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The FDA’s recent approval of Biogen’s Alzheimer’s disease treatment Aduhelm has encouraged a new roster of contenders, including Eli Lilly’s Donanemab, a relative newcomer to the antiamyloid antibody space. Read More
The global late-stage trial contained 25 cases of symptomatic COVID-19 at the time of the primary analysis, with the study enrolling almost 5,200 total participants. Read More
Buoyed by the FDA’s recent approval of Biogen’s Alzheimer’s disease (AD) treatment Aduhelm, Esai is hoping to seek an accelerated approval for its antiamyloid candidate lecanemab. Read More
Pfizer has entered into a $2.26 billion purchase agreement with Canadian drugmaker Trillium Therapeutics in a move to expand its portfolio of cancer treatments. Read More
AstraZeneca said its monoclonal antibody treatment AZD7442 was shown to reduce the risk of developing COVID-19 symptoms by 77 percent vs. placebo in a phase 3 study — and it plans to use the findings to support global Emergency Use Authorizations and conditional approvals. Read More
Artificial intelligence-based software developed to conduct pharmacovigilance “appears suitable for the detection of safety signals,” the International Coalition of Medicines Regulatory Authorities (ICMRA) says in a new report on the use of AI for drug development. Read More
Moderna is launching a safety, tolerability and immunogenicity study of two messenger RNA (mRNA) vaccines against the human immunodeficiency virus (HIV). Read More
The combination treatment “significantly prolonged overall survival in the first-line treatment of advanced gastric cancer,” the trial’s principal investigator said. Read More
Innovent Biologics said its investigational gastric cancer drug sintilimab plus chemotherapy delivered promising results in a phase 3 trial as a first-line treatment. Read More