Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Sev­er­al coun­tries had restart­ed their por­tions of As­traZeneca’s glob­al Phase III Covid-19 vac­cine tri­al af­ter the study was paused world­wide in ear­ly Sep­tem­ber, but the US no­tably stayed on the side­lines — un­til now. Fri­day af­ter­noon the phar­ma gi­ant an­nounced the all clear from US reg­u­la­tors. And on top of that, J&J an­nounced Fri­day evening that it’s prepar­ing to re­sume its own Phase III vac­cine tri­al.

The FDA gave As­traZeneca the go-ahead to con­tin­ue the tri­al state­side af­ter con­clud­ing that it would be safe to press ahead, ac­cord­ing to a com­pa­ny state­ment sent to End­points News. The green light comes rough­ly a month-and-a-half af­ter the study had been vol­un­tar­i­ly stopped. Reg­u­la­tors had been in­ves­ti­gat­ing two cas­es of a pos­si­ble neu­ro­log­i­cal side ef­fect in the ex­per­i­men­tal vac­cine, but ap­pear sat­is­fied with their find­ings.

The news on the As­traZeneca tri­al was first re­port­ed by the Wall Street Jour­nal. The FDA did not find the vac­cine was re­spon­si­ble for the side ef­fects, ac­cord­ing to the Jour­nal, but could not rule out a link, ei­ther. Lat­er on Fri­day, J&J an­nounced that the in­de­pen­dent DSMB had rec­om­mend­ed re­sum­ing tri­al re­cruit­ment and fol­low­ing dis­cus­sions with the FDA, J&J is now prepar­ing to pro­ceed.

“The restart of clin­i­cal tri­als across the world is great news as it al­lows us to con­tin­ue our ef­forts to de­vel­op this vac­cine to help de­feat this ter­ri­ble pan­dem­ic,” As­traZeneca CEO Pas­cal So­ri­ot said in their state­ment. “We should be re­as­sured by the care tak­en by in­de­pen­dent reg­u­la­tors to pro­tect the pub­lic and en­sure the vac­cine is safe be­fore it is ap­proved for use.”

Go­ing for­ward, re­searchers and clin­i­cians at As­traZeneca tri­al sites will be re­quired to in­form vol­un­teers of the cas­es and look out for any po­ten­tial neu­ro­log­i­cal events, such as numb­ness.

As­traZeneca’s vac­cine had been on pace to re­ceive au­tho­riza­tion for emer­gency use be­fore the end of year pri­or to the tri­al’s halt in Sep­tem­ber. The com­pa­ny re­mains 3rd in End­points News’ Covid-19 vac­cine race track­er, be­hind on­ly Pfiz­er and Mod­er­na. With the US tri­al able to get back up and run­ning, As­traZeneca says it’s an­tic­i­pat­ing to have the re­sults of the study lat­er this year, de­pend­ing on the rate of in­fec­tion in the tri­al sites’ com­mu­ni­ties.

The two cas­es stud­ied by the agency in­clude an in­stance in Ju­ly when a pa­tient de­vel­oped what was thought to be trans­verse myelitis, a rare spinal in­flam­ma­tion dis­or­der, but turned out to be mul­ti­ple scle­ro­sis un­re­lat­ed to the vac­cine. Then in Sep­tem­ber, an­oth­er neu­ro­log­i­cal event in a British pa­tient al­so be­lieved to be trans­verse myelitis caused the glob­al tri­al halt.

Tri­als had al­ready re­sumed in the UK, home of As­traZeneca’s head­quar­ters, as well as Brazil, Japan, South Africa and In­dia. The EMA ini­ti­at­ed a rolling re­view of the vac­cine at the start of Oc­to­ber.

J&J had or­dered a pause to its late-stage Covid-19 vac­cine tri­als on Oct. 12 af­ter an in­ci­dent of a stroke, ac­cord­ing to an ear­li­er Wash­ing­ton Post re­port, though the ill­ness was orig­i­nal­ly undis­closed. J&J said that there was no clear cause of the event and no ev­i­dence it was a re­sult of its vac­cine.

The com­pa­ny al­so not­ed it will not say whether or not that par­tic­i­pant re­ceived an ex­per­i­men­tal vac­cine dose or place­bo in or­der to main­tain the dou­ble-blind­ed­ness of the study.

Like As­traZeneca, J&J is re­search­ing an ade­n­ovirus vac­cine, though the lat­ter’s vac­cine on­ly re­quires a sin­gle dose. J&J is plan­ning on re­cruit­ing 60,000 pa­tients.

Reuters had pre­vi­ous­ly re­port­ed that the As­traZeneca tri­al could re­sume this week, and Warp Speed chief Mon­cef Slaoui had told Bloomberg that he ex­pect­ed both to restart be­fore the end of the week.

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

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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So what hap­pened with No­var­tis' gene ther­a­py group? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

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.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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