Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP)

As­traZeneca wins fed­er­al class-ac­tion suit, judge dis­miss­es share­hold­er­s' mis­lead­ing claims

As­traZeneca nev­er got its Covid-19 vac­cine au­tho­rized in the US, and while share­hold­ers have tried tak­ing the UK phar­ma to court, a judge has now squashed that ef­fort.

Fed­er­al Judge Paul Oetken of the US South­ern Dis­trict of New York ap­proved the phar­ma com­pa­ny’s mo­tion Mon­day to dis­miss a class ac­tion suit. The law­suit al­leged the com­pa­ny made mis­lead­ing state­ments about the clin­i­cal test­ing of its Covid-19 vac­cine can­di­date AZD1222.

The suit was filed over mul­ti­ple is­sues cer­tain share­hold­ers raised in the phar­ma’s clin­i­cal tri­al. Al­leged fail­ures in­clud­ed As­traZeneca giv­ing some par­tic­i­pants half the prop­er dose of a vac­cine, and ac­cord­ing to the amend­ed com­plaint, “the Phase II/III clin­i­cal tri­als for AZD1222 con­sist­ed of a patch­work of dis­parate pa­tient sub­groups, each with sub­tly dif­fer­ent treat­ments, un­der­min­ing the va­lid­i­ty and im­por­tant of the con­clu­sions that could be drawn from the clin­i­cal da­ta across these dis­parate pa­tient pop­u­la­tions.” The le­gal ac­tion was filed in ear­ly 2021.

As­traZeneca filed a mo­tion to dis­miss, say­ing that the com­plaint did not state a claim.

Oetken was not con­vinced that the phar­ma made any in­ac­cu­rate state­ments. In his rul­ing, he wrote, “There is no gen­er­al­ized du­ty to dis­close neg­a­tive facts,” per prece­dent in oth­er cas­es.

“Plain­tiffs have not iden­ti­fied any in­ac­cu­rate, mis­lead­ing or in­com­plete state­ment re­lat­ing to AZD1222’s dos­ing dur­ing As­traZeneca and Ox­ford’s phase 2/3 clin­i­cal tri­als for AZD1222,” the judge wrote, adding that every­thing the plain­tiffs iden­ti­fied was com­plete­ly ac­cu­rate.

Be­yond that, the judge not­ed a few oth­er is­sues in the plain­tiff’s case for rea­sons why he threw it out: The plain­tiffs did not com­ply with his court’s in­di­vid­ual rules on amend­ing its com­plaint, de­spite hav­ing op­por­tu­ni­ty to do so; plain­tiffs did not sug­gest how they would amend the al­ready-amend­ed com­plaint to rem­e­dy the grounds for dis­missal; and on top of those fac­tors, “the Court con­cludes that amend­ment would be fu­tile un­der the cir­cum­stances.”

Mon­day’s rul­ing re­flects what As­traZeneca CEO Pas­cal So­ri­ot told the BBC in June. Re­gard­ing its Covid-19 vac­cine de­vel­op­ment, he said, “I don’t think I would do any­thing dif­fer­ent­ly from what we did.”

As­traZeneca did not re­spond to a re­quest for com­ment from End­points News in time for pub­li­ca­tion.

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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Bob Duggan (Duggan Investments)

Biotech bil­lion­aire Bob Dug­gan flies the white flag as Sum­mit hunts a new own­er, or part­ner, for sole clin­i­cal-stage ef­fort

Bob Duggan’s Summit Therapeutics $SMMT is running out of moves for its sole clinical-stage candidate.

The biotech issued a terse statement in an SEC filing that it’s pulling the plug on the only active clinical trial for ridinilazole, which has been through a failed late-stage trial for C. difficile. A pediatric study is being curtailed as Summit says it decided a few days ago to either partner out the therapy or get a buyer — if they can find one.

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User fees in ac­tion: FDA un­veils new short­ened sup­ple­ment re­view, rare dis­ease pi­lots

Thanks to PDUFA VII, signed into law last Friday by President Joe Biden, the FDA this week unveiled two new industry-friendly pilot programs to advance new rare disease endpoints via additional meetings, and to shorten FDA review times for supplemental apps aimed at unmet medical needs.

The agency this week released eagerly-awaited details behind the shortened pilot, known as the Split Real Time Application Review or STAR pilot program, which will speed up certain FDA reviews of efficacy supplements across all therapeutic areas (thanks to earlier submissions of data), but only for those that propose addressing an unmet medical need.

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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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