DoH published revised agenda for July 2024 PBAC meeting (12 April 2024)

12 April 2024 - Version 2 of the agenda for the July 2024 PBAC meeting is now available; two minor ...

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Alvotech and Teva announce US FDA Approval of Selarsdi (ustekinumab-aekn), biosimilar to Stelara (ustekinumab)

16 April 2024 - Selarsdi is expected to be marketed in the US on or after 21 February 2025, following a ...

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Fintempla (fenfluramine) oral solution approved in Japan for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome

17 April 2024 - – UCB’s Fintempla (fenfluramine) oral solution has been approved by the Japanese Ministry of Health, Labour, ...

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Lexeo Therapeutics granted FDA fast track designation for LX2006, an AAV based gene therapy candidate for the treatment of Friedreich’s ataxia cardiomyopathy

16 April 2024 - Lexeo Therapeutics today announced the US FDA has granted fast track designation to LX2006, the company’s AAVrh.10hFXN ...

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GSK’s 5 in 1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA

16 April 2024 - Submission based on results from pivotal Phase III trial showing all primary outcomes met. ...

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TLX101-CDx (Pixclara) granted FDA fast track designation

16 April 2024 - Telix Pharmaceuticals today announces that the US FDA has granted fast track designation for the Company's investigational ...

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Norgine submits marketing authorisation application via Project Orbis for eflornithine (difluoromethylornithine) in high-risk neuroblastoma

15 April 2024 - Norgine today announced its first marketing authorisation application submissions on 10 April 2024, seeking approval for eflornithine ...

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Updates to the HTA Policy and Methods Review Reference Committee (15 April 2024)

15 April 2024 - The HTA Review Reference Committee is finalising its report and recommendations to the Australian Government having ...

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HTA review - is today D day?

15 April 2024 - The review is due to be completed by 15 April 2024 (today). ...

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Cost based pricing for innovative medicines Is unviable and harmful

12 April 2024 - Barber et al. just published a fundamentally flawed study on diabetes medicines in JAMA Network Open.  ...

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Medicare drug price negotiations: policy implications of the first 10 drugs’ features

9 April 2024 - This article describes how CMS’s approach to implementing the negotiations will be shaped by the distinctive ...

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More treatments available to 30,000 New Zealanders

12 April 2024 - PHARMAC has decided to fund several medicines and widen access to two others, a move that will ...

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Formycon announces commercial launch of FYB201 (ranibizumab) in Canada (Ranopto) and Switzerland (Ranivisio)

11 April 2024 - Commercialization partner Teva markets FYB201 in Canada under the trademark Ranopto and in Switzerland under the trademark ...

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Waiting for new medicines in Canada, Europe, and the United States: study finds Americans get better and faster access to innovative drugs

11 April 2024 - A recent study published by the Canadian Health Policy Institute examined the availability and wait times ...

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NICE issues final draft guidance for use of remdesivir and also for tixagevimab-cilgavimab (Evusheld) for treatment of COVID-19

9 April 2024 - Final draft guidance for remdesivir and for tixagevimab with cilgavimab has been published by NICE. ...

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