New Pharma/Device Deals

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The US Food and Drug Administration (FDA) has approved a new stent for use in the treatment of kidney failure patients who are on hemodialysis.

Bard, now a part of healthcare tech giant Becton Dickinson (Franklin Lakes, NJ) was the originator of the Covera vascular covered stent. The stent, which is used to re-open narrowed access circuits in an arteriovenous fistula, has a “helical design for radial strength and flexibility” and an “atraumatic” tip for insertion comfort, according to According to Becton Dickinson, it is the first and only covered stent to be approved in the US market for treating stenoses in non-stented fistulae.

Bard joined Becton Dickinson in December 2017, in a $24 billion acquisition.

Baxter (Deerfield, IL) and bioMérieux (Marcy L’Etoile, France) have signed a deal to partner in the development of biomarkers to identify and help inform treatment of acute kidney injury (AKI). In April 2019, bioMérieux acquired Astute Medical (San Diego, CA), which developed the NEPHROCHECK test, an FDA-approved test for early risk assessment of AKI based on two biomarker levels.

“As a leader in pioneering diagnostic solutions, we’re looking forward to collaborating with Baxter. … To accomplish this, the team at the recently acquired Astute Medical is committed to the development of additional high medical value biomarkers for improved patient care,” said Mark Miller, bioMérieux executive VP and chief medical officer.

Akebia, based in Cambridge, MA, has expanded its pharmaceutical deal with Vifor Pharma to extend beyond one dialysis firm, Fresenius North America. The two companies drew up a new license agreement that would allow Vifor to sell vadadustat to certain third-party dialysis organizations for use in the United States. Vadadustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor in phase 3 development and is intended for anemia treatment in patients with chronic kidney disease (CKD). The drug is not yet approved by any regulatory authority.

The deal, according to the companies, could expand the potential opportunity for vadadustat under the agreement to include “up to 60% of US dialysis patients.” The expanded license agreement is subject to vadadustat’s approval by the FDA and also its inclusion in the Centers for Medicare & Medicaid Services ESRD Prospective Payment System.