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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

FDA un­veils new draft guid­ance to help with oligonu­cleotide ther­a­peu­tics de­vel­op­ment

While oligonucleotides, a wide variety of synthetically modified RNA or RNA/DNA hybrids that bind to a target RNA sequence to alter RNA and/or protein expression, have been winning approvals in recent years (e.g. Novartis’ cholesterol drug Leqvio), the regulatory agency is offering new draft guidance for those looking to follow a similar path.

The non-binding guidance, titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Guidance for Industry” deals with pharmacokinetic, pharmacodynamic, and safety assessments required as part of oligonucleotide therapeutics R&D.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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