New Drug Approvals

MAY 9, 2025

1] [8] Pharmacokinetics Elacestrant has an oral bioavailability of approximately 10%. [1] 1] [8] Pharmacokinetics Elacestrant has an oral bioavailability of approximately 10%. [1] 1] [4] It is taken by mouth. [1] 3] [7] PATENTS Cruskie MP, et al. 1] Its plasma protein binding exceeds 99% and remains independent of concentration. [1]

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Drug Target Review

JUNE 6, 2025

And in the small molecule space, it’s about overcoming pharmacokinetic factors and formulation issues.” Greally explains that this iterative approach allows for more rigorous evaluation of ADC candidates, particularly in relation to pharmacokinetics and in vivo performance.

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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?

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The Pharma Data

JUNE 11, 2025

Notably, BRUKINSA has emerged as the market leader in new CLL patient starts across all lines of therapy in the U.S. Conducted in healthy adult volunteers, these studies were designed to evaluate the pharmacokinetics and establish bioequivalence between the new tablet and the original capsule form. for the first time.

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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.

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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.

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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.

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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.

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RNA Bioinformatics Science Pharmacokinetics 59

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.

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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.

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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.

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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.

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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.

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Drug Target Review

JUNE 16, 2025

Unlike traditional pharmacokinetic (PK) studies that rely on plasma measurements alone, MSI, when combined with traditional histology, enables spatial mapping of drug distribution, metabolism and target engagement.

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Drugs Organic Chemistry Laboratories Pharmaceuticals 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.

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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.

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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?

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Metabolic Stability Clinical Trials Small Molecule Pharmacokinetics 92

DrugBank

APRIL 24, 2025

These therapies aim to reverse abnormal epigenetic patterns, restore normal gene function, and offer hope for previously uncurable diseases. Understanding these processes is critical for developing effective epigenetic therapies. These mechanisms form a complex, reversible regulatory network governing cellular identity and behavior.

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DNA Drugs Therapies Regulations 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.

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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

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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.

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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.

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Clinical Trials Trials Pharmacokinetics FDA 83

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.

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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.

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Treatment Licensing Licensing Science 52

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.,

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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.

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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.

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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.

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Drug Target Review

OCTOBER 24, 2023

Could you elaborate on the drug being developed by Microbiotica to stimulate cancer patients to respond favourably to immune checkpoint inhibitor therapy? It is likely the combination of these mechanisms of action that will make MB310 an effective therapeutic. How does it work and what are the potential benefits?

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The Pharma Data

JULY 12, 2021

These data include results from a late-breaking presentation from a Phase 2a study evaluating the safety and pharmacokinetics (PK) of once-monthly (QM) oral islatravir for pre-exposure prophylaxis (PrEP) through 24 weeks. Safety and Pharmacokinetics of Islatravir in Study Participants with Severe Renal Insufficiency. Abstract 2361.

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Pharmacokinetics Clinical Trials Trials Treatment 52

The Pharma Data

JUNE 7, 2022

Food and Drug Administration (FDA) has approved RIABNI™ (rituximab-arrx), a biosimilar to Rituxan ® , in combination with methotrexate for adults with moderate to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

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Drug Target Review

JULY 1, 2024

Could you elaborate on the potential market size for SRP-001 and how it fits into the broader landscape of pain therapies? SRP-001 is a novel non-opioid pain relief candidate that works centrally in the brain, offering robust pharmacokinetics without the adverse effects of current medications. South Rampart Pharma, Inc.

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Advarra

JUNE 20, 2023

cell and gene therapies), with other therapeutic areas then pushing it further. Because of this, oncology researchers may only have access to minimal existing scientific literature related to cell-based data and animal testing to predict an investigational therapy’s effect on human factors.

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The Pharma Data

NOVEMBER 11, 2020

We now have compelling data showing SLV213 has potent antiviral activity against SARS-CoV-2 as well as data on the safety, tolerability, and pharmacokinetics and pharmacodynamics of SLV213 in several preclinical model systems, including nonhuman primates,” said Felix Frueh, Ph.D., Cofounder and Chief Scientific Officer of Selva Therapeutics.

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The Pharma Data

OCTOBER 27, 2020

Former Sarepta Therapeutics executive Bo Cumbo left to launch his new gene therapy company, AavantiBio, with a $107 million Series A. AavantiBio’s strategic partnership with University of Florida’s Powell Gene Therapy Center provide their foundational research in rare genetic disorders. AavantiBio . Sirnaomics.

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Small Molecule Immune Response Clinical Development Therapies 52

Alta Sciences

APRIL 17, 2024

Psychedelics Psychedelic therapy (or psychedelic-assisted therapy) refers to the use of psychedelic drugs, such as psilocybin, MDMA, LSD, ketamine, and ayahuasca, to treat mental disorders, especially those that have no effective treatments available or are treatment resistant.

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The Pharma Data

JANUARY 31, 2021

Traumatic brain injury and other tauopathies can have devastating effects on cognitive function and quality of life, yet there are currently no therapies that can halt or slow the rate of decline in these patients,” said Martin Jefson, Ph.D., Pinteon’s chief executive officer. “We

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