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Northera Review Shows Regulatory Challenges In Difficult Therapeutic Space

 
• By Sue Sutter

Chelsea Therapeutics’ development program for droxidopa in neurogenic orthostatic hypotension led to discussion at a recent advisory committee meeting about the role of Special Protocol Assessments and appropriate validation of patient-reported outcome instruments.

The recent FDA advisory committee review of Chelsea Therapeutics International Ltd.’s neurogenic orthostatic hypotension drug Northera (droxidopa) reflects the development hurdles faced by sponsors attempting to navigate a small and difficult therapeutic space.

Chelsea is working in an orphan condition where only one other drug, midodrine (Shire PLC’s ProAmatine and generics), has received FDA approval. Yet midodrine has never been shown to have a symptomatic benefit in NOH, at least in the eyes of FDA’s Center for Drug Evaluation and Research

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• By Cathy Kelly

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

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• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

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• By Derrick Gingery, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.

US FDA Restoring Some Library Resources

 
• By Sue Sutter and Derrick Gingery

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.

More from North America

Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

Most Favored Nation Pricing Policy Floated In Medicaid, Coming Back To Medicare?

 
• By Cathy Kelly

President Trump's ongoing interest in the policy, which would ensure the US government pays no more for prescription drugs than the lowest price available in comparable countries, continues to gain attention.

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.