Uni­ty Biotech­nol­o­gy is still reel­ing rough­ly four months af­ter ax­ing its lead pro­gram, as it saw sig­nif­i­cant change at the ex­ec­u­tive lev­el Mon­day.

The com­pa­ny an­nounced that ARCH Ven­ture Part­ners’ Bob Nelsen, one of Uni­ty’s co-founders back in 2011, has left the board. In ad­di­tion, pres­i­dent and co-founder Ned David is step­ping down at the end of the year, and an­oth­er board mem­ber, David Lacey, is al­so leav­ing the biotech.

With the de­par­tures, Uni­ty is ap­point­ing Gilmore O’Neill to the board to chair the com­pa­ny’s sci­ence com­mit­tee.

“We are in­cred­i­bly grate­ful to Ned, Bob and Dave for their ser­vice,” chair­man Kei­th Leonard said in a state­ment. “Ned’s ear­ly re­search in­to fun­da­men­tal path­ways of ag­ing bi­ol­o­gy form the foun­da­tion of UNI­TY. Bob played an in­stru­men­tal role in cre­at­ing and shap­ing a com­pa­ny tar­get­ing dis­eases of ag­ing, and David’s drug dis­cov­ery in­sights have shaped our pipeline.”

Mon­day’s moves were not the first de­par­tures since Uni­ty’s lead pro­gram flopped a ma­jor Phase II in os­teoarthri­tis of the knee in Au­gust. That whiff set this re­struc­tur­ing in mo­tion, and Nelsen had long been one of the head­lin­ers in a celebri­ty group of in­vestors that al­so in­clud­ed Jeff Be­zos and Pe­ter Thiel. Uni­ty had raised more than $200 mil­lion over the last decade, hop­ing its big-name part­ners could vault it to the fore­front of the buzzy an­ti-ag­ing field.

The com­pa­ny pre­vi­ous­ly said in Sep­tem­ber it was slash­ing its work­force by 30% in or­der to con­tin­ue its re­fo­cus­ing to­ward oph­thal­mol­o­gy and neu­rol­o­gy, putting the San Fran­cis­co-based biotech on track to em­ploy 75 full-timers by the end of 2020.

Au­gust’s tri­al miss it­self in­volved a 183-per­son study for what was then Uni­ty’s on­ly clin­i­cal pro­gram, UBX0101. Pa­tients in the treat­ment arms showed vir­tu­al­ly no dif­fer­ence com­pared to those tak­ing place­bo, and the can­di­date didn’t even reg­is­ter a dose-de­pen­dent re­sponse.

On­ly pa­tients who re­ceived the low­est dose nu­mer­i­cal­ly out­per­formed the con­trol, but the p-val­ue clocked in at an abysmal p=0.52.

Uni­ty’s big the­o­ry re­volves around what are known as senes­cent cells — non-di­vid­ing cells that clut­ter an ag­ing body. Uni­ty says the buildup in such cells is as­so­ci­at­ed with the re­lease of dozens of pro­teins that pro­mote in­flam­ma­tion, and re­mov­ing them, with­out al­ter­ing the bal­ance of cells the body needs, could pro­mote a longer, health­i­er life.

With the os­teoarthri­tis pro­gram scrapped, Uni­ty is now fo­cus­ing on a dif­fer­ent group of senes­cent cells for eye dis­eases. The next ex­per­i­men­tal drug is UBX1325, which is de­signed to tar­get Bcl-xL. And if all goes ac­cord­ing to plan, Uni­ty ex­pects to dose the first pa­tients in a Phase I study for the can­di­date lat­er this year.

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.

The Centers for Medicare and Medicaid Services on Tuesday said it will only pay for Biogen’s Aduhelm and other FDA-approved anti-amyloid monoclonal antibodies for Alzheimer’s disease under CMS-approved randomized controlled trials.

The draft national coverage decision, which insurers nationwide are likely to follow, makes clear that CMS will be looking for randomized controlled trials that “demonstrate a clinically meaningful benefit in cognition and function.” That will be a tough task for Biogen, which previously showed conflicting benefits from past Aduhelm trials that were initially cut short due to futility and then resurrected for the accelerated approval.

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.