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AGC Biologics to Manufacture Teikoku Seiyaku's rhMMP-7 Drug Substance
AGC Biologics will provide process development and GMP manufacturing services for Teikoku Seiyaku’s rhMMP-7 therapy, supporting development of the novel biologic through its global microbial network in Germany and Japan.
Gilead Sciences Wins FDA Accelerated Approval for First HDV Treatment Hepcludex
Gilead Sciences receives Food and Drug Administration (FDA) accelerated approval for Hepcludex, the first and only approved treatment for chronic Hepatitis Delta Virus (HDV), addressing a major unmet need in severe viral hepatitis care.
Genethon and Ampersand Biomedicines Partner to Develop Precision Gene Therapy Vectors
Genethon and Ampersand Biomedicines join forces to engineer advanced AAV gene therapy vectors designed for greater tissue specificity, potentially enabling safer and more effective treatments for patients with rare genetic disorders.
Junshi Biosciences expands toripalimab’s treatment footprint in China with regulatory approval for a new urothelial carcinoma indication, strengthening immunotherapy options for patients with advanced bladder cancer.
Phase 2a study findings show RESP-X demonstrated safety, favourable dosing potential and encouraging efficacy signals, supporting further clinical development for respiratory patients colonised with Pseudomonas aeruginosa.
Lupin Secures China Approval for Oseltamivir Phosphate Oral Suspension
Lupin receives approval in China for Oseltamivir Phosphate Oral Suspension 6 mg/mL, expanding access to influenza treatment, particularly for pediatric patients.
Venus Remedies Secures Saudi FDA Approval for Plerixafor Oncology Therapy
Venus Remedies receives Saudi FDA approval for Plerixafor, marking its first global marketing authorisation for the specialty oncology therapy used in stem cell mobilisation for multiple myeloma and non-Hodgkin lymphoma patients undergoing autologous transplantation.
PCIM&H Concludes 5-Day Training Program for ASU&H Drug Regulators and Stakeholders
The Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) concluded a 5-day capacity building program for ASU&H drug regulators and stakeholders, aimed at strengthening regulatory knowledge, quality standards, and technical competencies across ASU&H sector.
India Brings Pregabalin under Schedule H1 to Curb Misuse and Strengthen Drug Regulation
Union Health Ministry has brought Pregabalin under Schedule H1 to strengthen prescription monitoring, regulate supply chains, and prevent misuse and unauthorised access to the widely used neurological medicine.
EMA Recommends Approval of Jascayd for IPF and Progressive Pulmonary Fibrosis
Jascayd receives positive CHMP recommendation for approval in Europe to treat Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF), addressing major unmet needs in severe and life-threatening lung diseases.
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