FDA hits Novartis with unexpected 3-month delay on MS drug ofatumumab

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Share:Last week, Novartis was touting positive data showing its repurposed leukemia drug ofatumumab outpaced Sanofi’s Aubagio in a multiple sclerosis trial. Now, Novartis has revealed that the FDA, which was supposed to hand down a verdict on the drug this month, needs until September to make the decision. What happened? Novartis isn’t saying much. MORE… […]

DIABETIC RETINOPATHY TREATMENT MARKET 2020 TO WITNESS REMARKABLE GROWTH | LEADING PLAYERS ARE SIRNAOMICS INC., AERPIO, ALLERGAN, SIRNAOMICS, INC., AMPIO PHARMACEUTICALS INC., GLYCADIA, INC.

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Share:The primary sources employed while generating this Diabetic Retinopathy Treatment Market report include the industry experts from the industry comprising the management corporation, processing organizations, analytical service suppliers of the industry’s value chain. All primary sources are interviewed to accumulate the data and validate qualitative & quantitative information and conclude future prospects. Secondary research consists […]

Novartis announces new late-breaking ofatumumab data at EAN demonstrating robust efficacy and safety in the treatment of relapsing forms of multiple sclerosis (RMS)

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Share: Rapid and profound depletion of B-cells contributed to a halt in disease activity in RMS patients1 A post hoc analysis showed 47.0% and 87.8% of patients treated with ofatumumab achieved no evidence of disease activity (NEDA-3) within the first (0–12 months) and second year (12–24 months) of treatment, respectively1 Regulatory action for ofatumumab in […]

NurOwn May Curb Damaging Brain Inflammation in ALS Patients, Study Suggests

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Share:NurOwn, a cell-based therapy that protects and helps repair nerve cells, also may be able to curb the damaging brain inflammation that contributes to the progression of amyotrophic lateral sclerosis (ALS), recent findings suggest. Researchers believe this newly-found potential may extend the benefits of NurOwn in ALS patients and possibly among those with other conditions. […]

BCLI: THE COUNTDOWN TO PHASE 3 ALS DATA BEGINS…

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Share:BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI) is currently conducting a Phase 3 clinical trial of NurOwn® in patients with amyotrophic lateral sclerosis (ALS) (NCT03280056). A total of 200 patients were randomized 1:1 to receive NurOwn® or placebo in the randomized, double blind, placebo controlled, multi-dose trial. Cells were extracted once from each patient prior to treatment, […]

Infectious-disease doctors ask government to explain how it decides who gets Gilead’s remdesivir

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Share:Within a week of the Food and Drug Administration’s authorization of remdesivir as a COVID-19 treatment, clinicians are pushing the Trump administration to clarify how it is selecting which hospitals get access to the drug. Shares of Gilead Sciences Inc. GILD, +0.18%, which developed remdesivir, edged up 0.2% in Thursday trades and are up 19.4% in 2020. MORE…

Regeneron scales up manufacturing, eyes human tests of COVID-19 antibody cocktail in June

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Share:As COVID-19 ravages across the globe, Regeneron has responded with its own two-pronged approach against the disease. After early results in China showed inhibiting IL-6 could manage a potentially deadly immune overreaction in serious COVID-19 patients, Regeneron and partner Sanofi started a phase 2/3 trial of their rheumatoid arthritis therapy Kevzara, following a similar move […]

Compass raises $80M to take magic mushroom drug toward phase 3

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Share:Compass Pathways has raised $80 million to prepare its psilocybin therapy for phase 3 development. The London-based biotech is advancing the drug, the active ingredient in magic mushrooms, for use in people with treatment-resistant depression. Psilocybin was studied in the 1960s, but research ground to a halt over the following decades. Teams at academic centers including the […]