The US FDA has urged protein therapeutics makers using continuous manufacturing to take steps to keep products virus free. The regulator made the suggestion in a recent concept paper along with more general advice on how industry can use 24/7 production to manufacture protein drugs more efficiently. Viral contamination is an issue for all biopharmaceuticals made in processes that use mammalian cell lines. The cells contain sequences that can produce potentially harmful virus-like particles that must be removed from the…

Novavax expects EUA submission for its COVID-19 vaccine to occur in the fourth quarter this year due to analytical work delays. Novavax was one of the forerunners of the COVID-19 vaccine pioneers, attempting to bring its prefusion protein-based vaccine NVX-CoV2373 – made using Novavax’ proprietary nanoparticle technology and Matrix–M adjuvant – to market with help from $1.6 billion of US government assistance through the ‘Operation Warp Speed’ program. However, while peers such as Pfizer, Moderna, and J&J have achieved regulatory…

Bluebird Bio has lifted the voluntary suspension on products containing its Zynteglo gene therapy after the EMA concluded the beta thalassemia therapy’s benefits outweigh its risks. The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) published its findings last week, concluding that there is “no evidence” Zynteglo causes a blood cancer known as acute myeloid leukaemia (AML). The EMA wrote “The PRAC reviewed two cases of AML in patients treated with an investigational medicine, bb1111 [also known as LentiGlobin] in a clinical trial for sickle…

A former Genentech principal scientist and her husband face jail after pleading guilty to stealing corporate information and sharing it with fellow competitors. Meanwhile, JHL’s former CEO and COO plead not guilty. According to the suit, the story goes back to 2009 where Xanthe Lam and her husband, Allen Lam, conspired to commit stealing trade secret information from Genentech and passing the information to Taiwanese firm JHL Biotech (now Eden Biologics). The husband and wife duo stole confidential property, the…

Offering the sale of unapproved influenza vaccine Fluzalp Quadrivalent has landed Davati Medical Supply with a US FDA warning letter. Fluzalp Quadrivalent is an intramuscular vaccine manufactured by Indian firm Anzalp Pharmasolutions. While Anzalp’s motto is ‘Healthcare with Ethics,’ the same cannot be said for US distributor Davati Medical, which received a US Food and Drug Administration (FDA) warning letter last month for offering the vaccine to US consumers, despite it not being approved in the region. The company claims…

Provention Bio says the US FDA’s Chemistry, Manufacturing and Controls (CMC) concerns relating to its type 1 diabetes candidate teplizumab are addressable in the short-term. Provention Bio has hit a snag in its Biologics License Application (BLA) for teplizumab (PRV-031), its investigational anti-CD3 monoclonal antibody (mAb) being developed for the delay of clinical type 1 diabetes. On July 2, the firm received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) citing concerns relating to pharmacokinetic/pharmacodynamic…