Atrium Health, formerly the Carolinas HealthCare System, has been active on multiple fronts battling COVID-19. The nonprofit network of over 40 hospitals and over 900 care locations in North Carolina, South Carolina, and Georgia have also emerged as a leading player...
Gilead
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Filgotinib Demonstrates Durable Efficacy and Consistent Safety Profile Through 52 Weeks in Clinical Trials
Gilead Sciences, Inc. (Nasdaq: GILD) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted Gilead K.K. (Tokyo, Japan) regulatory approval of Jyseleca (filgotinib 200 mg and 100 mg tablets), a...
Gilead Closer to Spending $20b to Acquire Immunomedics
Gilead is purportedly going to spend $20 billion to acquire Immunomedics, reports the Wall Street Journal. With an investigational product in the late-stage producing positive data last month, the company just benefited from an U.S. Food and Drug Administration...
NIH to Conduct Preclinical Studies of GS-441524, Gilead’s Possibly Superior Antiviral Thanks to Public Citizen Pressure
Early in August, TrialSite highlighted that consumer advocacy organizations such as Public Citizen continue to pester federal research agencies to pressure Gilead to develop a similar drug to remdesivir known as GS-441524. Gilead’s remdesivir patent lasts longer, or...
Gilead Submitted NDA While U.S. is Being Charged 50X What India Pays for Remdesivir in Pandemic Conditions
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Veklury® (remdesivir), an investigational antiviral for the treatment of patients with COVID-19. Veklury is...
Is Gilead & The Government Inhibiting Access to ‘Superior’ COVID-19 Treatment?
The consumer advocate organizations such as Public Citizen recently sent a letter to the CEO of biopharmaceutical company Gilead, as well as the nation’s top regulators urging strong collaboration to develop a drug similar to the well-known Remdesivir. While the...
The Global Need for Open and Equitable Access to Remdesivir
On 1 May 2020, the FDA issued emergency use authorization (EUA) for remdesivir to treat hospitalized patients with severe covid-19. The EUA was based on an analysis of preliminary data from the Adaptive covid-19 Treatment Trial (ACTT), a placebo-controlled randomized...
ICER Comes up with Remdesivir Treatment Cost: $4,460 per Course of Treatment
An influential organization in the pricing of drugs in America, the Institute for Clinical and Economic Review (ICER), recently revealed the results of an initial analysis used to inform the debate around remdesivir pricing—an important matter given the recent...
Gilead/Remdesivir Update: Politics & Methodology Issues Cloud Research
As reported by StatNews on May 5, Gilead announced April 29th that remdesivir was found to speed recovery from COVID-19, but effectively changing the study hypotheses midstream leads to doubt about the results. Why, it was asked, did the study’s main goal change only...
Remdesivir COVID-19 Study Evaluation Metrics Changed Last Minute to Make Standard of Care Declaration by NIAID
First, we preface in this writing that it is a good thing that Remdesivir produced positive results. The TrialSite News research team has written many a story sharing some promising observational snippets about the anti-viral drug that was originally developed to...
Multi-Site Chinese Study of Remdesivir Fails: What is the Whole Story?
For the average reader, the conflicting news in regards to Gilead’s remdesivir is rather perplexing. TrialSite News actually has been monitoring data feeds centering on this anti-viral, originally developed for Ebola, since the advent of the crisis. Early...
Gilead Reporting on Positive Signals in Regards to Remdesivir targeting COVID-19 Trials
Gilead is feeling bullish as they are aware of positive data emerging from the National Institute of Allergy and Infectious Diseases’ (NIAID) study of the investigational antiviral remdesivir and infectious diseases’ (NIAID) study of the investigational antiviral...
Odd Slip Up: WHO Inadvertently Shares Clinical Trial Data Revealing Remdesivir Not Effective
Remdesivir, a much-touted experimental drug currently under investigation for the novel coronavirus, failed its first randomized clinical trial, according to draft documents published inadvertently by the World Health Organization (WHO). Apparently, the antiviral drug...
Stanford Shatters Record for Study Start-up For NIH COVID-19 Study Investigating Remdesivir
Stanford University moved quickly to ramp up the Gilead remdesivir global clinical trial—and enrolled 30 participants quickly thereafter for the adaptive clinical trial. And the elite San Francisco Bay Area academic medical center recently began enrolling patients in...
Bay Area Women Severely Ill with COVID-19 Participates in Stanford-based Clinical Trial Assessing Remdesivir and Improves Within Days
A Bay Area woman in her 60s and her husband contracted COVID-19 on a cruise ship headed to Egypt—they couldn’t complete their trip as their conditions worsened and they believed they might have the novel coronavirus. Upon returning to Palo Alto, CA on March 3, the...
University Hospitals in Cleveland Secures COVID-19 Remdesivir Clinical Trial Participation
University Hospitals in Cleveland, Ohio has secured participation in two clinical trials that will offer the investigational antiviral drug remdesivir (Gilead) to hospitalized patients with pneumonia due to COVID-19. One clinical trial will focus on COVID-19 patients...
How Gilead’s Newest Takeover Deal Will Bolster Its Cancer Strategy
Gilead Sciences (GILD) will buy cancer-focused player Forty Seven (FTSV) for $4.9 billion, the biotech company said Monday, sending FTSV stock rocketing. The deal was rumored last week and allows Gilead to harness Forty Seven's cancer...
Rockefeller University Licenses Promising Early-Stage HIV Antibodies to Gilead
The Rockefeller University (Rockefeller) has entered into a licensing agreement with Gilead to advance the development of investigational drugs based on broadly neutralizing antibodies discovered at the university. In recent early-stage research, two of the...
Chinese Authorities Approve Clinical Trial Testing Remdesivir on Patients with 2019-nCoV
Chinese authorities, including the Chinese Ministry of Science and Technology (MOST) as well as the National Health Commission and the National Medical Products Administration, have approved an antiviral drug called Remdesivir for clinical trials in the battle against...
Does Kyverna Therapeutics Gilead Financing Introduce Disruptive Cell Therapy Platform to Attack Autoimmune Disease?
Engineering a new class of cell therapy for autoimmune diseases, Kyverna Therapeutics (Kyverna) announced it raised $25 million in a Series A financing from a group of investors, including prominent biotech Gilead. Proceeds will be used to advance their therapeutic...