Drug Target Review

JUNE 6, 2023

We are in an era of immuno-oncology (IO) revolution with many approved therapies now available to treat a broad range of cancers. For the last several years, the field has worked to unlock the potential of IO therapies for additional tumour types, and has explored options beyond checkpoint inhibitors.

Engineering 98

Engineering Immune Response Biochemical Pharmacology Clinical Trials 98

Drug Target Review

JUNE 12, 2023

TEAD proteins are known to be very important in cancer progression TEAD proteins are known to be very important in cancer progression, and there are a number of therapies in development. What are the preclinical characteristics of ISM6331, including its efficacy, safety profile, and drug metabolism and pharmacokinetics (DMPK) properties?

Metabolic Stability 92

Metabolic Stability Clinical Trials Small Molecule Therapies 92

The Pharma Data

APRIL 4, 2023

Biosimilars help patients to gain broader access to effective and high-quality treatments that improve their disease therapies,” said Rebecca Guntern, Head of Region Europe, Sandoz. The study met all its primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity between the two concentrations.

Biosimilars 40

Biosimilars Pharmacokinetics FDA Approval Packaging 40

Agency IQ

SEPTEMBER 15, 2023

In 2006, the FDA amended its final rule to add phenylephrine bitartrate (an effervescent formulation) to phenylephrine hydrochloride as GRASE over-the-counter nasal decongestant products included in that final monograph. The committee also made recommendations regarding pharmacokinetic and safety assessments.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

Agency IQ

JUNE 9, 2023

Though some of the concepts can be applied to more complex products such as biologics and cell and gene therapies, these products are more difficult to assess as many animal species that can be used for in vivo testing of small molecule products are not suitable, as their immune systems are not comparable to humans.

FDA 40

FDA Science Small Molecule Immune Response 40

Drug Target Review

OCTOBER 4, 2023

7 These inhibitors have faced challenges such as dose-limiting toxicity and poor pharmacokinetics, but geldanamycin ADCs have demonstrated increased survival in mice. Dual payload ADCs As effective as therapies have been in treating solid and haematological cancers, tumour heterogeneity and resistance remain major clinical challenges.

Small Molecule 126

Small Molecule Drugs Immune Response Targeted Protein Degradation 126

The Pharma Data

APRIL 7, 2021

The new route of administration offers comparable efficacy and safety to the TYSABRI intravenous (IV) formulation building on the therapy’s long-term data, established clinical benefits and well-characterized safety profile. TYSABRI is a trusted high-efficacy therapy with a well characterized safety profile for patients living with MS.

Clinical Trials 52

Clinical Trials Treatment Virus Pharmacokinetics 52