Biogen Inc.’s $56,000-a-year list price for its newly approved Alzheimer’s drug, Aduhelm (aducanumab), is sending tremors through the prescription drug pricing debate that could shift the epicenter of those discussions to drugs granted accelerated approval based on surrogate endpoints.

The FDA responded on Thursday to longtime industry calls for the agency to clarify the distinction between the “serving” and “remanufacturing” of a medical device with new draft guidance to provide consistency and a better understanding of the applicable statutory and regulatory requirements. The 35-page document details its current thinking on the distinction.

With the advent of wearable digital health technologies, patient-generated health data (PGHD) will play an increasingly central role in evidence generation for medical device companies. Speakers on a recent FDA workshop advised that there are several barriers to the use of PGHD for evidence generation, however, such as the perennial headache of data interoperability and a new twist on the question of patient trust, problems that are likely to plague the field for the foreseeable future.

The U.S. government on June 17 announced plans for a multi-faceted $3.2 billion investment in the development and manufacture of new antivirals for preventing serious COVID-19 illness and death.

With paralysis affecting more than 5 million Americans, devices that serve as brain-computer interfaces (BCIs) are increasingly important, even if few are commercially available. The FDA has responded to the predicament with a leapfrog guidance, a preliminary form of guidance designed to foster more interaction with industry and encourage developers to move along on development programs for devices that will aid patients in restoring lost motor and/or sensory capabilities.

Fractyl Health Inc. closed $100 million in new financing Wednesday to expand and accelerate clinical development efforts to reduce dependence on insulin among type 2 diabetes patients. The startup, which changed its name from Fractyl Laboratories Inc., will use the financing to support additional late-stage clinical studies for determining the potential of its Revita DMR.

Heralded as a potential turning point for U.S. innovation in the 21st century, the U.S. Innovation and Competition Act, S. 1260, is a big step closer to becoming law. The Senate voted 68-32 June 8 to pass the sweeping $250 billion bipartisan bill intended to give the U.S. an edge over China when it comes to innovation and investment in several critical industries.

The controversy over the use of paclitaxel in devices for the peripheral vasculature has taken a significant bite out of sales, but a new study serves to help reverse the narrative regarding mortality. According to a study of more than 168,000 Medicare patients, stents and angioplasty balloons coated with paclitaxel (PTX) were non-inferior to non-coated devices for mortality out to nearly three years, a finding that may encourage clinicians to return to normal utilization patterns and thus help to restore sales volumes.