Biologics

Michael B. Gerhardt, MD, is a sports medicine specialist and orthopedic surgeon at Cedars-Sinai Kerlan-Jobe Institute in Los Angeles and team physician for the LA Galaxy and U.S. Soccer Men's National Team.

Here are 10 must-read Q&As from 2018 on biologics.

Robert LaPrade, MD, is an orthopedic surgeon based in Colorado.

The FDA warned Genetech and its president Edwin Pinos for manufacturing stem cell products without FDA approval and deviating from current good manufacturing practice requirements, which may have led to microbial contamination.

The FDA recently vowed to crackdown on unsubstantiated and poor quality stem cell therapies in 2019. Biologic-based products and other emerging medical technologies are at the center of a debate over the best regulatory pathways to ensure patient safety.

A U.S. nonprofit organization found Biogen Inc's Spinraza treatment for spinal muscular atrophy and Novartis AG's experimental gene therapy are both expensive but have the potential to be more cost effective with additional research, according to Reuters.

Orthobiologics may become a mainstream treatment for knee osteoarthritis, according to orthopedic sports medicine surgeon Bert Mandelbaum, MD, in a Medscape column.

The first patient was enrolled in CartiHeal’s Agili-C implant investigational device exemption pivotal study at The Ohio State University Wexner Medical Center in Columbus.

Regenerative medicine company BioRez moved into its new office, research and technology space in New Haven, Conn.

James Bicos, MD, of Michigan Orthopaedic Surgeons in Bingham Farms, is a sports medicine and shoulder surgeon who has focused his career on procedures such as shoulder reconstructions, cartilage restoration, stem cell injections and meniscal transplants.