Bristol Myers Squibb's Opdivo (nivolumab) has gained FDA approval for perioperative treatment of early-stage non-small cell lung cancer (NSCLC). This approval marks Opdivo as the only PD-1 blocking immunotherapy cleared for use both before and after surgery in this setting.
The approval was based on the CheckMate-77T study, which demonstrated a 42% reduction in the risk of relapse, progression, or death in patients who received Opdivo and chemotherapy before surgery, followed by Opdivo alone after surgery, compared to those receiving chemotherapy and a placebo. This regimen includes neoadjuvant Opdivo in combination with chemotherapy, followed by adjuvant Opdivo as a single agent after surgery. Merck's Keytruda is approved for use in the perioperative and post-surgical settings, creating a competitive landscape in the NSCLC treatment arena.
Johnson & Johnson Invests in Manufacturing, Announces Layoffs
Johnson & Johnson (J&J) has announced a $2 billion investment to construct a new biologics manufacturing facility in Wilson, North Carolina. The facility will focus on producing medicines for cancer, immune-related conditions, and nervous system disorders. Construction is slated to begin in 2025, with an expected creation of 420 full-time positions. This investment underscores J&J's commitment to expanding its biologics manufacturing capabilities to meet anticipated demand.
However, alongside this investment, J&J is also reducing its workforce. The company is laying off 231 employees in its New Jersey operations. This decision aligns with similar actions taken by other pharmaceutical companies, including Bayer, which is eliminating 57 jobs in New Jersey, and Bristol Myers Squibb, which is reducing its headcount by 79 at its Lawrenceville campus. Pfizer is also planning to cut 210 jobs across three sites in Ireland.
WHO Recommends RSV Prevention
The World Health Organization (WHO) has recommended that pregnant women receive vaccinations against Respiratory Syncytial Virus (RSV) and that infants receive antibody treatments to prevent the disease. RSV typically begins in the fall, infecting most newborns. Pfizer markets its Abrysvo vaccine for older adults and pregnant women (32-36 weeks gestation), while Sanofi and AstraZeneca sell the antibody Beyfortus, approved in the U.S. last year.