Calliditas Therapeutics AB, filled with confidence by positive top-line results from a phase III trial of its oral budesonide, Nefecon, in patients with primary immunoglobulin A nephropathy (IgAN), said it plans to seek accelerated approval for the drug from the FDA in the first quarter of 2021.
HONG KONG – Incheon, South Korea-based Celltrion Inc. has gleaned positive results in a small early stage trial for its anti-COVID-19 monoclonal antibody CT-P59. The results were presented at the Korean Society of Infectious Diseases’ 2020 fall conference, which took place on Nov. 5.
Enthusiasm stayed high but abated somewhat throughout the day as Wall Street took in the positive interim phase III results from Biontech SE and Pfizer Inc. with the COVID-19 vaccine candidate BNT-162b2.
Zimmer Biomet Holdings Inc. fell in line with other orthopedic device companies that saw better than expected results for the 2020 third quarter. The company reported total revenue of $1.93 billion, up 1.1% from the same period in 2019.
Lenzilumab, the lead candidate from Humanigen Inc., has taken two large steps forward with positive interim phase III data and some support from the federal government. That, along with an Asia-Pacific region licensing from earlier in the week, has the relatively small company successfully “punching above our weight,” the CEO told BioWorld.
Assembly Biosciences Inc., a company testing the limits of sustained virologic response in people with chronic hepatitis B virus infection after they discontinue treatment, said nearly all participants in an ongoing phase II study returned to having detectable viral loads after going off a regimen featuring the company's core inhibitor, vebicorvir.
DUBLIN – Canakinumab, an interleukin-1 beta (IL-1beta) inhibitor, has joined a growing list of immunomodulatory therapies that have failed to demonstrate efficacy in COVID-19. Novartis AG said that an interim analysis showed the drug did not meet the primary endpoint of clinical response.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anavex, Assembly, Boehringer Ingelheim, Equillium, Homology, Humanigen, Janssen, Novartis, Pfizer, Puma, Seres, Viela.
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