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Formosa Pharmaceuticals Secures FDA Nod for New Steroidal Eye Drug, Set to Launch via Eyenovia
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Taiwan-based Formosa Pharmaceuticals (TPE: 6838) has received approval from the US Food and Drug Administration (FDA) for its new formulation of the steroidal eye drug clobetasol propionate (0.05%), designed to treat post-operative inflammation and pain following ocular surgery. The drug will be commercialized in the US by Eyenovia Inc., (Nasdaq:…
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MGI Tech Lands Eurofins Genomics Deal for T20 Ultra-High Throughput Sequencer in Europe
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MGI Tech (SHA: 688114), a China-based sequencing company, has announced a significant collaboration with Eurofins Genomics Europe Genotyping A/S, headquartered in France. As part of the deal, Eurofins has placed a corporate order for MGI’s DNBSEQ-T20×2 (T20) ultra-high throughput sequencer, which is accompanied by the genomics data center ZTRON Appliance,…
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Bayer Posts 1.2% YOY Sales Decline in 2023 with Pharmaceuticals and Consumer Health Segment Updates
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Germany’s Bayer (ETR: BAYN) has released its financial results for 2023, marking a year of declining sales that culminated in a 1.2% year-on-year (YOY) drop in constant currency and portfolio-adjusted terms, reaching €47.6 billion (USD 51.7 billion). The Pharmaceuticals segment generated €18.1 billion (USD 19.6 billion) with a 0.4% decline…
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Novo Nordisk’s Ozempic Meets Phase III Endpoints in Type 2 Diabetes and Chronic Kidney Disease Study
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Novo Nordisk (NYSE: NVO), a Denmark-based pharmaceutical company, has this week published results from a Phase III study assessing the impact of the GLP-1 receptor agonist Ozempic (semaglutide) on the progression of renal impairment in individuals with type 2 diabetes (T2D) and chronic kidney disease (CKD). Following the trial’s discontinuation…
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Sandoz Achieves FDA Milestone with Approval of First US Denosumab Biosimilars
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The US Food and Drug Administration (FDA) has granted Sandoz (SWX: SDZ), a Switzerland-based pharmaceutical company, registration approvals for its biosimilars Wyost (denosumab) and Jubbonti (denosumab). These biosimilars reference and share the same indications as Amgen’s (NASDAQ: AMGN) bone treatments Xgeva and Prolia, respectively. With this approval, Sandoz’s drugs become…
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Hybio Pharmaceutical Gets FDA Nod for Liraglutide Raw Materials with DMF Adequacy Letter
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Hybio Pharmaceutical Co., Ltd (SHE: 300199), a China-based pharmaceutical company, has announced that it has received a Drug Master File (DMF) First Adequate Letter from the US Food and Drug Administration (FDA) for its liraglutide raw materials. The letter indicates no comments and no deficiencies, which is a significant step…
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Shanghai RAAS Receives NMPA Approval to Initiate Clinical Trial for Hemophilia Preventive Treatment
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Shanghai RAAS (SHE: 002252), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to commence a Phase I clinical study for SR604. The drug candidate is intended as a preventive treatment for bleeding episodes in patients with hemophilia and…
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Bio-Thera Solutions Receives NMPA Approval for Three Cancer Treatments Including a Novel ADC
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Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for three of its drug candidates. These include BAT8010 in combination with BAT1006 for the treatment of locally advanced or metastatic solid tumors, as well as BAT7205 as…
