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

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024.

The decision to not re-commercialize Natpara will be a blow to not only the 2,400 people who were awaiting supplies of their reliable injection since 2019, but also the additional nearly 400 people who were accessing the drugs via the company’s Special Use Program as Takeda sought to resolve these manufacturing issues over the past five years.

Astellas and Pantherna have expanded their November 2021 pact surrounding the latter’s mRNA platform to include a new target organ, the duo announced Tuesday morning, though they did not specify what that target is.

German biotech Pantherna is home to two platform technologies — one that designs mRNAs for non-vaccine therapies and another that designs LNPs. Astellas and Pantherna’s deal appears to mainly revolve around the first platform, which Astellas said it is using to research direct reprogramming, or turning cells from one kind into another without an intermediate stem cell phase.

KalVista took a beating Tuesday after announcing it would scrap a Phase II trial for one of its experimental drugs.

The biotech said in an early morning press release that it is terminating the study for KVD824 after multiple patients in every treatment group saw unsafe, elevated levels of certain liver enzymes. By ending the trial now, KalVista hopes to save some money and funnel it toward another study for its lead program, CEO Andrew Crockett said in a statement.

Adamis Pharmaceuticals is slowly tumbling down, and the biotech is looking at all its options.

After a Phase II/III trial failure last month that sent the penny stock player down an additional 50% to just 15 cents a share, the company said Monday that it is examining options to get the best value for its investors. A statement from Adamis indicates that alternatives include anything from a partnership to a sale of Adamis’ two commercial products, Zimhi and Symjepi.