Covid-19 roundup: Mod­er­na sends in EUA for bi­va­lent teen boost­er; US trim­ming Pfiz­er/BioN­Tech do­na­tions

Though Mod­er­na’s bi­va­lent vac­cine to counter the Omi­cron vari­ant has cleared the ini­tial hur­dles in get­ting FDA au­tho­riza­tion, the vac­cine mak­er is mov­ing on to the next step.

On Twit­ter, the com­pa­ny an­nounced on Fri­day that it has filed a EUA for its bi­va­lent vac­cine for use in ado­les­cents aged 12 through 17 and for small­er chil­dren aged six through 11.

In an­oth­er tweet, Mod­er­na stat­ed that the ap­pli­ca­tion for chil­dren aged six months through six years of age will like­ly be fin­ished lat­er in the year.

Reg­u­la­to­ry bod­ies have been mov­ing fast on the new boost­ers as Mod­er­na got the OK from UK reg­u­la­tors in the mid­dle of Au­gust, with the FDA al­so giv­ing the thumbs up for both Mod­er­na’s and Pfiz­er/BioN­Tech’s bi­va­lent shots a few weeks lat­er. How­ev­er, those au­tho­riza­tions did not come with any new hu­man da­ta, and crit­ics ques­tioned the ef­fec­tive­ness of pre­vent­ing deaths or hos­pi­tal­iza­tions.

The lat­est da­ta from the CDC show that cas­es are trend­ing down­ward, for the time be­ing, but the US is still deal­ing with an av­er­age of over 54,000 cas­es and 347 deaths per day over the last week.

US re­duc­ing num­ber of Pfiz­er/BioN­Tech vac­cine do­na­tions as de­mand wanes

Last year, the Biden ad­min­is­tra­tion pledged to do­nate 500 mil­lion dos­es of the Pfiz­er/BioN­Tech vac­cine to 92 low- and mid­dle-in­come coun­tries as part of a wider do­na­tion of 1 bil­lion dos­es. How­ev­er, that do­na­tion is be­ing cur­tailed.

Ac­cord­ing to a re­port from Reuters, the US will cut down on the num­ber of dos­es it will de­liv­er by the end of 2022 to 600 mil­lion dos­es. Reuters said that Pfiz­er has enough sup­ply to de­liv­er the full or­der of 1 bil­lion, but that it is see­ing re­duced de­mand in the de­liv­ery ar­eas pri­mar­i­ly due to hes­i­tan­cy and “bar­ri­ers in ad­min­is­tra­tion.”

Pfiz­er has re­port­ed­ly de­liv­ered 400 mil­lion dos­es to 79 coun­tries as part of the or­der thus far.

While the dos­es may be on the down­swing, Pfiz­er is still boost­ing its do­na­tions of Paxlovid. The com­pa­ny, in a state­ment on Thurs­day, agreed to sup­ply up to six mil­lion dos­es of the an­tivi­ral to the Glob­al Fund. The fund plans to dis­trib­ute dos­es to low- and mid­dle-in­come na­tions as well.

It al­so has an agree­ment to sup­ply four mil­lion dos­es of Paxlovid to UNICEF al­so.

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.

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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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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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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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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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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Astel­las, Pan­th­er­na add or­gan to mR­NA tie-up; Rock­et launch­es sale of six fig­ures worth of stock

Astellas and Pantherna have expanded their November 2021 pact surrounding the latter’s mRNA platform to include a new target organ, the duo announced Tuesday morning, though they did not specify what that target is.

German biotech Pantherna is home to two platform technologies — one that designs mRNAs for non-vaccine therapies and another that designs LNPs. Astellas and Pantherna’s deal appears to mainly revolve around the first platform, which Astellas said it is using to research direct reprogramming, or turning cells from one kind into another without an intermediate stem cell phase.

Take­da to pull key hy­poparathy­roidism drug from the mar­ket en­tire­ly by end of 2024 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.

The decision to not re-commercialize Natpara will be a blow to not only the 2,400 people who were awaiting supplies of their reliable injection since 2019, but also the additional nearly 400 people who were accessing the drugs via the company’s Special Use Program as Takeda sought to resolve these manufacturing issues over the past five years.