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{ Category Archives: } Clinical Trials

BrainStorm to Showcase Alzheimer’s Disease Clinical Program in KOL Webinar

NEW YORK, July 1, 2020 /PRNewswire/ — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, will hold a Key Opinion Leader (KOL) webinar on the Company’s Alzheimer’s disease (AD) clinical program on Wednesday July 8th at 8.15am ET. The Company recently announced that it is expanding its clinical pipeline to develop NurOwn®…

BrainStorm to study stem cell treatment in Alzheimer’s patients

TEL AVIV (Reuters) – BrainStorm Cell Therapeutics Inc said on Wednesday it will begin a clinical trial of its experimental stem cell treatment in patients with Alzheimer’s disease. The U.S.-Israeli company is already conducting advanced trials of its treatment called NurOwn in patients with the neurodegenerative disease amyotrophic lateral sclerosis (ALS). MORE…

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

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……

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

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….

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

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

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

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…

Marketing COVID-19 is bad news for new drug launches. Which will suffer most?

The COVID-19 pandemic and the ensuing societal countermeasures are upending operations in many sectors—and biopharma isn’t immune. The current lockdown is not only hurting clinical trial enrollment but also delaying regulatory timelines for drugs nearing a decision. And with tried-and-true, in-person marketing techniques no longer allowed, new launches may also feel the pain—or hold off altogether. Consider Bristol…

IL-6 to the rescue? Sanofi, Regeneron barrel ahead into another pivotal effort testing Kevzara for Covid-19

Sanofi and Regeneron have hustled up a second pivotal trial for their IL-6 drug Kevzara as a potential therapy for severe cases of Covid-19. The partners swiftly assembled a study drawing patients from Italy, Spain, Germany, France, Canada and Russia, planning to sign up 300 patients in a Phase II to test a low and…

COVID-19 prompts Pfizer to stop enrollment in most studies

Pfizer has paused enrollment in many new and ongoing clinical trials in response to the COVID-19 pandemic, Reuters reports. The action sees Pfizer join Bristol Myers Squibb and Eli Lilly on the list of Big Pharma companies to revise their R&D plans in light of the novel SARS-CoV-2 coronavirus. Each company has responded slightly differently to…