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Cardiovascular Uncertainty Accompanies Canagliflozin To Advisory Panel

 
• By Cathy Dombrowski

Janssen’s diabetes therapy also will undergo discussions about renal and bone fracture risks during a Jan. 10 meeting of FDA’s Endocrinologic and Metabolic Drugs Advisory Committee.

Janssen Pharmaceutical Cos.’ diabetes drug canagliflozin will go to a Jan. 10 advisory committee without the malignancy concerns that were problematic for the first member of the SGLT2 inhibitor class, AstraZeneca PLC’s and Bristol-Myers Squibb Co.’s dapagliflozin, but with questions about cardiovascular safety that did not arise with the previous drug.

Both drugs are sodium glucose co-transporter 2 inhibitors, which cause renal elimination of glucose and would bring a new

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More from United States

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• By Sarah Karlin-Smith

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US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

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Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.

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• By Sarah Karlin-Smith

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More from North America

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

 
• By Dean Rudge

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Pharma Predicts Modest Tariff Impact, Depending On What Comes Next

 
• By Jessica Merrill

Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.