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{ Category Archives: } Clinical Trials

Bay Area woman lobbying for passage of ALS bill

When Jamie Berry noticed a slight limp in her right foot in late May, she didn’t think much of it. Berry tends horses and drives tractors on the 80-acre ranch her family leases in San Jose’s Almaden Valley, and she was also busy with an 8-year-old daughter, five dogs and an excavation business she runs…

Japan Grants Patent to Brainstorm Covering Technique for NurOwn

The Japan Patent Office has granted a patent to Brainstorm Cell Therapeutics covering the proprietary technique that generates the company’s cell-based therapy NurOwn from mesenchymal stem cells (MSCs). Through this technique, researchers can harness MSCs directly from a patient and mature them into cells that produce high levels of neurotrophic factors, which are compounds that…

Novartis presents data at ACTRIMS-ECTRIMS for Kesimpta® (ofatumumab) in newly diagnosed treatment-naïve adults with relapsing multiple sclerosis

New post hoc data from Phase III ASCLEPIOS trials showed newly diagnosed, treatment-naïve patients experienced reductions in annualized relapse rates, MRI lesion activity and reductions in time to disability worsening when treated with Kesimpta vs teriflunomide(1) Additional safety data in over 1,800 patients who continued Kesimpta treatment or switched therapy from previous studies reinforce the…

Trump Administration’s Operation Warp Speed Accelerates AstraZeneca COVID-19 Vaccine to be Available Beginning in October

Responding to President Trump’s call to develop 300 million doses of SARS-CoV-2 vaccine by January under Operation Warp Speed, the U.S. Department of Health and Human Services (HHS) and AstraZeneca are collaborating to make available at least 300 million doses of a coronavirus vaccine called AZD1222, with the first doses delivered as early as October…

NOVARTIS IMMUNO-ONCOLOGY DRUG CANDIDATE FAILS SKIN CANCER TRIAL

ZURICH (Reuters) – Swiss drugmaker Novartis said on Saturday that its investigational spartalizumab immuno-oncology drug mixed with the approved medicines Tafinlar and Mekinist failed in a late-stage trial for a type of advanced skin cancer. The drug did not improve progression-free survival in previously untreated patients with BRAF V600 mutation-positive cutaneous melanoma, compared to Tafinlar…

Celularity announces the activation of first California Clinical Trial Site following CIRM Grant Award to Advance Treatments for COVID-19

FLORHAM PARK, N.J., Aug. 5, 2020 /PRNewswire/ — Celularity today announced that it has been awarded a $750,000 COVID-19 Project grant by the California Institute for Regenerative Medicine (CIRM), one of the three clinical awards targeting the coronavirus. This grant will support California Institutions participating in the Phase I/II clinical trial of human placental hematopoietic stem cell derived natural killer (NK)…

The CRA’s Guide to Monitoring Clinical Research

The guide that has trained thousands of CRAs is updated! The CRA’s Guide to Monitoring Clinical Research: A definitive resource for building mastery and complying with official regulations and guidelines. Use this guide to advance your career — plus ensure your trials follow critical requirements from FDA, ICH and NIH. In order to play a…

Imvax Inc. Raises $112 Million in Series C Financing

Imvax Inc. Raises $112 Million in Series C Financing Funds to support Phase 2 Clinical Development of IGV-001 for treatment of Glioblastoma multiforme,  Phase 1 research into additional solid tumor indications and build out of the operational capabilities PHILADELPHIA, JULY 16, 2020 – Imvax, Inc., a clinical-stage biotechnology company whose groundbreaking personalized neo-antigen immunotherapy, IGV-001, is being…

Brainstorm Cell Therapeutics : Hosting KOL Webinar to Discuss NurOwn® Phase 2 Alzheimer’s Disease Program

NEW YORK, July 8, 2020 /PRNewswire/ — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, is hosting a Key Opinion Leader (KOL) webinar on its Alzheimer’s Disease (AD) program today at 8:15 AM Eastern Time. The Company recently announced that it is expanding its clinical pipeline to develop NurOwn® and begin…

200 ALS Patients Finish Dosing in Phase 3 Trial of NurOwn Cell Therapy

Patient dosing has finished in the pivotal Phase 3 trial assessing the safety and efficacy of repeat administrations of NurOwn, a cell-based therapy for people with amyotrophic lateral sclerosis (ALS), BrainStorm Cell Therapeutics, the therapy’s developer, announced. The Phase 3 trial (NCT03280056), which enrolled about 200 participants, is underway at six U.S. sites: the University of California, Irvine; Cedars-Sinai Medical Center; California Pacific Medical Center; Massachusetts General Hospital;…