pharmaphorum
AUGUST 24, 2020
Lynne will chair the 2-day conference and also speaking on day one on Microbiological Quality Considerations in Non-Sterile Pharmaceutical Manufacture and Control of BCC. Monocyte Activation Test: The In-vitro Pyrogen Test Based on Human Immune Cells for Batch Release Testing of Medical Products. in Biology and Ph.D.
FDA Law Blog: Biosimilars
OCTOBER 4, 2023
The court did not make much of Plaintiff’s argument that a manufacturer cannot terminate its participation in Medicare for close to two years, see Motion at 8; Complaint at 27-28, potentially dismissing it as a mere administrative matter. Standing The Defendants questioned, and the court reviewed, Plaintiffs’ standing. Order at 24.
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Pharmaceutical Business Review
FEBRUARY 24, 2025
A fully human anti-cluster of differentiation (CD3) monoclonal antibody, intranasal foralumab is tailored to modulate the immune system and reduce neuroinflammation, which is a significant factor in the progression of conditions like Alzheimer’s and multiple sclerosis.
Safe Biologics
MARCH 10, 2025
After years of mounting pressure from a broad coalition of stakeholders including patients, physicians, pharmacists, and pharmaceutical manufacturers, meaningful reform for Pharmacy Benefit Managers (PBMs) finally seemed within reach this past December. PBM Reform: Could 2025 Finally See a Long-Awaited Overhaul?
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