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May 2018
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Press Release
AveXis Reports First Quarter 2018 Financial and Operating Results
-- Significant progress across operating functions including licensing, clinical trials and regulatory interactions -- -- AVXS-101 pre-BLA meeting with FDA is scheduled to be… -
Key Release
Sandoz receives complete response letter from the US FDA for proposed biosimilar rituximab
Holzkirchen, 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… -
Press Release
Kymriah® (tisagenlecleucel), first-in-class CAR-T therapy from Novartis, receives second FDA approval to treat appropriate r/r patients with large B-cell lymphoma
Kymriah 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… -
Key Release
Novartis provides update on proposed acquisition of AveXis
Basel, 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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Press Release
Novartis receives FDA approval of Tafinlar® + Mekinist® for adjuvant treatment of BRAF V600-mutant melanoma
Tafinlar + 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… -
Press Release
New Novartis Phase III data for brolucizumab demonstrate reliability of 12-week treatment interval
Patients 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… -
Press Release
AveXis Announces First Patient Dosed in Phase 3 Trial of AVXS-101 in Pre-Symptomatic SMA Types 1, 2 and 3
CHICAGO, 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… -
Press Release
Novartis launches FocalView app, providing opportunity for patients to participate in ophthalmology clinical trials from home
FocalView 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… -
Press Release
AveXis 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… -
Press Release
New Novartis analyses at AAN show siponimod's efficacy on disability and cognition in secondary progressive MS patients
Analyses 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… -
Press Release
AveXis to Present AVXS-101 Data at the Annual Meeting of the American Academy of Neurology
Includes 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… -
Key Release
Novartis appoints John Tsai Head of Global Drug Development and Chief Medical Officer
Basel, 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…