dshade
4 years ago
good news today - Novartis Says Asciminib Showed Superior MMR Rate to Bosulif in Leukemia Trial
December 08 2020 - 11:00AM
Dow Jones News
By Michael Dabaie
Novartis AG said asciminib showed superior major molecular response rate to Bosulif in a chronic myeloid leukemia trial.
The company said results from a Phase III study demonstrate that at 24 weeks, asciminib nearly doubled the major molecular response rate compared with Bosulif in patients resistant to, or intolerant of, at least two prior tyrosine kinase inhibitor therapies.
The data were presented at a late-breaking abstracts session during the 62nd American Society of Hematology Annual Meeting & Exposition, Novartis said.
In the trial, 233 patients were randomized to receive asciminib 40 mg twice daily or Bosulif 500 mg once a day.
Novartis said the U.S. Food and Drug Administration granted Fast Track designation for asciminib. The company said it plans submission to U.S. and EU health authorities in the first half of 2021.
DewDiligence
5 years ago
NVS concedes Beovu has new safety issue:
https://www.brolucizumab.info/ Novartis has now completed its review of these post-marketing safety case reports… Based on internal and SRC assessment, it was concluded that there is a confirmed safety signal of rare adverse events of “retinal vasculitis and/or retinal vascular occlusion with or without presence of intraocular inflammation that may result in severe vision loss.”
Based on this review, Novartis has initiated a safety information update to Beovu prescribing information worldwide. Currently approved prescribing information includes intraocular inflammations, visual acuity decrease (including blindness) and retinal artery occlusion as separate terms. We will work with regulatory authorities to finalize the prescribing information update.
In addition, we are working with our data monitoring committees and informing investigators of ongoing clinical trials. Novartis-sponsored studies will be amended so that protocols, Informed Consent Forms and Investigator Brochures reflect this new safety information. Investigators are also being informed to re-consent patients.
whytestocks
5 years ago
News: $NVS ROSEN, A LEADING GLOBAL LAW FIRM, Continues to Investigate Securities Claims Against Novartis AG - NVS
NEW YORK, Nov. 09, 2019 (GLOBE NEWSWIRE) -- Rosen Law Firm, a global investor rights law firm, continues to investigate potential securities claims on behalf of shareholders of Novartis AG (NYSE: NVS) resulting from allegations that Novartis may have issued materially misleading business in...
Read the whole news NVS - ROSEN, A LEADING GLOBAL LAW FIRM, Continues to Investigate Securities Claims Against Novartis AG - NVS