Chair of FDA's vac­cine ad­comm — who's al­so a lead in­ves­ti­ga­tor of Mod­er­na's vac­cine — re­cus­es her­self from Covid-19 talks

When the FDA’s Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee meets next month to dis­cuss the de­vel­op­ment and au­tho­riza­tion of Covid-19 vac­cines, the chair­woman won’t be there.

Hana El Sahly

Hana El Sahly has re­cused her­self from the ex­pert pan­el’s re­view of the top­ic, cit­ing her role as a lead in­ves­ti­ga­tor in Mod­er­na’s Phase III tri­al, Reuters re­port­ed. An as­so­ciate pro­fes­sor of vi­rol­o­gy and mi­cro­bi­ol­o­gy at Bay­lor Col­lege of Med­i­cine in Hous­ton, El Sahly was ap­point­ed the chair­woman last year.

The FDA has yet to re­lease the ros­ter for the Oct. 22 meet­ing. The vac­cine ad­vi­so­ry com­mit­tee cur­rent­ly con­sists of 15 vot­ing mem­bers; they are set to de­lib­er­ate on Covid-19 vac­cines gen­er­al­ly in­stead of de­bat­ing any spe­cif­ic ap­pli­ca­tion.

While this marks the first in­stance an FDA ad­vi­sor has stepped aside due to po­ten­tial or per­ceived con­flict of in­ter­est, it fol­lows two high-pro­file res­ig­na­tions from Mod­er­na’s board for the same rea­son.

Mon­cef Slaoui, the for­mer head of Glax­o­SmithK­line’s vac­cines de­part­ment, stepped off once the White House tapped him as the chief sci­en­tif­ic ad­vi­sor of Op­er­a­tion Warp Speed. Two months lat­er, Brigham and Women’s pres­i­dent Eliz­a­beth Nabel fol­lowed in his foot­steps as her hos­pi­tal was set to be a site for Mod­er­na’s Phase III tri­al.

Work­ing on the broad­er, na­tion­al lev­el, El Sahly re­cent­ly de­scribed her role to the lo­cal af­fil­i­ate ABC13: “Re­view­ing the re­lat­ed doc­u­ments, the com­mu­ni­ca­tions that sort of laid the ground for the process of get­ting the study start­ed.”

Al­though reg­u­la­tors are not bound to fol­low the ad­comm’s rec­om­men­da­tions, this par­tic­u­lar meet­ing is spe­cial. FDA com­mis­sion­er Stephen Hahn has spot­light­ed the event — which will be open to the pub­lic — as an il­lus­tra­tion of the kind of trans­paren­cy and sci­ence-dri­ven ap­proach that his agency is striv­ing for.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Teresa Graham, incoming Roche Pharmaceuticals CEO

In­com­ing Roche CEO builds out his top team, tap­ping Genen­tech vet to lead phar­ma di­vi­sion

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

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.

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.

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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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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?’”

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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.