FDA Releases Guidance on Osteoporosis Treatment
The agency published guidance on the nonclinical evaluation of osteoporosis treatments.
On June 13, 2016, FDA released draft guidance on the nonclinical evaluation of treatments for osteoporosis. The guidance provides FDA’s recommendations for designing nonclinical studies of osteoporosis biopharmaceuticals.
According to FDA, long-term nonclinical bone quality studies should be conducted for osteoporosis treatments because of concerns about long-term adverse effects of these drugs on bone quality and “because there are no validated and reliable methods for the noninvasive assessment of bone quality in humans.” The guidance addresses toxicology, bone quality, and biopharmaceutical nonclinical studies. Regulatory aspects and anabolic agents are also discussed.
Source: FDA
EMA Recommends Imfinzi-Based Perioperative Regimen for Treating Resectable NSCLC
March 10th 2025The committee’s recommendation is based on results from a Phase III trial in which Imfinzi demonstrated a reduced risk of recurrence, progression, or death by 32% compared to neoadjuvant chemotherapy alone.
International Women’s Day 2025: A Promising Future for Gender Diversity in Pharma
March 8th 2025In an interview with BioPharm International®, Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.
