BRISTOL MYERS SQUIBB

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.

10-year follow-up data from Bristol Myers Squibb's CheckMate-067 trial showed 43% of melanoma patients alive after receiving Opdivo and Yervoy combo, with median overall survival of 71.9 months. BMS also ended collaboration with Immatics, returning development of IMA401 to the biotech.

At ESMO's annual meeting, Pfizer's ponsegromab showed promise in treating cancer cachexia, helping patients regain weight and improve symptoms. Johnson & Johnson's TAR-200, a chemotherapy-releasing device, demonstrated efficacy in bladder cancer, with 42% of patients showing no cancer evidence. BioNTech and Instil Bio presented early data on drugs targeting PD1 and VEGF, similar to Summit Therapeutics' successful trial. Long-term studies revealed Keytruda's superior survival rates over Yervoy in melanoma patients. Scorpion Therapeutics' STX-478 showed potential as a PI3Ka inhibitor with manageable side effects.

The CheckMate -067 trial showed 10-year survival improvements with Opdivo (nivolumab) plus Yervoy (ipilimumab) or Opdivo monotherapy vs. Yervoy monotherapy in advanced melanoma, with median OS of 71.9 months, 36.9 months, and 19.9 months, respectively. The combination therapy demonstrated a 58.3% objective response rate after 10 years, with no new safety signals.

The Renal Cell Carcinoma Clinical Trial Pipeline Market is projected to grow significantly from 2024 to 2031, driven by technological innovations, rising demand, and regulatory changes. The market is segmented by type and application, with key players including Amgen, AstraZeneca, and Pfizer. Clinical trials focus on novel therapies, drug combinations, and targeted treatments, aiming to improve outcomes for renal cell carcinoma patients.

Drugmakers like Bristol Myers Squibb, AstraZeneca, and Eli Lilly invest billions in radiopharmaceuticals, which deliver radiation directly to tumors. These drugs, in development for various cancers, attach radioactive material to targeting molecules, sparing healthy cells. Novartis' successes with Lutathera and Pluvicto have spurred interest, but manufacturing and logistics remain complex. The market potential ranges from $5 billion to tens of billions, depending on efficacy across cancer types.