Johnson & Johnson CDR (CAD Hedged)

Janssen-Cilag applied to the European Medicines Agency to expand AKEEGA usage for adults with metastatic hormone-sensitive prostate cancer who have homologous recombination repair gene alterations.

Johnson & Johnson successfully defended its Invega Sustenna schizophrenia drug patent against appeals from Teva and Viatris, maintaining market exclusivity until 2031.

Johnson & Johnson submitted a supplemental New Drug Application to the FDA for CAPLYTA (lumateperone) for schizophrenia relapse prevention based on Phase 3 data showing 63% reduction in relapse risk versus placebo.

European health authorities have reclassified JNJ-1900 (NBTXR3) from a medical device to a medicinal product, harmonizing its regulatory status with the US and other major markets.

The FDA is revising labeling for all extended-release ADHD stimulants to include warnings about weight loss and adverse reactions in children under six years old.

AbbVie has agreed to acquire cell therapy developer Capstan Therapeutics in a deal worth up to $2.1 billion in cash, gaining access to innovative in vivo CAR-T technology.

A federal court ruled against Johnson & Johnson's proposal to shift from upfront drug discounts to a rebate model in the 340B Drug Pricing Program, which requires pharmaceutical manufacturers to sell outpatient drugs at reduced prices to healthcare providers serving low-income and rural populations.

Total M&A deal value in Alzheimer's disease jumped from $2 billion in 2022 to $18 billion in 2024, representing a 780% increase following the approval of disease-modifying treatments.

The FDA eliminated Risk Evaluation and Mitigation Strategy (REMS) programs and reduced post-treatment monitoring from four weeks to two weeks for Bristol Myers Squibb's CAR T-cell therapies Breyanzi and Abecma.

Johnson & Johnson has launched the Tecnis Odyssey IOL in Europe, the Middle East, and Canada, expanding access to its presbyopia-correcting intraocular lens technology.