Advarra

AUGUST 16, 2022

The law established the Office of Orphan Products Development , providing financial incentives for pharmaceutical companies to develop orphan drugs and making it more viable to invest in orphan drug research and development. The impact was clear: Between 1983 and 2020, FDA approved 599 orphan drugs.

Disease 52

Disease Clinical Trials FDA Approval FDA 52

Agency IQ

NOVEMBER 27, 2023

The FDA estimated that the products containing the affected API had likely been on the market for about four years before this discovery. In a study of more than 12,000 small molecule drugs , researchers found 40.4% limits, or conduct a national assessment before determining any market actions. guidelines.

Regulations 40

Regulations Production FDA Packaging 40

The Pharma Data

NOVEMBER 10, 2020

Innovent has built an international team with expertise in cutting-edge biological drug development and commercialization. TYVYT® is the only PD-1 inhibitor included in the NRDL.

Biosimilars 52

Biosimilars Clinical Trials International Clinical Development 52

DrugBank

FEBRUARY 12, 2025

CMap utilizes gene expression profiles to connect drugs, genes, and diseases, enabling researchers to identify potential repurposing candidates based on their transcriptional signatures. Thalidomide : Initially marketed as a sedative in the late 1950s, thalidomide was withdrawn from the market due to its severe teratogenic effects.

Cell Based Assays 52

Cell Based Assays Drugs Pharmacokinetics Disease 52

Agency IQ

AUGUST 11, 2023

The FDA estimated that the products containing the affected API had likely been on the market for about four years before this discovery. The 2014 guideline established a baseline for measuring and reporting genotoxic impurities during development and following market authorization. To ensure the safety of the U.S.

FDA 40

FDA Science Production Regulations 40

Agency IQ

AUGUST 2, 2024

(ACT EU) / Clinical Trials Coordination Groups (CTCG) 9/11/2024 9/11/2024 Public launch event on the guideline on good pharmacovigilance practices Module XVI on risk minimization measures and its Addendum II Webinar ( OPEN ) EMA 9/12/2024 9/12/2024 ENVI meeting Committee meeting ( OPEN ) Environment, Public Health and Food Safety (ENVI) 9/13/2024 9/13/2024 (..)

Regulations 40

Regulations Clinical Trials Production Trials 40

Codon

JUNE 2, 2024

This discordance, or lack of “ predictive validity ” when translating results across organismal boundaries, is perhaps most harmful in the biomedical field; despite extensive testing in mouse models, only 10 percent of drugs that make it to clinical trials ever make it to market.

Laboratories 130

Laboratories Research Disease Science 130

Drug Target Review

FEBRUARY 11, 2025

The financial burden of drug development is substantial, often exceeding $2 billion per drug. Given that only a fraction of early-stage drug candidates progress to market, the costs associated with these failures are inevitably absorbed into the overall development costs.

Drug Development 59

Drug Development Bioinformatics Drugs Small Molecule 59