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 […]
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 […]
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 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 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 […]
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 […]
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; […]
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® […]
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…
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… […]