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Halozyme announces FDA approval for Tecentriq Hybreza™, a subcutaneous anti-PD-(L)1 immunotherapy using ENHANZE® technology, reducing injection time to 7 minutes from 30-60 minutes for IV infusion, available for adult indications of IV Tecentriq®.

OBiS Insights pre-meeting ESMO24 report profiles 275 new, unapproved cancer drugs, classified as 40% antibody-based, 37% small molecule, and 23% mixed bag. The report excludes drugs not in abstract titles and will update during the conference. 43% of these drugs were discussed at recent ASCO24 meetings.

Immunotherapy less risky for non-small cell lung cancer patients with BMI under 28, while chemotherapy is optimal for those with BMI 28 or higher, according to Osaka Metropolitan University study.

Illumina's TruSight Oncology Comprehensive, an FDA-approved IVD biomarker test kit, detects variants in 517 genes across nearly 30 solid tumor types, enabling personalized targeted therapies and faster treatment interventions within 4-5 days.

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).

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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.