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.

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; 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.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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Sen. Kyrsten Sinema (D-AZ) (Tom Williams/CQ Roll Call via AP Images)

De­moc­rats se­cure sup­port from key sen­a­tor ahead of po­ten­tial drug pric­ing vote

Senate Democrats may have all the votes they need to pass major drug pricing reform, after Sen. Kyrsten Sinema (D-AZ) reportedly pledged her support on Thursday — but will they fit it in before recess?

Sinema said she has agreed to “move forward” with the reconciliation bill with some stipulations, including the removal of a carried tax provision, according to recent reports. The bill is still expected to reduce the deficit by $300 billion, and Sen. Chuck Schumer (D-NY) said that he now anticipates “support from the entire Senate Democratic conference,” the Washington Post reported. 

CDC, NIH, FDA lead­ers call for US-based clin­i­cal tri­al of small­pox drug in treat­ing mon­key­pox

With the rising number of monkeypox cases, leading researchers at the CDC, FDA and NIH are calling on a randomized clinical trial to see if an approved smallpox drug is effective at treating monkeypox.

No monkeypox treatments are approved in the US, so patients looking to get relief for their lesions and other symptoms from the virus must go through a set of hurdles to get the smallpox drug through a government expanded access program. Approved for smallpox in 2018, the drug is marketed as TPOXX by the biotech SIGA. The European Union approved it for monkeypox in addition to smallpox earlier this year and the UK followed suit in July.

CDER director Patrizia Cavazzoni, FDA commissioner Robert Califf and OPDP acting director Catherine Gray

Drug pro­mo­tion en­force­ment so far sim­i­lar un­der new FDA chief, with just 4 let­ters in first half of 2022

Will a trio of new bosses at the FDA lead to an increase in drug advertising enforcement? It’s a good question, but with few letters sent out so far, there’s just not enough information to tell, says one longtime FDA regulatory watchdog.

“I don’t think there is anything to indicate the Administration is leaning one way or another,” Mark Senak, a lawyer at FleishmanHillard who tracks FDA actions on his Eye on FDA blog, said in an email. “It is worth noting that we have a new FDA Commissioner, new head of CDER and a new head of OPDP which opens up the possibility of change, but there has not yet been enough enforcement activity to identify real change.”

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