Francis deSouza, Illumina CEO (Kevin Dietsch/Getty Images)

Ahead of ex­pect­ed EU ob­jec­tions, Il­lu­mi­na de­fends Grail ac­qui­si­tion

Ahead of ex­pect­ed ob­jec­tions by Eu­ro­pean reg­u­la­tors Wednes­day to its deal to ac­quire Grail, Il­lu­mi­na de­fend­ed it­self in pa­pers sub­mit­ted to the agen­cies Tues­day.

Il­lu­mi­na is an­tic­i­pat­ing a for­mal bloc ob­jec­tion to the $8 bil­lion Grail buy­out, it said in a brief­ing doc­u­ment for EU com­pe­ti­tion au­thor­i­ties, and tried to pre­empt the move by as­sert­ing the deal is not an­ti-com­pet­i­tive. It’s an ar­gu­ment Il­lu­mi­na has used pre­vi­ous­ly, but it’s un­clear whether or not the new brief will prove per­sua­sive.

Bloomberg and Reuters were the first to re­port the news late Tues­day.

As of press time Wednes­day morn­ing, it re­mained un­clear when ex­act­ly the ob­jec­tions would come, or what de­tails they might in­clude. Bloomberg re­port­ed, how­ev­er, that Il­lu­mi­na could face up to a $400 mil­lion fine.

Though Il­lu­mi­na faced an­titrust mea­sures from both the EU and the FTC, the biotech marched on ahead with the buy­out re­gard­less. In Au­gust, the com­pa­nies com­plet­ed the merg­er in a move that was seen as “provoca­tive,” per a Fi­nan­cial Times re­port at the time. Amer­i­can reg­u­la­tors ini­tial­ly sought an in­junc­tion to block the deal from clos­ing.

But once the an­titrust is­sues cropped up in Eu­rope, the FTC moved to con­duct its re­view in an in-house hear­ing rather than in the courts. Last month, the EU is­sued an or­der that Grail be kept as a sep­a­rate com­pa­ny and run by in­de­pen­dent man­agers. It was the first in a se­ries of in­ter­im mea­sures ex­pect­ed to try to un­do the ac­qui­si­tion be­fore the EU re­view ends next Feb­ru­ary.

Il­lu­mi­na found­ed Grail and spun it out in 2016, but an­nounced re-ac­qui­si­tion plans in Sep­tem­ber 2020. That news came just two weeks af­ter Grail had filed for a po­ten­tial­ly mas­sive IPO, aim­ing to com­bine Il­lu­mi­na’s ge­net­ic se­quenc­ing tech with Grail’s screen­ing tests for ear­ly can­cer de­tec­tion.

The move re­sult­ed in the com­pa­nies al­most im­me­di­ate­ly be­ing caught up in the FTC’s crosshairs, how­ev­er, with Pres­i­dent Joe Biden and new agency chair Lina Khan hav­ing sig­naled a more ag­gres­sive stance to­ward phar­ma M&A. Reg­u­la­tors had con­cerns over Il­lu­mi­na’s hold on the DNA se­quenc­ing mar­ket af­fect­ing po­ten­tial Grail com­pe­ti­tion, as all liq­uid biop­sy com­pa­nies re­ly on such tech­nol­o­gy.

It’s not the first time in re­cent years Il­lu­mi­na has po­ten­tial­ly run afoul of an­titrust reg­u­la­tors, as they suc­cess­ful­ly blocked the com­pa­ny’s at­tempt to ac­quire Pa­cif­ic Bio­sciences in ear­ly 2020.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

What's fair? New ICER re­port shows pay­ers gen­er­al­ly en­sur­ing fair ac­cess to drugs

The nonprofit Institute for Clinical and Economic Review on Wednesday released a new report highlighting the ways in which payers are generally ensuring fair access to prescription drugs, even when based on a set of criteria set by the nonprofit.

While noting the lack of transparency hindered the report’s results, ICER said that the “great majority” of payer policies in the formularies evaluated are structured in a way to support many key elements of how ICER defines “fair access.”

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi snaps up new vac­cine can­di­date and de­vis­es mR­NA game plan around it — but not for what you think

Paul Hudson has spotlighted vaccines, immunology and dermatology as some of the top R&D focuses at Sanofi. His latest deal brings all of them together.

The French pharma giant isn’t sharing any financial details about the buyout of Origimm, a low-profile, private Austrian biotech whose technology promises to identify antigens causing skin disease and build vaccines against them. Their lead candidate targets acne vulgaris.

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As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

GSK 'Target the Future' Ad Campaign

Glax­o­SmithK­line's friend­ly ‘shark tank’ crowd­sources ideas for mul­ti­ple myelo­ma, kicks off big­ger push

GlaxoSmithKline is inviting everyone to its friendly shark tank. Its “Think Tank” challenge launching today aims to gather the best pitches for ideas in multiple myeloma with a final pitch-off “Shark Tank” TV show-style finish next year.

The innovation contest kicks off GSK’s bigger “Target the Future” unbranded campaign to advance innovation and awareness in multiple myeloma.

“We have a good sense of where the unmet need lies and what tools may be welcomed by this community, and we’ll continue to do that as part of this program, but the ‘Think Tank’ kickoff is to bring new ideas to the table — things that come from a more grassroots perspective than a large pharma perspective,” Christine Roth, senior VP and global head of oncology at GSK, said.

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