With a jam-packed pipeline to parse, No­var­tis chief Vas Narasimhan has helped in­vestors out in the past by high­light­ing a few key pro­grams his team thinks could be easy win­ners. One of those drugs has now hit the skids in two late-stage tests, los­ing some of its lus­ter as a po­ten­tial cen­ter­piece med­i­cine mov­ing ahead.

No­var­tis’ lige­lizum­ab, a “high-affin­i­ty” an­ti-im­munoglob­u­lin E an­ti­body failed to beat out stan­dard-of-care Xo­lair — its own part­nered drug with Genen­tech — in two Phase III stud­ies in pa­tients with the skin dis­ease chron­ic spon­ta­neous ur­ticaria, the com­pa­ny said Mon­day.

In the Phase III PEARL-1 and PEARL-2 stud­ies, lige­lizum­ab best­ed a place­bo con­trol af­ter 12 weeks of dos­ing but couldn’t match up to Xo­lair in re­duc­ing pa­tients’ symp­toms. The drug­mak­er will dive in­to these da­ta as it re­con­sid­ers its path for­ward for the drug in this dis­ease, No­var­tis said.

John Tsai

No­var­tis R&D chief John Tsai added: “We are dis­ap­point­ed that we have been un­able to demon­strate su­pe­ri­or ef­fi­ca­cy for lige­lizum­ab ver­sus stan­dard of care in the treat­ment of CSU. We will con­tin­ue to eval­u­ate the po­ten­tial for lige­lizum­ab to bring ben­e­fit to pa­tients in the ar­eas of chron­ic in­ducible ur­ticaria (CIn­dU) and food al­ler­gy, where there is sig­nif­i­cant un­met need.”

The set­back comes just weeks af­ter Narasimhan tout­ed the can­di­date as a like­ly win­ner. No­var­tis is still plan­ning to pur­sue lige­lizum­ab’s case in in­ducible ur­ticaria and food al­ler­gy, where it still be­lieves the can­di­date has a chance of suc­cess. This set­back against Xo­lair is par­tic­u­lar­ly vex­ing giv­en that lige­lizum­ab showed head-to-head ben­e­fit over Xo­lair in re­duc­ing hives in a Phase IIb dose-find­ing study.

As lige­lizum­ab’s chances in this dis­ease fal­ter, No­var­tis has al­so tri­aled remi­bru­ti­nib, its next-gen BTK in­hibitor, in mul­ti­ple Phase III tri­als in CSU, hop­ing for a bet­ter re­sult.

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.

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.

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.