Two years af­ter the FDA’s con­tro­ver­sial ap­proval of Bio­gen’s Alzheimer’s drug Aduhelm, four of the top agency of­fi­cials who came un­der scruti­ny for their close re­la­tion­ship with the drug­mak­er dur­ing the ap­proval process have left the agency.

Three of those four se­nior of­fi­cials, who man­aged and worked close­ly with the clin­i­cal and biostats re­view­ers as­signed to the Aduhelm ap­pli­ca­tion, have now end­ed up work­ing at drug­mak­ers. The land­ing spot for the fourth — Bil­ly Dunn, for­mer di­rec­tor of the Di­vi­sion of Neu­rol­o­gy Prod­ucts — has yet to be made pub­lic.

Aduhelm, or ad­u­canum­ab, end­ed up a com­mer­cial flop, but opened the door for Ei­sai and Bio­gen’s fol­low-on Alzheimer’s drug Leqem­bi, which will like­ly be a block­buster. But the ap­proval of the drug, strug­gles to get it re­im­bursed at CMS and na­tion­wide, and the in­ves­ti­ga­tions that fol­lowed, con­tin­ue to have an im­pact on not just Bio­gen but the en­tire in­dus­try.

Ac­cord­ing to the House Com­mit­tee on Over­sight and Re­form and the Com­mit­tee on En­er­gy and Com­merce’s in­ves­ti­ga­tion in­to the Bio­gen and FDA re­la­tion­ship, the com­pa­ny and agency of­fi­cials met in Ju­ly 2019, a full year be­fore Bio­gen would even com­plete its sub­mis­sion for ad­u­canum­ab, and as part of a work­stream out­side of a typ­i­cal ap­pli­ca­tion’s re­view.

Al­most four months pri­or to this first meet­ing, in March 2019, Bio­gen an­nounced pub­licly it was shut­ter­ing two Phase III tri­als, ef­fec­tive­ly end­ing de­vel­op­ment on ad­u­canum­ab, as a fu­til­i­ty analy­sis con­duct­ed by an in­de­pen­dent da­ta mon­i­tor­ing com­mit­tee in­di­cat­ed that they were un­like­ly to meet their pri­ma­ry end­point.

Dunn, who led the ef­forts around ad­u­canum­ab and start­ed at the FDA’s Di­vi­sion of Neu­ro­log­i­cal Prod­ucts in 2005 be­fore ris­ing to the top of the of­fice in 2020, de­cid­ed to leave the agency in late Feb­ru­ary, ef­fec­tive im­me­di­ate­ly and with lit­tle ex­pla­na­tion.

It’s still un­clear where he will end up, and the Alzheimer’s As­so­ci­a­tion of Amer­i­ca and his for­mer deputy Er­ic Bast­ings, who moved over to Io­n­is as a VP, told End­points News they don’t know where Dunn is head­ed. End­points was un­able to reach Dunn di­rect­ly for com­ment. Tere­sa Bu­rac­chio, deputy of the Of­fice of Neu­ro­science who is not on the list above, took over Dunn’s role as di­rec­tor of the neu­ro­science of­fice on an act­ing ba­sis.

Bast­ings pre­vi­ous­ly told End­points of his own de­par­ture, “The op­por­tu­ni­ty with Io­n­is is why I chose to re­tire from the FDA,” but he said he could not com­ment on his role in the Aduhelm-re­lat­ed in­ves­ti­ga­tions.

Mean­while, FDA’s Kun Jin, af­ter more than 27 years at the agency, was named VP and head of bio­sta­tis­tics at Anavex Life Sci­ences in March. And ear­li­er this week, Bio­haven, a clin­i­cal-stage bio­phar­ma com­pa­ny, named Nick Koza­uer, for­mer act­ing deputy di­rec­tor of the FDA’s Di­vi­sion of Neu­rol­o­gy Prod­ucts and eight-year FDA vet, as SVP for clin­i­cal de­vel­op­ment and reg­u­la­to­ry strat­e­gy.

Nei­ther re­spond­ed to re­quests for com­ment.

Ran­jit Mani, clin­i­cal team leader for Dunn’s neu­rol­o­gy di­vi­sion, con­firmed that he is still work­ing at the FDA but de­clined to com­ment on the Aduhelm in­ves­ti­ga­tions. None of the oth­ers from FDA on the list from the con­gres­sion­al in­ves­ti­ga­tion re­spond­ed to a re­quest for com­ment. The on­ly Bio­gen em­ploy­ee on the list, Saman­tha Budd Hae­ber­lein, saw her em­ploy­ment as SVP end in mid-March but it’s un­known where she’s head­ed.

