Quality control issues have landed UCB Pharma a Form 483 following an inspection of its facilities in Braine-l’Alleud, Belgium. UCB Pharma underwent an inspection of its manufacturing facilities in April, resulting in the issuance of a Form 483 by the regulatory authority. A Form 483 is a document used by the US Food and Drug Administration (FDA) to notify a company of observed deviations from Good Manufacturing Practices (GMP) during an inspection. During the inspection, the FDA identified certain deviations…

Sarepta Therapeutics says the US FDA needs additional time to review Duchenne muscular dystrophy (DMD) gene therapy delandistrogene moxeparvovec (SRP-9001). In November 2022, the US Food and Drug Administration (FDA) accepted the submission from Sarepta for its potential DMD gene therapy SRP-9001. The Agency initially provided the firm with an action date of May 29, 2023; however, this has now been delayed until June 22, 2023. The additional time requested by the FDA to complete the review will also include…

US approval of Alvotech’s Humira (adalimumab) biosimilar could be delayed by six months after the FDA found further issues at a manufacturing facility in Reykjavik, Iceland. Thanks to a 2017 settlement with AbbVie, Amgen launched the first biosimilar of best-selling monoclonal antibody Humira earlier this year. At the end of next month, up to nine more biosimilars could be competing for a slice of the $18.6 billion market. Iceland-based firm Alvotech has two separate applications for AVT02, with the first Biologics…

Krystal Biotech has won approval for Vyjuvek (beremagene geperpavec), a topical gel gene therapy to treat the skin condition dystrophic epidermolysis bullosa (DEB). The handful of gene therapies on the market are single-dose injections or infusions, but the US Food and Drug Administration (FDA) approved the first ‘redosable’ gene therapy Friday, in the form of Krystal’s Vyjuvek. Vyjuvek is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, which when administered topically to DEB wounds delivers two copies of the…

Gamida Cell says its two-pronged strategic approach includes accomplishing a successful commercial strategy with FDA approved Omisirge and pursuing partnerships. In April, the US Food and Drug Administration (FDA) approved Gamida’s Omisirge (omidubicel), an allogeneic cell therapy for patients with blood cancers who are set to undergo stem cell transplantation. Omisirge is a modified allogeneic cord blood-based cell therapy to quicken the recovery of neutrophils and reduce the risk of infection. It is intended for use in patients with blood…

Eli Lilly expects mirikizumab to become the first interleukin-23 subunit alpha (IL-23p19) to treat ulcerative colitis once manufacturing issues highlighted by the US FDA are resolved. Last month, the US Food and Drug Administration (FDA) issued a complete response letter (CRL) to Eli Lilly for mirikizumab, its monoclonal antibody candidate for the treatment of ulcerative colitis (UC). Patrik Jonsson, president of Lilly Immunology, discussed his company’s approach to resolving the issue at the Bank of America Securities 2023 Healthcare Conference…

Running vaccine trials in developing countries is a significant challenge due to complex regulations and CRO management difficulties according to new analysis. The study – published in the current edition of the journal Vaccine X – looked at approaches to clinical development vaccine developers in emerging countries are using. The overall aim is to identify industry needs in terms of organizational development and training. The authors quizzed members of the Developing Countries Vaccine Manufacturers Network (DCVMN) – a voluntary alliance…

Arexvy has become the first FDA approved vaccine to treat respiratory syncytial virus (RSV) and will be produced across GlaxoSmithKline’s European and US manufacturing network. The US Food and Drug Administration (FDA) approved Arexvy last week, for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV). “Arexvy contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant,” a spokesperson told BioProcess Insider. “Arexvy will have two vials (one antigen…

Aseptic manufacturing concerns have landed Eli Lilly and Rentschler separate Form 483s at facilities that have previously fallen foul of the US FDA. The US Food and Drug Administration (FDA) inspection of the 1555 South Harding Street, Indiana, Indianapolis facility in October 2022 resulted in Eli Lilly receiving a Form 483 with three observations. The document cites Lilly’s aseptic technique for drug product filling operation as “deficient,” with concerns surrounding unprotected sterile surfaces and the actions of operators at the…

Europe’s cell and gene therapy sector has stagnated but advocacy group the Alliance for Regenerative Medicine (ARM) hopes upcoming legislation can reinvigorate the sector. In many areas of pharma, Europe has been at the forefront. The continent approved biosimilars, for example, nearly a decade before the US. And for cell and gene therapies (CGTs), the European Medicines Agency (EMA) has often given the green light ahead of their regulatory counterparts across the globe. For example in 2022, Europe approved both…