Day: October 2, 2023

Roche to present new key clinical and real-world data at ECTRIMS-ACTRIMS 2023 showcasing strength of long-term outcomes in MS and NMOSD

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Late-breaking results from Phase III trial of OCREVUS (ocrelizumab) subcutaneous injection and Phase II trial of BTK inhibitor fenebrutinib in multiple sclerosis (MS) will be presented 10-year OCREVUS efficacy and safety data show significant benefit in slowing long-term disability progression and consistent long-term safety profile in MS Additional OCREVUS real-world and clinical data show impact for underrepresented populations including more than 3,200 pregnant women and Black and Hispanic/Latinx patients with MS Longer-term safety data and late-breaking efficacy data from Phase III trial of ENSPRYNG (satralizumab) in neuromyelitis optica spectrum disorder (NMOSD) will be presented Basel, 02 October 2023 – Roche (SIX: RO, ROG; OTCQX: RHHBY) will present new data for OCREVUS® (ocrelizumab) and investigational Bruton’s tyrosine...

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Novartis investigational iptacopan Phase III study demonstrates clinically meaningful and highly statistically significant proteinuria reduction in patients with IgA nephropathy (IgAN)

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Ad hoc announcement pursuant to Art. 53 LR Phase III APPLAUSE-IgAN study met its pre-specified interim analysis primary endpoint, demonstrating superiority of iptacopan vs placebo in proteinuria reduction1 Iptacopan is an investigational, first-in-class, oral factor B inhibitor targeting the alternative pathway of the complement system2–4 IgAN is a complement-mediated kidney disease, affects mostly young adults, and is a major cause of chronic kidney disease and kidney failure worldwide5–9 Novartis plans to review interim results with FDA to enable a potential regulatory submission for accelerated approval; study continues with final readout (24 months) in 20254 APPLAUSE-IgAN is the third positive Phase III trial for iptacopan and development program is ongoing across five indications; regulatory review is underway for paroxysmal...

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Basilea announces FDA acceptance of New Drug Application for antibiotic ceftobiprole

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Seeking approval for Staphylococcus aureus bacteremia (SAB), acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP) Prescription Drug User Fee Act (PDUFA) goal date set for April 03, 2024 Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, October 02, 2023 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial or fungal infections, announced today that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for the antibiotic ceftobiprole, which was submitted to the FDA on August 3rd this year. With this NDA, Basilea is seeking approval for treating patients in three indications: Staphylococcus aureus bacteremia (SAB), including...

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Coherent to Demonstrate Next-Generation Transceiver and Semiconductor Laser Technology for 800G and 1.6T Transmission in AI Networks at ECOC 2023

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The live demonstrations will include the following: OSFP 800G-FR4 DSP-based optical transceiver, highlighting 200G optical lanes OSFP 800G-DR8 linear pluggable optical (LPO) transceiver 200G PAM4 Mach-Zehnder modulated laser with differential driver from Semtech, highlighting advanced integrated InP laser technology PITTSBURGH, Oct. 02, 2023 (GLOBE NEWSWIRE) — Coherent Corp. (NYSE: COHR), a leader in optical communications components and subsystems, today announced that it will demonstrate next-generation transceivers and laser technology for 800G and 1.6T datacom transmission at ECOC 2023 in Glasgow, Scotland, October 2-4, stand #406. Such advances are critical to sustaining the accelerating growth of the cloud driven by artificial intelligence and machine learning (AI/ML). 800G-FR4 Optical Transceiver This live demonstration...

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