As US cas­es of the mon­key­pox out­break have now risen above 14,000, the gov­ern­ment is mov­ing quick­ly to make more dos­es avail­able, with the Jyn­neos vac­cine look­ing to be de­ployed wider as Bavar­i­an Nordic’s sites in Eu­rope get the all-clear from the FDA.

Mean­while, a Grand Rapids, Michi­gan-based CD­MO land­ed a deal with Bavar­i­an Nordic, to fill and fin­ish the vac­cine. Grand Riv­er Asep­tic Man­u­fac­tur­ing, a rel­a­tive­ly new play­er in the CD­MO world, on­ly be­ing around since 2010, an­nounced it re­ceived the deal from Bavar­i­an Nordic as well as ap­proval from HHS and BAR­DA to in­crease the do­mes­tic sup­ply of Jyn­neos.

Tom Ross, CEO of Grand Riv­er, said in an in­ter­view with End­points News, that a ma­jor rea­son why the com­pa­ny man­aged to net such a high-pro­file con­tract was due to the com­pa­ny’s pre­vi­ous work with BAR­DA in Op­er­a­tion Warp Speed, pro­duc­ing the J&J vac­cine dur­ing the height of the Covid-19 pan­dem­ic.

“When Bavar­i­an Nordic was look­ing for a US-based CD­MO I think we were one of the few com­pa­nies that BAR­DA had rec­om­mend­ed and that led to some dis­cus­sions and we were very im­pressed by Bavar­i­an Nordic I think they liked what we had to of­fer here and they came out and saw our fa­cil­i­ties,” Ross said to End­points.

Ross al­so added that an­oth­er piece that at­tract­ed Bavar­i­an Nordic was that Grand Riv­er has in­vest­ed a large amount of cap­i­tal to im­prove its fa­cil­i­ties re­cent­ly. The com­pa­ny net­ted a $120 mil­lion grant from the US gov­ern­ment to ex­pand its fill-fin­ish sites, with the com­pa­ny in­vest­ing $40 mil­lion of its own mon­ey to ex­pand its 80,000-square-foot, large-scale fill­ing fa­cil­i­ty and 200,000-square-foot fin­ish­ing cen­ter in Grand Rapids. The com­pa­ny has al­so re­cent­ly fin­ished two new man­u­fac­tur­ing lines in a $50 mil­lion in­vest­ment as well.

For the deal with Bavar­i­an Nordic, Grand Riv­er will re­ceive the bulk drug sub­stance and Grand Riv­er do­ing the for­mu­la­tion and fill­ing vials and even­tu­al­ly dis­trib­ute through Bavar­i­an’s dis­tri­b­u­tion chan­nel. Ross said that Grand Riv­er will be pro­duc­ing mil­lions of vials, but the ex­act num­ber is yet to be de­ter­mined as it is un­cer­tain how many dos­es will be need­ed.

While the fi­nan­cial terms of the deal were not dis­closed to End­points, the com­pa­ny is plan­ning to make more hires over the next two to three months and has al­ready ramped up the hir­ing process, Ross said.

And while the over­all deal came to­geth­er in a very short pe­ri­od, ac­cord­ing to Ross, the tech trans­fer is now kick­ing in­to gear in an ac­cel­er­at­ed fash­ion, but it will take a few months to get ful­ly up and run­ning as it con­ducts en­gi­neer­ing runs and oth­er process­es. Ross told End­points that full-scale com­mer­cial pro­duc­tion is ex­pect­ed to start in 2023 Ross said.

While Ross did not com­ment on the record if Grand Riv­er will net an­oth­er BAR­DA con­tract for mon­key­pox vac­cine man­u­fac­tur­ing, he did note that the sit­u­a­tion is a bit dif­fer­ent from the Covid-19 sit­u­a­tion that it has faced but that some of the el­e­ments re­main.

“It’s not as big as a COVID re­sponse, of course, but in terms of the in­ten­si­ty the tim­ing, and the ur­gency it’s all the same,” he said. “It’s im­por­tant to re­spond and try to do what we can col­lec­tive­ly to re­spond, and the vac­cine is one of the tools.”

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 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.

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.

Sen. Elizabeth Warren (D-MA) is calling on senior Federal Trade Commission officials to “closely scrutinize” two proposed pharma mergers.

Warren expressed concern over “rampant consolidation in the pharmaceutical industry,” in particular Amgen’s $28 billion plans to take over Horizon Therapeutics, and Indivior’s proposed acquisition of Opiant for $145 million upfront, in a letter to FTC Chair Lina Khan and Commissioners Alvaro Bedoya and Rebecca Kelly Slaughter earlier this week.