FDA cre­ates um­brel­la emer­gency path­way for Covid-19 serol­o­gy tests

The FDA has cre­at­ed a new path­way to sup­port the emer­gency au­tho­riza­tion of tests for an­ti­bod­ies of the virus that caus­es COVID-19.

Serol­o­gy tests could play an im­por­tant role in the safe lift­ing of lock­downs by en­abling au­thor­i­ties to iden­ti­fy in­di­vid­u­als with an­ti­bod­ies of the SARS-CoV-2 virus and cal­cu­late what pro­por­tion of a pop­u­la­tion has al­ready been in­fect­ed. The path­way un­veiled by the FDA on Wednes­day gives test de­vel­op­ers a new route to an emer­gency use au­tho­riza­tion (EUA).

The new route, de­scribed by the FDA as an “um­brel­la” EUA, will en­able serol­o­gy tests to be mar­ket­ed af­ter be­ing put through an in­de­pen­dent val­i­da­tion study at the Na­tion­al Can­cer In­sti­tute or an­oth­er des­ig­nat­ed gov­ern­ment agency. The FDA al­so will need to con­firm a test meets the cri­te­ria out­lined in its Scope of Au­tho­riza­tion.

In the Scope of Au­tho­riza­tion, the FDA set out the val­i­da­tion process. The FDA-des­ig­nat­ed lab­o­ra­to­ries will use the tests to an­a­lyze 30 or more sam­ples known to con­tain SARS-CoV-2an­ti­bod­ies, as well as 80 with­out.

To pass, a test must achieve a sen­si­tiv­i­ty or 90% and speci­fici­ty of 95% for IgG and IgM an­ti­bod­ies. That bench­mark is in line with the per­for­mance of di­ag­nos­tics au­tho­rized so far un­der the EUA path­way.

Ra­ja Kr­ish­namoor­thi

De­vel­op­ers of di­ag­nos­tics that meet all the per­for­mance cri­te­ria must in­clude cer­tain in­for­ma­tion on the prod­uct la­bel. The FDA ex­pects de­vices cleared un­der the um­brel­la path­way to ship with de­tailed in­struc­tions for per­form­ing the test and an­a­lyz­ing its re­sults, as well as a warn­ing about the risk of false pos­i­tives.

The cre­ation of the path­way comes amid scruti­ny of the FDA’s ap­proach to the avail­abil­i­ty of serol­o­gy tests. To date, the FDA has grant­ed EUA to serol­o­gy tests man­u­fac­tured by eight com­pa­nies. More or­ga­ni­za­tions have made serol­o­gy tests avail­able with­out se­cur­ing EUA by tak­ing ad­van­tage of the Pol­i­cy D path­way. The path­way per­mits man­u­fac­tur­ers to start mar­ket­ing tests af­ter val­i­dat­ing their per­for­mance and no­ti­fy­ing the FDA.

Rep. Ra­ja Kr­ish­namoor­thi (D-IL), the chair­man of the House Sub­com­mit­tee on Eco­nom­ic and Con­sumer Pol­i­cy, has crit­i­cized the FDA for of­fer­ing test de­vel­op­ers that flex­i­bil­i­ty, ar­gu­ing in a let­ter to FDA Com­mis­sion­er Stephen Hahn ab­di­gat­ing “re­spon­si­bil­i­ty [to pro­tect the pub­lic health] and trust­ing pri­vate in­dus­try to reg­u­late it­self is un­ac­cept­able.”

Kr­ish­namoor­thi’s con­cerns were based in part on non-peer-re­viewed re­search pub­lished on the medRx­iv pre-print serv­er that not­ed “het­eroge­nous as­say per­for­mance,” lead­ing the House sub­com­mit­tee to al­so write to four of the com­pa­nies that sell tests as­sessed by the re­searchers.

RAPS: First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.

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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