Psilera Raises $2.5 Million with Oversubscribed Series Seed from...
Psilera will utilize funding to submit an investigational new drug (IND) for transdermal delivery of DMT and establish clinical proof-of-concept, while bolstering its scientific and clinical team to...(PRWeb July 01, 2021)Read the full story at https://www.prweb.com/releases/psilera_raises_2_5_million_with_oversubscribed_series_seed_from_leading_institutional_investors_to_accelerate_clinical_pipeline_focused_on_dmt/prweb18046014.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - July 1, 2021 Category: Pharmaceuticals Source Type: news
Morrisville biotech raises $43.5M, earns key FDA status for polio-based cancer treatment
The company, which spun out of Duke University, has received investigational new drug status for its modified polio virus that targets cancer cells. (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 21, 2021 Category: Biotechnology Authors: Sonia Waraich Source Type: news
Morrisville biotech raises $43.5M, earns key FDA status for polio-based cancer treatment
The company, which spun out of Duke University, has received investigational new drug status for its modified polio virus that targets cancer cells. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - April 21, 2021 Category: Pharmaceuticals Authors: Sonia Waraich Source Type: news
MTTI wins patent for PET necrosis imaging agent
Biopharmaceutical company Molecular Targeting Technologies (MTTI) has receive...Read more on AuntMinnie.comRelated Reading:
Isotopia to supply MTTI with Lu-177
New radiotracer for neuroendocrine tumors appears safe
FDA grants EBTATE investigational new drug status
Molecular Targeting licenses agent from MCW
Molecular Targeting licenses dyes from MGH (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - April 13, 2021 Category: Radiology Source Type: news
Mineralys Therapeutics Closes $40 Million Series A Funding
Financing Co-led by HBM Healthcare Investments and Samsara BioCapital
Food and Drug Administration Accepts Investigational New Drug Application for MLS-101 and Advances to Phase 2 Proof-of-Concept Clinical Trial
Company Announces Jon Congleton as Chi... Biopharmaceuticals, Cardiology, Venture Capital, Personnel Mineralys Therapeutics, aldosterone synthase, hypertension (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 6, 2021 Category: Pharmaceuticals Source Type: news
FDA grants EBTATE investigational new drug status
Biotechnology developer Molecular Targeting Technologies has received investigationa...Read more on AuntMinnie.comRelated Reading:
Molecular Targeting licenses agent from MCW
Molecular Targeting licenses dyes from MGH
Molecular Targeting, Bexion join forces (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - March 4, 2021 Category: Radiology Source Type: news
Division of Oncology 2 (DO2)
The Division of Oncology 2 (DO2) regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs) and Biologic Licensing Applications (BLAs) for the following therapeutic areas: gastrointestinal, lung, and head and neck cancers; neuro-oncology, rare cancers, pediatric (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 28, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine
FDA releases a new draft guidance on investigational new drug (IND) submissions for individualized ASO drug products. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 4, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Pittsburgh-based LyGenesis receives FDA clearance for new drug application
Pittsburgh-based LyGenesis Inc. received U.S. Food and Drug Administration clearance for its Investigational New Drug application, according to a news release.
LyGenesis was founded to develop cell therapies to enable organ regeneration. With this new application, LyGenesis will move forward with a Phase 2a study on the safety, tolerance and efficacy of its novel cell therapy for end stage liver disease, according to the release.
LyGenesis also recent ly finalized $11 million in private financing… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - December 31, 2020 Category: American Health Authors: Julia Mericle Source Type: news
BAT progresses COVID-19 candidate vaccine into Phase I human clinical trials
(R&D at British American Tobacco) BAT's US Bio-tech arm, Kentucky BioProcessing (KBP) today announced plans to commence a Phase I first-time-in-human study of its COVID-19 vaccine candidate following approval of its Investigational New Drug application by the US Food and Drug Administration (FDA). Enrolment for the study is expected to begin shortly. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - December 16, 2020 Category: International Medicine & Public Health Source Type: news
Rhizen Pharmaceuticals gets USFDA approval for phase one clinical trials for Covid-19 drug
The Switzerland-based firm, which is a clinical-stage oncology-focussed biopharmaceutical company, has received approval for its investigational new drug (IND) application from the US Food and Drug Administration (FDA) to study its oral Dihydroorotate dehydrogenase (DHOHD) inhibitor for SARS-CoV-2 infection, Rhizen Pharmaceuticals S A said in a statement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 2, 2020 Category: Pharmaceuticals Source Type: news
COVID-19 vaccine candidate tested preclinically at UAB nears first clinical test in people
(University of Alabama at Birmingham) A COVID-19 vaccine candidate that underwent extensive preclinical testing at the University of Alabama at Birmingham this spring and summer is poised for clinical testing to begin in December. Maryland-based Altimmune Inc., a clinical stage biopharmaceutical company, has submitted an Investigational New Drug, or IND, application to the United States Food and Drug Administration to commence a Phase 1 clinical study of its single-dose intranasal COVID-19 vaccine candidate, AdCOVID. (Source: EurekAlert! - Infectious and Emerging Diseases)
Source: EurekAlert! - Infectious and Emerging Diseases - November 25, 2020 Category: Infectious Diseases Source Type: news
Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND
This guidance is intended to assist clinical investigators, sponsors, sponsor-investigators, and institutional review boards (IRBs) in determining whether research studies involving human subjects must be conducted under an investigational new drug application (IND). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - November 18, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Zydus Cadila files investigational new drug application for COVID-19 treatment
Drug firm Zydus Cadila on Tuesday said it has filed the investigational new drug (IND) application for ZYIL1, positioned for management of critically ill COVID-19 patients. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 3, 2020 Category: Pharmaceuticals Source Type: news
Arca Biopharma files application for Covid-19 drug treatment
Westminster-based biotech company Arca Biopharma has submitted an Investigational New Drug application for Covid-19.
The application was filed under the Coronavirus Treatment Acceleration Program. The application will evaluate the use of one of Arca Biopharma's drugs, AB201, as a treatment for patients hospitalized with Covid-19.
The 13-employee Arca Biopharma typically focuses on genetically targeted therapie s for cardiovascular diseases. AB201 is believed to be effective with RNA viruses, which… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - September 22, 2020 Category: Pharmaceuticals Authors: Jensen Werley Source Type: news
