Perhaps the biggest indicator of U.S. President Donald Trump’s activism in his second term is the 225 executive orders (EOs) he issued in 2025. The pace of those orders seems to have slowed, with “only” 16 released in the last quarter of the year. Four of the recent EOs could impact drug and device companies in a myriad of ways.
At the Biotech Showcase 2026 – part of the broader hoopla in San Francisco surrounding the J.P. Morgan 2026 Healthcare Conference – a panel of investors and another of pharma dealmakers discussed what to expect from drug company deals in 2026. The calendar flipping marks a good time to look ahead, but the delineation doesn’t really change anything for dealmakers who have experienced a slow shift in attitudes of investors over the last few months that will likely continue into the year ahead.
The U.S. FDA has approved Zycubo (copper histidinate) as the first treatment for Menkes disease, a rare, genetic disease affecting children who cannot absorb copper through their intestines, leading to seizures, weak muscles, a failure to thrive and, ultimately, if left untreated, an early death by age 3.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Alessa, Aquestive, Kezar, PDS, Uniqure.
Biopharma happenings, including deals and partnerships, and other news in brief: Acepodia, Anaptys, Avista, Biocytogen, Cytoreason, Dewpoint, GSK, Iktos, Link Cell Therapies, Madrigal, Medilink, Nona, Pfizer, Pierre, Roche, Sanofi, Tesaro.
A second complete response letter issued by the U.S. FDA for Atara Biotherapeutics Inc.’s allogeneic T-cell immunotherapy Ebvallo (tabelecleucel) for Epstein-Barr virus positive post-transplant lymphoproliferative disease is “a complete reversal of position” by the agency, which had previously confirmed the single arm Allele trial was enough to support a BLA under the accelerated approval pathway, the company said.
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