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.”

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

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, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.