News about Global Pharma

Japan Grants SAKIGAKE Status to AskBio's Gene Therapy Products, Boosting Global Pharma Manufacturing Momentum

This designation underscores Japan’s commitment to accelerating breakthrough therapies that demonstrate novel mechanisms of action, strong preliminary data, and meaningful potential for addressing severe, underserved conditions.

Global Pharma | 10/12/2025 | By Darshana

Amneal Gets FDA Approval for Epinephrine Vials

The FDA has approved Amneal’s epinephrine injection in both single- and multi-dose vials, strengthening the company’s injectables portfolio with a critical medicine widely used in hospitals for emergency and perioperative care.

Global Pharma | 10/12/2025 | By Akanki

Ouro Medicines Receives US FDA ODD for Gamgertamig (OM336) for Immune Thrombocytopenia

Ouro Medicines has secured a second ODD from the FDA for gamgertamig (OM336), this time for immune thrombocytopenia (ITP), following an earlier designation for autoimmune hemolytic anemia (AIHA). It comes as the company completes dosing in the first cohort of its global basket trial in autoimmune cytopenias.

Global Pharma | 09/12/2025 | By Akanki

China Adds Leqembi to Innovative Drug Insurance List

BioArctic’s partner Eisai said Leqembi has been added to China’s new Commercial Insurance Innovative Drug List, a move by the NHSA that broadens access to the Alzheimer’s therapy for patients in the early stages of the disease.

Global Pharma | 09/12/2025 | By Akanki

HUTCHMED Gains Wider NRDL Coverage and First Commercial Insurance Listing in China

Effective January 1, 2026, HUTCHMED will see expanded NRDL coverage for ELUNATE, ORPATHYS and SULANDA, while TAZVERIK has been added to China’s first National Commercial Health Insurance Innovative Drug List, marking its entry into commercial insurance coverage.

Global Pharma | 08/12/2025 | By Dineshwori

Immix Biopharma Prices USD 100 Million Stock and Pre-Funded Warrant Offering

Immix Biopharma has priced its USD 100 million offering of common stock and pre-funded warrants, with plans to use the proceeds—alongside existing cash reserves—to advance the development of NXC-201 and support working capital and general corporate needs.

Global Pharma | 08/12/2025 | By Dineshwori

OTR Therapeutics Raises USD 100 Million to Advance Transformative Therapies

OTR Therapeutics has secured USD 100 million in Series A funding to accelerate the development of its pipeline of differentiated therapies aimed at addressing major unmet needs across immunology, inflammation, oncology, and other disease areas.

Global Pharma | 05/12/2025 | By Dineshwori

Formycon, MS Pharma Ink MENA Deal for Keytruda Biosimilar FYB206

Formycon has signed an exclusive commercialisation agreement with MS Pharma for its Keytruda biosimilar candidate FYB206 in the MENA region. The deal includes an upfront payment, milestone-based fees, and a significant share of regional gross profits generated in the region.

Global Pharma | 05/12/2025 | By Dineshwori

Innovent Biologics and Takeda Finalise Global Collaboration for Next-Generation IO and ADC Therapies

As part of the agreement, Takeda will pay Innovent an upfront payment of USD1.2 billion, including a USD100 million equity investment at HKD112.56 per share.

Global Pharma | 05/12/2025 | By Dineshwori

Nona Biosciences Taps Dr. Hongjiang Miao to Advance A3 Strategy and AI-Driven Drug Discovery

Dr. Hongjiang Miao will lead the Nona AI team to advance the company's A3 (Antibody engineering × AI × Automation) strategy and further transform Nona into an AI-driven drug discovery company.

Global Pharma | 04/12/2025 | By Dineshwori