Biopharma News

Dave Miller, PhD, explains how a development-first approach, scientific depth, and regulatory trust build lasting partnerships in the CDMO space.

Dave Miller, PhD, discusses how tailored solutions, trust, and lifecycle planning are redefining partnerships in bio/pharmaceutical development.

FDA reinstates Vinay Prasad to lead CBER as gene therapy safety concerns spotlight regulatory challenges in biotech manufacturing.

Help us get a better picture of how new tariffs and trade policy have impacted you and your organization.

Germany-based biotech boosts animal-free supplement production, enabling greater scalability and supply security for next-gen cell therapies worldwide.

Prasad’s short FDA tenure brought stricter review standards for gene and COVID vaccines, sparking biotech concern and political backlash.

Imfinzi’s application is supported by Phase III trial data showing improved pathologic complete response in early-stage gastric cancer.

The licensing agreement between the two companies gives Pfizer the rights to develop, manufacture, and commercialize 3SBio’s bispecific antibody, SSGJ-707, which is in clinical trials for the treatment of a variety of cancers.

US pharma firms face higher drug costs, delayed launches, and compliance risks from proposed sectoral tariffs, prompting urgent supply chain reviews.

US pharma tariffs may start low and rise, risking drug shortages, higher costs, and pressure on generics amid reshoring push.

Tariffs on APIs and finished drugs could take effect as early as August 1, with accelerated investigations raising urgency for supply chain planning.

The agency has extended the review period for GSK’s biologics license application for belantamab mafodotin-blmf for the treatment of relapsed/refractory multiple myeloma.

The investment is part of CGT Catapult’s Cross-Catapult Investment Pilot and will accelerate the pre-clinical development of Spliceor’s trans-splicing gene therapy platform.

Minimize contamination in cell therapy manufacturing with isolators, staff protocols, sterile materials, and validated suppliers for process integrity.

Genascence’s first-in-class gene therapy blocking interleukin 1, GNSC-001, will enter a Phase IIb/III study in 2026.

Biopharma job cuts surge in 2025, hitting R&D, manufacturing, and commercial roles and causing professionals to face shifting priorities and tighter pipelines.

The company’s gene therapy, AAVB-039, for the treatment of Stargardt disease progresses to a Phase I/II clinical trial.

Northway Biotech will develop and scale production of AATec’s ATL-105 for the treatment of non-CF bronchiectasis.

FDA will review GSK’s application to expand the use of its respiratory syncytial virus vaccine, Arexvy, to adults aged 18–49 who are at increased risk.

The IL-36 inhibitor is being explored for additional inflammatory skin conditions, aiming to expand treatment options for underserved patient groups.

Trump’s tax bill could reshape drug R&D, manufacturing, Medicaid access, clinical trials, and biotech funding, impacting strategy across the bio/pharmaceutical industry.

Once limited to experimental vaccine platforms, messenger RNA (mRNA) is now taking center stage across the entire biotech landscape.

Regulatory shift reflects maturation of CAR-T field and impacts biopharm manufacturing, development, and discovery.

The next-generation monoclonal antibody could potentially be used to prevent and treat active COVID-19 infections, according to its developer, providing a non-vaccine option.

The biotech company urges government action to support newborn genome screening, emphasizing the need for rare disease care, testing, and family resources.

The agency has recommended conditional marketing authorization for Zemcelpro (dorocubicel/unexpanded umbilical cord cells) to treat adults with hematological malignancies (blood cell cancers).