On why all four se­nior FDA lead­ers de­part­ed so quick­ly fol­low­ing the re­lease of the De­cem­ber 2022 con­gres­sion­al in­ves­ti­ga­tion, an FDA spokesper­son con­firmed that all the oth­ers on the list still work at the agency, and added, “While we are un­able to say specif­i­cal­ly why the in­di­vid­u­als left, CDER Staff leave the FDA for a va­ri­ety of rea­sons.”

Roche and Genentech announced Wednesday that the FDA approved its antibody-drug conjugate Polivy, combined with the cancer regimen known as R-CHP, for first-line use in diffuse large B-cell lymphoma, or DLBCL.

The label expansion is for adults with previously untreated DLBCL, not otherwise specified (NOS) or high-grade B-cell lymphoma (HBCL) or those with an International Prognostic Index (IPI) score — developed to better predict outcomes of non-Hodgkin’s lymphoma patients — of two or greater. Regulators also converted Polivy’s previous accelerated approval into a full approval, for relapsed or refractory DLBCL after at least two prior therapies. That original indication was approved in 2019.

Patients taking Legend Biotech and Johnson & Johnson’s cancer cell therapy Carvykti had a 74% reduction in the risk of multiple myeloma progression or death, according to a leaked abstract from an upcoming medical meeting.

The data, which emerged Tuesday night and have since been taken down, could put Carvykti ahead of competitor Abecma, a CAR-T developed by Bristol Myers Squibb and 2seventy bio, in earlier lines of treatment if and when it’s approved for those indications. The study’s results surprised analysts, with a Cowen analyst describing it as “game-changing efficacy,” and sent Legend’s shares $LEGN 14% higher after Wednesday’s opening bell.

Monica Bertagnolli, the top surgeon and clinical trial expert who began leading the National Cancer Institute less than a year ago, may be President Joe Biden’s first nominee to run the NIH, according to multiple news reports.

If confirmed by the Senate, Bertagnolli would replace Lawrence Tabak, who has been serving as acting NIH director since Francis Collins stepped down in November 2021 after a 12-year tenure. The Wall Street Journal and Washington Post first reported the White House’s plan to nominate her.

The UK-based trade union Unite is calling for walkouts at several GSK manufacturing sites due to pay disputes.

Unite said Wednesday that hundreds of GSK manufacturing workers will be staging walkouts in May over pay disputes as 750 workers who are members of the trade union have rejected GSK’s pay rate increase, calling it “significantly below inflation rate pay offer. ”

GSK has offered a 6% pay increase and a one-time lump sum of £1,300 ($1,616.92), which the pharma said is a package equivalent to a 9.7% increase. GSK said it is disappointed that the union has decided to take action, a company spokesperson emailed to Endpoints News.

Most of the antibody-drug conjugate talk lately has been centered around Pfizer’s $43 billion deal with Seagen, but Bristol Myers Squibb is looking to up its game in the field by inking a modest upfront for work out of a German biotech.

The Big Pharma will pay $22.75 million to Munich-based Tubulis to snag exclusive rights to the startup’s platform to make ADCs for solid tumors. BMS will choose antibody targets and Tubulis will then hand over linker-payloads from its platform to create a matching ADC.

Radiopharmaceutical biotech Abdera has raised $110 million in a Series B to get its first candidate into the clinic and build out its pipeline.

Abdera was born out of a partnership between two Canadian groups — antibody biotech AbCellera and life science venture firm adMare BioInnovations. The groups came together two years ago with an idea for a platform that could build targeting vectors specifically for radiotherapies. “The vast majority of the field up until recently has really been focused on trying to sort of repurpose antibodies that have already been made in oncology or other targeting ligands,” co-founder and SVP of research Adam Judge told Endpoints News.

Cancer diagnostics and genomic profiler Foundation Medicine is laying off about 135 staffers, the company disclosed earlier this month.

The Roche subsidiary, valued at about $5.3 billion when the Swiss Big Pharma fully bought it out a few years ago, has liquid- and tissue-based biopsy tests approved by the FDA for various solid tumors and works with biopharma partners on companion diagnostics for their clinical trials, including Bristol Myers Squibb.

For more than 50 years, it’s been known that some patients’ tumors have an abundance of sialoglycans, complex carbohydrate chains attached to proteins and lipids, and those patients tend to do a lot worse.

It was later discovered that the upregulation of sialoglycans suppresses the immune system in more than 50% of cancer patients, according to Palleon Pharmaceuticals. Led by research from Nobel laureate Carolyn Bertozzi’s lab, the team at Palleon is now working on a way to use glycans as a form of checkpoint therapy – and they offered a look at their first-in-human data at this year’s American Association for Cancer Research Conference.