The Pharma Data

APRIL 4, 2023

As part of the comprehensive submission package to the European Marketing Authorization, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing its approved adalimumab 50 mg/mL 2 with the 100 mg/mL (HCF). About Sandoz Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars.

Biosimilars 40

Biosimilars Pharmacokinetics FDA Approval Packaging 40

Drug Target Review

JUNE 12, 2023

TEAD proteins are crucial for tumour progression and drug resistance, making them an attractive focus for therapeutic interventions. Leveraging AI-guided structure-based drug design, Insilico’s research and development team generated an impressive portfolio of over 6,000 molecules and identified three highly promising hit series.

Metabolic Stability 92

Metabolic Stability Clinical Trials Small Molecule Pharmacokinetics 92

Drug Target Review

OCTOBER 4, 2023

Antibody-drug conjugates (ADCs) have been a groundbreaking approach to cancer treatment with their ability to deliver cytotoxic drugs directly to diseased cells while sparing healthy tissues. 1 However, efforts proved less effective than the original drugs, owing mostly to insufficient toxicity against cancer cells.

Small Molecule 126

Small Molecule Drugs Immune Response Targeted Protein Degradation 126

New Drug Approvals

JANUARY 9, 2024

2006 Mar 1; 20(5):601-12, 2006), in contrast with CDK9, which phosphorylates both Ser-2 and Ser-5 of the CTD heptad (Pinhero et al., For drug development, it is typically advantageous to employ individual stereoisomers as they exhibit marked differences in pharmacodynamic, pharmacokinetic, and toxicological properties.

Production 62

Production DNA RNA Regulations 62

Metabolite Tales Blog

MARCH 1, 2023

2 Figure 1 Not only does the carboxylic acid moiety of the infamous drug zomepirac undergo conjugation to an unstable acyl glucuronide, the pyrrole undergoes oxidative metabolism to an epoxide intermediate that can be trapped by glutathione (Figure 2). 2a Figure 2 Also reported are more complex “per-oxidative” oxidations.

Metabolic Stability 52

Metabolic Stability Pharmacokinetics Drugs Science 52

Agency IQ

JUNE 9, 2023

FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity Late last week the FDA released a final guidance document containing recommendations on the nonclinical assessment of potential immunotoxicity for drugs and certain biologics.

FDA 40

FDA Science Small Molecule Immune Response 40

Drug Discovery World

FEBRUARY 15, 2023

Evolution of such defence mechanisms can lead to multi-drug resistance, further disease progression, and cancer metastasis. Benefits over 2D monolayer culture include the possibility of investigating drug penetration and drug resistance offered by the tumour cells.

Research 130

Research Therapies Immune Response Clinical Trials 130