⇨ Bio­Marin says that the FDA is in­di­cat­ing that it won’t be hold­ing a pan­el re­view for peg­valiase as a new treat­ment for phenylke­tonuria (PKU). That is like­ly to some­what im­prove its odds of suc­cess, with a pri­or­i­ty re­view and a PDU­FA date of Feb­ru­ary 28, 2018.

⇨ Flex­ion Ther­a­peu­tics has sent a no­tice to As­traZeneca ter­mi­nat­ing their deal on FX005’s sus­tained-re­lease p38 MAP, or mi­to­gen-ac­ti­vat­ed pro­tein, ki­nase in­hibitor de­vel­op­ment pro­gram. Flex­ion has dumped the drug from its pipeline.

⇨ Cana­da’s Ab­Cellera Bi­o­log­ics has forged a deal with GSK where it will ap­ply its high-through­put sin­gle-cell an­ti­body screen­ing plat­form to iden­ti­fy an­ti­bod­ies against an undis­closed mem­brane pro­tein tar­get.

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.