2004 and Pharmacokinetics - Drug Discovery Digest

Therapeutic Oligos 2025 Keynote Speakers Announced

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

RNA Bioinformatics Science Pharmacokinetics

First patients dosed in Phase 1a clinical trial of UCL-backed G-Quadruplex (G4) targeting treatment for solid tumors, including pancreatic cancer

Sygnature Discovery

NOVEMBER 29, 2023

The QN-302 Phase 1 clinical trial is a multi-site, open-label, dose-escalation and dose expansion, safety, pharmacodynamic and pharmacokinetic study of intravenous QN-302 in patients with advanced or metastatic solid tumors. A total of up to 36 patients will be enrolled in the dose escalation (Phase 1a) portion of the study.

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Clinical Trials Treatment Trials Small Molecule

Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19

The Pharma Data

JULY 23, 2021

Outside Japan, the antibody combination has been authorised for emergency use or temporary pandemic use in additional territories and regions, including in the European Union, United States, India, Switzerland and Canada.

Treatment

Treatment Virus Clinical Trials Pharmaceuticals

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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AI in Drug Discovery - A Highly Opinionated Literature Review (Part II)

Practical Cheminformatics

JANUARY 8, 2024

A 2004 paper by Vigers and Rizzi proposed a similar strategy for docking studies. In addition to optimizing potency against a target of interest, we must design selective compounds with optimal pharmacokinetic profiles and a host of other desirable properties. It should be noted that this isn’t a new idea. What’s old is new again.

Drugs

Drugs Small Molecule Bioinformatics Packaging

First patients dosed in Phase 1a clinical trial of UCL-backed G-Quadruplex (G4) targeting treatment for solid tumors, including pancreatic cancer

Sygnature Discovery

NOVEMBER 29, 2023

The QN-302 Phase 1 clinical trial is a multi-site, open-label, dose-escalation and dose expansion, safety, pharmacodynamic and pharmacokinetic study of intravenous QN-302 in patients with advanced or metastatic solid tumors. A total of up to 36 patients will be enrolled in the dose escalation (Phase 1a) portion of the study.

Clinical Trials

Clinical Trials Treatment Trials Small Molecule

EMA issues advice on Lilly’s bamlanivimab (LY-CoV555) alone and administered together with etesevimab (LY-CoV016) for the treatment of confirmed COVID-19 in the European Union

The Pharma Data

MARCH 5, 2021

of regulation 726/2004 provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. The CHMP scientific opinion under Article 5.3

Treatment

Treatment Hospitals Long-Term Care Facilities Therapies

GSK and Vir Biotechnology announce the start of the EMA rolling review of VIR-7831 (sotrovimab) for the early treatment of COVID-19

The Pharma Data

MAY 7, 2021

Separately, the CHMP is also reviewing sotrovimab under Article 5(3) of Regulation 726/2004 and is expected to provide EU-wide recommendations for national authorities who may take evidence-based decisions on the early use of the medicine, ahead of any formal Marketing Authorisation.

Treatment

Treatment Vaccine Virus Trials

TACACICLIB, AUR-102, AURIGENE

New Drug Approvals

JANUARY 9, 2024

1004-1014, 2004). For drug development, it is typically advantageous to employ individual stereoisomers as they exhibit marked differences in pharmacodynamic, pharmacokinetic, and toxicological properties. 2006 Mar 1; 20(5):601-12, 2006), in contrast with CDK9, which phosphorylates both Ser-2 and Ser-5 of the CTD heptad (Pinhero et al.,

Production

Production DNA RNA Regulations

Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

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.

Making a “Miracle” HIV Medicine

Codon

FEBRUARY 23, 2025

million by 2004. Pharmaceutical developers often avoid fluorine because the element can alter pharmacokinetics, making it hard to predict how a drug will be absorbed, metabolized, and excreted. By Kamal Nahas Scientists had no antiretroviral drugs when the AIDS crisis began in 1981. For more than two decades, the U.S.

Clinical Trials

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Drug Discovery Digest

Therapeutic Oligos 2025 Keynote Speakers Announced

First patients dosed in Phase 1a clinical trial of UCL-backed G-Quadruplex (G4) targeting treatment for solid tumors, including pancreatic cancer

Webinars

Trending Sources

Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19

Webinars

AI in Drug Discovery - A Highly Opinionated Literature Review (Part II)

First patients dosed in Phase 1a clinical trial of UCL-backed G-Quadruplex (G4) targeting treatment for solid tumors, including pancreatic cancer

EMA issues advice on Lilly’s bamlanivimab (LY-CoV555) alone and administered together with etesevimab (LY-CoV016) for the treatment of confirmed COVID-19 in the European Union

GSK and Vir Biotechnology announce the start of the EMA rolling review of VIR-7831 (sotrovimab) for the early treatment of COVID-19

TACACICLIB, AUR-102, AURIGENE

Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

Making a “Miracle” HIV Medicine

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