Development

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

Incorporating sustainable practices into process designs as early as possible ensures optimal performance.

The company hopes that its proprietary circVec technology platform will become a gold standard for nucleic acid and viral therapeutics.

This article provides an overview and introduction to the use of analytics in biopharmaceutical development and manufacturing.

Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.

The company’s intent is to establish Merck Wilmington Biotech as the future United States home for producing Keytruda for US patients.

Among the new data the company plans to show in its presentations is the successful, repeated dosing of an mRNA-LNP in monkeys.

Black Hawk’s subsidiary, BH Merger Sub, will merge with Vesicor as part of the agreement.

Groundbreaking clinical studies and new research collaborations are pushing ahead even as uncertainty lingers about the geopolitical climate’s impact on development.

Transfer RNA is being investigated as a treatment for as many as 400 rare and ultra-rare diseases affecting the liver.

The investment agreement will support the company’s ongoing clinical trials for its treatment for the rare genetic condition, spinocerebellar ataxia.

CAR T-cell therapies, TILs, and other advanced therapies are pushing progress in the treatment of cancers.

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.

If approved, zanidatamab would be the first HER2-targeted therapy licensed for biliary tract cancer in the EU.

Avidicure is a new biotechnology company that has been launched on the back of a $50 million seed financing round for developing a new multifunctional antibody modality for treating cancer.

The proposed business combination would create a publicly traded, clinical-stage biopharmaceutical company that will focus on developing a pipeline of next-generation cancer therapies.

The first patient has been dosed in a Phase II clinical trial for the company’s MB-105 first-in-class CD5-targeted CAR-T cell therapy.

The investment will be done over five years and will include new, state-of-the-art R&D facilities as well as new or expanded manufacturing sites in multiple US states.

Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.

Using cholesterol-modified oligonucleotides, the research team aims to improve the delivery of antisense nucleotide-based therapies for treating neurodegenerative diseases and brain cancers.

The 6000-square-foot facility will provide cell therapy developers the support they need to transition to CGMP manufacturing, and an expanded footprint of the new center is expected to open in Philadelphia later in 2025.

This collaboration aims to advance a first-in-human clinical study by using autologous iPSC technology.

Eculizumab-aagh (EPYSQLI) is now available in the US to treat patients living with difficult-to-treat rare diseases such as paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and generalized myasthenia gravis.

Novartis will invest $23 billion during the next five years to expand manufacturing and R&D in the US, which will include seven new facilities and a new research hub.

The spray-dried formulations for Ethris’ mRNA vaccine candidates will be developed at Lonza’s Bend, Ore., Center of Excellence in accordance with GMP standards.

Through this collaboration, Circio will combine its circVec DNA vectors with Entos’ Fusogenix PLV delivery technology, which is expected to enhance delivery efficiency and reduce toxicity.

The EMA has issued a new proposal that aims to encourage biosimilar development and improve patient access to biosimilar therapies.

Hurdles exist across all aspects and phases of drug development and manufacturing.