The FDA’s back­log of drug man­u­fac­tur­ing fa­cil­i­ty in­spec­tions con­tin­ues to be a sore spot for the agency, as FDA said Mon­day that a to­tal of 52 new drug (but no bi­o­log­ics) ap­pli­ca­tions still re­main de­layed due to the back­log from the pan­dem­ic.

And while the agency has main­tained that it won’t is­sue a CRL for a de­layed in­spec­tion, the num­ber of de­layed ap­pli­ca­tions is ris­ing as FDA said in May that 48 new drug ap­pli­ca­tions have been de­layed due to FDA’s in­abil­i­ty to con­duct pre-ap­proval, pre-mar­ket, or pre-li­cense in­spec­tions as of last March.

The agency’s in­abil­i­ty to work over­seas has al­so hurt its out­put well in­to 2021, with just 37 for­eign drug in­spec­tions be­tween April and Sep­tem­ber 2021. Pri­or to the pan­dem­ic, the FDA typ­i­cal­ly con­duct­ed about 1,000 for­eign drug in­spec­tions per year.

“FDA be­gan the new fis­cal year with on­go­ing trav­el re­stric­tions and oth­er un­cer­tain­ties con­tin­u­ing to im­pact over­sight op­er­a­tions. FDA is con­tin­u­ing to com­plete mis­sion-crit­i­cal work, pri­or­i­tize oth­er high­er-tiered in­spec­tion­al needs (e.g., for-cause in­spec­tions), and car­ry out sur­veil­lance in­spec­tions us­ing risk-based ap­proach­es for eval­u­at­ing pub­lic health im­pact,” FDA said in its new re­port.

The agency has sought to shift to more re­mote as­sess­ments of fa­cil­i­ties, but the le­gal de­f­i­n­i­tion of an in­spec­tion is one that is con­duct­ed on site.

“As we have done through­out the pan­dem­ic, FDA will use every op­tion avail­able to meet our reg­u­la­to­ry re­spon­si­bil­i­ties and pro­tect the pub­lic health, in­clud­ing con­tin­ued col­lab­o­ra­tion with state, lo­cal, trib­al, ter­ri­to­r­i­al, and for­eign reg­u­la­to­ry part­ners,” the agency added.

De­spite the back­log, there were a few bright spots in the re­port too.

In ear­ly 2021, the FDA es­ti­mat­ed that more than 15,000 sur­veil­lance in­spec­tions through­out the US had been post­poned thanks to the Covid-19 pan­dem­ic. The agency pre­dict­ed that it would com­plete 14% of those in­spec­tions, in­clud­ing 26% of the re­main­ing hu­man and an­i­mal med­ical do­mes­tic sur­veil­lance in­spec­tions. The agency ex­ceed­ed that num­ber two-fold, it re­port­ed, a com­ple­tion rat­ing of 134%.

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.

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.

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.