Practical Cheminformatics

JANUARY 8, 2024

In November and December, several large pharmas held “AI Day” presentations featuring LLM applications for clinical trial data analysis. These information retrieval capabilities have many applications, from writing computer code and collating clinical trial results to summarizing papers on a specific topic. What’s old is new again.

Drugs 141

Drugs Small Molecule Bioinformatics Packaging 141

The Pharma Data

JULY 23, 2021

In addition to the REGN-COV 2067 trial in non-hospitalised patients, Ronapreve is currently being assessed in a phase II/III clinical trial for the treatment of COVID-19 in hospitalised patients (REGN-COV 2066).

Treatment 52

Treatment Virus Clinical Trials Pharmaceuticals 52

Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

Clinical Trials 52

Clinical Trials Treatment Trials Small Molecule 52

Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

Clinical Trials 40

Clinical Trials Treatment Trials Small Molecule 40

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. ” To support the opinion, the EMA reviewed Phase 2 and Phase 3 results from Lilly’s BLAZE-1 trial. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity.

Treatment 40

Treatment Hospitals Long-Term Care Facilities Therapies 40

The Pharma Data

MAY 7, 2021

The EMA will evaluate all data on sotrovimab, including evidence from clinical trials, as they become available. The multi-center, double-blind, placebo-controlled, Phase 3 COMET-ICE trial investigated sotrovimab in adults with mild or moderate COVID-19 at high risk of progression to severe disease. About the COMET-ICE Study Design.

Treatment 40

Treatment Vaccine Virus Trials 40

Agency IQ

FEBRUARY 12, 2024

A new real-world evidence guidance on the list is meant to address the integration of randomized controlled trials for drug and biological products into routine clinical practice. This is a topic that the agency has been keenly aware of for years, but it’s not clear from the title if it will refer to how the FDA will use A.I.

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40