BRISTOL MYERS SQUIBB

Pancreatic cancer, a leading cause of cancer deaths worldwide, affects older adults more frequently and has a poor prognosis. 2024 guidelines recommend tailored FOLFIRINOX and gemcitabine-based therapies. Over 2,000 trials since 2019, led by North America, Asia-Pacific, and Europe, are advancing treatments. Novotech, a global CRO, supports oncology trials, highlighting progress in chemotherapy, RAS-targeted therapies, and personalized medicine.

The NURE-Combo trial showed neoadjuvant nivolumab plus nab-paclitaxel followed by adjuvant nivolumab was safe and active in muscle-invasive bladder cancer patients, achieving a 32.3% ypT0N0 response. The combination's safety profile was manageable, with no grade 4 or higher adverse events reported.

BioNJ Manufacturing Briefing 2024 highlighted trends, funding, training, quality management, Fourth Industrial Revolution impacts, and FDA innovations in biopharmaceutical manufacturing.

FDA approves Merck’s Keytruda for first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma, based on KEYNOTE-483 trial results showing significant survival and progression-free survival benefits.

Dr. Donald Robinson, a pioneer in psychopharmacology, and his wife Mary Lou, a community leader, established the Dr. Donald and Mary Lou Robinson Scholarship at Marshall University. Their legacy includes groundbreaking research, community service, and support for future medical students.

Immunotherapies like Keytruda celebrate 10 years, sparking debate on patient cure declarations. The psychedelics industry features key figures like Robin Carhart-Harris. Pfizer critiques Medicare's digital mental health app proposal. Senate aide Shawn Bishop, key in drug pricing policy, is departing. FDA drafts guidance for international cancer trials, emphasizing data applicability to U.S. patients.

The FDA will respond to the New Drug Application for Bristol Myers Squibb and Karuna Therapeutic’s schizophrenia drug, KarXT, by September 26, 2024. KarXT, a muscarinic M1/M4 agonist, shows promise in reducing schizophrenia symptoms without metabolic, endocrine, or motor adverse effects, potentially positioning it as a first-line treatment alongside standard serotonin/dopamine antagonists.

Dedicated scientists pioneer life-changing medicines through cell therapy, targeted protein degradation, radiopharmaceuticals, advanced small molecules, and biotherapeutics, focusing on areas with few treatment options or setting new care standards.

PD-1 inhibition with pembrolizumab before and after surgery significantly improves 5-year overall survival (86.6% vs 81.7%) in high-risk early triple-negative breast cancer, according to KEYNOTE-522 trial results.

The NIAGARA study showed AstraZeneca's Imfinzi improved event-free survival in muscle-invasive bladder cancer, with a 25% reduction in death risk. This contrasts with Bristol Myers Squibb's Opdivo, which was previously approved for adjuvant use. The FDA's cautious stance on perioperative studies may delay Imfinzi's approval, despite its potential impact. Other ongoing trials, like KEYNOTE-866 and VOLGA, aim to further evaluate immunotherapies in this setting.