Industry News

FDA has approved the first topical gene therapy product for treating wounds in patients with dystrophic epidermolysis bullosa.

FDA has approved AbbVie’s EPKINLY (epcoritamab-bysp), a bispecific antibody for treating relapsed or refractory diffuse large B-cell lymphoma.

Biotech firm Lumen Bioscience has received fast track designation from FDA for its oral biologic drug candidate for treating C. difficile infection.

The agency found insanity conditions and CGMP violations at Pharmedica USA, LLC’s Phoenix facility during an inspection.

Waters Corporation expected to boost growth in bioanalytical characterization for new modalities with acquisition of Wyatt Technology.

The two draft guidance documents provide recommendations for the approval of pediatric drugs, biologics, and vaccines under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act.

CATTI has launched an in-person training site at the University of Guelph in Ontario, Canada, for training personnel in cell and gene therapy manufacturing.

The agency’s safety committee is reviewing hydroxyprogesterone medicines and issuing a reminder on safety issues regarding fluoroquinolone antibiotics.

The agency has published guidance on good practices for securing the supply of medicines.

The report outlines highlights from the agency’s medicines evaluations and milestones for 2022.

In a brief, the Federal Trade Commission cited concerns about the acquisition resulting in an increased monopoly on Amgen’s newly acquired thyroid eye disease and chronic refractory gout treatments.

The NSF-sponsored program aims to help partners collaborate to create opportunities for significant economic, societal, and technological opportunities for growth in their regions.

The data, published in the scientific journal Nature, demonstrated that half of patients developed T cells that could potentially fight pancreatic ductal adenocarcinoma.

Congress have initiated a range of legislative proposals to further manage PBMs and the pharma market.

EMA and European regulators are lifting their COVID-19 business continuity measures as the pandemic’s peak ends.

GSK’s Alexvy vaccine is the first to receive FDA approval for respiratory syncytial virus.

The recent revision is intended to provide guidance on QRM principles and tools that can be used for different aspects of pharmaceutical quality.

This specific guidance refers to a DCT as a clinical trial where some or all the trial-related activities occur at locations other than traditional clinical trial sites.

JP Bornholdt, director of modular operations, CRB, discusses continuous and modular manufacturing.

Wood CEO Ken Gilmartin gives his insight on what's currently in demand in terms of new bio/pharma manufacturing facilities.

The event, cosponsored by FDA and USP, hosted regulators and industry leaders to discuss the challenges in strengthening the medical product supply chain.

Bas Trietsch, chief technology officer, MIMETAS, discusses the successes he's encountered so far using organ on a chip technology in bio/pharmaceutical research.

clonoSEQ Assay is authorized by FDA for MRD assessment in lymphoid malignancies and is highly accurate, sensitive, and standardized compared to other technologies used for disease burden assessment.

Yaakov Nahmias, founder and chief scientific officer of Tissue Dynamics, discusses the barriers in implementing organ on a chip technology.

Isaac Bentwich, MD, CEO and co-founder of Quris-AI, discusses organ on a chip technology.

James Rorke, vice-president, operations, Steriline North America, discusses the benefits of automation in fill/finish operations.

Martin Smyth, senior vice-president of Go-To-Market Strategy at MasterControl, discusses gaps in digitalization in the pharma industry.

Alessandro Zannini, sales director, engineering division, Stevanato Group, discusses artificial intelligence and digitalization in the pharma field.

Mariano Mattei, vice-president of cybersecurity and CISO for Azzur Group, goes in depth about cybersecurity in the pharma field.

Emily Moran, senior vice-president of vector manufacturing and supply chain at The Center for Breakthrough Medicines, talks about manufacturing processes for viral vectors in the cell and gene therapy space, and more.