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PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

The Pharma Data

RE47,739 (‘739) by more than four years until March 5, 2027. Patent Term Extension (PTE) certificate for IBRANCE® (palbociclib). The certificate extends the term of U.S. The PTE certificate was granted under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984.

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Gilead expands Arcellx cancer cell therapy deal

BioPharma Drive: Drug Pricing

The deal gives Gilead an estimated 13% ownership in Arcellx and extends the company’s cash runway into 2027.

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Article EMA Thank You Updated EUDAMED roadmap projects mandatory use of some processes as early as December 2025

Agency IQ

The independent auditing schedule showed publication of full functionality in mid-2027. The first five modules would be audited between Q2 2024 and Q1 2025 and the CI/PS module between Q4 2026 and Q1 2027, with publication of complete functionality occurring by the end of Q2 2027. There’s a notable absence from this roadmap.

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7 Ideas to Implement & Maintain a Research Data Management Platform

thought leadership

billion USD by 2027, with the goal of improving the generation, collation, storage, and utilization of data 1. Investments in digital transformations are expected to grow from $594.5 billion USD in 2022 to $1.548.9 This drive to better manage and protect data is not a luxury.

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How point-of-care technology providers can drive market growth with liquid handing instruments

Tecan

By Joe Guterl More than $72 billion – that is what some researchers estimate will be the global point-of-care (POC) biochemical diagnostic testing market size in 2027, up from $36 billion in 2021.

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FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

FDA Law Blog: Biosimilars

This FR Notice and draft strategy document are part of FDA’s commitment under the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for Fiscal Years 2023-2027 (PDUFA VII), wherein FDA committed to advance the use and implementation of innovative manufacturing.

FDA 57
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Update on CDER, CBER, and CDRH Meetings with Industry

FDA Law Blog: Biosimilars

FDA notes that all in-person FTF formal meetings at CDER and CBER will have a hybrid component (virtual attendees in addition to in-person attendees).

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