Westminster-based Arca Biopharma is developing a treatment for Covid-19
Arca Biopharma is in the process of developing a Covid-19 treatment.
The Westminster-based biotech company, which focuses on genetically targeted therapies for cardiovascular diseases, plans to submit its Investigational New Drug application with the U.S. Food and Drug Administration in September. The application is for AB201, a drug that has the potential to work as a treatment for severe Covid-19 patients, said Derek Cole, head of investor relations for the company.
AB201 is a drug that Arca… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - August 28, 2020 Category: Pharmaceuticals Authors: Jensen Werley Source Type: news
Westminster-based Arca Biopharma is developing a treatment for Covid-19
Arca Biopharma is in the process of developing a Covid-19 treatment.
The Westminster-based biotech company, which focuses on genetically targeted therapies for cardiovascular diseases, plans to submit its Investigational New Drug application with the U.S. Food and Drug Administration in September. The application is for AB201, a drug that has the potential to work as a treatment for severe Covid-19 patients, said Derek Cole, head of investor relations for the company.
AB201 is a drug that Arca… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - August 28, 2020 Category: Biotechnology Authors: Jensen Werley Source Type: news
Ensuring the Safety of Patients in Clinical Trials Studying Investigational New Drugs to Prevent or Treat COVID-19
FDA has a critical role in ensuring the safety of patients in clinical trials studying drugs for the prevention or treatment of COVID-19 that require an investigational new drug (IND) application. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 14, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Merck initiates first clinical trial of TLR7 and 8 inhibitor as a potential treatment for severe symptoms of COVID-19 infection
Merck, a leading science and technology company, announced the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug application (IND) for M5049 for the treatment of patients with Covid-19 pneumonia. Merck will initiate a Phase II randomized, controlled clinical study evaluating the safety and efficacy of M5049 in this patient population. (Source: World Pharma News)
Source: World Pharma News - July 3, 2020 Category: Pharmaceuticals Tags: Featured Merck Group Business and Industry Source Type: news
Citius Receives FDA Response on Pre-Investigational New Drug (PIND) Application for its Induced Mesenchymal Stem Cells (iMSCs) to Treat Acute Respiratory Distress Syndrome (ARDS) in Patients with COVID-19
FDA provides very specific guidelines to study iPSC-derived MSCs
Company intends to submit an IND application for its iMSC therapy for patients with ARDS associated with COVID-19
CRANFORD, N.J., June 26, 2020 -- (Healthcare Sales & Marketing Network)... Biopharmaceuticals, FDA Citius Pharmaceuticals, Induced Mesenchymal Stem Cells, ARDS (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 26, 2020 Category: Pharmaceuticals Source Type: news
FDA approves Octapharma USA IND application for severe COVID-19 patients
(Yankee Public Relations) The US Food and Drug Administration (FDA) has approved the investigational new drug (IND) application submitted by Octapharma USA for a phase three clinical trial on the efficacy and safety of Octagam 10% [Immune Globulin Intravenous (Human)] therapy in COVID-19 patients with severe disease progression. (Source: EurekAlert! - Infectious and Emerging Diseases)
Source: EurekAlert! - Infectious and Emerging Diseases - May 20, 2020 Category: Infectious Diseases Source Type: news
CPG Sec. 444.100 Recovery of Investigational New Drugs from Clinical Investigators
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 6, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Alpha Cognition, Inc. Receives FDA/PMDA Regulatory Guidance for Alpha-1062 Alzheimer's Therapy
VANCOUVER, British Columbia, April 30, 2020 -- (Healthcare Sales & Marketing Network) -- Alpha Cognition Inc. (ACI) today announced that in a pre-Investigational New Drug (Pre-IND) meeting, the U.S. Food and Drug Administration (USFDA) agreed upon a clini... Biopharmaceuticals, Neurology, FDA Alpha Cognition, Alzheimer's Disease, amyotrophic lateral sclerosis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 30, 2020 Category: Pharmaceuticals Source Type: news
Two area women are among the first to donate blood plasma in an emergency clinical trial to help treat severely ill patients battling COVID-19
The project is part of the National COVID-19 Convalescent Plasma Project, which the Food and Drug Administration has approved as an Emergency Investigational New Drug (EIND). (Source: SUNY Upstate Medical)
Source: SUNY Upstate Medical - April 18, 2020 Category: Universities & Medical Training Tags: News Coronavirus Source Type: news
Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application
Clinical / Medical (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 16, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Vaccines, Antibodies and Drug Libraries. The Possible COVID-19 Treatments Researchers Are Excited About
In early April, about four months after a new, highly infectious coronavirus was first identified in China, an international group of scientists reported encouraging results from a study of an experimental drug for treating the viral disease known as COVID-19.
It was a small study, reported in the New England Journal of Medicine, but showed that remdesivir, an unapproved drug that was originally developed to fight Ebola, helped 68% of patients with severe breathing problems due to COVID-19 to improve; 60% of those who relied on a ventilator to breathe and took the drug were able to wean themselves off the machines after 18...
Source: TIME: Health - April 14, 2020 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized COVID-19 Source Type: news
FDA Accepts IND for NK Cell Therapy CYNK-001 to Treat Patients with COVID-19
The FDA cleared the investigational new drug (IND) application for the use of CYNK-001 in adults with COVID-19. (Source: CancerNetwork)
Source: CancerNetwork - April 3, 2020 Category: Cancer & Oncology Authors: Hannah Slater Source Type: news
The FDA is facilitating access to convalescent plasma collected from recovered COVID-19 patients
The FDA is facilitating access to convalescent plasma, antibody-rich blood products that are taken from blood donated by people who have recovered from the COVID-19 virus, that could shorten the length, or lessen the severity, of the illness. The agency will be using multiple pathways to support these efforts and has posted information for investigators wishing to study convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections through the process of single patient emergency Investigational New Drug Applications for individual patients. (Source: World Pharma News)
Source: World Pharma News - March 25, 2020 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news
Through the emergency Investigational New Drug (eIND) application process, FDA is facilitating the use of #COVID19 convalescent plasma as an investigational treatment for individual #COVID19 patients with serious or immediately life-threatening #COVID19. https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds …
Through the emergency Investigational New Drug (eIND) application process, FDA is facilitating the use of #COVID19 convalescent plasma as an investigational treatment for individual #COVID19 patients with serious or immediately life-threatening #COVID19. https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 24, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news
