Days af­ter En­her­tu reeled in an­oth­er FDA nod, with the first-ever green light for HER2-low breast can­cer, an­oth­er an­ti­body drug con­ju­gate biotech claims it has se­cured the largest pre­clin­i­cal ADC pact to date for a sin­gle as­set.

As­traZeneca and Dai­ichi Sankyo made waves with their near­ly $7 bil­lion col­lab­o­ra­tion back in spring 2019, but at that point, En­her­tu was al­ready near­ing the FDA’s doors with clin­i­cal da­ta. The lat­est ADC tie-up to en­ter the bio­phar­ma fray cen­ters around a pre­clin­i­cal as­set, Mer­sana Ther­a­peu­tics’ XMT-2056.

Pro­topa­pas called the GSK col­lab­o­ra­tion the “biggest pre­clin­i­cal ADC deal ever” for a sin­gle as­set. Im­muno­Gen, which will hear back from the FDA by Nov. 28 on its own ADC, inked a $1.7 bil­lion biobuck deal with Eli Lil­ly in Feb­ru­ary, but that was for mul­ti­ple po­ten­tial tar­gets.

Mer­sana it­self signed a bil­lion-dol­lar, back­end-heavy deal ear­li­er this year, com­ing to­geth­er with John­son & John­son in a $40 mil­lion up­front agree­ment.

With the up­front cash from GSK and $225.1 mil­lion as of June 30, Mer­sana has enough mon­ey to bankroll op­er­a­tions in­to the first half of 2024, the biotech said Mon­day af­ter the clos­ing bell.

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.