ImmunityBio said the Saudi FDA encouraged submission of a regulatory package for recombinant BCG and opened talks on expanding ANKTIVA with checkpoint inhibitors to additional tumor types. The company expects to file the rBCG package within weeks.
Crescent Biopharma dosed the first patient in its ASCEND Phase 1/2 trial of CR-001, a PD-1 x VEGF bispecific antibody for solid tumors. The company also reported Q1 2026 results and outlined pipeline milestones including ADC combination trials expected in the second half of 2026.
AbbVie filed an sBLA for SKYRIZI as a subcutaneous induction therapy for Crohn's disease, supported by Phase 3 AFFIRM data. SKYRIZI and Rinvoq combined for $25.9B in 2025 revenue, exceeding 2027 guidance. The FDA also approved Venclexta plus acalabrutinib in CLL.
Bayer’s sevabertinib has obtained domestic approval as an imported rare drug for HER2-mutant non-small cell lung cancer. The oral reversible HER2-targeted TKI was previously approved by the FDA for previously treated patients.
Updated phase I data showed zoldonrasib produced a 52% confirmed objective response rate and 93% disease control rate in previously treated KRAS G12D-mutant NSCLC. No grade 4 or higher treatment-related adverse events were observed at the recommended phase II dose.
Studies on immune checkpoint inhibitor therapy found pretreatment biomarkers strongly predicted checkpoint inhibitor-associated autoimmune diabetes, while hyperglycemia during treatment was common and did not worsen disease progression.
Ten-year follow-up of the phase 3 ESPATUE trial found similar overall and progression-free survival with chemoradiotherapy boost or surgery in resectable advanced NSCLC after induction therapy.
China's regulatory reforms since 2015 have streamlined clinical trial and drug approval processes, accelerating development of advanced therapies like CAR-T and bispecific antibodies. These changes have boosted investor confidence and created opportunities for global pharmaceutical partnerships with Chinese biotech companies that have innovative pipelines but lack international marketing capabilities.
FDA has cleared a robotic nipple-sparing mastectomy platform after clinical trials showed excellent results with preserved breast sensation. Researchers are advancing immunotherapy combinations for breast cancer and novel strategies to overcome drug resistance in EGFR-mutated lung cancer, including protein degraders and dual-binding inhibitors.
Pharmaceutical M&A is shifting toward late-stage clinical assets with proven human data, particularly in GLP-1 obesity drugs, oncology, and central nervous system disorders. Companies like Viking Therapeutics, Structure Therapeutics, and Revolution Medicines represent compelling acquisition targets with advanced clinical programs. This trend reflects industry prioritization of de-risked assets that can accelerate commercialization pathways.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07563205 |
Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer |
RECRUITING | |
| NCT07559123 |
Imaging-based PRediction of Eligibility for ChemoImmunotherapy in reSEctable NSCLC, iPRECISE |
RECRUITING | |
| NCT07550920 |
Relatrilfa-α Plus Single-Agent Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III NSCLC (Phase 2) |
NOT_YET_RECRUITING | PHASE2 |
| NCT07530744 |
Post-Market Registry of Transbronchial Cryo-assisted RFA During Routine Standard Bronchoscopic Tumor Stagng and Resection |
NOT_YET_RECRUITING | NA |
| NCT07530276 |
A Prospective Observational Study of Changes in Cortisol Levels After Neoadjuvant Immunotherapy and Their Prognostic Value in Patients With NSCLC |
ACTIVE_NOT_RECRUITING | |
| NCT07516015 |
Clinical Effectiveness and Safety of SHR-A1811 in Chinese Patients With HER2-Altered NSCLC |
NOT_YET_RECRUITING | |
| NCT07479277 |
Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC |
RECRUITING | NA |
| NCT07413952 |
Limertinib Plus Radiotherapy for EGFR-Mutant NSCLC With Brain Metastases |
NOT_YET_RECRUITING | PHASE2 |
| NCT07412041 |
Precise Exercise Regimen for Cancer Care (PERCC): A Pilot Study |
NOT_YET_RECRUITING | NA |
| NCT07397338 |
Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors |
RECRUITING | PHASE1/PHASE2 |
