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It’s al­ways a bit­ter­sweet mo­ment say­ing good­bye, but as Josh Sul­li­van goes off to new ad­ven­tures we are grate­ful for the way he’s built up the End­points Man­u­fac­tur­ing sec­tion — which the rest of the team will now car­ry for­ward. If you’re not al­ready, this may be a good time to sign up for your week­ly dose of drug man­u­fac­tur­ing news. Thank you for read­ing and wish you a rest­ful week­end.

With a rapid rise of mon­key­pox cas­es caus­ing con­cerns around the world, vac­cine pro­cure­ment is weigh­ing on the mind of gov­ern­ment of­fi­cials. Bavar­i­an Nordic land­ed con­tracts with both the US’ BAR­DA and an un­named Eu­ro­pean coun­try to sup­ply its small­pox vac­cine, Jyn­neos. While the BAR­DA’s $119 mil­lion op­tion has a longer term time­frame, the Eu­rope pur­chase high­lights an “emer­gency sit­u­a­tion.” At the same time, Emer­gent BioSo­lu­tions ac­quired Tem­bexa, a small­pox treat­ment, from Chimerix for $225 mil­lion in cash. Ex­perts reck­on that small­pox vac­cines should of­fer some pro­tec­tion against mon­key­pox, and pre­vi­ous vac­ci­na­tions, cou­pled with the right pub­lic health re­sponse, should stem the cur­rent out­break.

For decades, pro­tein de­sign was a bi­o­log­i­cal bor­der­land. But in the last few years, a se­ries of break­throughs has sud­den­ly turned an aca­d­e­m­ic cu­rios­i­ty in­to a vi­able way of de­vel­op­ing new drugs, in­clud­ing ones that are more ac­cu­rate, more com­plex, or can be de­vel­oped faster than med­i­cines made through oth­er meth­ods. In his fi­nal End­points In Fo­cus, Ja­son Mast takes us in­side the lab of David Bak­er — once among the field’s long rangers — at the Uni­ver­si­ty of Wash­ing­ton’s In­sti­tute for Pro­tein De­sign to take a peek at how de­sign-based ap­proach­es are trans­form­ing drug de­vel­op­ment.

Mauled by the bear mar­ket, a mul­ti­tude of biotechs con­tin­ue to feel the heat — and the list might sur­prise you. Agios is shak­ing things up as 50 ex­plorato­ry re­search em­ploy­ees will be let go and CSO Bruce Car will de­part the com­pa­ny at the end of Ju­ly. With piv­otal da­ta still years away, Schol­ar Rock, the dark­horse SMA play­er, plans to lay off 39 peo­ple while CMO Yung Chyung steps down. French biotech Nanobi­otix, which IPO’d dur­ing the pan­dem­ic boom, is chop­ping pre­clin­i­cal re­search, amend­ing some on­go­ing stud­ies and mov­ing some em­ploy­ees ful­ly re­mote to stay afloat. San Fran­cis­co’s Ap­plied Mol­e­c­u­lar Trans­port will cut its work­force by 40% on top rolling back pro­grams, and among those leav­ing is its CSO. Small cap biotech Aque­s­tive, mean­while, didn’t pro­vide a rea­son for why long­time CEO Kei­th Kendall is hand­ing the ba­ton to COO Daniel Bar­ber.

Long­time CDER di­rec­tor Janet Wood­cock, who’s now serv­ing as FDA com­mis­sion­er Rob Califf’s prin­ci­pal deputy, would take on more of a role as “a strate­gic thought part­ner, with de­ci­sion-mak­ing au­thor­i­ties” at sev­er­al dif­fer­ent of­fices with­in the agency, ac­cord­ing to a new memo. In­sid­ers said the an­nounce­ment ef­fec­tive­ly means she won’t be re­turn­ing to or step­ping on the toes of any­one serv­ing in the var­i­ous roles she held pre­vi­ous­ly.

Days af­ter Mod­er­na sent new CFO Jorge Gomez pack­ing — af­ter just one day on the job — over an in­ves­ti­ga­tion launched by his for­mer em­ploy­er, the mR­NA biotech said it was blind­sided by the probe. Al­though den­tal equip­ment com­pa­ny Dentsply be­gan in­ves­ti­gat­ing Gomez in ear­ly March, Mod­er­na claimed it was un­aware un­til the pub­lic dis­clo­sure on May 10. It de­cid­ed to part ways with Gomez that same day. And Flag­ship’s Noubar Afeyan, who’s al­so chair of the Mod­er­na board, de­fend­ed the vet­ting and hir­ing process.

While calls to di­ver­si­fy clin­i­cal tri­als have grown loud­er in re­cent years — gain­ing sup­port from fed­er­al agen­cies such as the FDA and NIH — progress has large­ly stalled, ac­cord­ing to a new re­port that sug­gests swaths of pa­tients in mi­nor­i­ty groups con­tin­ue to be left out. Pfiz­er is delv­ing in­to the is­sue through a new part­ner­ship with Head­lands Re­search that aims to ini­ti­ate re­search sites in ar­eas with di­verse pop­u­la­tions, while J&J launched its “De­pres­sion Looks Like Me” cam­paign in hopes of nor­mal­iz­ing the dis­cus­sion around de­pres­sion — es­pe­cial­ly for peo­ple in the LGBTQ+ com­mu­ni­ty.

FI­NANC­ING

CORO­N­AVIRUS

MAR­KET­INGRX

MAN­U­FAC­TUR­ING

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

Pfizer’s second crack at steering a NASH candidate through a battered field seems to be going better than the first.

The pharma giant has scored the FDA’s fast track designation for an experimental combination therapy as a treatment for NASH with liver fibrosis. The combo consists of ervogastat, a diacylglycerol O-acyltransferase 2 inhibitor (DGAT2i), and clesacostat, an acetyl-CoA carboxylase inhibitor (ACCi).

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Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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