Orthobiologics Face Pressure from Lack of Clinical Evidence

Orthobiologics Face Pressure from Lack of Clinical Evidence
In the race to capitalize on patient-driven interest in stem cells, biologic solutions and “regeneration” of a more vital, healthy and functional body, there has been an explosion of offerings that lack scientific controls, validity and meaningful evidence.

Bone Therapeutics to End Phase III PREOB Study

The Data and Safety Monitoring Board recommended discontinuation of the Phase III hip osteonecrosis study of Bone Therapeutics' PREOB viscosupplement, following interim analysis of results.

Orthobiologics: Conversations with CEOs

At AAOS, we sat down with the CEOs of Bioventus and Histogenics to ask about opportunities that their companies are embracing, as well as the health of the orthobiologics market. Both mentioned advancements in therapies demonstrated through clinical trials and outcomes, and both discussed the importance of keeping younger, active patients healthy and mobile. Here we recap a portion of those conversations.

Anika Responds to CINGAL’s Drug Classification

In late 2015, FDA assigned Anika Therapeutics' CINGAL to the Center for Drug Evaluation and Research (CDER) and not the Center for Device and Radiological Health (CDRH) for its premarket review-a decision with which Anika's leadership says it disagrees.