Drug Discovery World

AUGUST 10, 2022

For example, it is challenging to regulate transgene copy numbers in each T cell, posing safety risks. Although transgenes show a preference for certain sites, the CAR transgene could integrate into the T cell genome at any location, including within a sequence that regulates oncogene expression, thereby increasing cancer risk.

Therapies 246

Therapies Virus Treatment Engineering 246

Drug Discovery World

APRIL 12, 2023

2016) 5 , CN Bio’s PhysioMimix TM OOC found that the anti-interleukin-6 receptor antibody used to treat rheumatoid arthritis also affected small drug pharmacokinetics by modulating cytochrome P450 enzymes. In a study by Long et al.,

Drug Development 130

Drug Development Drugs Small Molecule Immune Response 130

Drug Discovery World

JANUARY 20, 2023

2016) 5 , CN Bio’s PhysioMimix TM OOC found that the anti-interleukin-6 receptor antibody used to treat rheumatoid arthritis also affected small drug pharmacokinetics by modulating cytochrome P450 enzymes. In a study by Long et al.,

Drug Development 130

Drug Development Drugs Small Molecule Immune Response 130

Drug Target Review

JULY 1, 2024

SRP-001 targets the central nervous system (CNS) by producing N-arachidonoylaminophenol (AM404) in the midbrain’s periaqueductal grey (PAG) region, crucial for pain sensation and regulation. was founded in 2016 to develop safer, non-opioid therapies for acute and chronic pain. South Rampart Pharma, Inc.

Treatment 59

Treatment Clinical Trials Molecular Biology Therapies 59

Drug Discovery World

FEBRUARY 15, 2023

The number of new cases recorded between 2016 and 2018 was 375,400, with 167,142 deaths caused by cancer between 2017 and 2019. However, over the last few decades, it has been widely accepted that interaction between the tumour and host immune response plays a critical role in regulating tumour biology and hence its progression.

Research 130

Research Therapies Immune Response Clinical Trials 130

The Pharma Data

DECEMBER 21, 2020

As UNITY reported in its press release, this “Phase I, first-in-human, open-label, single-ascending dose study being conducted by UNITY is designed to evaluate the safety, tolerability, and pharmacokinetics of UBX1325 in patients with advanced DME.

Clinical Development 40

Clinical Development Disease Treatment Licensing 40

Agency IQ

FEBRUARY 23, 2024

This workshop built on three prior workshops held by the FDA-AACR, which took place in 2015, 2016 and 2017. And I do think it’s really important to go as high up as we can safely, because there are issues that have already been mentioned – inter-tumor heterogeneity, issues of tumor penetration and [pharmacokinetics] PK.”

Science 40

Science FDA Trials Clinical Pharmacology 40

The Pharma Data

DECEMBER 15, 2020

The researchers regulated the abnormal immunological memory processes found in these patients. Scientists documented a significant depletion of long-lived plasma cells, a reduction of interferon type I activity, and a down-regulation of T-cell transcripts associated with chronic inflammation. Bioelectronic Platform.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

FDA Law Blog: Biosimilars

MAY 21, 2024

We wondered how given that HHS and the Drug Enforcement Administration (“DEA”) conducted eight-factor scheduling analyses in 2016, concluding that there was “no substantial evidence that marijuana should be removed from Schedule I.” 12, 2016) ; Denial of Petition to Initiate Proceedings to reschedule Marijuana, 81 Fed. 12, 2016).

Regulations 69

Regulations FDA Licensing Licensing 69

Agency IQ

DECEMBER 11, 2023

Previously, burdensome side effects may have been written off as a necessary part of treatment and benefits measured in additional weeks or months of survival time; today, though, patients, clinicians, and regulators expect more. In July, a new contract notice indicated that this is an area of interest for FDA as well.

FDA 40

FDA Science Clinical Trials Trials 40

Agency IQ

JUNE 28, 2024

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time. ANNA ESHOO (D-Calif.)

FDA 40

FDA Science Clinical Trials Production 40