Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Biogen, Drug Farm, Glaukos, Guerbet, Immix , Johnson & Johnson, Shorla.
The days of the U.S. FDA considering as trade secrets country-of-origin info for drugs and their ingredients have to end, the Senate Aging Committee was told at a Jan. 29 hearing on truth in drug labeling.
Oncology-focused Eikon Therapeutics Inc. set the terms of its IPO Jan. 28, selling 17.648 million shares at a price range between $16 to $18 per share. At the top of the range, the Millbrae, Calif.-based biopharma company would raise about $317.7 million.
For years, Japan’s “drug lag” was shorthand for slow regulatory reviews and delayed approvals compared with the U.S. and Europe. But even as regulatory timelines have shortened, review capacity has expanded and international alignment has improved, Japanese patients still face gaps in access to innovative drugs.
The presbyopia space gained another player as Tenpoint Therapeutics Ltd. won the U.S. FDA’s go-ahead for Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution, 2.75%/0.1%, previously known as Brimochol PF), the first and only dual-agent eye drop for the treatment of adult presbyopia.
In its fourth major biopharma deal since its 2019 founding, Repertoire Immune Medicines signed a partnership with Eli Lilly and Co. to develop tolerizing therapies for several autoimmune diseases, gaining an up-front payment of $85 million, with a potential $1.84 billion in development and commercial milestone payments coming later, along with tiered royalties.