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BioWorld - Sunday, December 28, 2025
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Concept of business partnership

Leads Biolabs joins a $1B development deal with Dianthus

Oct. 16, 2025
By Lee Landenberger
No Comments
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.
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Shaky hands holding glass

Praxis soars on essential tremor phase III, preps for NDA

Oct. 16, 2025
By Karen Carey
No Comments
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.
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Genedx’s Director of Laboratory Innovation Joe Devaney

Illumina's constellation tech a star in Genedx pilot

Oct. 15, 2025
By Annette Boyle
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.
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World with digital overlay

BIX 2025: What ‘radical’ changes in US, China mean for bio sector

Oct. 15, 2025
By Marian (YoonJee) Chu
No Comments
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.
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Pen and paper

White House ushering in new era of EO governance?

Oct. 15, 2025
By Mari Serebrov
No Comments
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.
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Thinning hairline

Pelage’s regenerative approach to hair loss draws $120M in series B

Oct. 15, 2025
By Jennifer Boggs
No Comments
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.
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Judge's gavel with US flag

Federal Circuit affirms $1 damages award to Rex Medical

Oct. 14, 2025
By Mark McCarty
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.
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AI-generated digital horse illustration

PTO director strikes a blow for ML patent subject matter eligibility

Oct. 14, 2025
By Mark McCarty
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.
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Johnson & Johnson signage

Johnson & Johnson plans orthopedics break up

Oct. 14, 2025
By Annette Boyle
Breaking up isn’t so hard to do, it seems. Just two years after spinning off its consumer products as Kenvue Inc., Johnson & Johnson aims to part ways with its orthopedics unit, which will take up the Depuy Synthes name first created when Synthes Inc. married into the J&J Depuy ortho unit in 2012 for a tidy sum of $19.7 billion. Depuy was itself acquired in 1998.
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Map of Australia as blue circuit board, digital network

Digital mental health concerns on tap at FDA, TGA

Oct. 14, 2025
By Mark McCarty
Digital mental health tools are popping up with some regularity lately, but both Australia’s Therapeutic Goods Administration and the U.S. FDA have enough concerns about these products that they are taking a closer look at their risks and benefits.
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