ASPET

SEPTEMBER 28, 2023

These protocols were then used to determine the plasma pharmacokinetics of agmatine and the extent of distribution to the CNS. Upon application of this protocol to pharmacokinetic study, IV agmatine showed a half-life in plasma ranging between 18.9 The protocol also adequately withstood stability and dilution conditions.

Pharmacokinetics 100

Pharmacokinetics FDA Therapies Drugs 100

DrugBank

MARCH 19, 2025

Unlike the traditional “ one-size-fits-all ” model, precision medicine leverages individual patient data, genetic profiles, environmental exposures, and lifestyle factors to design therapies tailored to each person’s unique needs. Precision medicine's benefits extend far beyond cancer care.

Therapies 90

Therapies Clinical Trials Pharmacokinetics Treatment 90

Elrig

MARCH 25, 2025

Earlier in her career, she held several leadership roles within AstraZeneca, including Senior Director for Drug Metabolism & Pharmacokinetics and Director for Lead Optimisation & Enabling Technologies within medicinal chemistry.

RNA 59

RNA Bioinformatics Science Pharmacokinetics 59

LifeSciVC

OCTOBER 10, 2024

To that end, our Phase 1 monotherapy data hit the mark and showed early evidence of precisely what we were looking for: A dose-dependent pharmacokinetic profile that achieved target exposures at dose levels that were well-tolerated by patients. The post ESMO Reflections: Glimmers of Hope with the Next Wave of I-O Therapies?

Therapies 66

Therapies Clinical Development Pharmacokinetics Treatment 66

DrugBank

OCTOBER 17, 2024

By harnessing the vast amounts of data generated throughout the development pipeline, pharmaceutical companies can accelerate the discovery of novel therapies, optimize clinical trial design, enhance drug safety monitoring, and deliver personalized medicine, ultimately improving patient outcomes and transforming the future of healthcare.

Drug Development 98

Drug Development Metabolic Stability Clinical Trials Drugs 98

Alta Sciences

FEBRUARY 19, 2025

The guidance ensures that these targeted evaluations help identify and mitigate safety concerns early in the development process, supporting the safe progression of oligonucleotide therapies into clinical trials. An oligonucleotide is a short strand of nucleotides, the building blocks of DNA or RNA, used in genetic research and therapy.

Drug Development 52

Drug Development Clinical Pharmacology Immune Response Drugs 52

ASPET

AUGUST 29, 2023

A single subcutaneous dose of STAR-0215 ({greater than or equal to} 100 mg) was predicted to be active in patients for 3 months or longer, based on simulations using a minimal physiologically based pharmacokinetic (mPBPK) model.

Treatment 100

Treatment Pharmacokinetics Therapies Disease 100

The Pharma Data

OCTOBER 19, 2020

But Intellia Therapeutics hopes to change that bleak prognosis with a potentially curative therapy to reverse the gene mutation in ATTR patients. . Their NTLA-2001 candidate uses their proprietary non-viral lipid nanoparticle platform, which will deliver this CRISPR/Cas9-based therapy. Source link.

Therapies 52

Therapies Pharmacokinetics Trials Clinical Trials 52

Drug Target Review

SEPTEMBER 25, 2024

Most targeted cancer therapies used today operate by inhibiting targets along well-known oncogenic signalling cascades. The reactivation of oncogenic signalling upstream or downstream of the driving oncogene is a well-studied source of resistance to targeted cancer therapies.

Small Molecule 105

Small Molecule Therapies Regulations Treatment 105

Drug Target Review

DECEMBER 12, 2023

We use hydrophilic linkers, which prevent ADC aggregation and generate highly stable ADCs, in combination with a unique attachment site on the antibody to create ADCs that retain pharmacokinetic properties similar to the original unconjugated antibody. This helps to maximize the targeted payload delivery to tumor cells.

Treatment 114

Treatment Engineering Pharmacokinetics Doctors 114

Drug Target Review

JUNE 5, 2023

It also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious. ZW191 also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious.

