Teva, Sun and the AAM are among those urging the CMS to rescind its proposal to reimburse Part B drugs approved under section 505(b)(2) as multiple source products. The proposal would target one relatively small but growing part of Medicare Rx spending and reflects CMS’ ongoing concern with fast rising costs in the program.

BMS, Biogen and other urge CMS to rescind its proposal to reimburse Part B drugs approved under section 505(b)(2) as multiple source products. The proposal would target one relatively small but growing part of Medicare Rx spending and reflects CMS’ ongoing concern with fast rising costs in the program

Precise amounts to be supplied by each company will depend in part on whether the monoclonal antibody drugs are used for prevention or treatment because dosage strengths will be different.

Former chief of White House Domestic Policy Council advises cell and gene therapy companies on strategies for promoting enhanced FDA review capabilities as part of Prescription Drug User Fee Act reauthorization negotiations.

US government’s $450m manufacturing commitment for Regeneron’s antibody cocktail and Gilead’s price for remdesivir drive lower expectations on pricing for the antibody treatments, especially since it seems likely there could be several competing products.

US government’s $450m manufacturing commitment for Regeneron’s antibody cocktail and Gilead’s price for remdesivir drive lower expectations on pricing for the antibody treatments, especially since it seems likely there could be several competing products.