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Indoco Remedies Secures US FDA Approval for Generic Brivaracetam Oral Solution
Indoco Remedies receives US FDA approval to market generic brivaracetam oral solution for partial-onset seizures in the US market.
Advanced Drug Formulation Platform Drives ANZ Licensing Pact Between Formosa and Arrotex
Taiwan-based clinical-stage biotech company Formosa Pharmaceuticals has entered into an exclusive licensing agreement with Arrotex Pharmaceuticals Pty Ltd. for the commercialization of clobetasol propionate ophthalmic suspension 0.05% (APP13007) in Australia and New Zealand.
UK Medicines Manufacturing Faces Acute Skills Gap; VR Training Boosts Competency by 40 percent
Advanced medicines manufacturing in the UK is grappling with a significant skills shortage, with too few young professionals entering the sector, according to Ivan Wall, Professor of Regenerative Medicine at University of Birmingham and co-director of RESILIENCE: UK Medicines Manufacturing Skills Centre of Excellence.
CDSCO to Outsource GMP Audits and Add 1,500 Experts to Boost Scientific Oversight
Central Drugs Standard Control Organisation has announced plans to strengthen its regulatory framework by outsourcing Good Manufacturing Practice (GMP) audits to accredited third-party agencies and expanding its scientific workforce by approximately 1,500 experts.
Morepen Bags INR 825 Crore Global Deal
Morepen has secured a ?825 crore global deal, marking its expansion into the high-growth Contract Development and Manufacturing Organisation (CDMO) segment.
GVRP Partners with Yurogen Biosystems to Advance Biologics Drug Discovery in India
Under this partnership, GVRP will serve as the commercial interface for Yurogen Biosystems in India, enabling streamlined market access, client engagement and programme coordination, while all scientific execution and service delivery will continue to be carried out by Yurogen Biosystems.
Exclusive licensing deal grants Arrotex rights to market clobetasol propionate ophthalmic suspension for post-surgical ocular inflammation and pain, expanding Formosa’s footprint in Oceania.
CStone Pharmaceuticals Secures UK MHRA Approval for Sugemalimab in Stage III NSCLC
The UK Medicines and Healthcare products Regulatory Agency grants a new indication for sugemalimab monotherapy in unresectable Stage III NSCLC, expanding its European footprint and global commercial reach.
India, Brazil Ink MoU to Deepen Regulatory Cooperation in Pharma and Medical Products
India’s CDSCO and Brazil’s ANVISA exchanged MoU in the presence of Prime Minister Narendra Modi and President Luiz Inácio Lula da Silva to strengthen regulatory cooperation in pharmaceuticals and medical products.
FDA clears 14-month, chemotherapy-free combination for first-line treatment of chronic lymphocytic leukaemia and small lymphocytic lymphoma, backed by positive Phase III AMPLIFY trial data.
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