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RSS FeedPosted by Michael Wonder on 15 Nov 2023
Early benefit assessment: meaningful RCTs are also feasible in late oncological treatment lines
15 November 2023 - Two randomised controlled studies in the third and fourth lines for colorectal and breast cancer each show ...
Posted by Michael Wonder on 15 Nov 2023
FDA approves new drug under special pathway for patients receiving haemodialysis
15 November 2023 - The US FDA has approved Defencath (taurolidine and heparin) catheter lock solution to reduce catheter-related bloodstream infections ...
Posted by Michael Wonder on 15 Nov 2023
Roche’s subcutaneous injection of Tecentriq recommended by the EU’s CHMP for multiple cancer types
14 November 2023 - If approved, Tecentriq subcutaneous would be the first injectable PD-(L)1 cancer immunotherapy in the EU, cutting treatment ...
Posted by Michael Wonder on 14 Nov 2023
ICER publishes evidence report on treatment for pulmonary arterial hypertension
14 November 2023 - Sotatercept added to background therapy appears to improve clinical outcomes, but there are uncertainties on long ...
Posted by Michael Wonder on 14 Nov 2023
Bayer provides update on Aliqopa (copanlisib)
14 November 2023 - Bayer today announced that, following discussions with the US FDA, it will work with the FDA on ...
Posted by Michael Wonder on 14 Nov 2023
FDA grants fast track designation to SonALAsense’s Sonala-001 in combination with the Insightec transcranial ultrasound device for sonodynamic therapy of DIPG, a rare paediatric brain cancer
14 November 2023 - SonALAsense today announced that the US FDA has granted fast track designation to the development program of ...
Posted by Michael Wonder on 14 Nov 2023
Biocon Biologics receives UK (MHRA) approval for Yesafili, biosimilar aflibercept
13 November 2023 - Biocon Biologics has announced that MHRA in the UK has granted marketing authorisation for Yesafili, a biosimilar ...
Posted by Michael Wonder on 14 Nov 2023
Inequitable conduct and invalidation of patents related to FDA regulated products
13 November 2023 - Median brand name drug launch prices increased from $2,115 in 2008 to $180,007 in 2021. ...
Posted by Michael Wonder on 14 Nov 2023
Ancillary product patents to extend biologic patent life
13 November 2023 - In 2021, 46% ($260 billion) of all gross prescription drug spending in the US was on biologic ...
Posted by Michael Wonder on 14 Nov 2023
Imfinzi plus chemotherapy approved in China as first immunotherapy regimen for patients with locally advanced or metastatic biliary tract cancer
14 November 2023 - Approval based on results from TOPAZ-1 global Phase 3 trial and a Chinese patient cohort which ...
Posted by Michael Wonder on 14 Nov 2023
Ipsen and Medison Pharma announce Health Canada approval of Bylvay (odevixibat) for the treatment of pruritus due to progressive familial intrahepatic cholestasis
13 November 2023 - Bylvay (odevixibat) is the first and only oral treatment available in Canada for the treatment of ...
Posted by Michael Wonder on 13 Nov 2023
Informing real-time decisions with post-market drug evidence
10 November 2023 - It’s been one year since CADTH launched the Post-Market Drug Evaluation (PMDE) Program to provide decision-makers with ...
Posted by Michael Wonder on 13 Nov 2023
MediWound receives positive CHMP opinion recommending approval for NexoBrid to treat paediatric patients
13 November 2023 - The label expansion will solidify NexoBrid’s position in the EU as a safe and effective non-surgical treatment ...
Posted by Michael Wonder on 13 Nov 2023
SMC - November 2023 decisions
13 November 2023 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 13 Nov 2023
GSK receives positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia
13 November 2023 - If approved, momelotinib will become the first and only treatment in the EU specifically indicated for myelofibrosis ...