News

Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, has been chosen to lead the Center for Biologics Evaluation and Research at FDA.

The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.

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.

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.

BioPharm International® sat down with Noah Kopcho, field application scientist at Gyros Protein Technologies, to talk about the challenges in the production of AAV vectors.

BioPharm International® spoke with Lun Xin, associate director at WuXi Biologics, about how automation can accelerate and improve the formulation of high-concentration biologics.

BioPharm International® spoke with Lun Xin, associate director at WuXi Biologics, about high-concentration biologics and some of the biggest challenges associated with their formulation.

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.

The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.

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.