Johnson & Johnson

Lykos Therapeutics CEO Amy Emerson to step down after FDA rejection of MDMA therapy aid approval. Michael Mullette appointed interim CEO. Company plans to cut 75% of workforce and resubmit MDMA approval application.

Evernorth Health Services will offer a private-label biosimilar of Stelara (ustekinumab) starting in early 2025, with a price over 80% lower than Stelara's list price. The biosimilar will be available for $0 out of pocket for eligible patients through Accredo, potentially saving individual patients around $4,000 per year. Evernorth has already seen strong interest in its private-label Humira biosimilar, with over 25% of eligible Accredo patients using it.

Pharmaceutical industry faces significant challenges with over 14,000 layoffs in 2024 due to deteriorating financial performance, rising costs, and regulatory pressures. Companies like Pfizer and Takeda are cutting costs and closing R&D facilities, prioritizing short-term financial health over long-term innovation. The U.S. Inflation Reduction Act is expected to further strain the industry by reducing revenue streams starting in 2026, adding to the impact of inflation, supply chain disruptions, and patent expirations. These financial pressures force companies to streamline operations and reduce expenditures, potentially leading to slower innovation and reduced capacity to bring new therapies to market.

Johnson & Johnson submitted a BLA to the FDA for nipocalimab, an investigational therapy for generalized myasthenia gravis (gMG), based on data from the Phase III Vivacity-MG3 trial. Nipocalimab, an FcRn blocker, showed sustained disease control in gMG patients over 24 weeks, marking the longest controlled safety and efficacy assessment in this patient group.

Patients with myasthenia gravis in Europe often wait over a year for diagnosis, which correlates with worse clinical profiles including higher MGFA class III disease, fatigue, anxiety, and depression. The study emphasizes the need for early and accurate diagnosis and treatment strategies.

Johnson & Johnson submits a Biologics License Application to the FDA seeking the first approval of nipocalimab globally for treating generalized myasthenia gravis (gMG). The application included data from the Phase 3 Vivacity-MG3 study showing superior outcomes for antibody positive participants who received nipocalimab plus standard of care compared to placebo plus standard of care. Nipocalimab is the first-and-only FcRn blocker to demonstrate sustained disease control in gMG.

Rana Zia Ur Rehman from Johnson & Johnson presented at the Digital Biomarkers in Clinical Trials Summit on using digital biomarkers for inflammation monitoring, highlighting the potential of PPG-based devices despite challenges like motion artifacts. His studies validated PPG devices against ECG, emphasizing the need for careful data analysis to account for external factors and circadian patterns.

FDA approves Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) for first-line treatment of EGFR-mutated advanced NSCLC, marking a significant development for patients with unmet needs.

Johnson & Johnson announces the publication of positive Phase 2 UNITY study results of nipocalimab in The New England Journal of Medicine for treating alloimmunized pregnant individuals at risk of early onset severe hemolytic disease of the fetus and newborn (HDFN), showing 54% achieved live birth at or after 32 weeks gestational age without intrauterine transfusion (IUT), suggesting nipocalimab could be the first non-surgical treatment for high-risk HDFN pregnancies.

FDA approves Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for induction and consolidation in newly diagnosed multiple myeloma (NDMM) patients eligible for autologous stem cell transplant (ASCT), supported by Phase 3 PERSEUS study data showing significant improvement in progression-free survival (PFS) and deeper responses with D-VRd compared to VRd.