Eu­ro­pean Com­mis­sion lays ground­work to un­wind Il­lu­mi­na's $7B+ Grail merg­er

The Eu­ro­pean Com­mis­sion has rec­om­mend­ed steps that — though not yet fi­nal — would re­quire Il­lu­mi­na to “swift­ly” un­wind its con­tro­ver­sial $7.1 bil­lion Grail buy­out.

The Com­mis­sion de­liv­ered a “state­ment of ob­jec­tions” on Mon­day, de­tail­ing the process Il­lu­mi­na would need to take in di­vest­ing Grail, its blood test­ing spin­out launched in 2016. Il­lu­mi­na re-ac­quired Grail back in Au­gust, de­spite crit­i­cism from both the FTC and EU.

The FTC filed a com­plaint against the merg­er last March over con­cerns that it would sti­fle in­no­va­tion for liq­uid biop­sy can­cer screen­ing tests called mul­ti-can­cer ear­ly de­tec­tion (MCED) tests, which are de­vel­oped by Grail.

“With this trans­ac­tion, Il­lu­mi­na would have an in­cen­tive to cut off GRAIL’s ri­vals from ac­cess­ing its tech­nol­o­gy, or oth­er­wise dis­ad­van­tage them,” Eu­ro­pean Com­mis­sion EVP Mar­grethe Vestager said in a state­ment ear­li­er this year.

Il­lu­mi­na, how­ev­er, ar­gued that the merg­er is “pro-com­pet­i­tive and will ac­cel­er­ate in­no­va­tion.”

“Il­lu­mi­na can make GRAIL’s life-sav­ing mul­ti-can­cer ear­ly de­tec­tion test more avail­able, more af­ford­able, and more ac­ces­si­ble – sav­ing lives and low­er­ing health­care costs,” gen­er­al coun­sel Charles Dadswell pre­vi­ous­ly said in a news re­lease.

While the FTC com­plaint was dis­missed in Sep­tem­ber, the EU blocked the ac­qui­si­tion just days lat­er.

In fol­low­ing that de­ci­sion, the Com­mis­sion said in its rec­om­men­da­tions on Mon­day that Il­lu­mi­na should “re­store GRAIL’s in­de­pen­dence from Il­lu­mi­na, to the same lev­el that GRAIL had pri­or to the com­ple­tion of the trans­ac­tion.”

It al­so pro­posed that “GRAIL must be as vi­able and com­pet­i­tive af­ter the di­vest­ment as it was be­fore Il­lu­mi­na’s ac­qui­si­tion, to en­sure that the in­no­va­tion race be­tween GRAIL and its ri­vals can con­tin­ue as be­fore,” and en­sure that Grail and Il­lu­mi­na re­main sep­a­rate un­til the busi­ness­es are un­wound.

The rec­om­men­da­tions are not yet fi­nal, leav­ing room for both Grail and Il­lu­mi­na to re­spond. Il­lu­mi­na told End­points News in an emailed state­ment that it has ap­pealed the EU’s Sep­tem­ber de­ci­sion to pro­hib­it the deal, and that the “di­vest­ment or­der should be stayed” un­til the ap­peal is re­solved.

“We be­lieve di­vest­ment is not pro­por­tion­al to the spec­u­la­tive harm al­leged by the Com­mis­sion, es­pe­cial­ly giv­en the ben­e­fits this merg­er will bring to pa­tients in the EU and across the globe,” a spokesper­son said. “Il­lu­mi­na has sep­a­rate­ly ap­pealed a Ju­ly 2022 de­ci­sion by the Gen­er­al Court of the Eu­ro­pean Union re­gard­ing the Eu­ro­pean Com­mis­sion’s ju­ris­dic­tion to chal­lenge the GRAIL deal.”

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.