The U.S. Patent and Trademark Office (PTO) has proposed to limit the use of administrative challenges to patents when the patent in dispute is already the subject of litigation in district court, a change that many in the life sciences might see as an improvement over the current hyper-litigious environment.

Aicuris Anti-Infective Cures AG is preparing to file for U.S. FDA approval after reporting positive phase III results for lead antiviral pritelivir in the healing of refractory herpes simplex virus lesions in immunocompromised patients.

Dianthus Therapeutics Inc. has joined the recent trend of companies licensing therapies in development from China. The company will pay as much as $1 billion to Nanjing Leads Biolabs Co. Ltd. for DNTH-212, a bifunctional BDCA2 and BAFF/APRIL inhibitor to treat autoimmune disorders.

Success by nearly all measures with Praxis Precision Medicines Inc.’s essential tremor phase III candidate, ulixacaltamide, drove the company’s stock up significantly and provided solid data for an NDA filing planned for early 2026.

Genedx LLC partnered with Illumina Inc. to test whether Illumina's constellation map read technology could shed light on hard-to-detect variants that appear in rare diseases. Constellation met or exceeded the ability of other sequencing methods to detect variants implicated in multiple disorders and worked across a range of sample types, a study presented at the American Society for Human Genetics (ASHG) Annual Meeting in Boston on Oct. 15 found.

Sweeping “radical” changes in both the U.S. FDA and China’s drug development landscape are keeping the global life science industry on its toes in assessing what’s temporary and what’s not, speakers said at the Bioplus Interphex (BIX) Korea 2025 conference in Seoul, South Korea, on Oct. 15.

While the pace of executive orders (EOs) coming out of the White House has slowed, the Trump administration is still churning them out. As of the end of the third quarter, President Donald Trump had issued 209 EOs. Of those, BioWorld tracked 37 that directly impact drug and device R&D, regulatory burdens, pricing and market competition.

Touting a science-driven, regenerative medicine-based treatment for hair loss “designed for the 21st century,” Pelage Pharmaceuticals Inc. drew a solid group of investors to the table in an oversubscribed $120 million series B round to fund an upcoming phase III program for PP-405, a topical small molecule targeting hair follicle stem cells.

Patent litigation doesn’t always create outlandish damages awards but when it does, the outlandishness typically trends toward inordinately large sums. This was decidedly not the case in the Federal Circuit hearing in a patent lawsuit pitting Intuitive Surgical Inc., of Sunnyvale, Calif., against Rex Medical LP, of Conshohocken, Pa., given the damages awarded to Rex amounted to a mere $1.

John Squires, the recently anointed director of the U.S. Patent and Trademark Office, has determined that a machine learning patent application met the standard for patent subject matter eligibility, an outcome that seems to bode well for ML-based patent applications going forward.