Tag Archive for: monoclonal antibody

After missing their initial target in March 2024, Eisai and Biogen have initiated a rolling BLA for a subcutaneous maintenance formulation of Leqembi, which could offer a more convenient dosing schedule for Alzheimer’s disease patients.

In a neurology update for investors, Roche touted data from a small Ib/IIa trial for trontinemab, an investigational therapy for Alzheimer’s disease which demonstrated “rapid and robust” amyloid plaque reduction.

The Swiss pharma’s fourth-quarter sales fell short of analysts’ estimates on Wednesday, as the company said it dropped a late-stage blood cancer hopeful after failing a Phase III study.

The pharmacy benefit management subsidiary of CVS Health is favoring Humira’s biosimilars for its major formularies, with AbbVie’s branded product to be nixed on April 1, 2024.

The deal would help boost AbbVie’s plans to expand into the cancer drug market as its top-selling product Humira, a rheumatoid arthritis treatment, faces fierce competition in the United States.

Bouncing back from two Complete Response Letters, Alvotech’s BLA for its Humira biosimilar AVT02 has been accepted by the regulator with a target action date of Feb. 24, 2024.

Beyfortus, which received FDA Fast Track for this designation, is a monoclonal antibody with activity against RSV.

Elanco Animal Health said on Tuesday the U.S. Department of Agriculture (USDA) has provided a conditional license for its antibody to treat canine parvovirus, making it the first approved therapy.

The FDA has granted emergency use authorization (EUA) to InflaRx’s vilobelimab, now to be marketed as Gohibic, for hospitalized adult patients with COVID-19, the German biotech announced Tuesday.

The buyout will grant Leap Therapeutics access to Flame Bioscience’s portfolio, which includes a clinical-stage monoclonal antibody that is under investigation as a potential treatment for gastric, gastroesophageal junction, and pancreatic cancers.