Business and Finance News, In Brief
Executive Summary
Oral Treprostinil Meets Phase III Endpoint
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Merck Pulls EPS Guidance To Avoid "Indiscriminate Short-Term Cost Cutting"
In Kenneth Frazier's first financial call as CEO, the exec withdrew Merck's long-term earnings guidance, citing healthcare reform costs, European pricing pressure and a late-stage pipeline setback.
Part D Price Negotiation Round One: Several Likely Candidates May Not Feel The Cut
Heavily rebated drugs may already be meeting the price goals established by the Senate legislation. As a result, price negotiation for drugs covered under Part B are likely to yield greater savings to the Medicare program than Part D.
Senate Proposes Smaller Boost Than House For FDA FY2023 Appropriation
Senate Appropriations Committee proposes $1.185bn to CFSAN and $2.19bn to CDER, both levels short of House appropriators passed in June. FDA requested $30.36m in user fees from monograph drugs but no amount was specified in Senate draft bill.