December 2019 - Bionest

23

Dec 2019

Bionest

The SMA Market: Assessing the Unknowns

Challenges and opportunities in the field of spinal muscular atrophy, including how new disease-modifying therapies are likely to change SMA’s course over time.

16

Dec 2019

Bionest

New Risk-Based Oversight of Software as a Medical Device

A review of new FDA draft guidance documents that describe how the agency plans to regulate software designed to aid clinical decision making.

9

Dec 2019

Bionest

First Peanut Allergy Immunotherapeutic Recommended for FDA Approval

No standardized oral immunotherapeutics have existed for peanut allergies. Could this soon change?

2

Dec 2019

Bionest

The Relationship Between ICER and Industry is Evolving

ICER is expected to update the assessment framework underpinning its evidence reports on new drugs and health care interventions at the end of this year. What changes are likely to be made?