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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 13 Oct 2024
US FDA approves Dong-A ST’s Imuldosa (ustekinumab-srlf), a biosimilar to Stelara
11 October 2024 - Dong-A ST announced on October 11 2024 that Imuldosa (ustekinumab-srlf/DMB-3115), a biosimilar referencing Stelara, has won ...
Posted by Michael Wonder on 11 Oct 2024
Novavax's updated 2024-2025 Nuvaxovid COVID-19 vaccine receives authorisation in the EU
9 October 2024 - Novavax today announced that the European Commission granted marketing authorisation for Novavax's updated 2024-2025 Nuvaxovid COVID-19 vaccine ...
Posted by Michael Wonder on 11 Oct 2024
FDA approves new treatment for haemophilia A or B
11 October 2024 - Product is first non-factor and once weekly treatment for haemophilia B. ...
Posted by Michael Wonder on 11 Oct 2024
MHRA approves Comirnaty KP.2 COVID-19 vaccine for adults
10 October 2024 - The MHRA has today approved an adapted Pfizer/BioNTech COVID-19 vaccine (Comirnaty) that targets the KP.2 COVID-19 sub-variant ...
Posted by Michael Wonder on 11 Oct 2024
Johnson & Johnson submits application to the EMA for Darzalex (daratumumab) SC based quadruplet regimen for newly diagnosed multiple myeloma patients
10 October 2024 - Submission supported by data from the Phase 3 CEPHEUS study for the treatment of patients with newly ...
Posted by Michael Wonder on 11 Oct 2024
EMA confirms acceptance of marketing application for AVT03, a proposed biosimilar to Prolia and Xgeva
10 October 2024 - Alvotech announced today that the EMA has accepted a marketing authorisation application for AVT03, a proposed biosimilar ...
Posted by Michael Wonder on 11 Oct 2024
Roche Canada announces Columvi (glofitamab for injection) is publicly reimbursed in 7 provinces, including Quebec, Ontario, Manitoba, Saskatchewan, Nova Scotia and Newfoundland
9 October 2024 - Columvi is now publicly covered in 7 provinces, which equates to approximately 74% of the total Canadian ...
Posted by Michael Wonder on 10 Oct 2024
Volixibat granted breakthrough therapy designation for cholestatic pruritus in primary biliary cholangitis
10 October 2024 - Designation based on positive interim analysis of Phase 2b VANTAGE study. ...
Posted by Michael Wonder on 10 Oct 2024
Pulmonary fibrosis drug Ofev nears key reimbursement decision in Korea
10 October 2024 - The Pharmaceutical Reimbursement Evaluation Committee under HIRA is reportedly set to review Ofev (nintedanib), a treatment ...
Posted by Michael Wonder on 10 Oct 2024
FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer
10 October 2024 - Today, the FDA approved inavolisib (Itovebi, Genentech) with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, ...
Posted by Michael Wonder on 10 Oct 2024
Biden-Harris Administration Takes Next Step on Proposed Model to Lower Prescription Drug Costs for People with Medicare
9 October 2024 - Today, the US Department of Health and Human Services, through the Centers for Medicare & Medicaid Services, ...
Posted by Michael Wonder on 10 Oct 2024
Alnylam submits supplemental new drug application to the US FDA for vutrisiran for the treatment of transthyretin amyloidosis with cardiomyopathy
9 October 2024 - Priority review voucher utilised to accelerate review period. ...
Posted by Michael Wonder on 10 Oct 2024
Capricor Therapeutics announces initiation of rolling submission of biologics license application with US FDA for deramiocel for the treatment of Duchenne muscular dystrophy
9 October 2024 - Company plans to complete rolling BLA submission by end of 2024; application may be eligible for ...
Posted by Michael Wonder on 10 Oct 2024
PHARMAC improves access to three cancer medicines
10 October 2024 - PHARMAC will improve access to three cancer medicines from 1 November 2024. ...
Posted by Michael Wonder on 10 Oct 2024
FDA grants fast track designation for biomarker guided DB104 (liafensine) in patients with treatment resistant depression
9 October 2024 - Denovo Biopharma today announced that the US FDA has granted fast track designation for DB104 (liafensine) being ...