Novartis marks 30 years since its 1996 merger, citing advances in targeted therapy, cell therapy, gene therapy, and malaria. It also named a Levant Country President and won two clinical research awards in Saudi Arabia.
Phase III data show deramiocel slowed upper limb decline by 54% in Duchenne muscular dystrophy. The FDA is re-evaluating the BLA with HOPE-3 results, with a submission of the clinical study report expected in February 2026.
Johnson & Johnson plans a $1B Pennsylvania cell therapy facility and ranked ninth in Gartner's 2026 supply chain ranking. It also committed $1B to a Jacksonville contact lens plant.
Gilead Sciences reported Q1 2026 total product sales of $6.9 billion, up 5% year over year, with HIV revenue growing 10% to $5.0 billion. The company raised its full-year 2026 base business revenue guidance by $400 million to $29.4–$29.8 billion. Non-GAAP diluted EPS was $2.03, up 12%, while the company advanced its oncology and cell therapy pipeline.
The global growth and differentiation factors market is projected to grow at an 8.2% CAGR through 2035, driven by expanding cell therapy manufacturing. GMP-grade revenue is expected to surpass research-grade by 2030 as the industry transitions to clinical and commercial production.
Global biologics market projected to grow to USD 1.28 trillion by 2035; Japan cell and gene therapy market to reach USD 2.15 billion by 2034; Japan biologic drug lifecycle management market to hit USD 9.69 billion by 2033.
Kyverna Therapeutics reports positive long-term follow-up results for its CAR-T therapy miv-cel in generalized myasthenia gravis, with plans to submit a biologics license application in the first half of 2026. The company has $279.3 million in cash providing runway into 2028 to fund launch and Phase 3 trials.
Johnson & Johnson invests over $1 billion in a new Pennsylvania cell therapy manufacturing facility for cancer and neurological diseases. The expansion addresses growing demand for advanced therapies while highlighting workforce training challenges in GMP environments. Other developments include new cell line technology for viral vector production and CRISPR-edited CAR-T manufacturing partnerships.
The FDA has lifted a Complete Response Letter and resumed review of Capricor Therapeutics' Biologics License Application for deramiocel, setting a PDUFA date of August 22nd. The company ended 2025 with $318M in cash.
AstraZeneca announced a $15 billion investment in Chinese R&D facilities through 2030, elevating China to a global innovation hub, while former China chief Leon Wang faces charges for unlawful data collection, illegal trade, and medical insurance fraud.