Treatment 100

Treatment Pharmacokinetics Drugs Cell Biology 100

Drug Target Review

DECEMBER 11, 2024

This approach not only boosts our clients’ ability to achieve high accuracy and meet regulatory requirements but also supports the seamless transition of innovative therapies from the lab to the clinic with confidence. Once the IS has been selected, a quantitation range can be set using reference solutions.

International 52

International Laboratories Drugs Pharmacokinetics 52

The Pharma Data

NOVEMBER 17, 2020

The study demonstrated favorable proof-of-concept for LYT-100’s tolerability and pharmacokinetic (PK) profile, which will also enable twice-a-day (BID) dosing of LYT-100 in future studies.

Pharmacokinetics 52

Pharmacokinetics Treatment Trials Production 52

DrugBank

MARCH 7, 2024

Among the notable contenders are: Semaglutide Analogs : Building upon the success of Ozempic, researchers are exploring analogs of semaglutide, the active ingredient in Ozempic, with enhanced potency and improved pharmacokinetic profiles. While challenges persist, the weight loss drug boom shows no signs of waning.

Pharmaceutical Companies 98

Pharmaceutical Companies Clinical Trials Pharmaceuticals Therapies 98

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. Each class of immunomodulator has a defined complexity and mechanism of action.

Clinical Trials 52

Clinical Trials Trials Pharmacokinetics Small Molecule 52

The Pharma Data

JULY 21, 2021

In the ongoing Phase 2a (NCT04003103) randomized, double-blind, parallel assignment, placebo-controlled, multicenter trial in adults at low-risk for acquiring HIV-1 infection, participants were randomly assigned (2:2:1) to one of three oral once-monthly therapy groups: islatravir 60 mg, islatravir 120 mg or placebo.

Clinical Trials 52

Clinical Trials Pharmacokinetics Trials International 52

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

MARCH 25, 2021

With more than six years of patient experience, a positive benefit-risk profile, strong clinical data and robust real-world data, the totality of evidence solidifies the role of IBRANCE plus endocrine therapy as a treatment for patients with HR+, HER2- metastatic breast cancer.”. The analysis also showed the two-year OS rate was 78.3%

Therapies 52

Therapies Clinical Trials Trials Treatment 52

The Pharma Data

OCTOBER 14, 2021

The results, which demonstrate that patients treated with Biogen’s portfolio of MS therapies mount an effective antibody response to COVID-19 vaccination, are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021.

Vaccine 52

Vaccine Therapies Immune Response Disease 52

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

The Pharma Data

JULY 2, 2023

The new approach in cancer therapy with innovative mechanism-of-action for ferroptosis induction A team of researchers led by Dr. Marcus Conrad from Helmholtz Munich discovered a novel anti-cancer drug, called icFSP1, which sensitizes cancer cells to ferroptosis.

Therapies 40

Therapies Small Molecule Pharmacokinetics Disease 40

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 Pharmacokinetics 92

Drug Target Review

MARCH 17, 2025

However, a deeper understanding of brain function particularly the role of synaptic plasticity is now opening the door to innovative therapies. The drug’s pharmacokinetics (PK) and pharmacodynamics (PD) are closely linked.

Treatment 52

Treatment Licensing Licensing Science 52

Alta Sciences

OCTOBER 30, 2023

TOP NONCLINICAL SCIENTIFIC RESOURCES eBook : Safety Assessment for Ophthalmic Products Designing preclinical studies for ocular therapies take a lot of deliberation. The Altascientist : Issue No. Read or listen now. Watch it now. The Altascientist : Issue No.

Science 52

Science Clinical Trials Pharmacokinetics Clinical Pharmacology 52

The Pharma Data

DECEMBER 17, 2020

Previous technologies have been constrained by dose-limiting toxicities, poor pharmacokinetic profiles, and attenuated efficacy. Janux’s proprietary TRACTr technology is designed to integrate tumor-specific activation with crossover pharmacokinetics to produce best-in-class T cell engager therapeutics. “At

Immune Response 52

Immune Response Pharmacokinetics Engineering Licensing 52

The Pharma Data

OCTOBER 15, 2020

The study, which involves approximately 50 patients with the rare liver and lung disease, raised concerns about the experimental treatment’s safety and pharmacokinetic profile. That trial is continuing to enroll and dose patients, and results are expected in the first half of 2021. James Miessler.

