The U.S. Federal Trade Commission (FTC) is seeking comments on a consent agreement designed to remedy the anticompetitive effects of New York-based Bristol-Myers Squibb Co.’s (BMS) proposed $74 billion acquisition of Celgene Corp. Under the proposed consent agreement, Celgene would divest all rights and assets related to Otezla (apremilast) to Amgen Inc., of Thousand Oaks, Calif. A phosphodiesterase 4 inhibitor approved by the FDA in 2014, Otezla is the most popular oral drug used to treat moderate-to-severe psoriasis in the U.S., the FTC said in a notice to be published in Tuesday’s Federal Register. However, BMS is developing a selective tyrosine kinase 2 inhibitor that is the most advanced oral psoriasis treatment in development. Otezla’s orphan drug exclusivity will end in mid-2026, and it’s protected by several patents, some of which extend to 2034, according to the FDA Orange Book. Comments on the consent order should be submitted to the FTC by Jan. 2.
The FDA finalized its 2018 draft guidance on adaptive designs for clinical trials of drugs and biologics. The guidance describes the principles the FDA considers important for designing, conducting and reporting effectiveness and safety results from an adaptive trial. It also discusses the types of information sponsors should submit to facilitate the agency’s evaluation of trials with adaptive designs, including Bayesian adaptive and complex trials that rely on computer simulations. In addition to revisions to the Bayesian subsection, the final guidance clarifies the prespecification principle for adaptive design and cross-references the agency’s newly published draft guidance on interacting with the FDA on complex innovative trial designs. The agency anticipates that about 40 sponsors per year will submit documented plans for clinical trials containing a proposed adaptive design and 15 will submit 20 marketing applications that rely on a trial with an adaptive design, according to a notice published in Monday’s Federal Register.
The U.S. Patent and Trademark Office is extending the comment period for its request for public comment on the impact of artificial intelligence technologies on intellectual property law and policy. Comments should be submitted by Jan. 10, according to a notice scheduled for publication in Tuesday’s Federal Register.