A non­prof­it drug man­u­fac­tur­er is mov­ing for­ward with plans to stem the ris­ing tide of in­sulin costs in the US.

Utah-based Civi­ca has se­lect­ed Ger­man-based re­search or­ga­ni­za­tion Pro­fil as its hu­man clin­i­cal tri­al part­ner to sup­port the de­vel­op­ment of Civi­ca’s af­ford­able in­sulins. Civi­ca is plan­ning to pro­duce three in­sulin biosim­i­lars – dubbed glargine, lispro and as­part – each of which will be avail­able both in vials and pre-filled pens.

Civi­ca has plans to sell the in­sulins at sig­nif­i­cant­ly low­er prices than what is cur­rent­ly avail­able on the mar­ket, al­though the House re­cent­ly passed a Pres­i­dent Joe Biden-backed cap on in­sulin prices at $35 per month. The Sen­ate has yet to vote on the bill.

“The need for af­ford­able in­sulin is ur­gent, es­pe­cial­ly for unin­sured and un­der­in­sured pop­u­la­tions. With its ex­ten­sive ex­pe­ri­ence and qual­i­ty track record, Pro­fil is the ide­al clin­i­cal tri­al part­ner for Civi­ca,” said Civi­ca CEO Ned Mc­Coy in a state­ment.

Found­ed in 1999, Pro­fil is a full-ser­vice CRO that be­gan as a spin-off from the Uni­ver­si­ty of Dus­sel­dorf. Since its found­ing, the com­pa­ny has en­gaged in sev­er­al stud­ies re­lat­ed to di­a­betes and obe­si­ty.

Civi­ca is plan­ning to set its prices at $30 per vial max and no more than $55 for a box of five pen car­tridges, with those prices avail­able to those who are both in­sured and non-in­sured. How­ev­er, Civi­ca’s plans are con­tin­gent on FDA ap­proval and the com­pa­ny is an­tic­i­pat­ing that its in­sulins will be avail­able for pur­chase be­gin­ning in 2024.

The is­sue of more af­ford­able in­sulin has be­come a ma­jor top­ic of dis­cus­sion as of late, while the price has con­tin­ued to steadi­ly rise over the past sev­er­al years.

For Civi­ca, the com­pa­ny has been on this path since its found­ing in 2018 and has been gain­ing mo­men­tum over the past year. In 2021, the com­pa­ny an­nounced plans to in­vest $124.5 mil­lion to build its first in-house man­u­fac­tur­ing op­er­a­tion in Pe­ters­burg, VA, which is ex­pect­ed to be open by 2024.

While those still pay­ing heady amounts for in­sulin wait for con­gress or Civi­ca, ac­cord­ing to GoodRx, the cheap­est in­sulin glargine vial is about $125, while the cheap­est in­sulin lispro vial is about $360, and the cheap­est in­sulin as­part pack of 5 pens is about $90.

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.