The Pharma Data

NOVEMBER 8, 2020

It is estimated that there will potentially be 13 million moderate-to-severe acne patients treated with oral antibiotics in the urban Chinese population by 2028, which represents a significant opportunity to launch an innovative product whose clinical development is largely de-risked. Guidance for FY 2020.

Licensing 52

Licensing Licensing Marketing Treatment 52

Agency IQ

MAY 28, 2024

It would also introduce new requirements for human clinical trials, post-market surveillance and vigilance. CE mark in addition to its own UKCA mark, with a plan to continue doing so through 2028 or 2030, depending on the legislation to which the CE mark applies. Devices with Canadian licenses or those cleared via the U.S.

International 40

International Regulations Licensing Licensing 40

Agency IQ

AUGUST 16, 2024

The June 2023 guidance recommends that studies involve two monitors (one with graduate-level professional training and clinical experience in psychotherapy, licensed to practice independently) to observe study participants during treatment sessions. FDA accepted the Lykos NDA in February 2024, and the submission received priority review.

FDA 40

FDA Trials Therapies Regulations 40

The Pharma Data

NOVEMBER 4, 2020

Reaffirmed c linical trial results from study of VASCEPA in China are expected by year end 2020 : Assuming positive results from this study conducted by Amarin’s commercial partner for VASCEPA in China, regulatory submission in China could follow promptly thereafter. This compares with licensing and royalty revenue of $0.2

Production 40

Production Trials Disease FDA 40

Codon

SEPTEMBER 29, 2024

2028 Over the next year, the scientific community ferociously interrogated the model. The average pass rate of phase I trials went up by 5 percent. At best, the corporations with the best models released weak versions to the public under non-commercial licenses. The next model of life had officially been released.

Engineering 142

Engineering Virus DNA Therapies 142

The Pharma Data

JANUARY 9, 2021

Pipeline progress is expected across the vaccines, therapeutics, and devices portfolios, anticipating at least one Phase 3 launch and one Biologics License Application (BLA)/Emergency Use Authorization (EUA) filing. FOOTNOTES. (1)

Government 40

Government Vaccine Production Licensing 40

The Pharma Data

SEPTEMBER 15, 2020

27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame. Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mostly mild to moderate tolerability profile as was observed in Phase 1. Protease Inhibitor Program.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52