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Showing 1196 results
May 2018
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Key ReleaseSandoz receives complete response letter from the US FDA for proposed biosimilar rituximabHolzkirchen, May 2, 2018 - Sandoz, a Novartis division, announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics Licensing…
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Media ReleaseKymriah® (tisagenlecleucel), first-in-class CAR-T therapy from Novartis, receives second FDA approval to treat appropriate r/r patients with large B-cell lymphomaKymriah demonstrated an overall response rate of 50%, with median duration of response not yet reached at the time of data cut-off, indicating sustainability of response[1] Kymriah is the only…
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Key ReleaseNovartis provides update on proposed acquisition of AveXisBasel, May 1, 2018 - Novartis AG (NYSE: NVS) ("Novartis") today announced that the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the "HSR Act") applicable to…
April 2018
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Media ReleaseNovartis receives FDA approval of Tafinlar® + Mekinist® for adjuvant treatment of BRAF V600-mutant melanomaTafinlar + Mekinist is the first oral targeted adjuvant combination therapy to demonstrate significant clinical benefit in patients with a BRAF V600 mutation, following complete surgical resection…
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Media ReleaseNew Novartis Phase III data for brolucizumab demonstrate reliability of 12-week treatment intervalPatients identified for brolucizumab 12-week treatment interval in Phase III HAWK and HARRIER trials had an 87% and 83% probability of successfully continuing on a 12-week interval through week…
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Media ReleaseAveXis Announces First Patient Dosed in Phase 3 Trial of AVXS-101 in Pre-Symptomatic SMA Types 1, 2 and 3CHICAGO, April 25, 2018 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS), a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening…
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Media ReleaseNovartis launches FocalView app, providing opportunity for patients to participate in ophthalmology clinical trials from homeFocalView is a first-of-its-kind app designed to modernize ophthalmic clinical trials, making them more accessible and flexible Using patients' self-recorded measurements, FocalView aims to…
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Media ReleaseAveXis Presents Initial Data from Pivotal U.S. Trial for SMA Type 1 and 24-Month Follow-Up Data from Phase 1 Trial of AVXS-101 in SMA Type 1 at the Annual Meeting of the American Academy of Neurology– A mean increase in CHOP-INTEND of 17.3 was observed at three months post gene therapy in SMA Type 1 U.S. pivotal trial – – All patients in the therapeutic dose cohort in the Phase 1 trial…
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Media ReleaseNew Novartis analyses at AAN show siponimod's efficacy on disability and cognition in secondary progressive MS patientsAnalyses of the EXPAND study showed that siponimod (BAF312) reduced the risk of disability progression largely disassociated from relapses in patients with secondary progressive multiple sclerosis…
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Media ReleaseAveXis to Present AVXS-101 Data at the Annual Meeting of the American Academy of NeurologyIncludes Initial Data from SMA Type 1 Pivotal Trial (STR1VE) and 24-Month Follow-Up Data from Phase 1 Trial CHICAGO, April 19, 2018 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS), a…
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Key ReleaseNovartis appoints John Tsai Head of Global Drug Development and Chief Medical OfficerBasel, April 19, 2018 - Novartis announced today the appointment of John Tsai, M.D. as Head of Global Drug Development (GDD) and Chief Medical Officer. Dr. Tsai will join Novartis on May 1, 2018, and…
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Media ReleaseNovartis delivered a strong first quarter and acted to become a more focused medicines companyNet sales grew 4% (cc[1], +10% USD) mainly driven by: Entresto grew to USD 200 million, +126% (cc) driven by increased uptake world wide Cosentyx was USD 580 million, +35% (cc) with strong…
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