The Premier Consulting Blog

AUGUST 8, 2024

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees. i] United States Federal Register.

Pharmacokinetics 52

Pharmacokinetics Drugs FDA Production 52

Drug Target Review

SEPTEMBER 19, 2024

Could you give us an overview of IRLAB’s current drug development pipeline? Top-line data from the Phase IIb study is expected at the beginning of 2025. The third project in clinical phase, IRL757, is in Phase I and is being developed for the treatment of apathy.

Disease 52

Disease Drugs Treatment Drug Development 52

Codon

SEPTEMBER 29, 2024

2025 While the broader life sciences community had pivoted towards working on traditional mechanistic interpretations of biology, one graduate student still believed there was something to be learned using the models of life so celebrated previously. The 2025 genetic network paper fit that bill exactly.

Engineering 130

Engineering Virus DNA Therapies 130

LifeSciVC

JANUARY 16, 2024

Rise of the best-in-class biologics plays: Are you looking to in-license or invest in “de-risked” biology that is already in the clinic? Whether trial design, execution, or otherwise, drug development even where there is precedent is a challenging road and should not be taken for granted. Join the club.

Small Molecule 139

Small Molecule Trials Therapies Disease 139

Agency IQ

JULY 22, 2024

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). Novel drug products are defined as products that have never been approved for any indication.

Clinical Trials 52

Clinical Trials Trials Science FDA 52

Agency IQ

JUNE 21, 2024

Modeled on the Operation Warp Speed vaccine development communications approach, the pilot aims to test out a rapid communications approach for accelerating rare disease drug development.

Disease 40

Disease Science FDA Production 40

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

FDA 40

FDA Science Regulations Production 40