Regulations

EMA thumbs up to more CDMO sites supporting COVID vaccines

The European Medicines Agency (EMA) has approved a Delpharm plant in France and a Catalent facility in the US to support supply of Pfizer and Moderna’s COVID-19 vaccines, respectively. The approvals from the EMA’s human medicines committee (CHMP) this week aim to increase manufacturing capacity and supply of the two COVID-19 vaccines in the EU. The first saw the Agency approve a fill-finish site in Saint Remy sur Avre, France operated by contract development and manufacturing organization (CDMO) Delpharm. The…

Lilly hit by FDA 483 with 7 observations at IN plant

An Eli Lilly aseptic facility in Indianapolis, which fills COVID-19 antibodies along with other drugs, has received a US FDA Form 483 with seven observations. The Form 483 (available below) was published last week and highlights the issues the US Food and Drug Administration (FDA) found after inspecting the facility in Indianapolis, Indiana in February and March this year. Among the seven observations noted, the Agency highlighted failures by Lilly to establish an adequate system for monitoring environmental conditions in…

Novavax: Analytical work keeping vaccine at bay, Fujifilm not to blame

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…

Bayview’s back: FDA gives Emergent green light to resume vaccine production

Emergent took a $54 million hit from remediation efforts and inventory write-downs at its Bayview plant and saw a $108 million reduction in its CDMO backlog. But now the firm is free to restart vaccine production for customer J&J. Emergent BioSolution’s Bayview, Maryland facility had been contracted by both Johnson & Johnson and AstraZeneca to make their respective COVID-19 vaccines, but an ingredient mix up rendered 15 million doses unusable and landed the plant with a Form 483 and a directive…

Second Bluebird gene therapy approval a boon for Minaris

CDMO Minaris says it will be the commercial manufacturer for Skysona (elivaldogene autotemcel, Lenti-D), a second Bluebird Bio gene therapy approved by the European Commission. The European Commission (EC) granted marketing authorization of Skysona for the treatment of early cerebral adrenoleukodystrophy (CALD) yesterday. The one-time gene therapy uses a patient’s own hematopoietic stem cells (HSC) to treat the underlying cause of the neurologic condition CALD. SKYSONA uses ex vivo transduction with the Lenti-D lentiviral vector (LVV) to add functional copies…

Bluebird resumes Zynteglo sales after positive EMA committee review

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…

Ins & Outs: Ex-Genentech employees plead guilty to sharing trade secrets with competitors

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…

FDA slams unapproved flu vaccine seller Davati Medical

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…

FDA quality concerns land Provention diabetes mAb with a CRL

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…

US FDA aims to clarify reporting rules for biologics CMC changes

Biologic drug makers that tweak manufacturing processes after approval have a better idea of when and how to inform the US FDA of the changes thanks to new agency guidelines. The US regulator issued the final guidance document last week, explaining the aim is to help biologics makers determine which reporting category is appropriate for a chemistry, manufacturing, and controls (CMC) change. The guidance – which applies to biologics, vaccines, cell and gene therapies, plasma-derived medicines but not whole blood…