The FDA qui­et­ly an­nounced on Tues­day that just be­fore New Year’s eve, the agency again paused all of its non-mis­sion-crit­i­cal in­spec­tions in the US, like­ly lead­ing to an even larg­er back­log of in­spec­tions world­wide.

The pause, which will last at least two weeks, is meant to en­sure the safe­ty of FDA em­ploy­ees and the com­pa­nies it reg­u­lates as the agency fur­ther adapts to the spread of Omi­cron.

“Through Jan.19, the agency in­tends to con­tin­ue mis­sion-crit­i­cal work but has tem­porar­i­ly post­poned cer­tain in­spec­tion­al ac­tiv­i­ties with the hopes of restart­ing these ac­tiv­i­ties as soon as pos­si­ble,” the FDA said in a state­ment.

The agency had on­ly just re­turned to rel­a­tive­ly nor­mal do­mes­tic in­spec­tions last Ju­ly, af­ter a long pre­vi­ous pause that be­gan as the pan­dem­ic hit in ear­ly 2020. In a re­port from last No­vem­ber, the agency not­ed that 52 new drug ap­pli­ca­tions were de­layed as a re­sult of the in­spec­tion back­log cre­at­ed by that long pause.

On the for­eign in­spec­tion side, where ac­tiv­i­ties have still been most­ly on pause since ear­ly 2020, FDA said it’s post­pon­ing the plan­ning of pri­or­i­tized sur­veil­lance for­eign in­spec­tion as­sign­ments that were sched­uled to be­gin in Feb­ru­ary 2022.

But the FDA said it will con­tin­ue con­duct­ing mis­sion-crit­i­cal for­eign and do­mes­tic in­spec­tions.

Be­tween April and Sep­tem­ber 2021, the FDA said it com­plet­ed just 37 for­eign drug in­spec­tions, which com­pares with more than 1,200 in 2019.

And the FDA’s to­tal tal­ly for drug and bi­o­log­ic in­spec­tions in 2020 shows how the agency con­duct­ed 1,500 few­er in­spec­tions in 2020, when com­pared to 2019 (and over 2,600 few­er when com­pared to 2011). On­ly 74 in­spec­tions end­ed with an Of­fi­cial Ac­tion In­di­cat­ed in 2020, which com­pared with 202 OAIs in 2019.

The agency has sought to shift to more re­mote as­sess­ments of fa­cil­i­ties, but that hasn’t proven to be a ma­jor help as the back­log is filled most­ly with sur­veil­lance in­spec­tions, and the le­gal de­f­i­n­i­tion of an in­spec­tion is one that is con­duct­ed on site.

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.

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.

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.

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.