The EU is re­port­ed­ly work­ing to­ward a cen­tral­ized pro­cure­ment deal for small­pox vac­cines to tack­le the ris­ing num­ber of cas­es of mon­key­pox, ac­cord­ing to sources who spoke to the Fi­nan­cial Times.

An­drea Am­mon, di­rec­tor of Eu­rope’s CDC, told the FT that the Eu­ro­pean Com­mis­sion is “def­i­nite­ly look­ing at what can be done cen­tral­ly” and cen­tral pro­cure­ment is “one of the op­tions that are looked at but of course coun­tries are al­so” look­ing in­to bi­lat­er­al av­enues.

While small­pox was erad­i­cat­ed decades ago, a vac­cine for that virus is about 85% ef­fec­tive at pre­vent­ing mon­key­pox in­fec­tion, ac­cord­ing to WHO, and at least one undis­closed coun­try has placed a deal for Bavar­i­an Nordic’s vac­cine, Jyn­neos.

The EU news comes a day af­ter the deputy di­rec­tor of Africa CDC warned against vac­cine hoard­ing by wealth­i­er na­tions and two days af­ter Roche un­veiled three new tests to de­tect the virus. Aside from Jyn­neos, the FDA has al­so pre­vi­ous­ly ap­proved SIGA Tech­nolo­gies’ Tpoxx as a treat­ment for mon­key­pox in 2018.

Bavar­i­an Nordic told End­points in a state­ment that the com­pa­ny is speak­ing with Eu­rope’s Health Emer­gency Pre­pared­ness and Re­sponse Au­thor­i­ty and in­di­vid­ual coun­tries in the EU, but de­clined to pro­vide fur­ther com­ment “on spec­u­la­tion about po­ten­tial deals at this time.” — Kyle LaHu­cik

Mereo head­ed to AS­CO with TIG­IT drug da­ta as it seeks to stay on Nas­daq

UK on­col­o­gy biotech Mereo Bio­phar­ma is go­ing to AS­CO with da­ta from a Phase Ib/II com­bi­na­tion study with TIG­IT drug etig­ilimab and Bris­tol My­ers’ Op­di­vo (nivolum­ab). Ac­cord­ing to Mereo, the study looked at 27 ef­fi­ca­cy-evalu­able sub­jects with se­lect lo­cal­ly ad­vanced or metasta­t­ic sol­id tu­mors.

Out of the 27 pa­tients, 12 had a clin­i­cal ben­e­fit with 1 com­plete re­sponse, 2 par­tial re­spons­es, 9 sta­ble dis­ease des­ig­na­tions, and 15 sub­jects had “ra­di­o­log­i­cal/clin­i­cal pro­gres­sion.” In to­tal, Mereo is re­port­ing an over­all re­sponse rate of 11% and dis­ease con­trol rate of 44% — and no new safe­ty sig­nals.

While Mereo will be at AS­CO with a poster on this da­ta, it is al­ready keep­ing an eye on the fi­nan­cial side. Mereo al­so an­nounced Thurs­day that it re­ceived a let­ter from Nas­daq af­ter its Amer­i­can de­pos­i­to­ry shares failed to list at a min­i­mum bid price of $1 over the last 30 busi­ness days. Mereo $MREO not­ed that it had been giv­en 180 days — un­til Nov. 21, 2022 — to get its clos­ing bid price over $1 for 10 days in a row. If not, the biotech can be sub­ject to delist­ing, pend­ing a po­ten­tial fur­ther grace pe­ri­od or an ap­peal to a hear­ing pan­el. — Paul Schloess­er

The FDA’s Vaccine and Related Biological Products Advisory Committee on Tuesday gave the thumbs up — by a vote of 19-2 — that the FDA should require an Omicron-related component in this next season’s booster dose for Covid-19, which both Pfizer/BioNTech and Moderna are hard at work on.

And while neither booster will likely be ready to go with adequate supplies for all American adults by the beginning of the next school year, the situation is still complex and fluid, with CBER Director Peter Marks telling the committee that it’ll take companies at least three months to ready their supplies for this expected next wave.

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed.

IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported.