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Biocon Biologics and Civica Launch Private-Label Insulin Glargine in the US
The multi-year transformational agreement between Biocon Biologics and Civica creates an exclusive distributorship arrangement where Biocon Biologics will manufacture and supply Insulin Glargine medicine to Civica, and Civica will commercialise under Biocon Biologics’ existing marketing approval.
ManaMed Secures FDA Clearance for Next-Generation Tubeless Compression System, PlasmaFlow X
ManaMed, a US-based global leader in orthopedic mobility and post-operative rehabilitation equipment, has received FDA 510(k) clearance for PlasmaFlow X, its next-generation tubeless sequential compression system designed to redefine recovery and enhance patient comfort.
Korean biotech company SK Biopharmaceuticals and Brazil-based Eurofarma have established a joint venture, Mentis Care, in Canada to commercialise an AI-powered epilepsy management platform. The new company marks SK Biopharmaceuticals’ full-scale expansion into digital healthcare beyond its innovative drug development portfolio.
Alchem International Appeals to Delhi High Court against Single-Judge Order Banning 'Alchem' Use
The injunction prohibits Alchem from using its name in connection with medicines or medicinal products until further orders. Alchem’s appeal seeks to overturn the interim ban and restore its ability to use its brand amidst the ongoing trademark dispute.
Venus Remedies Opens Advanced 66,000 sq ft Fulfilment Facility in Mohali
The facility is equipped with temperature-controlled storage, RFID and barcode tracking systems, and automated sorting and retrieval mechanisms. It is compliant with a number of national and international regulatory standards including WHO-GDP, EU-GMP, PAHO, CDSCO, GDP-AEO, as well as ISO certifications.
Pelage Pharma Raises USD 120 Million to Advance Regenerative Hair Loss Therapy
Pelage Pharmaceuticals, a Los Angeles-based clinical-stage regenerative medicine company, has raised USD 120 million in a Series B funding round to accelerate the development of its innovative treatment for hair loss. The financing was co-led by ARCH Venture Partners and GV (formerly Google Ventures), with participation from existing investors.
FDA Expands Indications for Celltrion's YUFLYMA to Include Pediatric and Adolescent Patients
Celltrion has announced that the US Food and Drug Administration (FDA) has approved expanded indications for YUFLYMA (adalimumab-aaty) and its unbranded version to include the treatment of hidradenitis suppurativa (HS) in adolescent patients aged 12 years and older, and uveitis (UV) in pediatric patients aged 2 years and older.
Fabhalta from Novartis Meets Phase-III Goal in Slowing Kidney Decline in IgAN Patients
Fabhalta (iptacopan) from Novartis met its Phase III primary endpoint, slowing kidney function decline in IgA nephropathy (IgAN) patients. The first approved complement inhibitor for IgAN, Fabhalta builds on its 2024 U.S. accelerated approval, with data supporting a 2026 traditional FDA submission.
Sunshine Biopharma's Canadian subsidiary Nora Pharma Launches Generic Cholesterol Drug Pravastatin
Sunshine Biopharma’s wholly owned Canadian subsidiary, Nora Pharma, has launched Pravastatin, a generic prescription drug in the therapeutic class of Lipid Metabolism Regulators.
NAYA Therapeutics, a US-based clinical-stage biopharmaceutical company developing next-generation cancer therapies, has entered into a research and manufacturing partnership with China’s Alpha Nuclide, a radiopharmaceutical solutions company leading global efforts in Astatine-211 (211At) supply and CDMO services.
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