For several years, the U.S. CMS has been musing a coverage policy specifically for breakthrough medical devices, and the absence of activity on this front has once again drawn the attention of Congress. Rep. Cathy McMorris Rodgers (R-Wash.), said a representative of CMS had recently appeared before a House subcommittee for the first time in four years, and that the subcommittee is prepared to act on breakthrough devices coverage if CMS doesn’t produce a final rule this year.

A heart-protective cardiac myosin inhibitor and two biologics – one for a type of non-Hodgkin lymphoma and another for an inflammatory skin condition – were among the therapies recommended for approval by the EMA’s Committee for Medicinal Products for Human Use this week.

The U.S. FDA’s Oncologic Drugs Advisory Committee has recommended by a wide majority that the PARP inhibitor Lynparza (olaparib) in a combination therapy for treating prostate cancer should be restricted to only patients whose tumors have a BRCA mutation.

The supply chain for Seres Therapeutics Inc.’s oral microbiome therapeutic Vowst, formerly known as SER-109, to prevent recurrent Clostridium difficile infection (rCDI) is “well-established,” said David Arkowitz, the firm’s chief financial officer and head of business development. “It’s the same supply chain that we used for phase III [trials], and we’ve been manufacturing product for launch for some time.” Arkowitz spoke during a conference call with investors April 27, regarding the previous day’s U.S. FDA go-ahead for Vowst, cleared for adults with rCDI, including first recurrence following antibacterial therapy.

The legislative pile-on continues as the U.S. Congress considers more ways to take down health care costs while defending innovation. The House Energy and Commerce Subcommittee on Health met April 26 to consider 17 draft discussion bills offered as bipartisan solutions to lower costs by increasing transparency and competition across the health care playing field.