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RSS FeedPosted by Michael Wonder on 16 Jul 2024
Health Canada grants marketing authorisation for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for people with cystic fibrosis aged 2 years and older with certain rare mutations
15 July 2024 - Approximately 200 people with certain rare CF mutations are now eligible for Trikafta. ...
Posted by Michael Wonder on 15 Jul 2024
Clinical benefit, reimbursement outcomes, and prices of FDA approved cancer drugs reviewed through Project Orbis in the USA, Canada, England, and Scotland: a retrospective, comparative analysis
11 July 2024 - Project Orbis is a global initiative that aims to streamline regulatory review processes across international regulators in ...
Posted by Michael Wonder on 15 Jul 2024
Onco360 selected as a limited distribution specialty pharmacy partner for Rytelo (imetelstat)
12 July 2024 - Onco360 has been selected as a pharmacy partner by Geron Corporation for Rytelo (imetelstat) as a ...
Posted by Michael Wonder on 15 Jul 2024
PHARMAC proposal to increase access to five medicines for cancer and other health conditions
12 July 2024 - PHARMAC is looking to increase access to five medicines for a number of cancers, including kidney ...
Posted by Michael Wonder on 14 Jul 2024
Fresenius announces EMA validation of marketing authorisation application for denosumab biosimilar candidates
11 July 2024 - Fresenius, via its operating company Fresenius Kabi, announced that the EMA has accepted for review the company’s ...
Posted by Michael Wonder on 13 Jul 2024
Health Canada approves Tagrisso with the addition of chemotherapy for patients with EGFR mutated advanced lung cancer
12 July 2024 - Approval based on FLAURA2 results, which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly ...
Posted by Michael Wonder on 13 Jul 2024
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) in giant cell arteritis
12 July 2024 - Submissions are supported by the Phase 3 SELECT-GCA study demonstrating upadacitinib 15 mg with a 26 week ...
Posted by Michael Wonder on 13 Jul 2024
FDA grants fast track designation to 9MW2821 for the treatment of patients with locally advanced or metastatic nectin-4 positive TNBC
12 July 2024 - Mabwell announces that its self-developed novel nectin-4-targeting ADC (9MW2821) has been granted fast track designation by the ...
Posted by Michael Wonder on 12 Jul 2024
Incorporating real option value in valuing innovation: a way forward
10 July 2024 - Considerable progress has been made in defining and measuring the real option value of medical technologies. ...
Posted by Michael Wonder on 12 Jul 2024
AskBio receives FDA fast track and MHRA Innovation Passport designations for AB-1005 investigational GDNF gene therapy for Parkinson’s disease
11 July 2024 - Bayer AG and Asklepios BioPharmaceutical today announced that the US FDA has granted fast track designation ...
Posted by Michael Wonder on 11 Jul 2024
FTC to sue drug managers over insulin prices
10 July 2024 - Antitrust agency is investigating how PBMs and manufacturers negotiate discounts. ...
Posted by Michael Wonder on 11 Jul 2024
Australian children with neuroblastoma given free access to 500,000 dollar cancer drug DFMO
10 July 2024 - Australian children and young adults with neuroblastoma, a cancer that affects the nervous system, will be ...
Posted by Michael Wonder on 11 Jul 2024
Novo Nordisk receives complete response letter in the US for once weekly basal insulin icodec
10 July 2024 - Novo Nordisk today announced that the US FDA has issued a complete response letter covering the ...
Posted by Michael Wonder on 10 Jul 2024
Pharma company lawsuit forces Dutch health agency to reassess cancer drug
9 July 2024 - The Dutch healthcare procurement agency has said it will reassess the breast cancer drug abemaciclib after ...
Posted by Michael Wonder on 10 Jul 2024
Aplidin will be re-evaluated by the EMA. The European Commission revokes the decision that initially denied PharmaMar's marketing authorisation for multiple myeloma due to a conflict of interest.
8 July 2024 - The European Commission has acknowledged that an expert from the Scientific Advisory Group, who was developing a ...