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Lupin Receives EIR from US FDA for its Aurangabad (CSN) Facility
Lupin has received an Establishment Inspection Report (EIR) from the US FDA for its Aurangabad (CSN) facility, marking the successful closure of a product-specific Pre-Approval Inspection conducted between September 1 and September 5, 2025.
Uhlmann Pac-Systeme Opens New Branch in Jakarta to Establish Local Presence
Uhlmann Pac-Systeme, a global leader in pharmaceutical packaging systems, has further expanded its footprint in Southeast Asia with the opening of a new branch in Indonesia.
Bry-Air Launches P80x Dehumidifier with MOF Technology for Pharma Industry
Bry-Air has announced the launch of its latest innovation — the P80x dehumidifier — equipped with state-of-the-art MIRACLE Next-Gen Rotor powered by MOF (Metal-Organic Frameworks) technology.
Bayer Warns of Higher 2025 Earnings Impact from Lawsuits and Restructuring Costs
The German life sciences company now expects special items to reduce its earnings before interest, tax, depreciation, and amortisation (EBITDA) by between EUR 3.5 billion and EUR 4.0 billion, higher than the earlier forecast of EUR 2.5 billion to EUR 3.5 billion.
LogiPharma, the world’s largest end-to-end life sciences supply chain event, has unveiled its 2025 Artificial Intelligence Report, revealing a major transition in how pharmaceutical companies are adopting AI technologies.
Zydus Lifesciences Receives USFDA Tentative Nod for Generic Multiple Sclerosis Drug
Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Diroximel Fumarate delayed-release capsules, 231 mg, a generic version of Vumerity delayed-release capsules of the same strength.
Sandoz and EirGenix Ink Global Licensing Deal for Pertuzumab Biosimilar
Sandoz, the global leader in affordable medicines, has signed a global license agreement with Taiwanese biotech company EirGenix to commercialise a proposed biosimilar of the oncology medicine pertuzumab. The milestone-based deal, valued at up to USD 152 million, includes an upfront payment and potential market-based incentives.
Novartis Reports Promising Results for New Anti-Malaria Drug to Tackle Growing Resistance
Novartis’ Phase III trial of KLU156 (GanLum) met its primary endpoint, showing a 97.4 percent PCR-corrected cure rate comparable to Coartem. If approved, GanLum would mark the first major malaria treatment breakthrough in over two decades, targeting drug-resistant parasites.
US FDA Appoints Richard Pazdur as Director of CDER
Pazdur is a 26-year veteran of the FDA and the Founding Director of its Oncology Center of Excellence (CoE). A regulatory innovator, he developed an integrated approach for cross-centre coordination of oncology product review to expedite the development of novel cancer therapies.
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and the Open Applications Group (OAGi) in the US have jointly unveiled a pioneering set of ontologies designed to enhance data interoperability and analytics capabilities across the biopharmaceutical industry.
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