Covid-19 roundup: No­vavax fi­nal­ly re­ceives the go-ahead in Eu­rope for its vac­cine; CDC strug­gles to track Omi­cron

The long wait for No­vavax’s promis­ing Covid-19 vac­cine will soon be over for Eu­ro­peans.

The Eu­ro­pean Med­i­cines Agency on Mon­day rec­om­mend­ed grant­i­ng a con­di­tion­al mar­ket­ing au­tho­riza­tion for No­vavax’s shot, to be known as Nu­vax­ovid, to pre­vent Covid-19 for all those over the age of 18. And lat­er Mon­day morn­ing, the Eu­ro­pean Com­mis­sion grant­ed that au­tho­riza­tion.

Clin­i­cal tri­als of the two-shot vac­cine, with each jab tak­en three weeks apart, showed it was safe and of­fered strong ef­fi­ca­cy, but the EMA warned that the vac­cine has not been test­ed against some vari­ants of con­cern like Omi­cron.

“Tak­en to­geth­er, the re­sults of the two stud­ies show a vac­cine ef­fi­ca­cy for Nu­vax­ovid of around 90%. The orig­i­nal strain of SARS-CoV-2 and some vari­ants of con­cern such as Al­pha and Be­ta were the most com­mon vi­ral strains cir­cu­lat­ing when the stud­ies were on­go­ing. There is cur­rent­ly lim­it­ed da­ta on the ef­fi­ca­cy of Nu­vax­ovid against oth­er vari­ants of con­cern, in­clud­ing Omi­cron,” the EMA said.

No­vavax and the Eu­ro­pean Com­mis­sion an­nounced an agree­ment in Au­gust to sup­ply up to 200 mil­lion dos­es of No­vavax’s vac­cine. The Serum In­sti­tute of In­dia will sup­ply ini­tial dos­es for the EU.

The vac­cine is al­so cur­rent­ly un­der re­view by mul­ti­ple reg­u­la­to­ry agen­cies world­wide, and the com­pa­ny ex­pects to sub­mit its com­plete chem­istry, man­u­fac­tur­ing and con­trols (CMC) da­ta pack­age to the US FDA by the end of the year.

Mean­while, the head of the EMA warned on Mon­day that the avail­able vac­cines, in­clud­ing the mR­NA and ade­n­ovirus-based ones, are los­ing their ef­fi­ca­cy with the new vari­ant.

“The da­ta com­ing in . . . it’s not at all de­fin­i­tive, there are very small num­bers, [but] it’s clear that there is a drop in ef­fec­tive­ness,” Emer Cooke, ex­ec­u­tive di­rec­tor of EMA, told the Fi­nan­cial Times.

CDC da­ta strug­gles con­tin­ue with Omi­cron

With Omi­cron emerg­ing, the US con­tin­ues to re­ly on in­ter­na­tion­al da­ta for a lot of its de­ci­sions, and pub­lic health of­fi­cials told POLITI­CO that the cur­rent lev­el of in­vest­ment by the fed­er­al gov­ern­ment to im­prove the coun­try’s da­ta sys­tems is not enough to over­haul their ex­ist­ing sur­veil­lance sys­tems if there’s an­oth­er mas­sive surge, like with Omi­cron, or an­oth­er pan­dem­ic.

“We’re re­ly­ing on every­one else’s da­ta. We should be pro­vid­ing da­ta to the world and we are not,” said Zeke Emanuel, a bioethi­cist and for­mer mem­ber of Pres­i­dent Biden’s tran­si­tion Covid-19 ad­vi­so­ry board. “We start­ed [the pan­dem­ic] with a se­ri­ous prob­lem of not enough da­ta and bad da­ta in­fra­struc­ture. We have not made the struc­tur­al in­vest­ments we need. The ide­al is that we have re­al time da­ta. And we don’t have that. We’re not even close to that.”

And with the Build Back Bet­ter bill now floun­der­ing, the $7 bil­lion to sup­port the im­prove­ment of pub­lic health in­fra­struc­ture across the coun­try is al­so on the ropes.

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.