Blog
RSS FeedPosted by Michael Wonder on 18 Jun 2025
Cancer inhibitors scrapped from basic insurance for some users
18 June 2025 - National health care institute Zorginstituut Nederland has scrapped several cancer inhibiting drugs from the basic health ...
Posted by Michael Wonder on 26 Jan 2024
Four dose Mounjaro “KwikPen” approved by MHRA for diabetes and weight management
25 January 2024 - The new presentation of Mounjaro gives four doses for once a week treatment over a month. ...
Posted by Michael Wonder on 26 Jan 2024
Outcomes from the December 2023 PBAC intracycle meeting
25 January 2024 - The outcomes from the December 2023 PBAC intracycle meeting are now available. ...
Posted by Michael Wonder on 26 Jan 2024
Liquidia provides update on new drug application for Yutrepia (treprostinil) inhalation powder
25 January 2024 - Liquidia announced today that the US FDA provided an update on its review of the new drug ...
Posted by Michael Wonder on 26 Jan 2024
Dupixent (dupilumab) FDA approved as first and only treatment indicated for children aged 1 year and older with eosinophilic oesophagitis
25 January 2024 - Approval based on Phase 3 EoE KIDS trial showing a greater proportion of children taking Dupixent achieved ...
Posted by Michael Wonder on 26 Jan 2024
Bristol Myers Squibb receives positive CHMP opinion for CAR T-cell therapy Abecma (idecabtagene vicleucel) in earlier lines of therapy for triple class exposed relapsed and refractory multiple myeloma
26 January 2024 - Recommendation for approval based on Phase 3 KarMMa-3 study in which Abecma demonstrated superiority over standard regimens, ...
Posted by Michael Wonder on 26 Jan 2024
CHMP issues negative opinion for renewal of conditional marketing authorisation for Translarna (ataluren) following re-examination procedure
25 January 2024 - PTC Therapeutics announced today that the CHMP of the EMA issued a negative opinion following the re-examination ...
Posted by Michael Wonder on 26 Jan 2024
Theratechnologies receives complete response letter from the FDA for the F8 formulation of tesamorelin sBLA
24 January 2024 - FDA requesting clarifications around chemistry, manufacturing and controls and additional information related to immunogenicity. ...
Posted by Michael Wonder on 26 Jan 2024
European Medicines Agency validates type II variation application for Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer
26 January 2024 - Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival. ...
Posted by Michael Wonder on 25 Jan 2024
PHARMAC joins global health technology assessment network
25 January 2024 - PHARMAC has joined the International Network of Agencies for Health Technology Assessment (INAHTA) - a network ...
Posted by Michael Wonder on 25 Jan 2024
Health Canada approves Otsuka and Lundbeck's Rexulti (brexpiprazole) for the symptomatic management of agitation associated with Alzheimer's dementia
24 January 2024 - Otsuka Pharmaceutical Canada and Lundbeck Canada announce that Health Canada has issued a Notice of Compliance ...
Posted by Michael Wonder on 25 Jan 2024
Hospital prices for physician administered drugs for patients with private insurance
25 January 2024 - In this study, we used 2020–2021 national Blue Cross Blue Shield claims data regarding patients in the ...
Posted by Michael Wonder on 24 Jan 2024
FDA's ISTAND Pilot Program accepts submission of first artificial intelligence based and digital health technology for neuroscience
23 January 2024 - FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research recently accepted a ...
Posted by Michael Wonder on 24 Jan 2024
US FDA seeks 'boxed warning' for CAR-T cancer therapies
22 January 2024 - The US health regulator on Monday asked a host of drug makers, including Gilead Sciences, Johnson ...
Posted by Michael Wonder on 24 Jan 2024
UroGen initiates submission of a rolling NDA to the FDA for UGN-102
24 January 2024 - UroGen Pharma today announced the submission of the Chemistry, Manufacturing, and Controls section of the new drug ...
Posted by Michael Wonder on 24 Jan 2024
Heron Therapeutics announces FDA approval of Zynrelef indication expansion to include additional orthopaedic and soft tissue procedures
23 January 2024 - Expanded indication for Zynrelef now covers approximately 13 million procedures annually. ...