Daily Biotech Pulse: Bausch Health Appeals Xifaxan Patent Decision,…

Daily Biotech Pulse: Bausch Health Appeals Xifaxan Patent Decision,…


Here is a summary of the most important developments in the biotech space over the last 24 hours:

Bausch Health Companies Inc BHC said it was intentional contest a decision that would likely invalidate patents related to Xifaxan.

“We are disappointed with today’s development. We expressly disagree with any conclusion that our patents are invalid and intend to appeal any such order,” he said Thomas AppionCEO of Bausch Health.

Bausch expects the court to bar Norwich’s ANDA until the HE patents expire in 2029. If Norwich removes HE security data to avoid the patents, the company said it would “strongly oppose” the move.

That European Commission has approved AbbVie Inc ABBV Rinvoq (upadacitinib) for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation who are non-responsive to nonsteroidal anti-inflammatory drugs.

That FDA approved for review ImmunityBio Inc IBRX Submission of N-803 for BCG-unresponsive, non-muscle invasive bladder cancer in situ with or without Ta or T1 disease.

The company submitted the application based on positive results from a number of studies, including the ongoing QUILT 3032 study.

The planned action date of the Prescription Drug User Fee Act is May 23, 2023.

Icosavax Inc ICVX announced the results an end-to-end drug investigation of IVX-411, a VLP vaccine candidate harboring the SARS-CoV-2 receptor-binding domain (RBD).

The investigation followed that of the company Phase 1/2 topline interim data.

The results of the study supported the company’s initial hypothesis that the decreased efficacy observed for IVX-411 was antigen-specific.

Bristol Myers Squibb & Co BMY Part A of the Phase 3 CheckMate-914 study evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as the adjuvant treatment of localized renal cell carcinoma did not meet the primary endpoint of disease-free survival.

The study included kidney cancer patients undergoing a…


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