CBER Director Peter Marks (Greg Nash/Pool via AP Images)

FDA hopes to sim­pli­fy and stan­dard­ize Covid shots with­out mak­ing them in­ter­change­able

The FDA’s ad­vi­so­ry com­mit­tee of out­side vac­cine ex­perts will meet Thurs­day to dis­cuss how to sim­pli­fy the Covid-19 vac­ci­na­tion process, make the strain se­lec­tion process eas­i­er and more reg­u­lar, and de­cide whether to use the same strain for both the pri­ma­ry and boost­er dos­es.

But de­spite a de­sire by the agency to sim­pli­fy the vac­ci­na­tion pro­duc­tion and ad­min­is­tra­tion process, the agency ac­knowl­edged that, for now, it may be chal­leng­ing to har­mo­nize dif­fer­ent vac­cines from Mod­er­na and Pfiz­er/BioN­Tech in­to a sin­gle, in­ter­change­able shot.

“The cur­rent di­ver­si­ty of vac­cine man­u­fac­tur­ers and com­plex­i­ties in glob­al sup­ply of COVID-19 vac­cines would make a glob­al­ly co­or­di­nat­ed, si­mul­ta­ne­ous vac­cine com­po­si­tion eval­u­a­tion and rec­om­men­da­tion quite chal­leng­ing,” the agency said in a brief­ing doc­u­ment re­leased ahead of its Jan. 26 Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee meet­ing.

Known as VRB­PAC, the ses­sions gath­er out­side ex­perts to make rec­om­men­da­tions on the vac­cine de­vel­op­ment process, but Thurs­day’s meet­ing in­cludes on­ly one ques­tion on whether the ad­vi­sors rec­om­mend har­mo­niz­ing the cur­rent pri­ma­ry and boost­er vac­cine com­po­si­tion in­to the same shot.

The dis­cus­sion and vote come as up­take of a bi­va­lent boost­er has stalled in the US, with ques­tions raised about ef­fi­ca­cy and a po­ten­tial new safe­ty sig­nal. At the JP Mor­gan Health­care Con­fer­ence ear­li­er this month, BioN­Tech ex­ec­u­tives stressed that they did not think Covid-19 vac­cines be­tween dif­fer­ent man­u­fac­tur­ers would be in­ter­change­able.

Such har­mo­niza­tion has been the agency’s even­tu­al goal: “This is one of the is­sues that needs some sim­pli­fi­ca­tion be­cause ul­ti­mate­ly we’d like things to be as sim­ple as they are with in­fluen­za vac­cines where it doesn’t mat­ter what man­u­fac­tur­er’s vac­cine you’ve re­ceived,” CBER Di­rec­tor Pe­ter Marks said late last month.

FDA’s plan for the fu­ture, ac­cord­ing to the brief­ing doc­u­ments re­leased on Mon­day, is to en­gage VRB­PAC in ear­ly June of each year re­gard­ing strain se­lec­tion for the fall sea­son, which would be de­ployed no lat­er than Sep­tem­ber each year. If a sur­pris­ing and more dan­ger­ous ver­sion of the virus emerged, it would meet soon­er.

“Of note, cir­cu­la­tion of a more path­o­gen­ic vac­cine-es­cape vari­ant of SARS-CoV-2 would like­ly prompt, on an as-need­ed and emer­gent ba­sis, an ad-hoc strain se­lec­tion meet­ing of VRB­PAC,” FDA said.

In ad­di­tion to tran­si­tion­ing to a sin­gle vac­cine com­po­si­tion for the pri­ma­ry and boost­er se­ries, FDA al­so said that on Thurs­day it hopes VRB­PAC mem­bers will con­sid­er whether to stan­dard­ize the vac­cine sched­ule for fu­ture rounds to “a two-dose se­ries in cer­tain young chil­dren, and in old­er adults and per­sons with com­pro­mised im­mu­ni­ty, and on­ly one dose in all oth­er in­di­vid­u­als.”

On ef­fi­ca­cy, FDA al­so brushed off any ques­tion marks re­lat­ed to the bi­va­lent boost­ers from Mod­er­na and Pfiz­er/BioN­Tech, par­tic­u­lar­ly among younger, less vul­ner­a­ble pop­u­la­tions, writ­ing:

Al­though there are lim­i­ta­tions spe­cif­ic to each of these ef­fec­tive­ness as­sess­ments, these da­ta pro­vide pre­lim­i­nary re­al-world ev­i­dence that sup­port the use of the bi­va­lent mR­NA boost­ers. Al­though the ben­e­fi­cial ef­fect as­so­ci­at­ed with a re­duc­tion in hos­pi­tal­iza­tion and death in these stud­ies is most ap­par­ent in old­er in­di­vid­u­als, younger in­di­vid­u­als ap­pear to al­so ben­e­fit with a re­duc­tion in symp­to­matic dis­ease and health care uti­liza­tion.

The ad­vi­so­ry com­mit­tee is al­so ex­pect­ed to re­view new da­ta on a po­ten­tial safe­ty sig­nal. Ear­li­er this month, the CDC and the FDA said they were in­ves­ti­gat­ing a “pre­lim­i­nary” sign of an in­creased risk of stroke in peo­ple aged 65 and old­er. Oth­er gov­ern­ments have found no such sig­nal in their own re­views, and oth­er US datasets have like­wise not seen such a risk. The doc­u­ments re­leased Mon­day didn’t con­tain any new in­for­ma­tion on the is­sue.

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.

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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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.

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.

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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.

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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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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.