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Array Withdraws Binimetinib's US Filing On Heels Of Late-Cycle Meeting With FDA

 
• By Sue Sutter

Company explored ‘a number of paths to approval’ with agency, but modest progression-free survival benefit in monotherapy treatment of NRAS-mutant melanoma appears to have doomed the new drug application, which was pulled less than two weeks before advisory committee review.

The late-cycle meeting required by the US FDA user fee review program cemented Array BioPharma Inc.’s decision to withdraw its new drug application (NDA) for the oncologic binimetinib (MEK162) ahead of an advisory committee review.

On March 17, Array withdrew the NDA for binimetinib, a MEK inhibitor, for monotherapy treatment of NRAS-mutant melanoma

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US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
• By Sue Sutter and Derrick Gingery

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• By Sue Sutter and Bridget Silverman

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Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
• By Neena Brizmohun

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EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
• By Eliza Slawther

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

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• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.