Regulations

Sanofi overcomes CDMO issues with sutimlimab approval

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…

FDA 483 shows 7 observations at Catalent fill/finish plant in Belgium

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…

Catalent hit with FDA 483 at Belgian fill and finish facility

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…

FDA halts US factory inspections amid omicron concerns

The US FDA has temporarily paused its inspectional activities to ensure the safety of its staff and the firms it regulates due to the spread of the omicron variant. The Omicron variant, which was first discovered in November 2021, has already caused global disruption, despite reports from the UK suggesting the risk of hospitalization is about one-third of the Delta variant. With case numbers surging, the US Food and Drug Administration (FDA) decided to implement specific temporary changes to its…

Novavax COVID-19 vaccine wins EMA approval

The European Medicines Agency (EMA) has recommended granting conditional marketing authorization for Novavax’s COVID-19 vaccine, NVX-CoV2373. Novavax’ COVID-19 vaccine, known as Nuvaxovid, is the fifth vaccine recommended in the European Union (EU) for preventing SARS-CoV-2. Additionally, the firm claims it is the first protein-based COVID-19 vaccine approved for use in Europe. Nuvaxovid is made using Novavax’ proprietary nanoparticle technology and Matrix–M adjuvant – to market and the firm received $1.6 billion of US government assistance through the ‘Operation Warp Speed’ program…

Flurry of biopharma cyber-attacks driven by COVID

Non-profit organization BIO-ISAC has called for drugmakers to review their cybersecurity after disclosing an attack targeting a biomanufacturing facility earlier this year. BIO-ISAC, an organization launched in August to provide early-warning and education of digital biosecurity threats, announced an undisclosed biomanufacturer was involved in an advanced persistent threat (APT) attack named Tardigrade in Spring 2021. “Through the subsequent investigation, a malware loader was identified that demonstrated a high degree of autonomy as well as metamorphic capabilities. In October 2021, further…

With quality issues fixed, Takeda preps Hikari plant for COVID vax production

Having in-licensed a COVID-19 vaccine from Novavax, Takeda will manufacture up to 250 million doses per year from its Hikari, Japan facility, freshly absolved by the US FDA. In June 2020, the US Food and Drug Administration (FDA) issued Takeda’s Hikari facility – located 40 km southwest of Hiroshima – a warning letter after inspectors identified issues with the plant’s Quality Unit (QU), including concerns about how the firm investigated unexplained discrepancy and batch failures – specifically the detection of…

J&J preps to enter cell therapy space as CAR-T approval decision approaches

J&J says it will learn from pioneers in the cell therapy space as it preps its production network for the potential launch of its BCMA CAR-T product. J&J division Janssen Biotech entered the cell and gene therapy space in 2017, teaming up with Legend Biotech for the development of ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor (CAR) T-cell candidate specifically targeting the B-cell maturation antigen (BCMA) and is known as LCAR-B38M in China . Nearly four years on, and the…

Boehringer’s adalimumab becomes first interchangeable mAb biosimilar

The US FDA has approved Boehringer Ingelheim’s Cyltezo as the first biosimilar interchangeable with AbbVie’s blockbuster monoclonal antibody Humira (adalimumab). While biosimilars have offered cheaper versions of biological drugs in the US for six years, the issue of interchangeability has muddied the waters. An interchangeable biosimilar is one that can be substituted at the pharmacy level for the reference product without the prescriber having to change the prescription. Interchangeability is an additional standard beyond the requirement for biosimilarity and thus…

CureVac manufacturing switch-up as it shelves COVID-19 vax

CureVac will shift its manufacturing setup to produce clinical material for second-generation mRNA vaccine candidates as it abandons CVnCoV.   Just one month ago, CureVac dropped two contract development manufacturing organization’s (CDMOs) after demand for mRNA COVID-19 candidate CVnCoV diminished but the firm remained confident future clinical trials would still go ahead.   Now, CureVac has decided to withdraw the first-generation vaccine candidate from the approval process with the European Medicines Agency (EMA) in a bid to “refocus efforts on improved second-generation vaccine candidates we are developing in collaboration with GSK.” According to the firm, its second-generation candidates are based on an improved mRNA setup and includes flu…