Peter Marks (Jim Lo Scalzo/Pool via AP Images)

FDA's VRB­PAC votes in fa­vor of adapt­ing the Covid-19 vac­cine to the lat­est Omi­cron vari­ant

The FDA’s Vac­cine and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee on Tues­day gave the thumbs up — by a vote of 19-2 — that the FDA should re­quire an Omi­cron-re­lat­ed com­po­nent in this next sea­son’s boost­er dose for Covid-19, which both Pfiz­er/BioN­Tech and Mod­er­na are hard at work on.

Wayne Maras­co

And while nei­ther boost­er will like­ly be ready to go with ad­e­quate sup­plies for all Amer­i­can adults by the be­gin­ning of the next school year, the sit­u­a­tion is still com­plex and flu­id, with CBER Di­rec­tor Pe­ter Marks telling the com­mit­tee that it’ll take com­pa­nies at least three months to ready their sup­plies for this ex­pect­ed next wave.

“Right now the crit­i­cal thing is the man­u­fac­tur­ers need to know what to put in­to their vac­cines,” Marks said. Over the com­ing months, there will be de­bate over who is most ap­pro­pri­ate for a boost­er, but it seems like most pan­elists would agree that those aged 50 or 55 and up might be el­i­gi­ble for a boost­er in the fall, Marks added. He al­so warned that half of Amer­i­cans still have not re­ceived a first boost­er, so FDA is hop­ing to con­vince peo­ple to sign on to the next boost­er cam­paign to help pre­vent an­oth­er big wave of hos­pi­tal­iza­tions and deaths. Marks said he to­tal­ly takes the point that “BA. 4 or 5 might not be cir­cu­lat­ing in the fall,” but by mov­ing to this bi­va­lent ver­sion, the US might be able to move close to what’s cir­cu­lat­ing.

Bruce Gellin

The rise of Omi­cron in late 2021 has brought with it two new sub­vari­ants, BA.4 and BA.5 more re­cent­ly, and Pfiz­er, Mod­er­na and No­vavax are de­vel­op­ing boost­er dos­es to com­bat these vari­ants and their sub­lin­eage bet­ter than their cur­rent vac­cines, which are based on the coro­n­avirus that emerged in late 2019.

Hen­ry Bern­stein

Ad­comm pan­elist Wayne Maras­co, pro­fes­sor of med­i­cine at Dana-Far­ber Can­cer In­sti­tute, vot­ed “yes” on the Omi­cron boost­er be­cause, “I think it’s im­por­tant to broad­en im­mu­ni­ty,” but adding, “I’m not sure if the da­ta are go­ing to show BA.4 or 5 peaks [in the fall]…but I was pret­ty im­pressed to­day that we can do bet­ter, and I’m not sure the mR­NA vac­cines as they have been pre­sent­ed so far are giv­ing us the best im­mu­ni­ty we can get here. This is a step in the right di­rec­tion but we need to reeval­u­ate.”

Paul Of­fit

Pan­elist Bruce Gellin, chief of pub­lic health strat­e­gy at the Rock­e­feller Foun­da­tion, said af­ter his “yes” vote that the process has been some­what sim­i­lar to the flu vac­cine se­lec­tion process but, “We weren’t asked to vote on sub­lin­eage, so we’re leav­ing that to the FDA, but we’ve heard a lot about the ‘4,5’, and I guess giv­en that, the con­ver­sa­tion be­tween FDA and WHO if the rec­om­men­da­tions are to make dif­fer­ent vac­cines. We’re go­ing to have to think through the range of for­mu­la­tions and the dif­fer­ent for­mu­la­tions of what’s in­clud­ed around the world.”

Hen­ry Bern­stein, a pe­di­a­tri­cian at Co­hen Chil­dren’s Med­ical Cen­ter, and Paul Of­fit, a pe­di­a­tri­cian at the Chil­dren’s Hos­pi­tal of Philadel­phia, both vot­ed against the in­clu­sion of an Omi­cron com­po­nent in fu­ture boost­ers. They ar­gued that there is no as­sur­ance that the cur­rent dom­i­nant vari­ant will still be the dom­i­nant vari­ant in the fall.

Jean-Paul Clozel, Idorsia CEO (Patrick Straub/Keystone via AP Images)

Idor­si­a's brain bleed drug flunks PhI­II tri­al, a decade af­ter pre­vi­ous flop

Idorsia’s long journey with clazosentan came to an abrupt “unexpected result” Monday morning with a Phase III flop.

The Swiss biopharma said the drug did not meet the main goal of the late-stage REACT study, conducted in the US, Canada and Europe since early 2019.

The 409-patient trial tested the intravenous drug’s ability to prevent complications due to delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage (aSAH), in which blood vessels in the brain narrow and blood accumulates around the brain’s surface, which then dials up the pressure on the brain.

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Kenji Yasukawa, Astellas CEO (Photographer: Akio Kon/Bloomberg via Getty Images)

Astel­las taps chief strat­e­gy of­fi­cer as next CEO to 'go on the ag­gres­sive'

Five years into its big R&D revamp, Astellas says it’s time for a changing of the guard.

Kenji Yasukawa, who took over as president and CEO in 2018, will step down to become chairman of the board in April, making room for Naoki Okamura to take over. Okamura joined the company in 1986 and has served in a variety of finance, business and strategy roles, including most recently as chief strategy officer.

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Clin­i­cal tri­al di­ver­si­ty da­ta show mis­match be­tween en­roll­ment and dis­ease preva­lence, GSK says

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

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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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.

Photo: Julia Weeks/AP Images

FDA ax­es re­quire­ment for pos­i­tive Covid test be­fore Paxlovid use

FDA announced today that doctors and pharmacists can now prescribe Paxlovid to patients without a positive test for Covid-19.

CDER Director Patrizia Cavazzoni reissued Paxlovid’s authorization letter Wednesday, saying it has revised the authorization to “no longer require positive results of direct SARS-CoV-2 viral testing.” The EUA now requires instead that adults and kids 12 years of age and older have a “current diagnosis of mild-to-moderate COVID-19.”

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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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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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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