Pfizer/Aventis File For Exubera In Europe; No Timeline Yet On U.S. Submission

With extensive use of inhaled insulin expected "right out of the box," the development partners are focused on getting Exubera through, not to, regulatory agencies as quickly as possible, Pfizer CFO Shedlarz says.

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Merck’s Keytruda Gains Medicare Negotiation Reprieve With Expanded Orphan Exemption

 
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Bristol Myers Squibb’s Opdivo and Merck's Welireg also could benefit from the delay in Medicare price negotiation process eligibility.

US FDA’s Biologics Center Departures Grew Before More Than 100 RIFs Exited

 

The Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-force was finalized.

US FDA Cancer Reviewers Heading For The Exits, Potentially Impacting Review Timelines

 

US FDA's cancer drugs division is feeling the effect of drug reviewer departures, despite efforts to keep them at the agency.