Johnson & Johnson

Biopharma layoffs continue into 4Q 2024, affecting companies like Thermo Fisher, Charles River, Pfizer, Evonik, Johnson & Johnson, Bayer, Bristol Myers Squibb, AGC Biologics, and others. These layoffs are part of restructuring initiatives, site closures, and focus shifts in strategic core growth areas.

Johnson & Johnson's nipocalimab receives breakthrough therapy designation from FDA for treating moderate-to-severe Sjögren's disease, a chronic autoimmune disorder with no current treatments addressing its underlying cause.

Johnson & Johnson announced FDA's Breakthrough Therapy designation for nipocalimab in treating moderate-to-severe Sjögren's disease, based on Phase 2 DAHLIAS study results showing a 70% improvement in systemic disease activity. This is the second BTD for nipocalimab, with the first for hemolytic disease of the fetus and newborn. The designation aims to expedite development and review of drugs for serious conditions, highlighting J&J's commitment to innovative treatments for autoantibody-driven diseases.

FDA grants nipocalimab Breakthrough Therapy designation for Sjögren's disease, supported by Phase 2 DAHLIAS study results showing a 70% improvement in systemic disease activity at Week 24 with nipocalimab 15 mg/kg compared to placebo. This is the second BTD for nipocalimab, previously granted for hemolytic disease of the fetus and newborn.

Johnson & Johnson seeks FDA approval for daratumumab (Darzalex) as subcutaneous monotherapy for high-risk smoldering multiple myeloma (SMM), potentially becoming the first treatment for this condition. Supported by the phase 3 AQUILA study, daratumumab targets CD38 on malignant cells, aiming to prolong progression-free survival in high-risk SMM patients.

Johnson & Johnson submits application to FDA for Darzalex Faspro approval in high-risk smoldering multiple myeloma, supported by AQUILA study findings.

Dr. Husseini Manji, former J&J neuroscience head, developed Spravato, a first-in-class depression medication approved by the FDA in 2019. Despite initial skepticism, Spravato is now poised for blockbuster status. Psychiatric drug development, once abandoned by Big Pharma, is experiencing a renaissance with over 160 mental health medications in clinical trials. Manji advocates for precise diagnoses and targeted treatments. Recent setbacks include Alto Neuroscience's ALTO-100 failing to beat a placebo in a mid-stage trial for major depressive disorder. Emerging precision approaches include targeting orexin receptors, AMPA modulation, kappa opioid receptors, and inflammation reduction.

The global biotechnology market is projected to reach $550.83 billion in 2024 and $2667.36 billion by 2034, driven by advancements in synthetic biology, CRISPR, and genomic sequencing. North America is expected to lead, with a revenue of $231.68 billion in 2024, due to established agricultural biotechnology and a robust GMO framework. Key players include Johnson & Johnson, Roche, Pfizer, and Novartis.

Biosimilars face barriers in the US, including the patent system, interchangeability, and PBM policies. The 'patent dance' under the BPCIA aims to expedite biosimilar market entry but is criticized for being cumbersome. Patent litigation often leads to biosimilar launch delays, as seen with adalimumab and ustekinumab biosimilars. Policy reforms, such as the Affordable Prescriptions for Patients Act, aim to address these issues but face legislative challenges.