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{ Category Archives: } Biotech (General)

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

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 RMS…

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….

BCLI: THE COUNTDOWN TO PHASE 3 ALS DATA BEGINS…

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

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…

$5.5 billion stem cell initiative facing rocky road

Backers of a $5.5 billion stem cell research proposal in California today have once again missed a self-imposed, but critical deadline as they continue to struggle with securing enough signatures to place the measure on the November ballot. The campaign’s website this morning listed what is now its third deadline for gathering the signatures of…

DEA Removes CBD from Controlled Substances Act

On Monday, April 6, GW Pharmaceuticals revealed that the company had received notice from the U.S. Drug Enforcement Administration (“DEA”) stating that its drug Epidiolex was no longer subject to the requirements of the Controlled Substances Act (“CSA”). In a company release announcing the agency decision, GW CEO Justin Gover stated, “This notification from DEA fully establishes…

BrainStorm Awarded $1.5M Non-Dilutive Grant for 2020 by the Israel Innovation Authority

NEW YORK and PETACH TIKVAH, Israel, April 03, 2020 (GLOBE NEWSWIRE) — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that its wholly-owned subsidiary, Brainstorm Cell Therapeutics Ltd., has been awarded a new grant of approximately $1.5 million by the Israel Innovation Authority (IIA). The grant…

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…