Stanley Erck, Novavax CEO (Andrew Harnik/AP Images)

UP­DAT­ED: Un­like 1-day VRB­PAC-to-EUA time­line of peers, No­vavax’s Covid-19 jab awaits FDA re­view of re­cent man­u­fac­tur­ing da­ta

Mod­er­na, Pfiz­er/BioN­Tech and John­son & John­son all re­ceived FDA clear­ance for their Covid-19 vac­cines a day af­ter the agency’s ad­vi­sors rec­om­mend­ed emer­gency au­tho­riza­tion. The same will not hap­pen for No­vavax.

The reg­u­la­tor’s out­side ex­perts rec­om­mend­ed 21 to 0 on Tues­day af­ter­noon to give an emer­gency green light to the Mary­land biotech’s vac­cine, but more than 36 hours lat­er, an of­fi­cial OK hasn’t been hand­ed down yet. The FDA re­ceived man­u­fac­tur­ing up­dates from the com­pa­ny just days be­fore the ad­vi­so­ry com­mit­tee’s hours-long hear­ing.

“On June 3, 2022, No­vavax sub­mit­ted an amend­ment with up­dat­ed man­u­fac­tur­ing and prod­uct in­for­ma­tion for the EUA to the FDA for re­view,” an FDA spokesper­son wrote in an emailed state­ment to End­points News. “FDA will care­ful­ly re­view this and any ad­di­tion­al in­for­ma­tion sub­mit­ted by the firm as part of its on­go­ing as­sess­ment and pri­or to au­tho­riz­ing the vac­cine for emer­gency use. The de­ci­sion to grant an EUA will al­so take in­to con­sid­er­a­tion the dis­cus­sion of clin­i­cal da­ta and vot­ing out­come of the June 7, 2022 VRB­PAC meet­ing.”

“The da­ta is a part of the stan­dard process im­prove­ments that have been made since sub­mis­sion and on June 3, No­vavax sub­mit­ted an amend­ment with this up­dat­ed man­u­fac­tur­ing in­for­ma­tion for the EUA to the FDA for re­view,” a com­pa­ny spokesper­son said in an emailed state­ment to End­points News.

Af­ter re­ceiv­ing more than a bil­lion dol­lars in gov­ern­ment fund­ing ear­ly in the pan­dem­ic, No­vavax failed to keep pace with its com­peti­tors, at least on the home front. The com­pa­ny’s vac­cine, made by the world’s largest vac­cine man­u­fac­tur­er, the Serum In­sti­tute of In­dia, has been giv­en var­i­ous lev­els of ap­proval in more than 40 coun­tries.

Fil­ip Dubovsky

No­vavax sub­mit­ted its CMC da­ta pack­age on Dec. 31, 2021, and then ap­plied for the EUA on Jan. 31.

The US has yet to sign off, and if the FDA does, the vac­cine will still have to wait for a nod from the CDC.

No­vavax, pub­lic com­menters, FDA of­fi­cials and some of the out­side ex­perts on Tues­day dis­cussed the vac­cine’s po­ten­tial to sway those who have yet to re­ceive an in­oc­u­la­tion for the pan­dem­ic virus. De­fin­i­tive proof of whether the tra­di­tion­al plat­form be­hind the vac­cine, as com­pared to the more nascent mR­NA tech­nol­o­gy in Mod­er­na and Pfiz­er’s, could not be pro­vid­ed by the com­pa­ny.

When asked by an ad­vi­sor whether the com­pa­ny had reached out to the vac­cine-hes­i­tant to see if they would take No­vavax’s vac­cine, CMO Fil­ip Dubovsky replied: “One in 10 Amer­i­cans hasn’t been vac­ci­nat­ed and we haven’t giv­en up on them.”

This sto­ry has been up­dat­ed with a com­ment from an FDA spokesper­son. 

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.

Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Up­dat­ing the Covid-19 vac­cine: FDA of­fers a qual­i­fied thumbs-up ahead of ad­comm

The FDA’s adcomm of outside vaccine experts will meet tomorrow to discuss how to protect the US from a likely coming wave of Omicron cases in the fall and winter, and whether to deploy vaccines that specifically target the Omicron variant.

While the data so far are limited, the FDA sounded an upbeat tone in the briefing documents on Pfizer/BioNTech’s candidates, released this weekend ahead of the VRBPAC meeting.

Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.