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Orexigen Eyes Earlier Resubmission Of Contrave NDA

 
• By Sue Sutter

The company is optimistic it can work out an agreement with FDA to re-file the obesity drug application before it has interim data from a cardiovascular outcomes trial in hand.

Although Orexigen Therapeutics Inc. failed in its latest bid to persuade FDA’s Center for Drug Evaluation and Research to consider approving Contrave (naltrexone/bupropion) before results come in from a dedicated cardiovascular outcomes study, the company believes the response received from the agency puts it on a path to a speedier NDA resubmission for the obesity agent.

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More from United States

Moderna Pivots To Increase Focus On Cancer Amid US Vaccine Policy Changes

 
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What MAHA Means For US FDA: Prevention Is Not What You Think

 
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Makary’s Reorganization Decision A Turning Point For US FDA?

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s disavowal of a proposed reorganization plan may be an important turning point in the Trump Administration. The move does not improve the situation, but may mean the administration stops actively making things worse.

Pink Sheet Podcast: Vaccine Review Political Interference, Missed Deadlines A Harbinger Of US FDA Problems?

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss FDA Commissioner Martin Makary’s decision to have one of his assistants lead negotiations for Novavax’s delayed COVID-19 vaccine review, as well as some recent missed review deadlines, which may be the result of recent FDA cuts.

More from North America

How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 
• By Joseph Haas and Nielsen Hobbs

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.

US FDA Not Industry’s ‘Sock Puppet,’ Ultragenyx’s Emil Kakkis Says

 
• By Sue Sutter

The biotech CEO said the Trump Administration’s treatment of FDA employees, including the HHS secretary’s comments about industry capture, are insulting to agency staff, but he is encouraged by FDA Commissioner Martin Makary’s talk of a new conditional approval pathway.

US FDA Asks Adcomm If Opioid Postmarketing Studies Are Relevant, Warrant Action

 
• By Sue Sutter

Two US FDA advisory committees will discuss results from epidemiological studies that attempted to quantify the prevalence, incidence and risk factors for misuse, abuse, overdose and death with opioid analgesics.