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.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

David Kirn, 4D Molecular Therapeutics CEO (via website)

FDA places hold on 4D Mol­e­c­u­lar’s Fab­ry gene ther­a­py

4D Molecular Therapeutics quietly tucked an FDA clinical hold on its Fabry gene therapy into an SEC filing.

Meanwhile, the biotech issued a press release the same day after the closing bell on Thursday touting an IND for another asset, in diabetic macular edema.

The California biotech had paused enrollment of patients in its two trials of the Fabry gene therapy (4D-310) last month after three patients experienced kidney issues, all of which were resolved within four weeks. At the time, 4DMT said it would wait until the second half of this year to look at 12-month clinical data on six patients in the Phase I/II trials, one in the US and one in Taiwan and Australia.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Photo: Julia Weeks/AP Images

FDA ax­es re­quire­ment for pos­i­tive Covid test be­fore Paxlovid use

FDA announced today that doctors and pharmacists can now prescribe Paxlovid to patients without a positive test for Covid-19.

CDER Director Patrizia Cavazzoni reissued Paxlovid’s authorization letter Wednesday, saying it has revised the authorization to “no longer require positive results of direct SARS-CoV-2 viral testing.” The EUA now requires instead that adults and kids 12 years of age and older have a “current diagnosis of mild-to-moderate COVID-19.”

FDA ap­proves GSK's ane­mia drug with safe­ty warn­ing — af­ter bat­ting back sim­i­lar drugs

GSK has secured the first of four US approvals it’s hoping for this year, as the FDA greenlit daprodustat as a treatment for anemia due to chronic kidney disease.

But the FDA limited the use of the drug, to be marketed as Jesduvroq, to patients who have been receiving dialysis for at least four months and stopped short of approving it for patients not dependent on dialysis — in line with the recommendations of the advisory committee it consulted.

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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