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As ADC molecular designs become increasingly diverse, drug product development requires a clear understanding of the interactions among formulation, stability, manufacturing, dosage form, and clinical administration. This webinar examines common ADC drug product challenges and shares case-study-based approaches to support clinical in-use evaluation through AsymBio’s integrated platform.

• New division will address the limitations of traditional peptide compounding through 3D printing and AI • PharmaTher plans to connect patients, physicians and qualified pharmacies through an integrated telemedicine platform • Positive PCAC recommendations represent an important potential step toward regulated access to compounded peptides in the United States

In briefing documents published Monday ahead of an advisory committee meeting for deramiocel, the FDA disagreed with Capricor’s assertion that a Phase 3 trial met its primary outcome measures.

While MapLight Therapeutics’ oral schizophrenia candidate reached the main endpoint of a Phase 2 trial, analysts say Bristol Myers Squibb’s Cobenfy is likely to hold its market share.

Despite a Phase 3 miss, Gossamer Bio is full steam ahead for its lung disease asset, pointing to previous “review issues” at the FDA as one of the reasons to continue development.