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Roche has said its investigational monoclonal antibody, tiragolumab, combined with Tecentriq (atezolizumab) and chemotherapy did not meet the endpoints of overall survival or progression-free survival in a phase 3 study in patients with extensive-stage small-cell lung cancer (ES-SCLC). Read More
In an effort to address differing definitions of the term “digital biomarker” and improve discussions on medical product development, FDA officials have penned an article meant to clear up misconceptions and spur alignment toward the agency-endorsed definition. Read More
Biogen will complete its FDA-mandated phase 4 Aduhelm study in four years — less than half the time the agency allotted when it granted accelerated approved for the controversial antiamyloid antibody last year. Read More
In the final quarter of 2021, makers of brand-name pharmaceuticals increased their drugs’ wholesale acquisition cost, or WAC, by 4.4 percent, up from 3.8 percent during the same period in 2020. However, when factoring in inflation, wholesale prices actually dropped by 2.3 percent. Read More
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee yesterday declined by a vote of 6-4 to recommend approval of Amylyx Pharmaceuticals’ AMX0035, a drug intended to treat amyotrophic lateral sclerosis (ALS). Read More
TLX66 was previously granted Orphan Drug status by the European Medicines Agency, but has not yet received a marketing authorization in Europe. Read More
The FDA has issued warning letters to two companies for making implied claims that their products could prevent or treat COVID-19, making them unapproved new drugs in the agency’s eyes. Read More
The first-line oral diabetes drug metformin has been linked to 40 percent higher risk of birth defects in the offspring of men who took it during the three months before conception. Read More
Sanofi and IGM Biosciences have signed an agreement to create, develop, manufacture and commercialize immunoglobulin M (IgM) antibody agonists against three oncology targets and three immunology/inflammation targets. Read More