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Endo's Belbuca Is First Buccal Film In Extended-Release Opioid Class

 
• By Sue Sutter

While Belbuca represents a new formulation, it does not contain the abuse-deterrent properties that FDA has been encouraging.

Endo Pharmaceuticals Inc.'s Belbuca (buprenorphine buccal film) will join a crowded market of extended-release/long-acting opioids with its expected first quarter 2016 launch, but its formulation differences might help it stand out.

On Oct

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

 
• By Joseph Haas

During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.

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

 
• By Michael McCaughan

US HHS Advisor Calley Means said new pathways for root-cause treatments are part of the HHS Secretary Robert F. Kennedy Jr.’s vision for the FDA. But what most biopharma companies consider preventative medicines are not what he has in mind, nor does he seem to see those companies as part of the solution.

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.