The Pharma Data

JANUARY 25, 2021

The Company may not redeem the notes prior to February 6, 2026. The initial conversion price of the notes represents a premium of approximately 47.5% over the last reported sale price of the Company’s common stock of $65.79 per share on January 25, 2021.

Marketing 52

Marketing Disease Clinical Trials Clinical Development 52

Agency IQ

JULY 26, 2024

In switching studies , a two-arm trial design is commonly employed. During the lead-in period, all patients are assigned to the reference product followed by randomization to either the “switching arm” or “non-switching arm” of the study. Comments are due September 23, 2024. If and when this new draft guidance is finalized, Q.I.20

Biosimilars 40

Biosimilars Science FDA Production 40

Agency IQ

AUGUST 18, 2023

Expert panels have two main tasks under the MDR and IVDR, which is to provide opinions and view as part of the clinical and performance evaluation consultation procedures (MDR Article 54 / IVDR Article 48). The second is ad hoc advice on clinical development plans and clinical investigation proposals.

Science 40

Science Regulations Laboratories Production 40

Agency IQ

APRIL 8, 2024

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

FDA 40

FDA Production Regulations Vaccine 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

The Pharma Data

JUNE 2, 2022

A 30-plus valent pneumococcal candidate vaccine is also in pre-clinical development. We look forward to working with the many talented people at Affinivax to combine our industry-leading development, manufacturing, and commercialisation capabilities to make this exciting new technology available to those in need.”

Vaccine 52

Vaccine Immune Response Clinical Trials Disease 52

The Pharma Data

MAY 31, 2022

A 30-plus valent pneumococcal candidate vaccine is also in pre-clinical development. We look forward to working with the many talented people at Affinivax to combine our industry-leading development, manufacturing, and commercialisation capabilities to make this exciting new technology available to those in need.”.

Vaccine 52

Vaccine Immune Response Clinical Trials Disease 52