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Amylyx Relyvrio: Pricing, Compounding, And The Shadow Of Makena
The new ALS product is a fixed-dose combo of two ingredients – sodium phenylbutyrate and taurursodiol – that some patients currently are compounding. Amylyx says it will explore ‘all options’ in addressing that, noting its strong IP for Relyvrio, but also committing to access.
Keeping Track: US FDA Clears Santen’s Omlonti, Fennec’s Pedmark; Lilly’s Retevmo Adds Tumor-Agnostic Claim
The latest drug approval news and highlights from the Pink Sheet’s US FDA Performance Tracker
Biogen/Eisai’s Lecanemab Suggests A New Model For Accelerated Approval In The US
Why not wait for the confirmatory trial to read out before approval, at least in the context of an especially uncertain or controversial surrogate marker?
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Pink Sheet Podcast: Drug Fix: ALS Drug Cleared, Lecanemab’s Hopeful Alzheimer’s Data, CMS’ Price Negotiation Needs
Pink Sheet reporters and editors discuss the newly approved ALS drug Relyvrio, the promising data on the Alzheimer’s drug lecanemab, and CMS’s efforts to build the drug price negotiation program.
October Outlook For US FDA Approvals: Goal Dates Are Sparse, But Backlog Looms
Upcoming user fee goal dates include AstraZeneca’s tremelimumab, Amicus’ AT-GAA, and drug delivery technology-driven NDAs from Supernus/US Worldmeds and scPharmaceuticals
OIG Accelerated Approval Report Spotlights Financial Costs Ahead Of Congressional Debate
First OIG report on FDA’s accelerated approval program as part of Aduhelm-spurred review doesn’t break new ground but will likely bring new wave of focus on the costs incurred to the government when drug companies fail to complete confirmatory trials in a timely manner just as reform advocates are hoping to muster enough attention on the topic to get legislative change this year.
Amylyx's Relyvrio: The Road To Regulatory Flexibility And US FDA Approval
A Pink Sheet timeline shows the regulatory highs and lows of AMX0035's path to US approval for treatment of amyotrophic lateral sclerosis.
Regulatory Flexibility: US FDA Approves Amylyx’s Relyvrio For ALS Despite ‘Degree Of Residual Uncertainty’
The single positive Phase II CENTAUR study, along with confirmatory evidence of benefit on long-term survival in the open-label extension, demonstrate substantial evidence of effectiveness, the agency says, acknowledging a level of uncertainty that is acceptable in the disease context.
How Will Approval Of Amylyx’s Relyvrio Impact The Ongoing PHOENIX Trial?
Launched in part to help resurrect AMX0035’s regulatory prospects, the multiregional PHOENIX study is winding down in the US. There still may be some risk of potential dropouts, however.
Medicare Part B Premium Reduction In 2023 Has Reserves Built In If Lecanemab Launches
But premiums in future years made need to keep pace with accelerating Medicare spending on Alzheimer’s drugs.
Eager But Wary: Industry Seeks More Useful, More Detailed Remote Regulatory Assessment Processes
Responses to US FDA draft guidance suggest more promptness while also more elaborate processes for agency decision making based on remote methods. Questions include what’s voluntary, what’s mandatory, what can be decided remotely, and how to remotely move on from warning letters.
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