Biologics

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.

Alpesh Patel, MD, director of the spine surgery fellowship and co-director of the Northwestern Spine Center in Chicago, discusses the key trends for orthopedics in 2019 and where he sees the biggest opportunity for growth.

Alejandro Badia, MD, is using the BioPro Modular Thumb Implant to treat basal joint arthritis.

MTF Biologics awarded 10 researchers more than $1.6 million in funding through its 2018 Research Grant Program.

The California Institute for Regenerative Medicine in Oakland awarded a $5.6 million research grant to UC Davis Health researchers Diana Farmer, MD, and Aijun Wang, PhD, for their work on stem cell therapies for spina bifida.