In a ma­jor blow to vac­cine ef­forts, se­nior FDA lead­ers step­ping down

Mar­i­on Gru­ber

Two of the FDA’s most se­nior vac­cine lead­ers are ex­it­ing from their po­si­tions, rais­ing fresh ques­tions about the Biden ad­min­is­tra­tion and the way that it’s side­lined the FDA.

Mar­i­on Gru­ber, di­rec­tor of the FDA’s Of­fice of Vac­cines Re­search & Re­view and 32-year vet­er­an of the agency, will leave at the end of Oc­to­ber, and OVRR deputy di­rec­tor Phil Krause, who’s been at FDA for more than a decade, will leave in No­vem­ber. The news, first re­port­ed by Bio­Cen­tu­ry, is a mas­sive blow to con­fi­dence in the agency’s abil­i­ty to reg­u­late vac­cines.

The bomb­shell an­nounce­ment comes at a par­tic­u­lar­ly cru­cial mo­ment, as boost­ers and chil­dren’s shots are be­ing weighed by the reg­u­la­tor. The de­par­tures al­so come as the ad­min­is­tra­tion has re­cent­ly jumped ahead of the FDA’s re­views of boost­er shots, an­nounc­ing that they might be avail­able by the week of Sept. 20.

A for­mer se­nior FDA leader told End­points that they’re de­part­ing be­cause they’re frus­trat­ed that CDC and their ACIP com­mit­tee are in­volved in de­ci­sions that they think should be up to the FDA. The for­mer FDAer al­so said he’s heard they’re up­set with CBER di­rec­tor Pe­ter Marks for not in­sist­ing that those de­ci­sions should be kept in­side FDA. What fi­nal­ly did it for them was the White House get­ting ahead of FDA on boost­er shots.

FDA’s for­mer act­ing chief sci­en­tist Lu­ciana Bo­rio added on Twit­ter, “FDA is los­ing two gi­ants who helped bring us many safe and ef­fec­tive vac­cines over decades of pub­lic ser­vice.”

“These two are the lead­ers for Bi­o­log­ic (vac­cine) re­view in the US. They have a great team, but these two are the true lead­ers of CBER. A huge glob­al loss if they both leave,” For­mer BAR­DA di­rec­tor Rick Bright wrote, weigh­ing in on the news. “Dr. Gru­ber is much more than the Di­rec­tor. She is a glob­al leader. Vi­sion­ary mas­ter­mind be­hind glob­al clin­i­cal reg­u­la­to­ry sci­ence for flu, Ebo­la, Mers, Zi­ka, Sars-cov-2, many oth­ers.”

Phil Krause

In a let­ter from Marks to staff, he ex­plained:

Janet Wood­cock told End­points that she wish­es Gru­ber and Krause well and thanks them for their sig­nif­i­cant ser­vice.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

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.

David Kirn, 4D Molecular Therapeutics CEO (via website)

FDA places hold on 4D Mol­e­c­u­lar’s Fab­ry gene ther­a­py

4D Molecular Therapeutics quietly tucked an FDA clinical hold on its Fabry gene therapy into an SEC filing.

Meanwhile, the biotech issued a press release the same day after the closing bell on Thursday touting an IND for another asset, in diabetic macular edema.

The California biotech had paused enrollment of patients in its two trials of the Fabry gene therapy (4D-310) last month after three patients experienced kidney issues, all of which were resolved within four weeks. At the time, 4DMT said it would wait until the second half of this year to look at 12-month clinical data on six patients in the Phase I/II trials, one in the US and one in Taiwan and Australia.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

John Roberts, exiting Vyant Bio CEO

Neu­rode­gen­er­a­tive biotech Vyant warns of po­ten­tial wind-down

The CEO and chief scientific officer of Vyant Bio are out the door as the little-known but publicly-listed neurodegenerative biotech searches for an exit or, if all else fails, a wind-down.

The soul-searching bookends a winding journey for the biotech, which rebranded and transitioned from diagnostics company Cancer Genetics in 2021 after a merger with StemoniX. That came after a failed merger attempt with NovellusDx (now Fore Biotherapeutics) in 2018. In the last few years, units have been sold off and the stock price $VYNT has plummeted from the $30 range to penny stock territory.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Medicago's vaccine greenhouse (Medicago via YouTube)

Cana­di­an plant-based vac­cine de­vel­op­er Med­ica­go shut­ters months af­ter lay­offs

Plant-based Covid-19 vaccine developer Medicago shut down this week with little fanfare. And its two subsidiaries, Medicago R&D and Medicago USA, are also closing their doors, according to a company news release.

The lone shareholder left standing, Japan-based Mitsubishi Chemical Group, “has determined not to make further investments in Medicago and to proceed with an orderly wind-up of its business and operations in Canada and in the United States.”

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?’”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

FDA ap­proves GSK's ane­mia drug with safe­ty warn­ing — af­ter bat­ting back sim­i­lar drugs

GSK has secured the first of four US approvals it’s hoping for this year, as the FDA greenlit daprodustat as a treatment for anemia due to chronic kidney disease.

But the FDA limited the use of the drug, to be marketed as Jesduvroq, to patients who have been receiving dialysis for at least four months and stopped short of approving it for patients not dependent on dialysis — in line with the recommendations of the advisory committee it consulted.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.