Ursula von der Leyen (Christian Hartmann/Pool Photo via AP Images)

Covid-19 roundup: Watch­dog crit­i­cizes EU Com­mis­sion over pres­i­den­t's texts; No­vavax signs vac­cine deal with Is­rael

The Eu­ro­pean Om­buds­man, an in­de­pen­dent in­ves­ti­ga­to­ry body in the EU, called out the EU Com­mis­sion for fail­ing to search for text mes­sages be­tween Com­mis­sion pres­i­dent Ur­su­la von der Leyen and Pfiz­er chief Al­bert Bourla.

Al­bert Bourla

Ac­cord­ing to Politi­co, text mes­sages be­tween von der Leyen and Bourla were re­quest­ed by a jour­nal­ist with net­zpoli­tik.org, a Ger­man-lan­guage news web­site that fo­cus­es on sur­veil­lance and pri­va­cy. Those mes­sages were ref­er­enced in an ar­ti­cle by the New York Times last year on the EU’s pur­chase of 1.8 bil­lion dos­es of the Pfiz­er-BioN­Tech vac­cine.

The NYT ar­ti­cle not­ed that “per­son­al diplo­ma­cy played a big role” in the deal be­tween Pfiz­er and the EU, say­ing that von der Leyen had been ex­chang­ing calls and text mes­sages with Bourla for a month at a low point in the pan­dem­ic, af­ter As­traZeneca an­nounced pro­duc­tion prob­lems for its vac­cine.

And de­spite the jour­nal­ist specif­i­cal­ly re­quest­ing those mes­sages, the om­buds­man, Emi­ly O’Reil­ly, found that the Com­mis­sion didn’t ask von der Leyen’s of­fice to search for text mes­sages. Rather, the Com­mis­sion asked for items that met the Com­mis­sion’s cri­te­ria for record­ing “doc­u­ments.” Those do not in­clude texts.

As for how O’Reil­ly re­spond­ed? It’s mal­ad­min­is­tra­tion.

“The nar­row way in which this pub­lic ac­cess re­quest was treat­ed meant that no at­tempt was made to iden­ti­fy if any text mes­sages ex­ist­ed,” O’Reil­ly said in a state­ment. “This falls short of rea­son­able ex­pec­ta­tions of trans­paren­cy and ad­min­is­tra­tive stan­dards in the Com­mis­sion.”

No­vavax signs deal with Is­rael for up to 10 mil­lion vac­cine dos­es

No­vavax an­nounced a deal this morn­ing with Is­rael’s Min­istry of Health to sell the coun­try sev­er­al mil­lion dos­es of its Covid-19 vac­cine.

Here’s the catch: It’s still not ap­proved in the coun­try.

Ac­cord­ing to the biotech, the two signed an agree­ment for Is­rael to buy five mil­lion dos­es of the vac­cine, and then leave open the op­tion for Is­rael to buy an­oth­er five mil­lion if the coun­try so choos­es. No­vavax said it will work with the health min­istry to ob­tain nec­es­sary au­tho­riza­tions and then fi­nal­ize plans for dis­tri­b­u­tion in Is­rael, pend­ing reg­u­la­to­ry ap­proval.

Any fi­nan­cial de­tails re­main un­spec­i­fied.

And while the vac­cine is await­ing the A-OK from Is­rael’s health reg­u­la­tor, the biotech’s shot has earned con­di­tion­al mar­ket­ing au­tho­riza­tion in the EU and an emer­gency use list­ing from the WHO. This is while No­vavax con­tin­ues to run two Phase III tri­als — one in the US and Mex­i­co, and the oth­er in the UK.

Mol­nupi­ravir shows ac­tiv­i­ty against Omi­cron in pre­clin­i­cal in vit­ro stud­ies

Mer­ck and Ridge­back an­nounced Fri­day morn­ing that their col­lab­o­ra­tive an­tivi­ral mol­nupi­ravir po­ten­tial­ly neu­tral­izes the Omi­cron vari­ant.

Wendy Hol­man

The two com­pa­nies said da­ta are in from six pre­clin­i­cal stud­ies in Bel­gium, Czech Re­pub­lic, Ger­many, Poland, the Nether­lands and the Unit­ed States. Ridge­back CEO Wendy Hol­man said in a state­ment that “based on its mech­a­nism of ac­tion, along with these new find­ings demon­strat­ing in vit­ro ac­tiv­i­ty across mul­ti­ple vari­ants, in­clud­ing Omi­cron, we an­tic­i­pate that mol­nupi­ravir will con­tin­ue to be ac­tive against vari­ants of con­cern.”

These re­searchers didn’t just study how mol­nupi­ravir can af­fect Omi­cron — they al­so looked at oth­er vari­ants and test­ed oth­er drugs.

In one study, re­searchers in Japan wrote a let­ter to the ed­i­tor at NE­JM af­ter look­ing at Gilead’s remde­sivir, along­side mol­nupi­ravir and Pfiz­er’s new an­tivi­ral against Omi­cron. They came to the con­clu­sion that all three may show ef­fi­ca­cy against Omi­cron.

How­ev­er, they ex­pressed that what they found might be lim­it­ed be­cause of a lack of clin­i­cal da­ta, em­pha­siz­ing that ad­di­tion­al da­ta are need­ed to val­i­date their pre­lim­i­nary find­ings.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.