David Meline Am­gen

Ahead of its third-quar­ter re­sults next week, Am­gen on Tues­day dis­closed the planned re­tire­ment of David Meline, who has served as the com­pa­ny’s chief fi­nan­cial of­fi­cer since 2014.

Meline will be re­placed by Ernst & Young vet, Pe­ter Grif­fith, as CFO come Jan­u­ary 1, 2020 — but un­til then Grif­fith will serve as ex­ec­u­tive vice pres­i­dent, fi­nance.

“Over the last 5 years at Am­gen, Meline in­sti­tut­ed many ma­jor changes that led to op­er­a­tional ef­fi­cien­cies and mar­gin ex­pan­sion while suc­cess­ful­ly re­turn­ing cash to share­hold­ers. Now that Am­gen is on sol­id foot­ing, it was a good time to step away,” Cowen’s Yaron Wer­ber wrote in a note. “We do not an­tic­i­pate any ma­jor changes to strat­e­gy or op­er­a­tions im­me­di­ate­ly due to this tran­si­tion as Am­gen is on sol­id foot­ing.”

Am­gen, whose ad­just­ed prof­it num­bers tend to al­ways beat Wall Street ex­pec­ta­tions, has had an event­ful year.

Pe­ter Grif­fith

The po­ten­tial of its ear­ly-stage KRAS drug AMG510 in cer­tain can­cers has sparked fever­ish ex­cite­ment and in­spired block­buster ex­pec­ta­tions; Am­gen in Sep­tem­ber halt­ed en­roll­ment for a can­cer drug tout­ed as a bright prospect in its ear­ly-stage on­col­o­gy pipeline af­ter signs of “car­diac tox­i­c­i­ty” in a sim­i­lar ex­per­i­men­tal drug with the same mech­a­nism raised safe­ty con­cerns at the FDA, prompt­ing a clin­i­cal hold; Am­gen’s once-re­ject­ed os­teo­poro­sis drug Eveni­ty se­cured FDA ap­proval; in a bid to se­cure a patent ad­van­tage in the PC­SK9 mar­ket, the com­pa­ny’s leg­endary lawyer corps lost a le­gal bat­tle against ri­vals Re­gen­eron and Sanofi — al­though the le­gal team did score a big win against No­var­tis’ gener­ics arm San­doz over the patents cov­er­ing Am­gen’s block­buster TNF in­hibitor En­brel; and with ru­mors of an Alex­ion buy­out loom­ing, Am­gen took Wall Street by sur­prise by spend­ing $13.4 bil­lion to buy the pso­ri­a­sis drug Ote­zla from Cel­gene — ahead of its $74 bil­lion merg­er with Bris­tol-My­ers Squibb.

Grif­fith joins Am­gen from a pri­vate eq­ui­ty and ad­vi­so­ry firm, Sher­wood Canyon Group, where he served as pres­i­dent. Pre­vi­ous­ly, he re­tired from EY fol­low­ing a more than 20-year tenure — most re­cent­ly he served as EY’s glob­al vice chair, cor­po­rate de­vel­op­ment.

Meline joined Am­gen from 3M, where he al­so served as CFO. Pre­vi­ous­ly, Meline worked for Gen­er­al Mo­tors, in­clud­ing vice pres­i­dent and CFO for GM North Amer­i­ca.

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.

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.