The US gov­ern­ment is sound­ing the alarm that com­ing up lat­er this year and in 2023, it won’t be able to pay for Covid-19 vac­cines, treat­ments and pro­phy­lac­tics mov­ing for­ward, and these prod­ucts will tran­si­tion to the com­mer­cial mar­ket.

While the US will dole out about 170 mil­lion of the up­com­ing bi­va­lent boost­ers for free this fall and win­ter, start­ing as ear­ly as Jan­u­ary 2023, the Biden ad­min­is­tra­tion an­tic­i­pates “no longer hav­ing fed­er­al funds to pur­chase or dis­trib­ute vac­cines and will need to tran­si­tion these ac­tiv­i­ties to the com­mer­cial mar­ket,” Dawn O’Con­nell, HHS’ as­sis­tant sec­re­tary for pre­pared­ness and re­sponse, wrote in a blog post yes­ter­day.

The drop-off in pay­ments comes as Con­gress couldn’t get its act to­geth­er to pass ad­di­tion­al fund­ing re­lat­ed to Covid-19, as Re­pub­li­cans pre­vi­ous­ly called on HHS to re­pur­pose mon­ey that it al­ready re­ceived in pri­or spend­ing pack­ages. But Sen­ate Dems late last month pro­posed $22 bil­lion in 2023 emer­gency sup­ple­men­tal fund­ing for the next phase of the pan­dem­ic, in­clud­ing $16 bil­lion to sup­port the R&D, man­u­fac­tur­ing, pur­chase and dis­tri­b­u­tion of vac­cines, ther­a­peu­tics, di­ag­nos­tics and oth­er med­ical coun­ter­mea­sures.

As far as when these tran­si­tions to the com­mer­cial mar­ket may oc­cur, on the ther­a­peu­tic side, where Eli Lil­ly’s bebtelovimab al­ready tran­si­tioned ear­li­er this month, the re­main­ing fed­er­al sup­ply of As­traZeneca’s pre­ven­ta­tive treat­ment Evusheld (about 750,000 cours­es of the 1.5 mil­lion or­dered re­main) as soon as ear­ly 2023, fol­lowed by Mer­ck’s oral an­tivi­ral Lagevrio (about 2.5 mil­lion cours­es re­main) some­time in Q1 or Q2 of next year, and Pfiz­er’s Paxlovid (7.3 mil­lion cours­es or­dered by states of the to­tal US or­der for 20 mil­lion cours­es) in mid-2023.

HHS yes­ter­day con­vened a meet­ing of more than 100 rep­re­sen­ta­tives from state and lo­cal gov­ern­ments, health care providers, in­sur­ers, phar­ma com­pa­nies, pa­tient ad­vo­cates, and more, to dis­cuss the path­way to com­mer­cial­iza­tion for both vac­cines and ther­a­peu­tics.

“Dur­ing the meet­ing, we dis­cussed our shared goals of tran­si­tion­ing these prod­ucts in a way that en­sures con­tin­ued eq­ui­table ac­cess for all Amer­i­cans and pre­pares us for what­ev­er may come next with this virus that has been any­thing but pre­dictable,” O’Con­nell said.

But all hope isn’t lost that Con­gress may find some agree­ment on ad­di­tion­al funds for Covid vac­cines and ther­a­peu­tics. Two top Re­pub­li­can sen­a­tors this week urged the Biden ad­min­is­tra­tion to put to­geth­er a plan for the next wave of vac­cine R&D.

Sens. Richard Burr of North Car­oli­na, who’s re­tir­ing this year, and James In­hofe of Ok­la­homa asked Biden to sub­mit to Con­gress a “con­crete pro­pos­al” to es­tab­lish an Op­er­a­tion Warp Speed 2.0 by the end of the year

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.

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.

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.