Category Regulatory

2024 Antibiotic Collaboration Trends: 133 Deals by Top Life Science Companies Since 2016

The Antibiotic Collaboration and Licensing Deals 2016-2024 report has been added to ResearchAndMarkets.com’s offerings. This report provides a comprehensive understanding and unprecedented access to antibiotic deals made by the world’s leading biopharma companies, covering agreements from 2016 to 2024. It…

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Brenus Pharma Takes Home French Tech Saint-Etienne Lyon’s Prestigious Start-up of the Year Prize

During its annual event “BIG UP,” French Tech Saint-Etienne Lyon awarded the prestigious BIG Start-up of the Year trophy, recognizing a start-up that embodies innovation and vitality within the region. Established in 2015, French Tech Saint-Etienne Lyon is a non-profit…

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Frexalimab Phase 2 Results: Reduction of Key Biomarker of Nerve Cell Damage in Relapsing MS

Sanofi’s CD40L monoclonal antibody, frexalimab, has demonstrated promising results in reducing a key biomarker associated with nerve cell damage in patients with relapsing multiple sclerosis (MS), suggesting potential benefits in delaying disability progression. Phase 2 findings presented at the 10th…

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argenx Gets FDA Nod for VYVGART® with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy

argenx Receives FDA Approval for VYVGART® Hytrulo with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy Today, Halozyme announced that the U.S. Food and Drug Administration (FDA) has approved argenx’s VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) co-formulated with ENHANZE® for the treatment…

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Bristol Myers Squibb Announces FDA Accelerated Approval of KRAZATI® for KRAS G12C-Mutated Colorectal Cancer

Today, Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for KRAZATI® (adagrasib) in combination with cetuximab. This targeted treatment is for adult patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC),…

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FDA Approves SKYRIZI® for Ulcerative Colitis, Expanding AbbVie’s IBD Portfolio

FDA Approves SKYRIZI® for Ulcerative Colitis, Expanding AbbVie’s IBD Portfolio AbbVie announced that the U.S. FDA has approved SKYRIZI® (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis. This marks SKYRIZI as the first IL-23 specific inhibitor approved for…

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Marinus Pharmaceuticals Releases Key Findings from IV Ganaxolone Phase 3 RAISE Trial for Refractory Status Epilepticus

Marinus Pharmaceuticals, a company focused on developing innovative therapeutics for seizure disorders, has announced topline results from the Phase 3 RAISE trial (NCT04391569). This double-blind, randomized, placebo-controlled study assessed the safety and efficacy of intravenous (IV) ganaxolone for treating refractory…

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Celltrion Presents Positive Phase III Results of CT-P47 for Rheumatoid Arthritis at EULAR 2024

Celltrion Unveils Positive Phase III Results of CT-P47 Biosimilar for Rheumatoid Arthritis at EULAR 2024 Celltrion has revealed encouraging findings from its Phase III study of CT-P47, a biosimilar referencing RoActemra® (tocilizumab), presented at the Annual European Congress of Rheumatology…

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Celltrion Unveils Promising Phase III Results for CT-P47, a Biosimilar to RoActemra®, in RA Patients at EULAR 2024

Celltrion today presented positive Phase III data for CT-P47, a biosimilar referencing RoActemra® in patients with moderate-to-severe rheumatoid arthritis (RA), at the Annual European Congress of Rheumatology (EULAR) 2024. The trial demonstrated that CT-P47 has equivalent efficacy and comparable safety…

Read MoreCelltrion Unveils Promising Phase III Results for CT-P47, a Biosimilar to RoActemra®, in RA Patients at EULAR 2024

BeiGene to Present SEQUOIA Study Data on BRUKINSA® and Venetoclax in High-Risk CLL/SLL at EHA2024

BeiGene Presents New Data on BRUKINSA® and Venetoclax Combination for High-Risk CLL/SLL at EHA2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, announced the presentation of new data from the SEQUOIA study of BRUKINSA® (zanubrutinib) at…

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Sparrow Pharma Shares Phase 2 Trial Data on Clofutriben and Prednisolone for Polymyalgia Rheumatica at EULAR 2024

Sparrow Pharmaceuticals presented data from an ongoing Phase 2 trial of the HSD-1 inhibitor clofutriben (SPI-62) and prednisolone for polymyalgia rheumatica (PMR) at EULAR 2024 in Vienna, Austria (June 12-15). The data suggest that HSD-1 inhibition can enable effective glucocorticoid…

Read MoreSparrow Pharma Shares Phase 2 Trial Data on Clofutriben and Prednisolone for Polymyalgia Rheumatica at EULAR 2024