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Sanofi Loses iGlarLixi Advantage Over Novo's iDegLira Amid Pen Problems

 
• By Derrick Gingery

FDA request for more information on pen injector forces three-month review extension, offsetting advantage from priority review voucher redemption.

FDA concerns about the device Sanofi proposed to deliver two anti-diabetic agents will prolong the review of the combination product, and the delay likely will cause the company to forfeit the advantage gained from the expensive priority review voucher that it used to even the race to market with Novo Nordisk AS.

Sanofi announced Aug

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How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 
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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 Asks Adcomm If Opioid Postmarketing Studies Are Relevant, Warrant Action

 
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Another Regeneron CRL Prompts Regulatory Operations Questions

 
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EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
• By Eliza Slawther

European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.

Trump Administration Push For Dismissal, Transfer Of Mifepristone Case Leaves Overhang For Pharma

 
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The Trump Administration requested a dismissal or transfer of a lawsuit seeking to tighten the safety requirements for the abortion pill mifepristone on procedural grounds, which still leaves the administration's position on the case's merits unclear.

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.