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BIOLOGICAL ASSESSMENT
BIOLOGICAL ASSESSMENT is a Biologic drug developed by Centre Hospitalier Universitaire Dijon. It is currently in Phase 3 development for Evaluation of biological effects in various disease states.
BIOLOGICAL ASSESSMENT is a drug that evaluates the biological effects of a substance.
BIOLOGICAL ASSESSMENT is a drug that evaluates the biological effects of a substance. Used for Evaluation of biological effects in various disease states.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | BIOLOGICAL ASSESSMENT |
|---|---|
| Sponsor | Centre Hospitalier Universitaire Dijon |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This drug assesses the biological effects of a substance, providing insights into its potential therapeutic applications. The assessment involves evaluating various biological parameters to determine the substance's efficacy and safety. This process helps researchers and clinicians understand the substance's mechanisms of action and potential benefits for human health.
Approved indications
- Evaluation of biological effects in various disease states
Common side effects
- Unknown
Key clinical trials
- Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer (PHASE2)
- Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial (PHASE2)
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- Safety Study of Intravenous Hydrogen-Oxygen Ultrafine Bubbles in Adults (PHASE1)
- Natural History Study of Children and Adults With Medullary Thyroid Cancer
- Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors (PHASE2)
- Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial (PHASE3)
- NCI COVID-19 in Cancer Patients, NCCAPS Study
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BIOLOGICAL ASSESSMENT CI brief — competitive landscape report
- BIOLOGICAL ASSESSMENT updates RSS · CI watch RSS
- Centre Hospitalier Universitaire Dijon portfolio CI
Frequently asked questions about BIOLOGICAL ASSESSMENT
What is BIOLOGICAL ASSESSMENT?
How does BIOLOGICAL ASSESSMENT work?
What is BIOLOGICAL ASSESSMENT used for?
Who makes BIOLOGICAL ASSESSMENT?
What development phase is BIOLOGICAL ASSESSMENT in?
What are the side effects of BIOLOGICAL ASSESSMENT?
Related
- Manufacturer: Centre Hospitalier Universitaire Dijon — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Evaluation of biological effects in various disease states
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing