Regulations Archives - Page 17 of 21 - BioProcess InternationalBioProcess International

FDA paves way for insulin biosimilars, but will they be interchangeable?

Sanofi will see its short-acting follow-on insulin Admelog be regulated as a biosimilar from 2020 under US FDA plans to promote competition. But the need for additional studies to show interchangeability could delay any impact, the firm says. The US Food and Drug Administration (FDA) has been actively pursuing efforts to increase adoption of biosimilar products over the past year. In July, the Agency published a ‘Biosimilars Action Plan’ aimed at promoting access to lower-cost biosimilar drugs while maintaining a desire…

MacroGenics clinical hold has no wider implications for bispecifics, say analysts

by BPI Staff

The US FDA has placed a partial clinical hold on MacroGenics’ CD3 bispecific candidate MGD009 following reports of hepatic adverse events. On December 6, the US Food and Drug Administration (FDA) sent Maryland-based clinical-stage biopharmaceutical company MacroGenics a letter indicating that a partial clinical hold has been placed on its Phase I monotherapy study of MGD009 and a combination study of MGD009 and MGA012 (anti-PD-1). No new patients will be enrolled in either study until the partial hold is lifted…

Pfizer Kansas plant hit by FDA 483 with 8 repeat observations

by Dan Stanton

The US FDA observed potential mold contamination and deficient aseptic processes during an inspection at Pfizer’s fill/finish facility in McPherson, Kansas. The McPherson facility was one of several manufacturing plants added to Pfizer’s network following the $17 billion (€14.9 billion) acquisition of Hospira in 2015. The plant has been subject to various regulatory issues, resulting in a US Food and Drug Administration (FDA) warning letter in February 2017 citing poor aseptic processing and repeat GMP violations. An October 2017 inspection resulted…

EU gives conditional nod for Takeda Shire megamerger

by Dan Stanton

The European Commission (EC) has approved Takeda’s $62 billion acquisition on the proviso the firm divests Shire’s inflammatory bowel disease (IBD) candidate. In May, Japanese firm Takeda struck a deal to acquire Ireland-headquartered rare diseases biopharmaceutical company Shire for $62 billion (€54 billion). Six months on, the merger is one step closer after receiving approval under the EU Merger Regulation, on the condition of divesting Shire’s IBD candidate SHP647. “We can today approve the merger between Shire and Takeda, but…

StemGenex warned as FDA clamps down on stem cell ‘bad actors’

by Dan Stanton

Marketing unapproved stem cell therapies and cGMP deviations have landed California’s StemGenex Biologic Laboratories with a US Food and Drug Administration (FDA) warning letter. The letter cites issues in good manufacturing practice (GMP) and the unlawful marketing of an unapproved stromal vascular fraction (SVF) stem cell therapy, processed from autologous adipose tissue. It was sent on October 31, following an FDA inspection at StemGenex Biologic Laboratories’ (SGBL) facility in San Diego, California in January this year. According to the Agency,…

FDA looks to NIPP inconsistent inspections in the bud

by Dan Stanton

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

by Dan Stanton

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’

by Dan Stanton

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

by Dan Stanton

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

by Dan Stanton

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…