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Abraxane White Paper Distribution At ASCO Draws FDA Advertising Letter

 
• By Brenda Sandburg

Celgene says the white paper – which FDA says promotes Abaxane as effective for unapproved uses and superior to Bristol-Myers Squibb’s Taxol – was intended solely for potential business partners interested in nab technology.

Firms need to be more restrictive in how they distribute business development materials at medical conferences, an FDA advertising letter to Celgene Corp.suggests.

In the untitled letter, dated Dec. 23, the agency objects to a

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Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By Sue Sutter

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.

Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
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Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.

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