The Pharma Data

APRIL 6, 2022

“With our portfolio of in-market medicines and up to 20 major pipeline assets that could be approved by 2026, Novartis is in a strong position to deliver above-peer-median sales and margin growth in the mid- and long-term.” ” Integrating Pharmaceuticals and Oncology business units.

International 52

International Pharmaceuticals Drug Development Marketing 52

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

Postapproval manufacturing changes for biological products During clinical development or following a product’s approval , sponsors and/or manufacturers may identify the need for a change in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling. Comments are due September 23, 2024.

Biosimilars 40

Biosimilars Science FDA Production 40

The Pharma Data

DECEMBER 12, 2020

AstraZeneca , with Alexion ‘s R&D team, will work to build on Alexion ‘s pipeline of 11 molecules across more than 20 clinical-development programmes across the spectrum of indications, in rare diseases and beyond. 2 EvaluatePharma, World Preview 2020, Outlook to 2026. AstraZeneca PLC. _.

Regulations 75

Regulations International Disease Small Molecule 75

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

The Pharma Data

JUNE 16, 2025

The ongoing Phase 3 pivotal study in children with ENPP1 Deficiency is a major milestone in its clinical development, with data expected to be available in early 2026. Furthermore, a pivotal study in infants is currently underway, alongside plans for a supportive study in the adolescent and adult population.

Therapies 40

Therapies Treatment Disease Clinical Development 40

The Pharma Data

JULY 6, 2021

Adjusted operating margins are expected to improve from the current mid-20s level to over 30% by 2026. The £33 billion sales ambition is before any significant revenue contribution from early-stage pipeline assets or any contribution from business development. Cash generated from operations is expected to exceed £10 billion by 2026.

Government 52

Government Vaccine Production Science 52

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

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. billion to be paid upon the achievement of certain paediatric clinical development milestones. The consideration for the acquisition comprises an upfront payment of $2.1 The transaction is expected to close in the third quarter of 2022.

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. billion to be paid upon the achievement of certain paediatric clinical development milestones. The consideration for the acquisition comprises an upfront payment of $2.1 The transaction is expected to close in the third quarter of 2022.

Vaccine 52

Vaccine Immune Response Clinical Trials Disease 52

Drug Target Review

MARCH 20, 2025

This potential breakthrough could transform both drug discovery and clinical treatment strategies, with the possibility of enhancing patient safety and improving outcomes in thrombotic conditions like atrial fibrillation. NYSE: MRK), which included leadership roles in early and late clinical development and cardiovascular discovery.

Therapies 52

Therapies Clinical Development Trials FDA 52