It’s all hands on the vir­tu­al deck at the FDA. And the folks at CDER are con­sid­er­ing set­ting up a new on­line ap­proach to hold­ing ad­comm meet­ings go­ing for­ward.

Mark Senak, who writes the Eye on FDA blog, posed a se­ries of ques­tions for CDER, in­clud­ing one on ad­comms, which are be­ing in­ter­rupt­ed as the coro­n­avirus pan­dem­ic spreads in the US and around the globe.

As of now, the FDA is can­cel­ing all non-es­sen­tial meet­ings at the agency, in­clud­ing the ad­comms, through April. But CDER does see a pos­si­ble op­por­tu­ni­ty for go­ing vir­tu­al — a big deal in an in­dus­try that re­lies on these meet­ings to keep its R&D strat­e­gy in­tact.

Here’s the ex­change be­tween Senak and CDER on the ad­comms:

Does FDA plan on at­tempt­ing vir­tu­al ad­vi­so­ry com­mit­tee meet­ings?

As this re­mains a dy­nam­ic sit­u­a­tion, we will con­tin­ue to as­sess and cal­i­brate our ap­proach. Where pos­si­ble the agency will lever­age tech­nol­o­gy to host meet­ings al­low­ing for re­mote par­tic­i­pa­tion. We thank you for your pa­tience. In con­sid­er­ing nec­es­sary steps for pro­tecting pub­lic health, in­clud­ing our spon­sors, our com­mit­tee mem­bers and our work­force, we are can­celling or post­pon­ing all non-es­sen­tial meet­ings through the month of April. We will re­assess on an on-go­ing ba­sis for fu­ture months. Where pos­si­ble the agency will lever­age tech­nol­o­gy to host meet­ings al­low­ing for re­mote par­tic­i­pa­tion.

→ A con­ser­v­a­tive group called the Job Cre­ators Net­work — which in­cludes Home De­pot co-founder Bernard Mar­cus as a key backer — is call­ing on Pres­i­dent Trump to clear away the “red tape” and make hy­drox­y­chloro­quine more eas­i­ly avail­able.

The drug is fre­quent­ly cit­ed by Trump as a pos­si­ble short-term panacea for the Covid-19 out­break. It’s al­so un­cer­tain whether it will help at all or cause more dam­age than good — some­thing that is be­ing test­ed in a clin­i­cal pro­gram now. In the mean­time, it’s be­come one of the most pop­u­lar drugs avail­able, mak­ing sup­plies scarce. And that’s what the group wants Trump to fix.

“We’re not ad­vo­cat­ing that peo­ple should take the drug,” a spokesper­son told the Wall Street Jour­nal. “We’re ad­vo­cat­ing that doc­tors should have the op­por­tu­ni­ty to pre­scribe it if they want to do so. The prob­lem is no one can find it. It’s a sup­ply-side is­sue.”

→ British Prime Min­is­ter Boris John­son has test­ed pos­i­tive for coro­n­avirus — on Wednes­day, he ad­dressed Mem­bers of Par­lia­ment in the House of Com­mons.

Over the last 24 hours I have de­vel­oped mild symp­toms and test­ed pos­i­tive for coro­n­avirus.

I am now self-iso­lat­ing, but I will con­tin­ue to lead the gov­ern­ment’s re­sponse via video-con­fer­ence as we fight this virus.

To­geth­er we will beat this. #Stay­Home­Save­Lives pic.twit­ter.com/9Te6aFP0Ri

— Boris John­son #Stay­Home­Save­Lives (@BorisJohn­son) March 27, 2020

→An­oth­er set of drug de­vel­op­ers have thrown their hat in­to the an­ti-Covid-19 ring. In ad­di­tion to pro­grams from Mod­er­na, which is al­lied with the NIH — and BioN­Tech, as well as Cure­Vac — Sanofi is al­so work­ing on an mR­NA vac­cine ap­proach with Trans­late Bio, in ad­di­tion to its pre­vi­ous­ly un­veiled tra­di­tion­al vac­cine pro­gram. (End­points Link)

Hep B vac­cine mak­er Dy­navax is al­so work­ing on a vac­cine, in col­lab­o­ra­tion with the Uni­ver­si­ty of Queens­land as part of a Coali­tion for Epi­dem­ic Pre­pared­ness (CEPI) ini­tia­tive.

→ Ex­ist­ing di­ag­nos­tic tests bank on PCR tech­nol­o­gy, which is en­gi­neered to hone in on the virus’ RNA genome. How­ev­er, if the per­son re­cov­ers from the coro­n­avirus in­fec­tion, that ev­i­dence dis­ap­pears. How­ev­er, an­ti­body tests — which re­ly on blood in­stead of nasal or throat swabs — are ex­pect­ed to re­veal who has had the in­fec­tion but was asymp­to­matic and has re­cov­ered. Once col­lect­ed, this in­for­ma­tion will re­veal the full scope of the pan­dem­ic and in­form con­tain­ment strate­gies across the globe. It will al­so help re­searchers work­ing on plas­ma ther­a­pies, which re­quire blood from sur­vivors.

New York-based Hen­ry Schein on Thurs­day said it was mak­ing avail­able an an­ti­body test (green­lit by the FDA un­der emer­gency guid­ance), which de­liv­ers re­sults with­in 15 min­utes from a pin­prick with no in­stru­men­ta­tion re­quired. The com­pa­ny ex­pects to have at least sev­er­al hun­dred thou­sand tests avail­able by March 30 and sig­nif­i­cant­ly in­creased avail­abil­i­ty be­gin­ning in April, it said.

Mean­while, the Unit­ed King­dom is work­ing on its own an­ti­body tests; sci­en­tists in Sin­ga­pore have used to trace chains of trans­mis­sion, and the CDC re­port­ed­ly has plans for its own.

→ Iron­wood Phar­ma, which sells the bow­el drug Linzess with part­ner Al­ler­gan, said the pan­dem­ic is im­pact­ing en­roll­ment in its late-stage gas­troe­sophageal re­flux dis­ease tri­al. Near­ly 70% of the en­roll­ment tar­get has been hit, but the com­pa­ny no longer ex­pects to re­port top-line da­ta in the sec­ond half of 2020.

→ A glove short­age is re­port­ed­ly loom­ing, as Malaysia — the coun­try that dom­i­nates pro­duc­tion — reels from staff cuts in plants as a re­sult of a lock­down in the re­gion.

→ The US mil­i­tary, ac­cord­ing to Reuters, plans to stop dis­clos­ing some of the more “gran­u­lar da­ta” about in­fec­tions with­in its ranks, fear­ing the in­for­ma­tion may be used by ad­ver­saries.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

The FDA released briefing documents this week from the agency and Pfizer each outlining their arguments for today’s Covid-19 booster shot adcomm, but one thing conspicuously missing was the question on which panel members would be voting. But late Thursday night, regulators published that question.

Adcomm members will be asked whether or not the safety and efficacy data from Pfizer/BioNTech’s original Phase III study “support approval” of a booster shot at least six months after the second dose in individuals older than 16. The question notably excludes the real-world data from Israel and other analyses that Pfizer and the Biden administration had said would be a centerpiece of their arguments for boosters.