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Fierce Pharma
fiercepharma. com > manufacturing > lessons-learned-kite-prepares-hit-ground-running-next-gen-car-t-decision-looms

With "lessons learned," Kite prepares to hit the ground running as next-gen CAR-T decision looms

10+ hour, 10+ min ago  (1002+ words) After recalibrating its production strategy in the late 2010s to better meet the realities of the CAR-T market, Gilead Sciences" Kite Pharma is preparing to hit the ground running with the potential approval of a next-generation multiple myeloma cell therapy later…...

Fierce Pharma
fiercepharma. com > marketing > pfizer-drafts-fernando-mendoza-new-face-its-game-inches-cancer-campaign

Pfizer drafts Fernando Mendoza as new face of its "game of inches" cancer campaign

4+ day, 16+ hour ago  (370+ words) Pfizer is kicking off the next stage of its cancer awareness program by teaming up with quarterback Fernando Mendoza. Back in February, Pfizer turned to one of the most iconic pep talks of all time as inspiration for its latest…...

Fierce Pharma
fiercepharma. com > pharma > citizen-petition-behalf-unnamed-pharma-calls-fda-tighten-its-crl-disclosure-practices

FDA citizen petition calls on agency to tighten up CRL disclosure practices

5+ day, 14+ hour ago  (423+ words) The FDA's new practice of releasing redacted complete response letters (CRLs) in the name of "radical transparency" is ruffling some feathers in the drug industry, as illustrated through a new petition filed on behalf of an unnamed pharma." The citizen…...

Fierce Pharma
fiercepharma. com > pharma > samsung-biologics-continues-growth-beat-labor-union-rally-sets-strike-motion

Samsung Biologics posts massive revenue growth as labor union rally sets strike in motion

6+ day, 14+ hour ago  (694+ words) Samsung Bio is bringing its financial hot streak into 2026, with no signs of stopping'save for a potential worker strike bubbling beneath the surface of its record-high revenues." The South Korean CDMO reported first-quarter revenues of 1. 26 trillion Korean won ($851. 9 million), good…...

Fierce Pharma
fiercepharma. com > pharma > merck-widens-its-foothold-hiv-treatment-market-fda-nod-novel-combo-pill-idvynso

Merck amps up presence in HIV treatment market with FDA nod for novel combo pill Idvynso

1+ week, 10+ hour ago  (299+ words) Merck is carving out its own place in the evolving HIV treatment space with an FDA approval for its Idvynso, a combination regimen that brings its novel islatravir'to market for the first time and serves as the cornerstone of what…...

Fierce Pharma
fiercepharma. com > pharma > sanofi-touts-tolerability-covid-shot-nuvaxovid-head-head-trial-vs-modernas-mnexspike

Sanofi touts tolerability of COVID shot Nuvaxovid in head-to-head trial vs. Moderna's m NEXSPIKE

1+ week, 1+ day ago  (348+ words) Sanofi's protein-based vaccine Nuvaxovid has conquered Moderna's next-generation messenger RNA shot m NEXSPIKE in a head-to-head trial assessing the tolerability of the two COVID vaccines. In the phase 4 double-blind, real-world study, which included 1, 000 adult participants in the United States, Nuvaxovid…...

Fierce Pharma
fiercepharma. com > ai-and-machine-learning > novartis-ceo-vas-narasimhan-joins-anthropic-board-pharmas-link-ai-deepens

Novartis CEO Vas Narasimhan joins Anthropic board as biopharma's ties to AI deepen

1+ week, 6+ day ago  (490+ words) AI heavyweight Anthropic has appointed Novartis CEO Vas Narasimhan to its board of directors as the link between the pharmaceutical industry and Silicon Valley deepens. Narasimhan shares Anthropic's vision that healthcare and life sciences are among the areas where AI…...

Fierce Pharma
fiercepharma. com > pharma > landmark-fsgs-nod-hand-travere-plots-path-grabbing-filsparis-3b-us-opportunity

Travere maps course for Filspari's $3 B US opportunity after landmark rare disease nod

2+ week, 6+ hour ago  (394+ words) With the path to blockbusterland now in sight, Travere Therapeutics is ready to hit the ground running after Monday's landmark approval for Filspari in focal segmental glomerulosclerosis (FSGS)." Together with the Ig AN population that the drug already covers, Filspari…...

Fierce Pharma
fiercepharma. com > marketing > pfizer-rebuked-fda-misleading-adcetris-ads-facebook

Pfizer rebuked by FDA for misleading Adcetris ads on Facebook

2+ week, 21+ hour ago  (333+ words) The FDA has scolded Pfizer over Facebook ads for the cancer drug Adcetris, accusing the Big Pharma of failing to adequately communicate the indication, contraindications and risks. Continuing a wave of actions against drug ads in recent weeks, the FDA'sent…...

Fierce Pharma
fiercepharma. com > pharma > corcepts-lead-drug-bounces-back-fda-snub-1st-approval-lifyorli-ovarian-cancer

Corcept's lead drug bounces back from FDA snub with different approval as Lifyorli in ovarian cancer

1+ mon, 3+ day ago  (612+ words) With a new U. S. green light in certain ovarian cancer patients, Corcept Therapeutics has redeemed its lead asset relacorilant after stumbling at the finish line in a separate indication late last year." The FDA has given the all-clear to Corcept's class-first…...