The ChEMBL-og

DECEMBER 13, 2023

Assays des cribe the experimental set-up when testing the activity of drug-like compounds against biological targets; they provide useful context for researchers interested in drug-target relationships. Furthermore, publication of late-stage animal toxicity assays can provide an insight into the mechanism of drug toxicity.

Pharmacokinetics 125

Pharmacokinetics Drugs Drug Development Science 125

Alta Sciences

SEPTEMBER 27, 2024

Featuring two scenarios that explore the complexities of bioanalysis for immunomodulators, The Altascientist offers practical considerations for ensuring accurate bioanalysis, as well as pharmacokinetic, pharmacodynamic , and safety data in clinical trials. WHAT IS THE ALTASCIENTIST?

Clinical Trials 52

Clinical Trials Trials Pharmacokinetics Small Molecule 52

DrugBank

MARCH 7, 2024

The landscape of weight loss drugs has been rapidly evolving, and 2024 is poised to be another transformative year in this market. Pharmaceutical researchers, in particular, have a keen interest in understanding the unfolding dynamics of this market. Let’s delve into what lies ahead in the coming year.

Pharmaceutical Companies 81

Pharmaceutical Companies Clinical Trials Pharmaceuticals Therapies 81

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. jpg Weight 1

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Drug Development Science 52

Drug Target Review

NOVEMBER 15, 2023

Drug discovery is an interdisciplinary process that relies heavily on expert input from diverse and multifaceted teams, from medicinal, synthetic, and computational chemists to biologists and drug metabolism and pharmacokinetics (DMPK) scientists.

Pharmacokinetics 105

Pharmacokinetics International Laboratories Drugs 105

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. Cancer research [Internet]. Cancer Research [Internet]. Available from: [link] 7.Bohnacker

Small Molecule 105

Small Molecule Therapies Regulations Treatment 105

Alta Sciences

AUGUST 7, 2023

We perform ocular pharmacokinetic studies in multiple species (rodent and non-rodent), using different types of formulations and routes of administration, and support study durations ranging from single-dose acute to studies of six and nine months.

Production 40

Production Pharmacokinetics Drug Development Drugs 40

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 16, 2024

My clinical background as a physician led me to drug development, where I realised I could have an even broader impact on patient well-being. In reality, our deep understanding of disease pathology and patient needs is instrumental in shaping both basic and clinical research into viable treatments.

Clinical Development 52

Clinical Development Drug Development Therapies Disease 52

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. In this role, she leads the team specialising in microbial cultivation and the application of genomics techniques to the human gut microbiota.

Treatment 122

Treatment Pharmacokinetics Pharmaceuticals Production 122

PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved. References Hingorani, A.D., Sci Rep 9, 18911 (2019).

Drugs 52

Drugs Pharmacokinetics FDA Approval Drug Development 52

Drug Target Review

DECEMBER 11, 2024

This issue poses a significant hurdle for drug developers, with no universal protocol currently in place to address these complexities. For these studies, a comprehensive approach to drug metabolism and pharmacokinetics (DMPK), along with immunogenicity is essential, drawing on expertise from multiple disciplines.

International 52

International Laboratories Drugs Pharmacokinetics 52

Alta Sciences

AUGUST 28, 2023

s novel, proprietary cytoprotective drug candidate, CMX-2043, for the treatment of acute TBI. The Phase I trial was performed to evaluate safety, tolerability, and pharmacokinetics in a group of 80 healthy participants in a two-part, double-blind, placebo-controlled study. To learn more about Altasciences, visit altasciences.com.

Trials 40

Trials Treatment Clinical Pharmacology Pharmacokinetics 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

Alta Sciences

SEPTEMBER 13, 2023

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials pmjackson Wed, 09/13/2023 - 17:01 September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions.

Clinical Trials 52

Clinical Trials Treatment Trials Drug Development 52

The Premier Consulting Blog

APRIL 15, 2024

We will use the term, nonclinical, to refer to any in vitro, ex vivo, or animal study conducted to support any stage of research and development of a new drug, such as proof-of-concept pharmacology studies through Good Laboratory Practice (GLP) toxicology studies.

FDA 52

FDA Pharmacokinetics Laboratories FDA Approval 52

The Pharma Data

DECEMBER 14, 2020

Preclinical research suggests that this antibody against the target can potentially address the existing pandemic, as well as escape mutants. . The Phase I trial is a randomized, double-blind, placebo-controlled study that is meant to evaluate the safety, pharmacokinetics and pharmacodynamics of single ascending doses of ABBV-47D11. .

Licensing 52

Licensing Licensing Pharmacokinetics Clinical Trials 52

PPD

JUNE 20, 2023

Biotech and biopharma companies with a dependable contract research organization (CRO) partner will derive strong value across all business cycles — ensuring project delivery excellence and continued speed to market. The drug development industry is undoubtedly in a season of change.

