Health Canada has granted authorization for Covifenz, a plant-based COVID-19 vaccine developed by Medicago and GlaxoSmithKline (GSK). Covifenz is made up of plant-based virus-like particles (VLP) and aims to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals between the ages of 18 to 64 years old. Medicago uses its Proficia technology to synthesize the virus’ code once a virus has been genetically sequenced. In doing so, the firm claims its genetic instructions can then be…

The US FDA has approved a CAR-T therapy developed by Johnson & Johnson and its partner Legend Biotech to treat white blood cell cancer. J&J division Janssen Biotech entered the cell and gene therapy space in 2017, teaming up with Legend Biotech for the development of Carvykti ( ciltacabtagene autoleucel; ciltacel), a chimeric antigen receptor T-cell (CAR-T) therapy that specifically targets the B-cell maturation antigen (BCMA) and is known as LCAR-B38M in China. Now, the US Food and Drug Administration (FDA) has…

The FDA has dismissed using special emergency authorization powers for rare disease advanced therapeutics but does hope to significantly speed up its feedback to sponsors. The US Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) authority allows the use of unapproved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological, and nuclear (CBRN) threats when certain criteria are met. Most recently, EUA powers have…

Lonza’s drug product services division is participating in the RealHope project to establish challenges that contribute to protein instability during the handling process. The Real-World Handing of Protein Drugs – Exploration, Evaluation and Education (RealHOPE) project aims to destabilize protein-based therapeutics by measuring real-life events during drug handling to significantly improve the safety and effectiveness of the drug development process. According to Swiss contract development manufacturing organization (CDMO) Lonza, assessing protein stability is required to ensure process optimization and the…

The US FDA approval of Enjaymo (sutimlimab) comes 13 months after Sanofi was hit by a complete response letter citing deficiencies at a third-party manufacturer. The US Food and Drug Administration (FDA) approved Enjaymo Friday, a treatment for patients with rare blood disorder cold agglutinin disease (CAD). The drug, which will be made available in the US at a wholesale acquisition cost of $1,800 per vial, is a humanized monoclonal antibody designed to selectively target and inhibit C1s in the…

The publication of a US FDA Form 483 reveals failures to implement sustainable corrective action and preventive action, and inadequate maintenance at a Catalent fill/finish facility. Earlier this month, we broke the news that contract development and manufacturing organization (CDMO) Catalent received a Form 483 at its European syringe filling facility in Brussels, Belgium. While the issues observed allegedly caused disruption in the supply of Novo Nordisk’s weight loss drug Wegovy (semaglutide), specific details were sparse. But this week, the…

A syringe filling facility in Brussels run by CDMO Catalent has received a US FDA Form 483 and has allegedly created supply issues for Novo Nordisk’s Wegovy. The 265,000 square-foot site described as Catalent’s flagship European syringe filling facility produces over 175 million units annually for the contract development and manufacturing organization’s (CDMO’s) customers. But a recent inspection by the US Food and Drug Administration (FDA) discovered concerns at the site and resulted in a Form 483. “We are treating…