Janet Woodcock, acting FDA commissioner (Greg Nash/Pool via AP Images)

Wood­cock de­fends FDA's re­sponse to Omi­cron be­fore Sen­ate health com­mit­tee

In what may be Janet Wood­cock’s fi­nal con­gres­sion­al hear­ing as the head of the FDA, she once again of­fered a can­did de­scrip­tion of the dif­fi­cul­ties of bat­tling the cur­rent Omi­cron out­break.

Speak­ing through two masks along­side oth­er CDC, NIH and HHS lead­ers, Wood­cock com­pared the cur­rent pan­dem­ic to a nat­ur­al dis­as­ter, adding, “I don’t think it will last a re­al­ly long time.”

“I think we need to fo­cus on con­ti­nu­ity of op­er­a­tions for hos­pi­tals,” she said in re­sponse to ques­tions from Sen. Mike Braun (R-IN) at the Sen­ate Health, Ed­u­ca­tion, La­bor and Pen­sions Com­mit­tee meet­ing on Tues­day. “I think it’s hard to process what’s ac­tu­al­ly hap­pen­ing right now, which is that most peo­ple are go­ing to get Covid.”

She stressed the need to make sure the hos­pi­tals, trans­porta­tion and oth­er es­sen­tial ser­vices aren’t dis­rupt­ed and af­ter that, she said, it’ll be im­por­tant to re­assess what has been done and needs to be im­proved up­on.

“There’s an ex­treme un­met med­ical need for ther­a­peu­tics at most stages of the dis­ease, par­tic­u­lar­ly in the late stages, where we still don’t have in­ter­ven­tions and peo­ple are dy­ing, go­ing in­to the ICU and go­ing on the ven­ti­la­tor,” Wood­cock said, not­ing there are 670 INDs that are on­go­ing. “Ro­bust de­vel­op­ment is still on­go­ing in the ther­a­peu­tic area.”

In ques­tion­ing re­lat­ed to the FDA’s au­tho­riza­tion of rapid tests, which has come un­der fire — as many sen­a­tors lament­ed the woe­ful­ly in­ad­e­quate rapid test sup­plies — Wood­cock said it was more of an is­sue of man­u­fac­tur­ing ca­pac­i­ty ver­sus the au­tho­riza­tion process.

In her writ­ten tes­ti­mo­ny, Wood­cock not­ed that the FDA’s ac­tions have re­duced the re­view times for tests “from a peak av­er­age of 90 days for EUA re­quests re­ceived in Sep­tem­ber 2020 to ap­prox­i­mate­ly 35 days for those re­ceived since Feb­ru­ary 2021.”

“We could do more with more re­sources,” she said. “It’s an in­cred­i­ble in­crease in work­load,” she said of the tests, while prais­ing the NIH’s stan­dard­iza­tion work that ac­cel­er­ates the au­tho­riza­tion of some new tests, some­times to as quick­ly as two days, Wood­cock said.

Re­pub­li­cans like rank­ing mem­ber Richard Burr crit­i­cized Pres­i­dent Biden’s an­nounce­ment about boost­ers for all pri­or to FDA au­tho­riza­tion, and then the FDA’s ad­comm had to “bend to the whims of the po­lit­i­cal de­ci­sion al­ready made,” which he said cre­at­ed skep­ti­cism and con­fu­sion with the launch of boost­ers.

“Now we’re beg­ging peo­ple to get boost­ers, which is where we should’ve been on Day 1,” Burr said.

Wood­cock tes­ti­fied that the vac­cines au­tho­rized re­main high­ly ef­fec­tive against pre­vent­ing hos­pi­tal­iza­tion and death, and an ad­di­tion­al boost­er pro­vides fur­ther pro­tec­tion.

Sen. Mitt Rom­ney (R-UT) al­so crit­i­cized the Biden ad­min­is­tra­tion for not build­ing enough test­ing ca­pac­i­ty and ag­gres­sive­ly ramp­ing up pro­duc­tion, while Sen. Su­san Collins (R-ME) ques­tioned what AS­PR has done with more than $80 bil­lion ap­pro­pri­at­ed for tests, and test pro­duc­tion, when “no one can find a rapid test when they need them.”

“This cri­sis is en­tire­ly pre­ventable. The fact is that the ad­min­is­tra­tion failed to an­tic­i­pate our test­ing needs,” she added.

AS­PR head Dawn O’Con­nell ex­plained that the test­ing mon­ey has been used for test­ing, and she men­tioned that some funds were used to test chil­dren cross­ing the bor­der.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

CMS spent more than $18B in four years on ac­cel­er­at­ed ap­provals with in­com­plete con­fir­ma­to­ry tri­als, in­spec­tor gen­er­al finds

The battle over whether and how to reform the FDA’s accelerated approval pathway is heating up again, just as the Senate punted any talks until the lame duck session just before the end of the year.

On Thursday, HHS’ inspector general released a new report reiterating concerns, also noted recently by the FDA’s Oncology Center of Excellence, about delayed or slowed confirmatory trials that are necessary to prove that the accelerated approvals were worth their salt in the first place.

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Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) (Olivier Douliery/Sipa USA (Sipa via AP Images)

Sen­ate pass­es bill to re­work an­i­mal test­ing re­quire­ments for drug de­vel­op­ers

The US Senate passed via unanimous consent on Thursday afternoon a bipartisan bill that would alter a federal mandate for animal testing on new drugs, but stops short of removing animal testing entirely.

Touted as a much-needed modernization of FDA’s rules, co-sponsor Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) have said the bill will stop lots of needless suffering of animals.

Cell and gene ther­a­pies from acad­e­mia: EMA to help 5 projects go­ing af­ter un­met clin­i­cal needs

The European Medicines Agency said Thursday that it’s launching a new pilot program to help academic and other nonprofit researchers developing advanced therapy medicinal products, which includes cell and gene therapies.

Academics have proven to be enormously useful in feeding new products, like chimeric antigen receptor (CAR)-T cell therapies first developed by Memorial Sloan Kettering, and ushered to the market by biopharma companies. Jean Bennett, formerly with the University of Pennsylvania, also saw her research lead to the approval of gene therapy Luxturna, which Roche now owns.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.