NOVARTIS

Novartis receives CHMP positive opinion for Kisqali® to reduce HR+/HER2- early breast cancer recurrence risk, based on NATALEE trial data showing 25% reduction in recurrence with Kisqali + endocrine therapy vs. endocrine therapy alone.

CHMP recommends Kisqali for adjuvant treatment of HR+/HER2- early breast cancer, based on NATALEE trial showing 25% reduced risk of recurrence with Kisqali + endocrine therapy vs. endocrine therapy alone. FDA approved Kisqali in this setting in September, with ESMO 2024 presenting updated NATALEE analysis showing deepened invasive disease-free survival benefit.

Early-phase oncology trials now focus on efficacy with novel immunotherapeutic agents like bispecific antibodies and CAR T-cell therapy, necessitating refined trial designs, patient selection strategies, pharmacodynamics markers, and adverse event management. Submissions on exceptional toxicities, progress reviews, and early-stage clinical trials are welcomed.

Peptide Therapeutics Market to grow from USD 43.11 billion in 2023 to USD 68.4 billion by 2031, driven by increasing prevalence of cancer and metabolic disorders, and advancements in drug delivery systems.

Judge allows FDA to approve generic version of Novartis' heart-failure drug Entresto. HIV-positive individuals can safely receive HIV-donated kidneys. J&J cuts neurology and psychiatry programs. FDA's accelerated approval pathway faces high-profile failures. Lab-grown blood vessels by Humacyte could revolutionize trauma treatment.

The 7th Annual Outsourcing in Clinical Trials DACH 2024 will be held in Zurich on 29-30 October, featuring discussions on VC investment criteria, European ICH GCP V3 regulatory changes, pharmacovigilance, AI in clinical trials, and diversity in trials, including WHO's new global guidance for equitable clinical trials.

Alnylam Pharmaceuticals submitted a Type II Variation to the European Medicines Agency for vutrisiran, an RNAi therapeutic for ATTR amyloidosis with cardiomyopathy, supported by positive phase III HELIOS-B study results. The company already markets vutrisiran in the EU as Amvuttra for hATTR amyloidosis. If approved, vutrisiran could become the new standard of care for ATTR-CM, expanding the eligible patient population and driving growth.