Can Chinese biopharma finally break the innovation ceiling in autoimmune disease? Inside the IBI3011 playbook

Can Chinese biopharma finally break the innovation ceiling in autoimmune disease? Inside the IBI3011 playbook

For decades, China’s biopharma sector was best known for its rapid scaling of biosimilars, generics, and “fast follower” biologics. Industry watchers, both inside and outside the country, regarded Chinese firms as volume leaders but not science front-runners. This is now changing. The first-in-human dosing of IBI3011, Innovent Biologics’ anti-IL-1RAP monoclonal antibody, marks a turning point […]

What the nanoparticle BCI model reveals about the future of brain interfaces

What the nanoparticle BCI model reveals about the future of brain interfaces

Subsense, Inc. has raised an additional $10 million in funding to accelerate the development of its non-surgical, nanoparticle-based brain-computer interface (BCI), bringing its total funding to $27 million. The financing, led by Golden Falcon Capital, follows early successes in nanoparticle design, in vitro signal stimulation, and the construction of a bio-integrated hardware-software platform intended to […]

Is Zegen-15 the breakthrough diabetic foot ulcer therapy insurers will finally cover?

Is Zegen-15 the breakthrough diabetic foot ulcer therapy insurers will finally cover?

Zegenex, a Pittsburgh-based biotechnology company focused on regenerative wound care, has secured a $215,000 social-impact investment from the Richard King Mellon Foundation to accelerate formulation and preclinical development of Zegen-15, a first-in-class small-molecule cream targeting chronic wounds, including diabetic foot ulcers. The funding positions Zegenex to begin clinical trials by the end of 2026 and […]

How eClinical Solutions is embedding agentic AI into trial data workflows for 2026

How eClinical Solutions is embedding agentic AI into trial data workflows for 2026

eClinical Solutions LLC has officially launched its elluminate AI agents, embedding agentic automation into its elluminate Clinical Data Cloud ecosystem. First previewed at the company’s ENGAGE conference in October 2025, these AI agents will become available in early 2026 and are designed to assist in four critical clinical trial workflows: data mapping, data review, risk-based […]

What the Cosette–Mayne Pharma breakdown signals for future pharma M&A in Australia

What the Cosette–Mayne Pharma breakdown signals for future pharma M&A in Australia

Cosette Pharmaceuticals, Inc. has officially terminated its proposed AUD 7.40-per-share acquisition of Mayne Pharma Group Limited after the Australian government blocked the transaction. The decision was confirmed on December 9, 2025, and followed by Mayne Pharma’s own termination notice issued on December 11. The companies cited both the Treasurer of Australia’s ruling and the expiry […]

Can CK0804 overcome JAK inhibitor resistance in myelofibrosis and reshape the Treg cell therapy landscape?

Can CK0804 overcome JAK inhibitor resistance in myelofibrosis and reshape the Treg cell therapy landscape?

Cellenkos, Inc., a clinical-stage biotechnology company developing allogeneic regulatory T cell (Treg) therapies, has unveiled new data from its investigational product CK0804, presented at the 67th American Society of Hematology (ASH) Annual Meeting. The findings highlight the potential of a dose-intensive regimen of CK0804 to reduce spleen volume, improve symptoms, and lower transfusion dependence in […]

Gonorrhea resistance crisis: Can Innoviva’s zoliflodacin rewrite treatment guidelines?

Gonorrhea resistance crisis: Can Innoviva’s zoliflodacin rewrite treatment guidelines?

Innoviva Specialty Therapeutics has reported publication of pivotal Phase 3 data in The Lancet showing that its investigational oral antibiotic zoliflodacin was non-inferior to the current standard-of-care dual therapy for uncomplicated urogenital gonorrhea. The study, conducted in partnership with the Global Antibiotic Research & Development Partnership, or GARDP, compared a single oral dose of zoliflodacin […]

Is Kazia’s paxalisib becoming the new backbone for checkpoint combos?

Is Kazia’s paxalisib becoming the new backbone for checkpoint combos?

Kazia Therapeutics Limited has presented new clinical and translational data at the 2025 San Antonio Breast Cancer Symposium demonstrating that paxalisib, its investigational brain-penetrant PI3K/mTOR inhibitor, may suppress circulating tumor cell clusters and reverse immune exhaustion in two of the most treatment-resistant breast cancer subtypes—HER2-positive metastatic breast cancer and triple-negative breast cancer. The early evidence, […]

Can next-gen immunotherapy combos finally crack the code in metastatic breast cancer?

Can next-gen immunotherapy combos finally crack the code in metastatic breast cancer?

The landscape of metastatic breast cancer treatment is facing a fundamental rethink, with the oncology field laser-focused on one of its greatest clinical challenges: how to break immune resistance and stop metastatic spread. Despite a wave of checkpoint inhibitor approvals and initial enthusiasm, progress in metastatic breast cancer—especially for subtypes like triple-negative and HER2-positive disease—has […]