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Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Worldwide Clinical Trials

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. Dosing Our pharmacy services can prepare liquid, solid, and intravenous dosage formulations. To accomplish this, we pay careful attention to both dosing and sample collection.

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Roche Invests $5.3B in Zealand’s Petrelintide, an Obesity Drug Candidate

XTalks

Roche, a global leader in biotechnology and diagnostics, has entered into an exclusive collaboration and licensing agreement with Zealand Pharma, a specialist in innovative therapeutics, to co-develop and co-commercialize petrelintide as a potential foundational therapy for people with overweight and obesity. billion $1.4

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Orvacabtagene autoleucel by Bristol-Myers Squibb for Relapsed Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

Orvacabtagene autoleucel is under clinical development by Bristol-Myers Squibb and currently in Phase II for Relapsed Multiple Myeloma. The company offers its products across the world to wholesalers, retail pharmacies, hospitals, medical professionals and government entities.

Pharmacy 100
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Danicamtiv, what is the likelihood that the drug will be approved?

Pharmaceutical Technology

Danicamtiv is under clinical development by Bristol-Myers Squibb and currently in the Phase I and Phase II in clinical pathway. The company offers its products across the world to wholesalers, retail pharmacies, hospitals, medical professionals and government entities.

Drugs 100
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10 Key Learnings from Successful Cellular and Gene Therapy Trials for Rare Diseases

XTalks

For rare disease studies where there is little or no clinical trial experience, outcome assessments would have to be validated within a clinical development program. This is important since not all pharmacies and sites are eligible to prepare and administer gene therapy due to biosafety and technical reasons.

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Innovations in Biosimilars: Insights and Trends from Samsung Bioepis

XTalks

Ilsun Hong VP and Product Evaluation Team Leader, Samsung Bioepis To have a biologic product ready for launch, it takes years of commitment from planning, early-stage development, clinical development, regulatory approval to supply readiness.

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PharmaDrug Enters Definitive Agreement for Acquisition of Sairiyo Therapeutics Inc. Who Recently Received Orphan Drug Designation from FDA for Esophageal Cancer

The Pharma Data

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration (“FDA”) approval.

Drugs 52