted by Michael Wonder on 18 Oct 2024
US FDA approves Vyalev (foscarbidopa and foslevodopa) for adults living with advanced Parkinson's disease
17 October 2024 - Adults treated with Vyalev reported superior improvement in "on" time without troublesome dyskinesia, compared to oral immediate-release ...
Posted by Michael Wonder on 18 Oct 2024
Fresenius Kabi launches Tyenne, the first and only approved tocilizumab biosimilar in Canada
17 October 2024 - Tyenne is the first and only tocilizumab biosimilar to be launched in Canada. ...
Posted by Michael Wonder on 18 Oct 2024
Government of Canada announces new appointment to the Patented Medicine Prices Review Board
17 October 2024 - Today, the Honourable Mark Holland, Minister of Health, announced a new appointment to the Patented Medicine ...
Posted by Michael Wonder on 18 Oct 2024
CSL Vifor and Travere Therapeutics announce SwissMedic approval of Filspari (sparsentan) for the treatment of IgA nephropathy
17 October 2024 - Temporary marketing authorisation is based on statistically significant and clinically meaningful results from the Phase 3 ...
Posted by Michael Wonder on 18 Oct 2024
Update on regulatory review of lecanemab for early Alzheimer's disease in Australia
17 October 2024 - Eisai announced today that the TGA of Australia issued a public statement about the initial decision ...
Posted by Michael Wonder on 17 Oct 2024
TGA's decision to not register lecanemab (Leqembi)
16 October 2024 - The TGA has made the decision not to register lecanemab (Leqembi) for the treatment of patients ...
Posted by Michael Wonder on 17 Oct 2024
First targeted treatment to reduce the risk of ALK positive lung cancer returning after complete tumour removal recommended by NICE
17 October 2024 - For the first time, NICE has recommended a targeted treatment option for ALK positive non-small-cell lung cancer, ...
Posted by Michael Wonder on 17 Oct 2024
Eplontersen approved to treat adults with rare inherited nerve disease or polyneuropathy
16 October 2024 - The MHRA has approved eplontersen (Wainzua) to treat adults with polyneuropathy associated with hereditary transthyretin amyloidosis, which ...
Posted by Michael Wonder on 17 Oct 2024
The science of biosimilars - updating interchangeability
18 October 2024 - Almost 15 years ago the US FDA was given the authority to approve biosimilars through the ...
Posted by Michael Wonder on 17 Oct 2024
Tonix Pharmaceuticals announces submission of the TNX-102 SL new drug application for fibromyalgia to the US FDA
16 October 2024 - New drug application based on two Phase 3 studies of TNX-102 SL in fibromyalgia with statistically significant ...
Posted by Michael Wonder on 17 Oct 2024
Gepotidacin accepted for priority review by US FDA for treatment of uncomplicated urinary tract infections in female adults and adolescents
16 October 2024 - Application supported by positive results from pivotal Phase 3 EAGLE-2 and EAGLE-3 trials. ...
Posted by Michael Wonder on 17 Oct 2024
Medicare’s first round of drug price negotiation - measuring success
16 October 2024 - The Federal Government has proven that it can navigate the difficult process of identifying drugs for price ...