Regulations

FDA looks to NIPP inconsistent inspections in the bud

The New Inspection Protocol Project (NIPP) intends to increase the speed and efficiency of sterile injectable facility inspections through the semi-automated generation of establishment inspection reports (EIRs). In efforts to modernize inspections program, the US Food and Drug Administration (FDA) has developed a new protocol to assess, record and report the data from surveillance and pre-approval inspections for sterile drug products. “The New Inspection Protocol Project (NIPP) is focused on modernizing our inspection approach and enabling continual improvement of our…

Samsung BioLogics vows to prove innocence as trading suspended

South Korea’s financial regulator has concluded Samsung BioLogics inflated its value ahead of its initial public offering (IPO) in 2016. The CDMO says it is filing an administrative lawsuit to clearly prove the legality of its actions. In April this year, South Korea’s financial regulators accused contract development and manufacturing organization (CDMO) Samsung BioLogics of accounting fraud, following a yearlong audit. Today the Securities and Futures Commission (SFC) ruled that Samsung BioLogics intentionally violated accounting rules by changing the accounting…

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…