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Pharma & Biotech

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

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Pharma & Biotech

Waskyra approved for Wiskott-Aldrich syndrome: What it means for stem cell alternatives

Fondazione Telethon has received regulatory approval from the United States Food and Drug Administration for Waskyra (etuvetidigene autotemcel), an ex vivo gene therapy designed to treat Wiskott-Aldrich syndrome, a rare X-linked primary immunodeficiency. This approval makes Waskyra the first gene therapy for this condition cleared for use in the United States and solidifies Fondazione Telethon’s

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Pharma & Biotech

Spiderwort Biotechnologies’ cellulose scaffolds show promise in spinal cord repair

Spiderwort’s spinal cord scaffold earns scientific validation as its dermal filler enters human trials Spiderwort Biotechnologies Inc. has reported two key developments in its cellulose-based regenerative platform, signaling a step forward in both neurorepair and aesthetic medicine. A peer-reviewed study published in Scientific Reports confirms that the company’s plant-derived scaffolds promote neural tissue repair and

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Pharma & Biotech

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

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Pharma & Biotech

What sterile drug manufacturers should expect from AST and Marchesini in 2026

AST, a United States-based provider of aseptic fill-finish systems for pharmaceutical and biotech manufacturers, has entered a strategic partnership with Italy’s Marchesini Group, a global leader in pharmaceutical packaging machinery. Under the agreement announced on December 10, 2025, Marchesini Group has acquired a 44.39 percent equity stake in AST. The deal aims to combine AST’s

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Pharma & Biotech

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

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Pharma & Biotech

Can mitochondrial stress be weaponized in cancer? Bantam starts BTM-3566 dosing

Bantam Pharmaceutical has treated the first patient with BTM-3566 in a Phase 1 clinical trial at the Princess Margaret Cancer Centre in Toronto. The study marks the first-in-human administration of the company’s lead investigational therapy, a first-in-class small molecule designed to treat aggressive cancers by modulating the OMA1-ATF4 integrated stress response pathway. This trial includes

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Pharma & Biotech

How Innoviva’s NUZOLVENCE could reshape STI care and resistance strategy

Innoviva Specialty Therapeutics has received approval from the U.S. Food and Drug Administration for NUZOLVENCE (zoliflodacin), a first-in-class, single-dose oral antibiotic for the treatment of uncomplicated urogenital gonorrhea in adults and adolescents. This approval, based on the largest-ever Phase 3 clinical trial for a new treatment against Neisseria gonorrhoeae, marks the first new oral gonorrhea

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Pharma & Biotech

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

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Pharma & Biotech

EMA backs ANKTIVA for bladder cancer: What it means for EU patients and future immunotherapies

ImmunityBio Inc. has received a positive recommendation from the European Medicines Agency for conditional marketing authorization of its immunotherapy ANKTIVA (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin for the treatment of BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ. The recommendation positions ANKTIVA as the first immunotherapy in the European Union for this indication,

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