Drug Target Review

SEPTEMBER 19, 2023

In addition, these models at the current state are better for short term tests, over a week or two and cannot be used for acquiring data from long term drug exposures. Miniature organs as test beds for new drugs Organoids are miniature human organs with clusters of cells derived from stem cells and mimic specific tissues.

Animal Testing 98

Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

Alta Sciences

OCTOBER 15, 2024

Jason started his career as a research assistant carrying out operational phases of drug metabolism and pharmacokinetic studies. As my experience in preclinical research grew, so did my curiosity in the overall drug development process; I wanted to expand into clinical research. What Was your dream job as a child?

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Drug Development Science 52

Drug Target Review

SEPTEMBER 25, 2024

However, this will not be straightforward, given that non-oncogene resistance is driven by complex transcriptional networks, and the key drivers that determine how these mechanisms could be targets for drug development remain elusive. Science Advances [Internet]. Available from: [link] 8.Boni Available from: [link] 9.Mohanty

Small Molecule 105

Small Molecule Therapies Regulations Treatment 105

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

While this hype may be warranted in some respects—a 60-year old legal provision has now been amended to acknowledge that the science of drug development is advancing—the change is mostly symbolic and is likely to take many years before we see it have a measurable impact. 42 U.S.C. § 262(k)(2)(A)(i)(I).

Animal Testing 64

Animal Testing Biosimilars Cell Based Assays FDA 64

Drug Target Review

OCTOBER 24, 2023

We also believe that drug development teams should routinely consider the potential modifying effect of the gut microbiome on drug potency and factor it into assessments of PK and PD. MB310 is a consortium of nine bacterial species for treatment of mild to moderate ulcerative colitis.

Treatment 122

Treatment Pharmacokinetics Pharmaceuticals Production 122

Drug Target Review

OCTOBER 16, 2024

I’ve always been drawn to the early stages of scientific discovery, where hypotheses are formed and developed into something tangible that can benefit patients. Being involved in these formative stages allows you to not only understand the challenges ahead but also shape the science to ensure it addresses patient needs.

Clinical Development 52

Clinical Development Drug Development Therapies Disease 52

Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

Science 40

Science FDA Trials Clinical Pharmacology 40

PPD

MAY 11, 2023

The global COVID-19 pandemic increased awareness of the importance of vaccine development — both for drug developers and the public. The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developed vaccines, there was variation among who could receive the shots and when.

Vaccine 52

Vaccine Clinical Trials Long-Term Care Facilities Trials 52

Agency IQ

MAY 17, 2024

How have pre-submission meetings for generic drug applicants changed under GDUFA III? Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. The generic drug user fee program is currently on its third iteration (i.e.,

Science 40

Science FDA Drugs Production 40

Drug Target Review

JULY 12, 2023

The goal of DCI in preclinical and clinical assessments is to achieve a manyfold higher drug free-fraction pharmacokinetic (PK) C max level (the plasma concentration of therapy in a specific area of the body) to break tumour addiction to the MAPK signalling pathway followed by a rapid drop off of drug levels enabled by a short plasma half-life.

Biochemical Assays 98

Biochemical Assays Treatment Bioinformatics Disease 98

Agency IQ

DECEMBER 11, 2023

Pediatric patients: Likewise, reviewers from OCE have persistently voiced the need for pediatric patients to be included earlier in the drug development process as well. As for older adults, differences in product performance for pediatric patients cannot be characterized sufficiently just be adjusting for age or weight.

FDA 40

FDA Science Clinical Trials Trials 40

Agency IQ

JUNE 9, 2023

BY RACHEL COE, MSC JUN 6, 2023 5:00 PM CDT What are nonclinical studies and when are they conducted in drug development?

FDA 40

FDA Small Molecule Science Immune Response 40

PerkinElmer

JUNE 3, 2022

Writing in JACS , the researchers concluded: “Based on the broad-spectrum antiviral effect combined with promising selectivity and in vitro pharmacokinetic profile, the scaffold represented by [this compound] is one of the most promising for development of an antiviral drug targeting SARS-CoV-2.” 2021;374(6575):1586-1593.

