Latest Gmp Manufacturing News

Starpharma launches a fully underwritten $32 million entitlement offer to fund the Phase 1 trial of its DEP® HER2-Lutetium radiopharmaceutical and accelerate its targeted oncology asset development.

Cann Group has boosted its private credit loan facility by $2 million to facilitate the early redemption of convertible notes, maintaining its debt restructuring momentum.

Germany’s Hesse State Office has issued new GMP guidance that questions the viability of fragmented medicinal cannabis supply chains, reinforcing ECS Botanics’ integrated manufacturing approach and potentially tightening market supply.

Neurizon Therapeutics has secured a critical five-year supply agreement with Elanco Animal Health for GMP-grade monepantel, underpinning the commercialisation readiness of its lead ALS drug candidate NUZ-001.

Island Pharmaceuticals has won a key regulatory boost as the US FDA granted Orphan Drug Designation to Galidesivir for post-exposure prophylaxis of Marburg virus disease, enhancing its commercial and development prospects.

Island Pharmaceuticals is accelerating development of its broad-spectrum antiviral Galidesivir, progressing clinical, regulatory, and manufacturing milestones under the FDA Animal Rule pathway with expanded USAMRIID collaboration and biodefence positioning.

Island Pharmaceuticals has expanded its partnership with USAMRIID to conduct a pivotal Galidesivir dose optimisation study against Marburg virus, targeting topline results in the second half of 2026.

Island Pharmaceuticals has kicked off GMP manufacturing of its antiviral Galidesivir to support late-stage Marburg virus studies under the FDA Animal Rule, marking a key step towards regulatory submission and biodefence readiness.

Amplia Therapeutics reported encouraging mature data from its ACCENT pancreatic cancer trial showing improved survival and response rates with narmafotinib. The company raised $27.5 million to fund development and manufacturing scale-up, while discontinuing a parallel trial due to chemotherapy toxicity.

Bioxyne has locked in a two-year, $50 million exclusive supply agreement with German pharmaceutical distributor ADREXpharma, granting exclusive rights to its Dr Watson® brand in Germany and reinforcing its foothold in Europe’s largest medicinal cannabis market.

Bioxyne expands its LATAM footprint by securing the first international medicinal cannabis flower supply agreement in Costa Rica, with initial shipments valued over $500,000 planned before June 2026.

Amplia Therapeutics and ANZGOG have initiated a clinical trial to test narmafotinib combined with chemotherapy in ovarian cancer patients unresponsive to platinum-based treatment, aiming to improve surgical outcomes and explore biomarker insights.