The Premier Consulting Blog

NOVEMBER 20, 2023

Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. billion each year.

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Laboratories FDA Clinical Development Regulations 52

DrugBank

SEPTEMBER 26, 2024

For instance, Inflectra , a biosimilar of Remicade, underwent a comprehensive clinical development program, including a Phase III trial demonstrating comparable efficacy and safety to the reference product in patients with rheumatoid arthritis. billion by 2028.

Biosimilars 74

Biosimilars Clinical Trials Production FDA 74

The Pharma Data

JANUARY 19, 2021

It hopes to raise about $160 million in aggregate principal amount of 7.375% senior notes due 2025 and $270 million in aggregate principal amount of 7.250% senior notes due 2028. Ortho Clinical Diagnostics is a leader in in vitro diagnostics. It is offering 70 million ordinary shares with a price between $20 and $23 per share.

Small Molecule 52

Small Molecule Trials Laboratories Immune Response 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 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

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. In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval.

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Vaccine Therapies Trials Clinical Trials 52