Atara Biotherapeutics

FUJIFILM Diosynth Biotechnologies celebrates the expansion of its California cell therapy facility, adding two new production suites and achieving EMA GMP certification, enhancing its capacity to support advanced therapies and meet regulatory expectations.

DelveInsight's 'Multiple Sclerosis Pipeline Insight 2024' report highlights 75+ companies developing 80+ therapies, including promising candidates like GA Depot, Remibrutinib, and IMU 838. Key events include Immunic's positive Phase 3 ENSURE trial interim analysis, Roche's FDA approval for Ocrevus injectable, and Sanofi's mixed results for tolebrutinib in Phase III trials. The report covers global pipeline stages, product types, molecule types, mechanisms of action, and routes of administration.

The red biotechnology market is projected to grow from $509.71 billion in 2023 to $867.20 billion by 2028, driven by advancements in personalized medicine, biosimilars, and genetic engineering. Major players include Pfizer, Roche, Bayer, and Amgen.

GenScript Biotech hosts global forum in London on Nov 20, 2024, focusing on cell and gene therapies, featuring keynotes by Dr. James M. Wilson and Dr. Miguel Forte, and panel discussions on challenges and innovations in cell therapy, gene therapy, and mRNA vaccines.

HighField Biopharmaceuticals presented positive safety and efficacy findings from its Phase 1 study of HF1K16 (K16), targeting myeloid-derived suppressor cells (MDSCs), at the ESMO Congress 2024. The study showed significant immune modulation and efficacy, with several R/R glioma patients surviving over 2 years.

2024 marks significant advancements in Cell and Gene Therapy (CGT), with Amtagvi, PM359, and INT2104 leading innovations. The '2024 GenScript Biotech Global Forum • London' will gather global experts to discuss CGT's future, featuring Dr. James Wilson, Miguel Forte, and Ying Huang. The forum aims to foster innovation and collaboration in CGT.

Atara Biotherapeutics granted 3,700 restricted stock units to a new employee, approved by the Compensation Committee under the 2018 Inducement Plan, with vesting over four years, in compliance with Nasdaq Listing Rule 5635(c)(4).

The FDA accepted Atara Biotherapeutics' BLA for tabelecleucel (tab-cel®) for EBV+ PTLD, granting Priority Review with a PDUFA date of January 15, 2025. Tab-cel is an allogeneic EBV-specific T-cell immunotherapy with Breakthrough Therapy and orphan drug designations, aiming to treat patients with at least one prior therapy. The BLA is supported by pivotal data from over 430 patients, showing a 48.8% Objective Response Rate. Atara has a global partnership with Pierre Fabre Laboratories for tab-cel commercialization, with potential milestone payments upon FDA approval.

Atara Biotherapeutics submits a Biologics License Application to the FDA for tabelecleucel (tab-cel®) as monotherapy for EBV+ PTLD patients who have received at least one prior therapy, with no FDA approved therapies in this setting. Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells, supported by pivotal data from over 430 patients. The therapy has Breakthrough Therapy and orphan drug designations, and has received marketing authorization in Europe, UK, and Switzerland under the brand name Ebvallo™.