News

The European Medicines Agency recommended Novartis’ Kymriah (tisagenlecleucel) and Kite’s Yescarta (axicabtagene ciloleucel), chimeric antigen receptor (CAR) T-cell therapies, for approval in the European Union.

The acquisition of Flex Concepts adds custom, single-use products to Entegris’ single-use bag product line.

The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.

Legislators look to widen access to medications for addiction treatment and overdose emergencies.

The company expanded its extended workbench laboratory services program to support the ongoing manufacturing and development of Flexion Therapeutics’s Zilretta (triamcinolone acetonide extended-release injectable suspension).

Hamilton Robotics and Waters Corporation have partnered to develop StarWorks, automated, end-to-end workstations for biopharmaceutical sample preparation.

Sciex’s latest additions to its biopharma portfolio helps to optimize workflow for better analytics in the lab.

The company unveiled its latest innovations to its mass spectrometry portfolio at ASMS in San Diego.

Amazon will acquire PillPack, an online pharmacy that offers pre-sorted doses of medications and home delivery.

Fagron Sterile Services is voluntarily recalling two lots of Neostigmine Methylsulfate 5mL syringes due to mislabeling.

Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.

This article highlights 15 years of changes in biopharmaceutical manufacturing.

After 30 years of biologic-drug advances, the industry and patients still have a lot to learn.

Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.

Modern technologies, including Industry 4.0 and the Industrial Internet of Things, offer opportunities to increase biopharmaceutical manufacturing efficiency.

FDA seeks more efficient testing to spur development of less costly biotech therapies.

Process analytical technology tools have enabled manufacturers to monitor and control their production processes.

Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals.

BioPharm International asked an FDA spokesperson how the agency plans on handling these issues in the future.

Increasing demand for biologics is driving the need for innovation in bioprocessing.

Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing.

Biosimilars and biobetters face developmental challenges to achieving commercialization.

Safeguarding the know-how behind biopharmaceutical innovation is crucial to the industry’s future, but, in the US, some argue it is becoming increasingly difficult to do.

Sanofi will sell Zentiva, its European generics business, to private equity investor Advent International.

The companies will partner to develop T-cell therapies for cancer.

The new resin used a combination of “jetting” technology and a high-performance Protein A ligand.

FDA sent a warning letter to Henan Lihua Pharmaceutical Co. Ltd. after inspectors found the company failed to ensure the accuracy of its data.

A new oral delivery method developed by the Harvard John A. Paulson School of Engineering and Applied Sciences could change the way diabetics regulate blood sugar levels.