Latest Gmp Manufacturing News

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.

Little Green Pharma (ASX:LGP) posted record quarterly and annual revenues driven by a surge in European sales, improved cashflow, and reduced debt. The company is on track to complete its merger with Cannatrek by June 1, 2026, while benefiting from the US rescheduling of medicinal cannabis to Schedule III.

Epsilon Healthcare has achieved its highest quarterly receipts ever with $3.14 million in Q1 2026, driven by strong expansion across contract manufacturing, clinics, and pharmacy operations.

Bioxyne Limited posted a record $21.3 million revenue in Q3 FY26, driven by strong demand for medicinal cannabis and psychedelics. The company secured a manufacturing agreement with Aurora Cannabis and initial orders for GMP psilocybin capsules, reaffirming FY26 guidance.