Paul Clan­cy

You can count one more top ex­ec at Bio­gen $BI­IB out the ex­it as new CEO Michel Vounatsos builds his team at the big biotech. And the de­part­ing ex­ec is head­ed straight to Alex­ion $ALXN, where Lud­wig Hantson has been build­ing his own team with an eye to strip­ping the pipeline ahead of a planned re­fur­bish­ment.

This time the ex­ec on the move is Paul Clan­cy, CFO at Bio­gen dur­ing the last event­ful decade at the big biotech.

Clan­cy sur­vived the bumpy de­par­ture of Jim Mullen in 2010 and helped steer the com­pa­ny as it launched a megablock­buster flag­ship drug in Tec­fidera un­der then CEO George Scan­gos.

Now Clan­cy is tak­ing on the top fi­nance job at Alex­ion at a time Hantson has gut­ted the old crew and brought in a whole new bunch to steer a dif­fer­ent course. Just a few weeks ago Hantson saw off R&D chief Mar­tin Mack­ay as well as CFO David An­der­son, who had been in that job on­ly six months. Clare Carmichael, the head of hu­man re­sources, left June 1 along with chief com­mer­cial of­fi­cer Carsten Thiel.

Bio­gen’s loss is Alex­ion’s gain. Bio­gen saw its shares drop 3% Wednes­day morn­ing, while Alex­ion stock surged 7%.

Alex­ion has un­der­gone a brain trans­plant af­ter the for­mer CEO and CFO came un­der scruti­ny for the way the com­pa­ny was push­ing ear­ly sales of Soliris to meet its num­bers. Now Hantson is al­so mak­ing it clear that the house clean­ing in the ex­ec­u­tive suite will be fol­lowed by a cleanup in R&D as well.

Lud­wig Hantson

Hantson — who has been open­ly com­plain­ing about the state of af­fairs at Alex­ion — re­port­ed­ly turned up at the Gold­man Sachs Health­care Con­fer­ence yes­ter­day say­ing he was think­ing of writ­ing off Kanu­ma, which quick­ly made the rounds on Twit­ter. Alex­ion ac­quired Kanu­ma in an $8.4 bil­lion buy­out of Synage­va and has lit­tle to show for it as sales fiz­zled.

ALXN1210 — an an­ti-C5 an­ti­body that in­hibits ter­mi­nal com­ple­ment for pa­tients with parox­ys­mal noc­tur­nal he­mo­glo­bin­uria (PNH) — was about the on­ly ex­per­i­men­tal prod­uct that earned much re­spect from Hantson. Hantson al­so re­cruit­ed his old R&D chief at Bax­al­ta, John Orloff, to helm the re­search crew as the com­pa­ny dumps what it doesn’t like and starts to re­tune the pipeline, just a few years be­fore its main­stay drug Soliris los­es patent pro­tec­tion in Eu­rope and the US in 2020 and 2021.

Hantson and Alex­ion, and now Clan­cy, don’t have much time if they want to turn the com­pa­ny around be­fore biosim­i­lars start to carve up its fran­chise.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.