Rachael Rollins (Charles Krupa/AP Images)

US seeks jail time for co-CEO of New Eng­land com­pound­ing cen­ter af­ter dead­ly 2012 fun­gal out­break

The US at­tor­ney for the dis­trict of Mass­a­chu­setts late last week called on the state’s dis­trict court to sen­tence the for­mer co-own­er of the now-de­funct New Eng­land Com­pound­ing Cen­ter to 18 months of jail time for his role in the cen­ter’s qual­i­ty de­vi­a­tions that led to more than 100 peo­ple dead from a fun­gal menin­gi­tis out­break.

Gre­go­ry Conigliaro was con­vict­ed of con­spir­ing with more than a dozen oth­ers at NECC to de­ceive the FDA and mis­rep­re­sent the fact that the cen­ter was on­ly dis­pens­ing drugs pur­suant to pa­tient-spe­cif­ic pre­scrip­tions.

Rachael Rollins, US at­tor­ney for the dis­trict of Mass­a­chu­setts, said this de­cep­tion oc­curred de­spite know­ing­ly ship­ping drugs in bulk across the na­tion.

Samir Nasr, the then-head of the FDA’s com­pound­ing team tes­ti­fied that the NECC “al­ways kept say­ing: We do pa­tient-spe­cif­ic. We are a com­pound­ing phar­ma­cy. We are reg­u­lat­ed by the state. We’re not – the FDA does not have ju­ris­dic­tion over us,” with Rollins adding:

Through this de­ceit, Conigliaro and NECC were able to avoid the FDA’s over­sight au­thor­i­ty—and the FDA’s re­quire­ment that drug-man­u­fac­tur­ers fol­low cGMPs—and op­er­ate in a slip­shod, un­safe man­ner, ul­ti­mate­ly lead­ing to the trag­ic out­break of fun­gal menin­gi­tis that killed more than one hun­dred in­di­vid­u­als and in­jured many hun­dreds more.

And while Conigliaro was not in­volved in the com­pound­ing of the preser­v­a­tive-free methyl­pred­nisolone ac­etate that led to the fun­gal menin­gi­tis out­break, nor did he over­see or work in the clean rooms where those and oth­er sub­stan­dard drugs were com­pound­ed, Rollins said that Conigliaro

com­mit­ted a grave, se­ri­ous of­fense—ob­struct­ing the work of a fed­er­al agency—the FDA—whose role is pre­cise­ly to en­sure the safe­ty, pu­ri­ty, and ef­fi­ca­cy of man­u­fac­tured drugs. He did so through lies, false schemes, and mis­rep­re­sen­ta­tions—all in ser­vice of NECC’s prof­its—of which Conigliaro re­ceived mil­lions of dol­lars. Conigliaro’s dan­ger­ous, and ul­ti­mate­ly dead­ly, of­fense war­rants a se­vere and sig­nif­i­cant pun­ish­ment.

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

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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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.