→ Daniel Menichel­la, the CEO of Cure­Vac and the face of its re­cent en­deav­ors to de­vel­op an mR­NA vac­cine against Covid-19, is step­ping down. Founder In­g­mar Ho­err is back in charge; the tran­si­tion hap­pens just days af­ter Menichel­la at­tend­ed the high-pro­file White House coro­n­avirus R&D meet­ing along­side oth­er bio­phar­ma ex­ecs. While Ho­err thanked Menichel­la for “his lead­er­ship hav­ing built a ter­rif­ic glob­al team” and ex­tolled the pipeline that he left be­hind, no rea­son was giv­en for the sud­den de­par­ture.

→ Al­most two years af­ter Mer­ck first hand­ed Sutro $60 mil­lion to start on im­munomod­u­la­to­ry drug dis­cov­ery, the part­ners are ex­tend­ing the re­search term by one year to seek more cy­tokine de­riv­a­tive pro­grams. One can­di­date gen­er­at­ed on the plat­form is mov­ing to­ward IND-en­abling stud­ies, CEO Bill Newell said.

→ Sum­mit, NJ-based En­gage Ther­a­peu­tics said its drug-de­vice com­bo hit the pri­ma­ry end­point on halt­ing seizures with­in two min­utes in a Phase IIb study. In the tri­al, pa­tients in­hale al­pra­zo­lam (aka Xanax) through the Stac­ca­to de­vice, which com­pris­es a heat­ing sub­strate, a thin film of the drug and an air­way. Study in­ves­ti­ga­tor Jacque­line French of NYU Lan­gone Health’s Com­pre­hen­sive Epilep­sy Cen­ter calls it an EpiPen-like res­cue treat­ment and plans to ini­ti­ate a Phase III lat­er this year.

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.