Johnson & Johnson

Johnson & Johnson announces MHRA authorization for BALVERSA® (erdafitinib) for treating adults with unresectable or metastatic urothelial carcinoma, specifically those with FGFR3 genetic alterations who have previously received PD-1 or PD-L1 inhibitor therapy. Erdafitinib, an FGFR kinase inhibitor, significantly improves overall and progression-free survival compared to chemotherapy, based on results from the Phase 3 THOR study.

Goodwin's two-part series on Greater China's life sciences sector highlights stable M&A activity in pharmaceutical/biotech despite market fluctuations. Notable 2024 deals include Fosun Pharma's $1.71B acquisition of Shanghai Henlius Biotech and Johnson & Johnson's $850M acquisition of Proteologix, Inc. Trends indicate a shift towards CAR-T cell therapies and large molecule/biologics, with medical devices also playing a significant role. Factors driving recovery include regulatory changes, market readjustments, and the maturing of early-stage investments.

Katherine Talcott, MD, discusses potential therapies for geographic atrophy (GA) secondary to age-related macular degeneration (AMD) at OSN New York 2024, highlighting ANX007, Danicopan ALXN 2040, AVD-104, JNJ-1887, ASP7317, RG6501, elamipretide, Glideuretinal, AREDS/AREDS2, and ONL1204. ANX007 showed significant protection from vision loss in the ARCHER Trial, while Danicopan ALXN 2040 is an oral agent inhibiting complement factor D. AVD-104 demonstrated visual acuity gains in the SIGLEC study. Gene therapies like JNJ-1887 and ASP7317 aim to protect retinal cells. Elamipretide showed positive effects on visual function in the ReCLAIM study. Glideuretinal and AREDS/AREDS2 are antioxidants, and ONL1204 is a Fas inhibitor reducing retinal cell apoptosis.

J&J's Balversa (erdafitinib) granted UK marketing authorization for treating unresectable or metastatic urothelial carcinoma with FGFR3 alterations, after prior PD-1/PD-L1 inhibitor therapy. Based on Phase III THOR study, erdafitinib showed improved overall and progression-free survival compared to chemotherapy.

Johnson & Johnson submits regulatory applications to FDA and EMA for DARZALEX FASPRO and DARZALEX SC formulations, seeking approval for high-risk smoldering multiple myeloma treatment, supported by Phase 3 AQUILA study data.

Johnson & Johnson seeks FDA and EMA approval for subcutaneous daratumumab and hyaluronidase-fihj (Darzalex Faspro) in high-risk smoldering multiple myeloma, supported by the AQUILA study. Initial AQUILA findings to be presented at the 2024 ASH Annual Meeting.

The FDA approved Johnson & Johnson’s Varipulse PFA Platform for drug-resistant paroxysmal AFib, featuring PFA therapy with the CARTO 3 system for ablation accuracy. The admIRE study showed 100% procedural success, 98% first-pass isolation, and 85% peak primary effectiveness. The platform integrates with CARTO 3 for efficient, fluoroscopy-free procedures, addressing the growing prevalence of AFib.

Johnson & Johnson submits regulatory applications to the U.S. FDA and European Medicines Agency for approval of a new indication for Darzalex Faspro in the U.S. and Darzalex subcutaneous formulation in the EU, supported by Phase 3 AQUILA study data for high-risk smoldering multiple myeloma.