Built on established products and royalties from drug delivery technology, Alkermes is getting ready to launch its first novel product. Scrip talked to CEO Richard Pops about the preparations.

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

Having developed a novel bioequivalent alternative to Biogen's Tecfidera brand through the FDA's 505(b)(2) pathway, Banner Life Sciences has defended itself, with success, against claims that its product infringed a key method-of-use patent shielding the multi-billion-dollar multiple-sclerosis brand.