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Hospira Inc.

Division of Pfizer Inc.

Latest From Hospira Inc.

Multiple Hacking Risks Found In Another Infusion Pump

After a hacker brought the issue to the attention of Smiths Medical, the company engaged US FDA and the Department of Homeland Security, which alerted users that Smith's Medfusion 4000 wireless syringe infusion pumps are at risk from multiple cybersecurity vulnerabilities.

Regulation Cybersecurity

Celltrion Biosimilar Is Latest To Run Into GMP Compliance Concerns

An FDA inspection uncovered a wide-ranging list of GMP problems at biopharmaceutical manufacturer Celltrion in South Korea. Among some of the problems that inspectors found were mold on walls in sterile areas, operators leaning over sterile areas with bare hands and arms, and employees using shared passwords. A resulting Form 483 report is the latest in a number of recent enforcement actions targeting proposed biosimilar drugs.

Manufacturing Quality

Humira Biosimilar: Boehringer Faces Same Launch Hurdles As Amgen

AbbVie seeks injunction against Boehringer Ingelheim's Cyltezo claiming infringement of 74 patents, 8 of which are in the initial round of litigation; as of Aug. 2, BI had not given 180-day launch notice.

Biosimilars Legal Issues

US Biosimilars: 40% First-Cycle Approval Rate Leaves Room For Improvement

Four of first 10 publicly disclosed applications were approved on first review cycle, and FDA has issued at least seven complete response letters. Increasing first-cycle approvals is a primary goal of the BsUFA II agreement.

Biosimilars Drug Review
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