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

The additional approval expands the label for Avtozma (tocilizumab-anoh) to now include the treatment of cytokine release syndrome, which aligns the therapy with all indications for which Actemra is approved in the US.

Solutions are emerging to manage advanced modalities and evolving regulatory requirements for viral clearance.

Biopharma’s future depends on seamless integration of technology, expertise, and strategy.

Jonathan D. Grinstein, PhD, Manfred Scholz, PhD, and Erik Wiklund, PhD, go behind the headlines to address a shifting policy landscape and what it means for the future of chronic disease, diagnostics, and next-generation cell and gene therapies.

The acquisitions include three testing laboratories that enhance Normec’s ability to serve key highly regulated sectors in the TICC industry.

Avantor's Jerry Keybl, senior vice-president, Biopharma Products and Strategy, highlights innovations in biomanufacturing and recalls his impressions of INTERPHEX 2025, held this past April.

Bristol Myers Squibb is seeking approval of Breyanzi (lisocabtagene maraleucel) to treat relapsed or refractory marginal zone lymphoma, making this the fifth cancer type for which the cell therapy would be approved.

While no new mRNA-based projects will be eliminated, other uses of mRNA technology within HHS are not impacted by the announcement.

Increasing efficiency and quality through effective application of advanced technologies is becoming predominant.

Advanced technology platforms optimize the efficiencies and sustainability of single-use bioreactors, setting the scene for the next evolutionary step in biomanufacturing.

The new platform delivers CAR-T DNA and transposase directly in vivo, potentially lowering manufacturing complexity and expanding treatment access.

Under the licensing agreement, the proposed biosimilar candidate, PolyPB016, will be developed and manufactured by Polpharma Biologics and commercialized by Fresenius Kabi.

Phase III study findings emphasize donanemab-azbt's (brand name Kisunla) ability to slow the decline of patients exhibiting early symptomatic Alzheimer’s disease.

At AAIC 2025, Roche presented new data from its Alzheimer’s disease research efforts across its diagnostics and pharmaceutical portfolios.

The acquisition highlights growing investor interest in gamma delta T-cell therapies and reflects increased monetization of biotech licensing agreements.

The new spinning plant to be built in Nobeoka City, Miyazaki, Japan will produce hollow-fiber cellulose membranes, expanding production of the virus removal filters.

The biological reagents provider is moving to a 5000-square-foot site in Cambridge Technopark to accommodate the company’s growth.

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If action is not taken within 60 days, the White House said it would “deploy every tool in our arsenal” to improve drug pricing practices for American patients.

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.

Smart technology, personalized medicine, and the customization of CDMO relationships are helping manufacturers meet shifts in client demand.

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

While little information is known about this particular case, its possible implications are far-reaching.

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.

Outsourcing is booming across all platforms, from fill/finish to cell therapies, as companies pursue efficiency, scale, and strategic flexibility.

Mirvetuximab soravtansine, brand name Elahere, is the first licensed treatment for women with platinum-resistant ovarian cancer in the UK in more than 10 years.

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

Speedier implementation of the Post-Approval Change Management Protocol is essential for it to have a positive effect on supply security, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.