Register for our free email digests:
Division of Pfizer Inc.
Latest From Hospira Inc.
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.
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.
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.
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.
- Diagnostic Imaging Equipment & Supplies
- Infusion Therapy Equipment and Supplies
- Monitoring Equipment & Devices
- Drug Delivery
- Generic Drugs
- Therapeutic Areas
- Hospital Products Division (Abbott)
- North America
- Parent & Subsidiaries
- Pfizer Inc.
- Senior Management
F. Michael Ball, CEO
Thomas E Werner, SVP, Fin. & CFO
Sumant Ramachandra, PhD, SVP, CSO
Marc Yoskowitz, SVP, Strategy & Corp. Dev.
- Contact Info
Phone: (224) 212-2000
275 N. Field Dr.
Lake Forest, IL 60045
You must sign in to use this functionality
All set! This article has been sent to email@example.com.
All fields are required. For multiple recipients, separate email addresses with a semicolon.