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Regulatory News, In Brief

Executive Summary

CDC panel recommends combined regimen of Pfizer’s Prevnar 13 and Merck’s Pneumovax 23 in immunocompromised adults; FDA issues “complete response” letters and completes review of compounded hydroxyprogesterone.

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Prevnar 13 Recommendation For Medicare Population May Be Short Lived

CDC advisory committee support for Pfizer pneumococcal vaccine in adults 65 and older comes with caveat that recommendation will be re-examined, and possibly revised, in 2018 due to effects of herd immunity.

Bankrupt KV Pharma’s Hopes For Makena Rest With Skeptical Judge

During a hearing in the company’s lawsuit against FDA, a federal judge repeatedly questions her authority to require the agency take enforcement action against compounding pharmacies; KV filed for bankruptcy protection three days earlier, citing its inability to realize full value of the pre-term birth drug due to competition from cheaper compounded versions of 17-P.

FDA’s Nonenforcement Actions Are Not Reviewable, Agency Argues In KV’s Makena Suit

The agency says its decisions not to take enforcement action against pharmacies compounding hydroxyprogesterone are discretionary and that KV has not shown that payers are likely to change their reimbursement policies if the court follows its request.

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