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 11 Dec 2024
FDA approves Acetadote sNDA
9 December 2024 - New dosing regimen simplifies administration. ...
Posted by Michael Wonder on 11 Dec 2024
Krystal Biotech provides update on EMA’s on-going regulatory review of B-VEC for dystrophic epidermolysis bullosa
9 December 2024 - CHMP opinion now expected in Q1, 2025. ...
Posted by Michael Wonder on 10 Dec 2024
EMA publishes agenda for 9-12 December 2024 CHMP meeting
9 December 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 10 Dec 2024
December 2024 decisions
9 December 2024 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 10 Dec 2024
ICER releases draft evidence report on treatment for acute pain
9 December 2024 - Public comment period now open until 13 January 2025; requests to make oral comment during public ...
Posted by Michael Wonder on 10 Dec 2024
New price deal paves way for NICE approval of treatment for rare genetic condition
10 December 2024 - A new treatment for Duchenne muscular dystrophy is set to be available to around 1,700 people in ...
Posted by Michael Wonder on 10 Dec 2024
MeiraGTx granted FDA regenerative medicine advanced therapy designation for AAV2-hAQP1 for the treatment of grade 2/3 radiation-induced xerostomia
9 December 2024 - MeiraGTx today announced that the US FDA has granted regenerative medicine advanced therapy designation to AAV2-hAQP1 for ...
Posted by Michael Wonder on 10 Dec 2024
PHARMAC seeks feedback to fund medicines for liver and ovarian cancer
9 December 2024 - PHARMAC is consulting on a proposal to fund bevacizumab (branded as Vegzelma) as a cancer medicine ...
Posted by Michael Wonder on 10 Dec 2024
FDA grants breakthrough therapy designation to Seres Therapeutics’ SER-155 for reduction of bloodstream infections in adults undergoing allogeneic haematopoietic stem cell transplantation
9 December 2024 - Designation based on encouraging Phase 1b clinical data, including that SER-155 resulted in a 77% relative risk ...
Posted by Michael Wonder on 10 Dec 2024
Moderna’s mRNA vaccines to be exempted from advisory committee scrutiny under $2 billion Morrison era deal
10 December 2024 - Critics say exemption ‘deeply concerning’ and risks creating separate assessment systems. ...
Posted by Michael Wonder on 10 Dec 2024
Datopotamab deruxtecan granted breakthrough therapy designation in US for patients with previously treated advanced EGFR mutated non-small cell lung cancer
9 December 2024 - First breakthrough therapy designation for Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan based on TROPION-Lung05 Phase 2 ...
Posted by Michael Wonder on 10 Dec 2024
Chiesi Global Rare Diseases and Protalix BioTherapeutics announce validation of variation submission by EMA for pegunigalsidase alfa
9 December 2024 - Application to label a less frequent dosing regimen at a dose of 2 mg/kg body weight ...
Posted by Michael Wonder on 10 Dec 2024
US FDA accepts GSK’s submission for the use of Nucala (mepolizumab) in COPD
9 December 2024 - Submission supported by MATINEE data showing significant and clinically meaningful reduction in annualised rate of moderate/severe exacerbations ...
Posted by Michael Wonder on 09 Dec 2024
Cladribine for the treatment of patients with relapsing multiple sclerosis
6 December 2024 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 08 Dec 2024
Ruxolitinib phosphate for the treatment of patients with acute graft versus host disease that responds inadequately to corticosteroids
6 December 2024 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...