Rob Califf (AP Images)

Does bio­phar­ma sup­port the Califf nom for FDA? Yeah, what­ev­er

Now that Pres­i­dent Joe Biden has drug his heels as long as pos­si­ble in se­lect­ing a new FDA com­mis­sion­er, we’re set to wel­come the new boss — same as the old boss.

Janet Wood­cock, whose pub­lic lega­cy may now boil down to the ap­proval of an un­proven Alzheimer’s drug and whose in­dus­try lega­cy cen­ters on putting the agency in sync with the largest drug de­vel­op­ers, is set to step aside as Robert Califf makes his way back to the helm. And the in­dus­try large­ly ap­pears to think that’s just fine.

We asked our read­ers what they thought about the move — which Wash­ing­ton in­sid­ers be­lieve is large­ly a slam dunk giv­en the last vote in Califf’s fa­vor. And 58% of­fered a quick and em­phat­ic thumbs up. True, right at 1 in four were not hap­py about the move. But with an­oth­er 18% lined up among the un­de­cid­eds, it’s clear he won’t face much if any crit­i­cism from in­sid­ers, who most­ly like him fine.

Califf, notes one sup­port­er, “knows what he is do­ing. FDA is in a good place and does not need rein­vent­ing. He will have to avoid Bio­gen like is­sues, but that is not hard.”

A key mo­ment in his past ex­pe­ri­ence run­ning the FDA oc­curred when Califf let Wood­cock move ahead with her con­tro­ver­sial OK for Sarep­ta’s still ex­per­i­men­tal Duchenne MD drug. Af­ter de­lay­ing the start of its con­fir­ma­to­ry tri­al, Sarep­ta will need more than 9 years to see through its post-ap­proval study. Bio­gen al­so gets 9 years. And no one is look­ing for the FDA to make things much hard­er for the av­er­age drug de­vel­op­er.

Califf will al­ways look a lit­tle lack­lus­ter com­pared to Scott Got­tlieb, a dy­nam­ic com­mish who al­so helped spot­light the re­volv­ing door be­tween the FDA and in­dus­try by leap­ing straight to Pfiz­er’s board. Califf is jump­ing in from Ver­i­ly. But he got his aca­d­e­m­ic cred at Duke, and he gets a lot of sup­port for that alone.

— He’s the clear best op­tion among some not-great can­di­dates (aside from Scott Got­tlieb, who ap­par­ent­ly was not in­ter­est­ed in the job).

“We need an FDA head and there isn’t any­one else who seems bet­ter,” notes an­oth­er read­er.

Oth­ers find that hard to be­lieve.

— This is a crit­i­cal time in the FDA’s fu­ture and it is time for new blood.

“Too close­ly con­nect­ed to in­dus­try and cur­rent gov­ern­ment,” writes an­oth­er in a com­ment re­peat­ed­ly echoed among the crit­ics.

That in­sid­er knowl­edge, though, can cut both ways with this crowd.

— Prag­mat­ic leader with an ex­cel­lent un­der­stand­ing of the clin­i­cal de­vel­op­ment process and a true com­mit­ment to in­no­va­tion for pa­tients that im­prove pa­tient out­comes.

— Thought­ful, ded­i­cat­ed, great per­spec­tive, trained as a clin­i­cian and clin­i­cal re­searcher, so he sees the field of ther­a­peu­tic de­vel­op­ment from a won­der­ful per­spec­tive. Cares about peo­ple and pub­lic health, does not view him­self as a “reg­u­la­tor”. He has all the right skills to lead FDA back to a trust­ed po­si­tion of lead­er­ship and pub­lic ser­vice in these fraught times of pub­lic opin­ion.

But the praise was large­ly mut­ed:

— Good enough con­sid­er­ing the al­ter­na­tives.

At this point, just mak­ing a choice and clear­ing up any un­cer­tain­ty will be re­as­sur­ing to a large seg­ment of in­dus­try lead­ers. And what­ev­er Janet Wood­cock does next, her dom­i­nant spir­it will con­tin­ue to in­flu­ence events at the FDA.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.