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A federal court in Delaware has ruled that Novartis Pharmaceuticals’ patent for its best-selling multiple sclerosis drug Gilenya (fingolimod) is valid, and HEC Pharm has infringed on it. Read More
Hospitalized COVID-19 patients with pneumonia improved sooner when treated with Vanda Pharmaceuticals’ investigational anti-inflammatory drug tradipitant compared to a placebo, according to interim results from a phase 3 trial. Read More
A second study evaluating the use of the popular heartburn drug famotidine in patients with severe COVID-19 has found that the treatment reduced deaths and the need for intubation. Read More
The FDA cited over-the-counter drugmaker OraLabs for laboratory control lapses and other failures observed during an inspection of its Parker, Colorado facility. Read More
Sanofi has agreed to pay $3.7 billion for San Francisco-based Principia Biopharma, giving the French drugmaker full control of a potential multiple sclerosis drug. Read More
The FDA is willing to consider a range of clinical trial designs and various endpoints for new drugs or biologics intended to treat acute myeloid leukemia (AML), according to a new draft guidance. Read More
CanSino Biologics’ experimental COVID-19 vaccine has entered a late-stage trial in Russia, the company leading the study announced yesterday. Read More