Fragment Screening 52

Fragment Screening Clinical Trials Vaccine Pharmacokinetics 52

Agency IQ

SEPTEMBER 22, 2023

The agency lists several situations in which mechanistic data may be suitable confirmatory evidence, like when a drug’s mechanism of action corrects an enzymatic or genetic defect caused by a single gene and/or enzyme defect. (3) We also expect that some of these confirmatory evidence types will be used far more sparingly than others.

FDA 40

FDA Science Trials Clinical Trials 40

Agency IQ

JULY 28, 2023

In announcing the contract, ACMT explained that while FDA has held a contract for years to access the ToxIC Registry, that contract involved a more specific goal and a concerted effort between the association and CDER’s Office of Surveillance and Epidemiology (OSE) and Office of Translational Sciences (OTS).

FDA 40

FDA Pharmacokinetics Clinical Pharmacology Government 40

New Drug Approvals

SEPTEMBER 13, 2024

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 12] Positron emission tomography imaging revealed that brain KORs were almost completely saturated by the drug 2.5 Drug Discovery. nM vs. 24.0

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Agency IQ

DECEMBER 1, 2023

Following this announcement, the FDA developed a transition plan that explained what would happen to its extensive catalogue of PHE-related guidance documents, 60 of which were related to life sciences policy. drug-drug interactions) and intrinsic factors (e.g.,

FDA 40

FDA Clinical Trials Vaccine Trials 40

The Pharma Data

AUGUST 30, 2021

Part B of the Phase 3 trial was informed by Part A , an open-label, single-ascending-dose, sequential cohort Phase 2 trial designed to assess the pharmacokinetics and safety of Dupixent in children aged 6 months to 5 years with uncontrolled severe atopic dermatitis.

Trials 52

Trials Disease Treatment Clinical Trials 52

The Pharma Data

AUGUST 29, 2020

“These positive Phase II results are promising and pave the way for further evaluation of oral LNP023 as a potential monotherapy treatment and standard of care for PNH,” said John Tsai, Head Global Drug Development and Chief Medical Officer, Novartis. “We

Treatment 52

Treatment Disease Small Molecule Production 52

The Pharma Data

DECEMBER 5, 2020

Senior Vice President, Translational & Clinical Sciences, Hematology at Regeneron. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. Andres Sirulnik , M.D.,

Production 40

Production Trials Treatment Disease 40

Agency IQ

DECEMBER 11, 2023

As AgencyIQ discussed at the time , the life sciences industry had long been expecting such a guidance from the FDA. Further, “there’s apparent tension between long standing practices of accepting foreign data to expedite drug development and a new emphasis on diversity and representativeness in clinical trials,” acknowledged Fashoyin-Aje.

FDA 40

FDA Research Clinical Trials Trials 40

Agency IQ

AUGUST 16, 2024

The final version newly clarifies that oncolytic viruses also fall outside the scope of the document and includes a new disclaimer that the guidance is not intended to address unique considerations of pediatric drug development. To be [administered with] food or not to be?

Production 40

Production FDA Science Clinical Trials 40

Alta Sciences

OCTOBER 30, 2023

Top 10 Life Science Resources pmjackson Mon, 10/30/2023 - 16:16 There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below! Watch the video. Listen here. Watch it now.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

Agency IQ

FEBRUARY 12, 2024

Another guidance will focus on pharmacokinetics in pregnancy, likely replacing a 2004 guidance document that the FDA never finalized, while a guidance the creation of a “REMS Logic Model” framework is meant to “link program design with assessment” – something called for in the most recent PDUFA VII commitment letter.

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

FDA 40

FDA Science Biosimilars Clinical 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.

FDA 40

FDA Science Clinical Trials Production 40