The most-clicked news item for Monday was “FDA Accepts First-Ever Biosimilar Application for Monoclonal Antibody.” This piece from RAPS.org details how a South Korean drug manufacturer Celltrion has submitted a biosimilar application to the FDA for Remsima, which is biosimilar to Jannsen’s Remicade.
The second most popular item was Fierce Biotech’s “J&J's diabetes combo wins FDA nod in a fast-crowding space.” JNJ’s new Invokamet, combines the SGLT2 blocker canagliflozin combined with metformin.
The third most-clicked news item was another Fierce Biotech piece - this one about Sanofi’s agreement to commercialize MannKind’s inhaled insulin Afrezza. “Sanofi fills some big shoes in $925M Afrezza pact with MannKind” discusses the details of the agreement, including the $150 million upfront payment, as well as predictions for the success of the collaboration.
The fourth most-clicked news item was from Bloomberg News - “Exact Sciences Wins U.S. Approval for Colon Cancer Test.” Cologuard is a non-invasive home DNA screening test that can be used to determine whether or not a colonoscopy is needed. The test is also the first to go through the parallel review process with the FDA and the Centers for Medicare and Medicaid Services.