Regulations

Jazz on Erwinaze shortage: ‘We can’t sell what we don’t have’

Jazz Pharmaceuticals says further supply outages for its cancer enzyme Erwinaze are expected amid ongoing manufacturing issues at its sole CMO. For the third quarter 2018, Jazz Pharmaceuticals reported net sales of its acute lymphoblastic leukemia (ALL) drug Erwinaze (asparaginase Erwinia chrysanthemi) of $41 million (€36 million), down 16% on the same period last year. “Supply challenges continued to impact product availability in the third quarter,” CEO Bruce Cozadd told stakeholders on a conference call (transcript here). He predicted further…

Novartis pulls US rituximab program citing FDA data demands

Novartis subsidiary Sandoz has decided not to pursue a biosimilar of Roche’s Rituxan in the US after receiving a complete response letter from the FDA. In June 2017, biosimilar developer Sandoz received approval in Europe for Rixathon, a version of Rituxan (rituximab), which Roche markets as Mabthera in the region. But across the Atlantic, the Swiss biopharma has failed to replicate such regulatory success, and received a US Food and Drug Administration (FDA) complete response letter (CRL) in June this…

Symbiosis: US FDA boost at Scottish aseptic viral vector plant

Symbiosis has received US FDA approval for viral vector manufacturing fill/finish at its biomanufacturing facility in Stirling, UK. In this Q&A, CEO Colin MacKay explains the significance of the accreditation with regards to industry demand and Brexit. Scottish contract development and manufacturing organization (CDMO) Symbiosis Pharmaceutical Services constructed its sterile manufacturing facility in 2011 and has had UK regulatory accreditation since 2012. The firm recently received approval from the US Food and Drug Administration (FDA), something CEO Colin MacKay told…

4D bioprinting and stem cells: Firms look to alternatives to animal testing

Servier will use 4D bioprinting technology to imitate human liver tissue in vitro, while STEMCELL Technologies is commercializing human pluripotent stem cell-derived kidney organoids. But can these models replace animal testing in preclinical research? French drugmaker Servier has (bio)inked a deal with Poietis to use its 4D bioprinting technology for the development and production of liver tissues. The tissue will be used to imitate human liver tissue in vitro in Servier’s preclinical testing. Poietis’ technology works through the “layer-by-layer additive…

Sanofi and Regeneron gain approval for skin cancer MAb

The US FDA has approved skin cancer drug Libtayo, a programmed cell death protein-1 (PD-1) inhibitor developed through a Sanofi and Regeneron collaboration. In 2007, Sanofi teamed up with Regeneron Pharmaceuticals to discover, develop, and commercialize fully-human therapeutic antibodies. While the discovery collaboration ended last year, Sanofi still owns a 22% stake in Regeneron. The the firms also continue to develop and commercialize a number of monoclonal antibodies, including its metastatic cutaneous squamous cell carcinoma (CSCC) product cemiplimab which the two…

Catalent clears up FDA 483 concerns at Indiana plant

The plant in Bloomington received a Form 483 with five observations in May, but Catalent says a second US FDA inspection shows issues have been resolved. The US Food and Drug Administration (FDA) recently published a Form 483 it issued to Catalent’s biomanufacturing facility in Bloomington, Indiana following an inspection in April and May this year. The Agency made five observations at the 875,000ft2 production and fill/finish facility, which the contract development and manufacturing organization (CDMO) gained as part of…

Sanofi prepped for production after EU Nanobody success

Ten weeks after acquiring Ablynx, Sanofi has received European approval for lead Nanobody-based drug Cablivi (caplacizumab). In June this year, Sanofi acquired Belgian biotech Ablynx for €3.9 billion ($3.5 billion), adding the firm’s pipeline of biotherapeutics based on the small-sized antibody, or Nanobody, technology. Now the French biopharma firm is set to commercialize lead product caplacizumab (anti-vWF Nanobody) in Europe under the brand name Cablivi after the European Commission granted it marketing authorization for the treatment of rare blood-clotting disorder…

False biosimilar communications: Originators rebuff Pfizer’s claims

Pfizer has accused Amgen, J&J and Roche of sending misleading communications about biosimilars in a Citizen Petition asking the US FDA to issue guidance on such behavior. In a Citizen Petition published on August 22, Pfizer said communication tools intended to incentivize the adoption of and switching of biosimilars have led to a robust uptake of biosimilars in Europe, but in the US “payer reimbursement policies are in fact impeding adoption of biosimilars.” The firm continued: “Dissemination of false or misleading…

Novartis constructing $92m CAR-T plant as Kymriah arrives in EU

Up to 450 jobs will be created as Novartis commits to a production site for cell and gene therapies in Switzerland. The investment will support CAR-T drug Kymriah, which received European approval this week. A year after the US Food and Drug Admistration (FDA) approved Kymriah (tisagenlecleucel), the European Commission (EC) has granted the Novartis’ therapy approval to treat B-cell acute lymphoblastic leukemia (ALL). In the US, the chimeric antigen receptor T cell (CAR-T) product is manufactured at Novartis’ Morris…

Kyowa Hakko fermentation plant hit with FDA warning

Kyowa Hakko has received a US FDA warning letter citing GMP and data integrity issues at its amino acid production facility in Yamaguchi, Japan. The warning letter dated August 10 2018 came following an inspection of Kyowa Hakko Bio’s Hofu facility in September 2017 by the US Food and Drug Administration (FDA). Deviations from current good manufacturing practice (cGMP) for active pharmaceutical ingredients (API) cited by the Agency included failures in Kyowa Hakko’s quality unit, along with a lack of…