News

Pfizer will expand its obesity drug pipeline with Metsera’s clinical incretin and amylin programs, highlighting advances in biopharma development and manufacturing.

Advances in digital technologies offer effective data handling for bio/pharma manufacturing.

The scaled adoption of cell and gene therapies demands a new era of agile, precise, and efficient quality control methods. Manufacturers and diagnostic partners must collaborate to create innovative, compliant testing strategies that preserve product integrity, meet tight timelines, and deliver life-saving treatments faster.

New GS knockout CHO-K1 systems accelerate biologics manufacturing by improving yields, scalability, and flexibility for biopharma development programs.

Regulatory crackdowns on risk disclosure rise, policy instability affects public health, and drug innovation focuses on advanced therapies and AI-driven discovery.

In the first-ever “Two-Minute Mysteries: BioPharma Stories,” Agilent’s Ken Boda shares the mystery of a low reading.

ACIP votes to separate MMR and varicella vaccines (MMRV) for children to cut febrile seizure rates.

CPHI Pharma Awards 2025 highlight breakthroughs in bio/pharma technology, sustainable manufacturing, and industry leadership.

Ex-CDC head Susan Monarez testifies she was fired for resisting RFK Jr.'s pressure to sideline science, raising alarms for bio/pharma's regulatory stability.

SynaptixBio CEO Dan Williams discusses how small biotechs drive rare disease innovation with genetic research, partnerships, and patient advocacy in a third interview installment.

Misleading promotions of GLP-1 and compounded semaglutide products are drawing renewed regulatory scrutiny over risk disclosure and safety messaging.

CSL will fund Phase III clinical development of VMX-C001 with an option to acquire VarmX.

A collaboration between Limula and Institut Paoli-Calmettes aims to advance automated stem cell transplant processing to improve cryoprotectant removal, enhance patient outcomes, and streamline manufacturing.

A published study finds that the therapy reported specific and potent cytotoxicity against acute myeloid leukemia, T-cell acute lymphoblastic leukemia, and other rare blood cancers.

Novartis and Monte Rosa expand collaboration using AI-driven molecular glue degraders to advance drug development for immune-mediated diseases.

FDA transparency, AI in manufacturing, automation for quality, and cell/gene therapy advancements are driving the biopharma industry forward.

Optimizing FDA 483 responses with strategic CAPA creates resilient quality compliance in biopharma manufacturing.

Automated facility upgrades for cell therapy enhance quality assurance, ensure regulatory compliance, and boost operational efficiency by minimizing manual risks.

Strategic AI integration in bio/pharma manufacturing enhances GxP compliance, quality, and operational efficiency through robust governance and risk management.

Aaron Cowley, Recipharm Advanced Bio; Renee Hart, LumaCyte; and Vibha Jawa, EpiVax, go behind the headlines to delve deeper into recent market deals driven by Big Pharma patent cliffs and the complex manufacturing of ATMPs.

Telix will now include an additional, confirmatory efficacy study analysis of existing data, hoping to satisfy FDA’s request for supplemental evidence and address concerns raised in a complete response letter.

Data integrity and quality are paramount for drug discovery, manufacturing efficiency, regulatory compliance, and patient safety.

Integra has secured €10.7 million (US$12.6 million) in funding for its FiCAT gene writing platform to enhance precise DNA integration for CAR-T engineering and rare disease therapy development.

Experts to share strategies on scale-up, process intensification, and data-driven methods shaping future stem cell manufacturing and therapies.

Allogeneic CAR-T therapies deliver scalable, off-the-shelf cancer therapy, while autologous CAR-T therapies provide patient-specific but time-intensive treatment.

The agency says it will now publish complete response letters promptly, offering developers early insight into regulatory deficiencies to improve development planning.

The nonprofit is calling upon its community of experts in both artificial intelligence and machine learning to continue building support for responsible adoption of AI in the bio/pharmaceutical industry.

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.