Clinical Trials 52

Clinical Trials Drug Development Trials Clinical Research 52

Conversations in Drug Development Trends

AUGUST 9, 2024

Advantages and Operational Challenges in Adaptive MRCTs Adaptive trial designs are gaining popularity in clinical research due to their ability to improve trial efficiency and uphold ethical standards, resulting in faster and more reliable outcomes.

Trials 80

Trials Clinical Trials Regulations FDA 80

The Pharma Data

SEPTEMBER 7, 2021

The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by researchers at the University of Minnesota Medical School. To learn more about the study or to review the volunteer qualifications, call 646-774-6243 or visit [link].

Clinical Trials 52

Clinical Trials Vaccine Trials Medical Schools 52

Drug Target Review

JULY 12, 2023

It also addresses challenges seen with traditional chemical or biological approaches in drug discovery, which often try to identify targets in cell lines that do not reliably exemplify a disease in relevant patient populations. Our approach is to treat cancer in fundamentally new ways based on emergent data to optimise therapeutic outcomes.

Biochemical Assays 98

Biochemical Assays Treatment Bioinformatics Disease 98

Alta Sciences

AUGUST 21, 2023

Efficient Characterization of ADME A critical feature of the bioanalytical platform selected for a drug development program is how well it characterizes the ADME (absorption, distribution, metabolism, excretion) of your molecule of interest. Why Partner With Altasciences for Your Bioanalytical Projects?

Assay Development 52

Assay Development Pharmacokinetics Drug Development Drugs 52

PerkinElmer

JUNE 3, 2022

Researchers are now studying the potential of protease inhibitors for the treatment of SARS-CoV-2. Inhibition of SARS-CoV-2 M pro therefore represents an attractive approach for the development of COVID-19 therapeutics. 2 PF-07321332, which is now being tested in clinical trials, 3 is a nitrile-containing derivative of PF-00835231.

Fragment Screening 52

Fragment Screening Clinical Trials Vaccine Pharmacokinetics 52

Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation.

FDA 40

FDA Research Clinical Trials Trials 40

The Premier Consulting Blog

SEPTEMBER 11, 2024

However, the use of this novel polymer posed several challenges related to: The number of qualification studies required , including large nonclinical safety and clinical evaluations due to the changes in the dosage regimen, RoA, pharmacokinetics (PK), and use of a novel polymer. Human factors. Pediatric considerations.

Drugs 52

Drugs Clinical Pharmacology Packaging Small Molecule 52

The Pharma Data

NOVEMBER 5, 2021

With presently no approved treatments, there’s a major unmet need for curatives that can delay progression to order failure, “ said John Tsai, Head of Global Drug Development and Chief Medical Officer at Novartis.

Disease 52

Disease Treatment Pharmacokinetics FDA 52

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 Progress in Brain Research.

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Agency IQ

JULY 28, 2023

FDA intends to award a sole source award to Eastern Research Group, Inc. In 2020, the agency awarded a contract to “establish a COVID-19 Sub-Registry to collect data on the safety of drug products used for the prevention or treatment of COVID-19 infection.” modernization efforts. Read the full AgencyIQ analysis here.

FDA 40

FDA Pharmacokinetics Clinical Pharmacology Government 40

Agency IQ

DECEMBER 1, 2023

As before, the guidance provides recommendations on drug development for COVID-19 across five domains: population, trial design, efficacy endpoints, safety considerations and statistical considerations. drug-drug interactions) and intrinsic factors (e.g.,

FDA 40

FDA Clinical Trials Vaccine Trials 40

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

The Pharma Data

NOVEMBER 6, 2020

Secondary outcomes were: (1) the effect of aducanumab on brain amyloid plaque content as measured by [18F]-florbetapir PET, (2) the pharmacokinetics of aducanumab and (3) the immunogenicity of aducanumab. The safety and tolerability of aducanumab was the primary aim of the study. About Alzheimer’s Disease. About Biogen. please visit [link].

Disease 40

Disease FDA Clinical Trials Licensing 40

The Pharma Data

AUGUST 30, 2021

Global Head of Research and Development at Sanofi. 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

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

The Pharma Data

OCTOBER 18, 2020

Several clinical sites are screening patients for the Phase 1 a/b multicenter, open-label, dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the maximum tolerated dose or recommended dose in patients with relapsed or refractory AML.

Small Molecule 40

Small Molecule Clinical Trials Trials Therapies 40

The Pharma Data

DECEMBER 5, 2020

Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.

Production 40

Production Trials Treatment Disease 40

Agency IQ

SEPTEMBER 22, 2023

When looking at all drugs approved between 2011 and May 2020, 136 drugs were approved on the basis of a single pivotal trial, according to AgencyIQ’s research. Three drugs were approved based on no pivotal trials (such as in cases where an approval leveraged literature on use of the drug). What’s next?

FDA 40

FDA Science Trials Clinical Trials 40