Feliza Mirasol

This collaboration between Andelyn Biosciences and Tern Therapeutics moves the gene therapy TTX-381 closer to approval for treating vision loss linked to CLN2 Batten disease.

FDA’s fast track designation may speed VMX-C001’s application review, addressing urgent surgery needs in patients on Factor Xa anticoagulants.

A joint venture between the two entities will integrate mRNA synthesis, LNP formulation, and clinical testing to speed therapies from plasmid design to first-in-human trials.

Aptamer will create Optimer binders for Invizius’ H-Guard technology to enhance complement-targeting therapies for safer, more precise treatments for immune disorders.

The partnership expands patient access in MENA by localizing biosimilar manufacturing and distribution for gastro, neuro, and dermatology treatments.

The acquisition expands tubular glass vial and ampoule capacity, expanding ready-to-use glass packaging capabilities in Europe.

EC clears ExCellThera’s Zemcelpro, a cord blood–based stem cell therapy that offers transplant access to blood cancer patients lacking suitable donors.

SynaptixBio CEO Dan Williams notes how rare-disease drug development is advancing on the back of FDA incentives, priority review vouchers, and a growing recognition of unmet needs.

The agreement expands researcher access to backbone modifications that boost stability and delivery of RNA therapeutics across diverse applications.

Ifinatamab deruxtecan shows promising trial results targeting B7-H3 in small cell lung cancer, offering a potential new option after chemotherapy failure.

Bristol Myers Squibb and SystImmune’s iza-bren shows promising efficacy and safety in EGFR-mutant NSCLC after TKI and chemotherapy, backed by data from global and China-based trials.

Third-party ICMC certification verifies multi-modality manufacturing readiness, meeting US and EU standards for advanced genetic therapies.

Dan Williams, PhD, SynaptixBio CEO, discusses how rare disease drug development leverages genetic targeting and drives innovation and investment in pharmaceutical technology and precision medicine.

The Hopewell, N.J., site adds scalable, end-to-end viral vector production with integrated quality systems to speed clinical and commercial gene therapy programs.

Strand advances targeted mRNA therapies, with Phase I STX-001 solid tumor data presented at the 2025 ASCO Annual Meeting.

The newly launched facility is located in The Woodlands, Texas, and will produce plasmid DNA as well as strengthen biopharma supply chains.

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.

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.

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

As more originator biologics lose patent exclusivity in the next decade, a healthy biosimilars pipeline is necessary but requires market support.

Although automation is increasingly adopted in biomanufacturing, challenges remain in implementing it at the cell harvesting step.

The biopharmaceutical landscape is undergoing a huge shift from traditional therapies to more specialty-driven modalities.

Through the collaboration, Pharmaron will validate and promote the application of CN Bio’s PhysioMimix technology with plans to integrate OOC technologies into its R&D platform.

AnalytiChem has launched the Redipor line of ready-to-use culture media, which brings three well-known brands under one global brand.