BioCentury | Aug 20, 2020
Regulation

Pandemic could give advantage to newly approved MS latecomer ofatumumab

...MS drug targeting B cells  By lauren martz, senior editor With FDA’s approval of Kesimpta ofatumumab...
...delay in the agency’s review. An IV version of the drug has been marketed as Arzerra...
...Novartis obtained rights to ofatumumab from GSK in all indications in 2015. Lauren Martz SubQ ofatumumab, subcutaneous ofatumumab Novartis...
BioCentury | Jun 4, 2020
Product Development

June 3 Quick Takes: Double double for BeiGene’s Brukinsa; plus Novartis, Merck-Vaxxas, Antibe, Mirum and more

...Novartis AG (NYSE:NVS; SIX:NOVN) said FDA has extended its review of a subcutaneous version of ofatumumab...
...it did not disclose a PDUFA date. An IV formulation of ofatumumab is approved as Arzerra...
...VEGFR-2 (KDR/Flk-1) - Vascular endothelial growth factor receptor 2 BioCentury Staff Brukinsa zanubrutinib (BGB-3111 ) SubQ ofatumumab, subcutaneous ofatumumab ATB-346 maralixibat...
BioCentury | Feb 28, 2020
Emerging Company Profile

Lava: better safety for bispecifics with γδ T cell engagement

...He was involved in the discovery and development of Genmab’s two approved cancer therapies, Arzerra ofatumumab...
BioCentury | Feb 26, 2020
Product Development

Regulatory Roundup: FDA reviewing GSK, Takeda applications for earlier lines of cancer treatment; plus Novartis, Halozyme-Genentech, MacroGenics, CSL, Lilly

...therapy Arzerra ofatumumab, Novartis AG (NYSE:NVS; SIX:NOVN) said FDA and EMA are reviewing applications for ofatumumab...
...mAb Ocrevus ocrelizumab Roche (SIX:ROG; OTCQX:RHHBY). Arzerra is approved to treat chronic lymphocytic leukemia (see “Ofatumumab...
...Poly(ADP-ribose) polymerase Elizabeth S. Eaton, Staff Writer Alunbrig (Brand), AP26113 (Compound #), brigatinib (Generic) Arzerra, ofatumumab (OMB157, humax-cd20, 2F2) Herceptin...
BioCentury | Jan 25, 2020
Product Development

A milestone year for Roche’s CNS gambit could kick off its plan for the decade

...There will be challenges. Ocrevus will see competition later this year from fellow anti-CD20 mAb ofatumumab...
BioCentury | Nov 1, 2019
Product Development

Novartis, Merck KGaA see opportunity in select pockets of MS patients

...CSE:GMAB; NASDAQ:GMAB) / Novartis AG (NYSE:NVS; SIX:NOVN) Ofatumumab...
...subcutaneous injection RRMS Ph III ASCLEPIOS I Ofatumumab...
...0.220 10.9% (A) Ph III ASCLEPIOS II Ofatumumab...
BioCentury | Oct 25, 2019
Product Development

Deciding factors in the shifting MS treatment landscape

...be correlated with disability progression. Ofatumumab’s subcutaneous edge Novartis plans to submit regulatory applications for ofatumumab...
...an emotional stress that comes with giving yourself an injection.” Novartis currently markets ofatumumab as Arzerra...
...RG1594 (Compound #), R1594 (Compound #), ocrelizumab (Generic), Anti-CD20 (Informal), Ocrevus (Other) Arzerra, ofatumumab (OMB157, humax-cd20, 2F2) ozanimod...
BioCentury | Sep 13, 2019
Clinical News

Novartis’ ofatumumab data comparable to Ocrevus in RRMS

...could soon have company in relapsing-remitting multiple sclerosis as Phase III data presented Friday for ofatumumab...
...to Arzerra in 2015, including MS indications, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). Erin McCallister, Senior Editor Arzerra, ofatumumab...
...2015, including MS indications, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). Erin McCallister, Senior Editor Arzerra, ofatumumab (OMB157, humax-cd20, 2F2) Ocrevus...
BioCentury | Aug 30, 2019
Clinical News

Aug. 30 Clinical Quick Takes: Pharnext falls on FDA request for second Phase III study, plus Genentech, Novartis and Seqirus

...Arzerra beats Aubagio in twin Phase III MS studies Novartis AG (NYSE:NVS; SIX:NOVN) said Arzerra ofatumumab...
...revaccinated against seasonal strains. Sandi Wong, Staff Writer and Paul Bonanos, Associate Editor Arzerra, ofatumumab (OMB157, humax-cd20, 2F2) Aubagio...
BioCentury | Jul 19, 2019
Financial News

Genmab’s plans after $500M NASDAQ debut

...Kempen. In addition to its two marketed products, Darzalex daratumumab for multiple myeloma and Arzerra ofatumumab...
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