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. Their pipelines were bursting with promising candidates, and their success rates in clinical trials were astronomical compared to the industry standard of just a few years back.

Engineering 132

Engineering Virus DNA Therapies 132

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. A Phase 3 trial is ongoing.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

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.

Licensing 52

Licensing Licensing Production Treatment 52

The Premier Consulting Blog

NOVEMBER 20, 2023

Clinical development experts would need to navigate the potential complexities arising from this regulatory shift, particularly in terms of trial design and evidence generation. For regulatory affairs specialists, this implies heightened diligence to ensure that LDTs align with premarket review standards.

Laboratories 52

Laboratories FDA Clinical Development Regulations 52

The Pharma Data

JANUARY 25, 2021

Prior to November 1, 2028, the notes will be convertible only upon satisfaction of certain conditions and during certain periods. The notes will bear interest at a rate of 2.25% per year, payable semi-annually in arrears on February 1 and August 1 of each year, beginning August 1, 2021.

Marketing 52

Marketing Disease Clinical Trials Clinical Development 52

Agency IQ

JANUARY 26, 2024

EMA regulators themselves published an article discussing the review process for companion diagnostics and the lack of opportunity to use a single submission for the drug clinical trial under the Clinical Trial Regulation and the performance study application according to the IVDR.

Regulations 40

Regulations Compliance Laboratories Production 40

The Pharma Data

JANUARY 9, 2021

There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements, including the impact of global economic conditions and public health crises and epidemics, such as the global pandemic that arose from COVID-19, on the markets, our operations, and employees as well (..)

Government 40

Government Vaccine Production Licensing 40

Agency IQ

AUGUST 16, 2024

SPA allows sponsors to gain regulatory perspective on whether a proposed trial design is adequate to support a marketing application, though the ultimate approval decision is based on the data submitted for review. 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. commercial team. “In . 4.3.

Production 40

Production Trials FDA Disease 40

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. Notably, IVDs would be regulated under the same proposed regulation.

International 40

International Regulations Licensing Licensing 40

Agency IQ

FEBRUARY 2, 2024

Companion diagnostics (CDx) and cancer trials: In 2023, the MDCG published guidance documents on classifying CDx. This remains a major area of concern for both industry and regulators, with a March 2023 survey from EFPIA finding that the challenges with the IVDR has led to issues with IVDs used in drug trials , and particularly cancer trials.

FDA 40

FDA Laboratories Regulations Production 40