Disease 52

Disease Small Molecule Pharmacokinetics Licensing 52

The Pharma Data

MARCH 9, 2022

Sanofi and Swedish Orphan Biovitrum AB (publ) (Sobi ® ) (STO:SOBI) today announced positive topline results from the pivotal XTEND-1 Phase 3 study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa (BIVV001) in previously treated patients ? 12 years of age with severe hemophilia A.

Treatment 52

Treatment Therapies Pharmacokinetics FDA 52

Conversations in Drug Development Trends

DECEMBER 20, 2023

Single-Arm Trial Design Single-arm trials have also become an increasingly common development strategy to support regulatory approval and allow patients expedited access to novel therapies, particularly in the accelerated access setting.

Clinical Trials 83

Clinical Trials Trials Pharmacokinetics FDA 83

DrugBank

FEBRUARY 26, 2025

This stagnation has created a perfect storm, threatening the effectiveness of current therapies and limiting the pipeline of new drugs. Advances in pharmacology and drug formulation have enabled researchers to refine these therapies and extend their utility.

Therapies 52

Therapies Pharmaceutical Companies Pharmacokinetics Treatment 52

The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic. It is approved in the U.S.

Therapies 52

Therapies Hospitals Treatment FDA Approval 52

The Pharma Data

JULY 6, 2021

New research from first-in-class marketed and investigational therapies in hemophilia, immune thrombocytopenia and acquired thrombotic thrombocytopenic purpura will be presented. Sanofi’s two marketed extended half-life factor replacement therapies shifted a two-decades-old treatment paradigm when launched in 2014.

Therapies 52

Therapies Pharmacokinetics Treatment RNA 52

The ChEMBL-og

APRIL 16, 2024

The data in MOLECULE_DICTIONARY.MAX_PHASE now includes consideration of: EMA approved drugs (max_phase=4 for human drugs), USAN clinical candidate drugs (assigned as max_phase = 1 based on USAN guidance that states “Firms usually apply for a USAN when the investigational therapy is in Phase I or Phase II trials”.

Clinical Trials 108

Clinical Trials FDA Cell Based Assays Compound Screening 108

LifeSciVC

APRIL 24, 2024

with gene editing or gene therapy, enzyme replacement therapy), agonism (e.g., For inhibition, is a small molecule or antibody-based approach best, or is the etiology tissue-centric so that an oligo, gene editing, or other strategy might address (e.g., in liver, in CNS)? with antibodies), or correction (e.g.,

Production 117

Production Small Molecule Regulations Trials 117

PPD

OCTOBER 12, 2023

Cell and gene therapies (CGTs) are one of the fastest growing areas in human therapeutics. Since chimeric antigen receptor T cell (CAR-T) therapy was first approved in 2017, there has been a marked increase of cell and gene therapy studies resulting in significant changes in the way diseases are treated as well as patient outcomes.

Laboratories 52

Laboratories Clinical Trials Protein Expression Pharmacokinetics 52

The Pharma Data

MARCH 5, 2021

Currently available BTK inhibitors irreversibly inhibit BTK and the long-term efficacy of these therapies can be limited by acquired resistance, most commonly through BTK C481 mutations. In rapidly growing tumors with inherently high rates of BTK turnover, resistance to covalent BTK therapies may be the result of incomplete target inhibition.

Clinical Trials 52

Clinical Trials Pharmacokinetics Trials Therapies 52

Drug Target Review

JULY 12, 2023

We also leverage existing clinical gene expression data from different subsets of molecularly profiled cancer patients, who differ in a certain aspect of disease or response to a particular therapy.

Biochemical Assays 98

Biochemical Assays Treatment Bioinformatics Disease 98

The Pharma Data

MAY 5, 2021

It also provided supporting pharmacokinetic data demonstrating the opioid antagonist’s safety and efficacy. . Farxiga received fast track, breakthrough therapy and priority review designations for the current indication. . controlled trial had not received previous systemic therapy for metastatic disease. New indications.

FDA Approval 52

FDA Approval FDA Therapies Pharmacokinetics 52