News

The pandemic made it daunting for companies to retain talent and then find it anew, but just as that cloud is lifting and workforce diversity is being embraced, AI beckons as a new challenge.

BioPharm International® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about the impact geopolitical changes in Europe might have on the bio/pharmaceutical industry.

While global harmonization exists, there are still differences between the US and European GMP requirements that manufacturers should know, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

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 bio/pharma industry is evolving with intention, intelligence, and a growing sense of shared purpose.

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.

The company’s exhibitions will be focused in the areas of its pipeline, proprietary capsid engineering, and manufacturing.

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.

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.

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

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss EMA’s revised guidelines on data protection in marketing authorization applications.

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.

Paige’s state-of-the-art foundation models will be integrated with Sonrai’s intuitive cloud-based data analysis and bioinformatics platform.

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.

The recombinant vaccine, under the brand name Vimkunya, is recommended for persons age 12 and older who are traveling to a country or territory where there is a chikungunya outbreak.

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