→ As Am­gen tracks mod­est growth of its Repatha fran­chise and braces for the ar­rival of cheap­er cho­les­terol-low­er­ing med­i­cines in the mar­ket, its com­mer­cial team is go­ing one step fur­ther to try and boost adop­tion of its PC­SK9 drug.

Mur­do Gor­don

Repatha’s list price will now be $5,850 across the board, not co-ex­ist­ing with the high­er cost op­tion. First in­tro­duced in Oc­to­ber 2018, that num­ber rep­re­sent­ed a 60% dis­count to the orig­i­nal $14,100 per year.

“We have seen sig­nif­i­cant im­prove­ments in ac­cess and af­ford­abil­i­ty, but not all Medicare pa­tients are ben­e­fit­ting from these im­prove­ments be­cause some Medicare Part D plans have not tran­si­tioned to the low­er list price op­tion of Repatha,” said Mur­do Gor­don, EVP of glob­al com­mer­cial op­er­a­tions, in a state­ment. “We are dis­con­tin­u­ing the orig­i­nal list price op­tion so that pay­ers and Medicare Part D health plans have clar­i­ty and can do their part: cov­er the low­er list price op­tion of Repatha to help every pa­tient pre­scribed Repatha fill their pre­scrip­tion at an af­ford­able, low fixed dol­lar co-pay.”

That rhetoric, fo­cused on costs to pa­tients and mid­dle­men’s roles, has been a key talk­ing point among bio­phar­ma com­pa­nies chas­tised for high drug prices.

David El­maleh AZTher­a­pies

While Repatha has per­formed bet­ter than Pralu­ent, the ri­val PC­SK9 ther­a­py from Re­gen­eron and Sanofi, sales are still far off from the block­buster fig­ures an­a­lysts had ex­pect­ed. And not on­ly has Am­gen lost a re­cent court fight to push that com­peti­tor out, it’s al­so fac­ing a new threat from The Med­i­cines Com­pa­ny’s in­clisir­an — an RNAi ther­a­peu­tic tout­ed as a su­pe­ri­or al­ter­na­tive to the an­ti­bod­ies.

→ Har­vard pro­fes­sor David El­maleh is adding CAR-Treg to his ar­se­nal of neu­roin­flam­ma­tion treat­ments at AZTher­a­pies through an ac­qui­si­tion of Smith Ther­a­peu­tics. The lit­tle biotech — al­so based in Boston — was found­ed by Philip Ash­ton-Rickardt, a for­mer Im­pe­r­i­al Col­lege Lon­don aca­d­e­m­ic who’s join­ing AZTher­a­pies as SVP of im­munol­o­gy. The pre­clin­i­cal CAR-Treg pro­grams he’s bring­ing to the com­pa­ny re­volves around im­muno­sup­pres­sive cells de­signed to damp­en mi­croglial ac­tiv­i­ty, there­by re­duc­ing in­flam­ma­tion.

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.