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: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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UP­DAT­ED: Feds clear the road for J&J to start de­liv­er­ing mil­lions of dos­es of their Covid-19 vac­cine — but frets linger about run­ner-up sta­tus

All the pieces needed to trigger a third wave of Covid-19 vaccine supply to start washing over the US fell neatly into place over the weekend.

After providing for a brief mime of regulatory judiciousness, the FDA stamped their emergency approval on J&J’s Covid-19 vaccine Saturday, adding to the Biden administration’s plan aimed at ending the pandemic in the near term — at least in the US. The CDC came through on Sunday with its stamp of approval and J&J is reportedly expected to start delivering vaccine sometime in the next few days.

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Amit Munshi, Arena

One of Are­na's top drugs flops in a PhI­Ib study for IBS pain. But re­searchers tease out a pos­si­ble path for­ward as CEO ex­plores 's­trate­gic op­tion­s'

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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