BRISTOL MYERS SQUIBB

Bristol Myers Squibb's schizophrenia drug KarXT, with a PDUFA date of 26 September 2024, shows strong clinical data and a differentiated mechanism. Concerns over its twice-daily dosing led Terran Biosciences to develop a once-daily oral and multi-month injectable prodrug version, TerXT and TerXT LAI, aiming to improve adherence. KarXT's potential to avoid traditional antipsychotic side effects like weight gain and diabetes risks is highlighted, with GlobalData forecasting $2.99bn in sales by 2030.

Various drugs and their statuses are listed, including IN-001 for anaphylaxis (Fast Track), Finereonone for heart failure (Phase 3), Tirzepatide for heart failure and obesity (Phase 3), TMB-001 for congenital ichthyosis (Phase 3), Bentracimab for ticagrelor reversal (Priority Review), Fabhalta for immunoglobulin A nephropathy (accelerated approval), RLS-0071 for acute graft-vs-host disease (Fast Track and Orphan Drug), CHIKV VLP for chikungunya (Priority Review), Diazoxide choline for Prader-Willi syndrome (Priority Review), Mirdametinib for neurofibromatosis type 1 (Priority Review), Setmelanotide for genetic obesity (Priority Review), AR882 for gout (Fast Track), SPN-830 for Parkinson disease (NDA review), BGB-16673 for chronic lymphocytic leukemia (Fast Track), Cabozantinib for neuroendocrine tumors (NDA review), Linvoseltamab for multiple myeloma (Complete Response Letter), Nivolumab plus ipilimumab for hepatocellular carcinoma (BLA review), Midomafetamine for PTSD (Complete Response Letter), and Tezepelumab-ekko for COPD (Breakthrough Therapy).

We sustainably create positive community impact through innovative medicines, inclusive culture, environmental protection, governance, and sustainable supply chains.

Roivant acquires mosliciguat from Bayer for pulmonary hypertension; Viridian's thyroid eye disease treatment succeeds in Phase 3; Verily alums launch Highlander Health for clinical research optimization; House passes BIOSECURE Act restricting business with Chinese biotechs; Candid Therapeutics raises $370M for bispecific antibody therapies; Merck's Keytruda faces potential competition from Akeso's ivonescimab; Penn's gene therapy ATSN-101 shows promise for rare blindness.

Recent FDA approvals of three new therapies for Duchenne muscular dystrophy have increased hope but also confusion among families. The lack of long-term data on gene therapy, especially in older and nonambulatory patients, and the potential for future treatment ineligibility due to antibody creation, adds to the complexity of decision-making. Families need better guidance from neurologists on therapy priorities and polypharmacy, as well as support to make informed decisions without judgment.

DelveInsight's 'Non-Small-Cell Lung Cancer Pipeline Insight 2024' covers 135+ companies and 150+ pipeline drugs, highlighting key players like BridgeBio Pharma, Daiichi Sankyo, and Merck. Prominent therapies include Trastuzumab deruxtecan, DS-1062a, and Pembrolizumab. Recent studies by Merck, AstraZeneca, and Gilead focus on Phase 3 trials for V940, Durvalumab, and Zimberelimab, respectively.

The Global Monoclonal Antibodies Market is projected to grow from USD 279.8 billion in 2024 to USD 804.7 billion by 2033, at a CAGR of 12.5%. North America is expected to dominate with a 47.5% share in 2024, driven by strong healthcare infrastructure and high R&D investments. Oncology is projected to lead the application segment with a 46.2% share. Major companies include Roche, Novartis, Johnson & Johnson, Pfizer, and Merck.

Nivolumab plus gemcitabine/cisplatin chemotherapy significantly improved response rates, overall survival, and progression-free survival in patients with lymph node–only metastatic urothelial carcinoma, according to a post hoc analysis of the CheckMate 901 trial presented at the 2024 ASCO Annual Meeting.

Global Monoclonal Antibodies Market to reach USD 804.7 billion by 2033, growing at a CAGR of 12.5% from USD 279.8 billion in 2024. Dominated by North America, human-derived antibodies, and oncology applications, with key players including Roche, Novartis, and Johnson & Johnson.

Adding novel agents to perioperative durvalumab for NSCLC led to higher pCR and mPR rates compared to historical rates with durvalumab and chemotherapy. The highest response rates occurred with the addition of Dato-DXd (pCR 34.1%, mPR 65.9%). All combinations demonstrated manageable safety profiles and surgical rates comparable to approved regimens.