PMPRB report examines availability and pricing of new medicines

22 May 2024 - The Patented Medicine Prices Review Board (PMPRB) published the eighth edition of its annual Meds Entry Watch ...

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Protecting Australians from unsafe compounding of replica weight loss products

22 May 2024 - The Albanese Government is acting to protect Australians from the risks posed by injecting potentially unsafe ...

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Federal Trade Commission actions on prescription drugs (2000-2022)

20 May 2024 -  The Federal Trade Commission’s oversight role in the pharmaceutical market is critical to the health of ...

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Overall survival benefits of cancer drugs initially approved by the US FDA on the basis of immature survival data: a retrospective analysis

13 May 2024 - New cancer drugs can be approved by the US FDA on the basis of surrogate endpoints while ...

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Effect of Project Orbis participation by the Swiss regulator on submission gaps, review times, and drug approval decisions between 2020 and 2022: a comparative analysis

13 May 2024 - Expedited market access for novel and efficacious drugs is warranted for patients. Since 2020, Swissmedic (The Swiss ...

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J&J, BMS lose challenges to US drug price negotiation program

29 April 2024 - A US judge on Monday rejected a challenge by Bristol Myers Squibb and Johnson & Johnson ...

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A milestone in facilitating the development of safe and effective biosimilars

26 April 2024 - This week, the FDA approved the 50th biosimilar, reflecting the markedly increased availability of biosimilar products—products that ...

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Bashing accelerated approval isn’t supported by the data

24 April 2024 - The FDA’s accelerated approval program aims to speed “approval of drugs that treat serious conditions, and ...

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New recommendations to strengthen supply chains of critical medicines

23 April 2024 - EMA has published a number of recommendations to address vulnerabilities in the production and delivery of medicines ...

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Associations between surrogate markers and clinical outcomes for non-oncologic chronic disease treatments

22 April 2024 - What is the strength of association between surrogate markers used as primary outcomes in clinical trials ...

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COVID-19 vaccine strain updates: global regulators agree on timing and data requirements

17 April 2024 - International regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine ...

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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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EMA says it will consider conditional approval for NASH drugs using intermediate outcomes

5 April 2024 - The EMA said in a new reflection paper that it will consider granting conditional marketing approval ...

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Patient advocates clash over wisdom of ‘approving drugs faster and faster’

26 March 2024 - Over 30 years ago, Gregg Gonsalves and other AIDS activists persuaded Congress to create the accelerated ...

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Deliberations at the CHMP regarding the marketing authorisation application in the EU for lecanemab have been rescheduled due to procedural reasons at the EMA

22 March 2024 - Eisai announced today that the oral explanation scheduled for 19 March at the CHMP for lecanemab, ...

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