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Phase I

Drug Development
Regeneron Launches Phase III COVID-19 Prevention Trial with Antibody Cocktail
Regeneron Pharmaceuticals, with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), is launching Phase III trials of REGN-COV2, the company’s two-antibody cocktail for the treatment and prevention of COVID-19.
July 6, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: July 3
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 3, 2020.
July 2, 2020
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1 min read
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BioSpace Editorial Staff
Drug Development
Clinical Catch-Up: June 29-July 3
Heading into the 4th of July holiday in the U.S., there was still a fair amount of clinical trial news last week. Here’s a look.
July 2, 2020
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7 min read
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Mark Terry
Drug Development
Pfizer and BioNTech’s COVID-19 Vaccine Shows Early Positive Data
Pfizer and BioNTech indicate that this data, along with preclinical data and additional data being generated, will be leveraged to choose a dose level and pick the best vaccine candidate out of the several being evaluated.
July 1, 2020
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4 min read
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Mark Terry
Drug Development
Inovio’s COVID-19 Vaccine Suggests Overall Immune Responses in Phase I Trial
INO-4800 is one of the experimental vaccines included in the U.S. government’s Operation Warp Speed that has a goal of having a vaccine available by January 2021.
June 30, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: July 1
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 1, 2020.
June 30, 2020
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3 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: June 29
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 29, 2020.
June 29, 2020
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2 min read
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BioSpace Editorial Staff
Drug Development
Clinical Catch-Up: June 22-26
It was a busy week for clinical trial updates. Here’s a look.
June 26, 2020
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7 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: June 26
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 26, 2020.
June 25, 2020
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3 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: June 24
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 24, 2020.
June 23, 2020
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4 min read
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BioSpace Editorial Staff
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PRESS RELEASES
Drug Development
SillaJen Submits CSR to the US FDA for REN026 Study in Patients with RCC
March 27, 2024
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5 min read
Drug Development
FSD Pharma Signs the Agreement With iNGENu CRO To Conduct a Clinical Study To Assess the Safety and Pharmacokinetics of Multiple Ascending Doses of Lucid-21-302 (Lucid-MS) in Healthy Adults
March 27, 2024
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7 min read
Drug Development
Immuneering Announces First Patient Dosed in its Phase 1/2a Trial of IMM-6-415 to Treat Advanced Solid Tumors with RAF or RAS Mutations
March 27, 2024
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6 min read
Drug Development
Cantargia Reports Progress Towards Start of DOD-Sponsored Clinical Trial of Nadunolimab in Leukemia
March 27, 2024
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4 min read
Drug Development
CinFina Pharma Announces FDA Clearance of Investigational New Drug Application and First Participants Dosed in Phase 1 Trial of CIN-110 for the Treatment of Obesity
March 26, 2024
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4 min read
Drug Development
MEI Pharma Reports Update from Clinical Study Evaluating Oral CDK9 Inhibitor Voruciclib in Combination with Venetoclax in Patients with Relapsed and Refractory Acute Myeloid Leukemia
March 26, 2024
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10 min read
Drug Development
TiumBio Submits CTA for Phase 1b Clinical Trial of TU7710, a Long-acting Recombinant Activated Factor VII, in Hemophilia A or B Patients
March 26, 2024
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3 min read
Drug Development
Opus Genetics Announces Completion of Dosing in First Cohort of Phase 1/2 Trial of Gene Therapy OPGx-LCA5 in Patients with Rare Inherited Retinal Disease LCA5
March 26, 2024
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3 min read
Drug Development
Tectonic Therapeutic Initiates Phase 1B Study for TX45 in Group 2 Pulmonary Hypertension in Patients with Preserved Ejection Fraction Heart Failure
March 26, 2024
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4 min read
Drug Development
Viking Therapeutics Announces Results from Phase 1 Clinical Trial of Oral Tablet Formulation of Dual GLP-1/GIP Receptor Agonist VK2735
March 26, 2024
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10 min read
Drug Development
Valneva Initiates Phase 1 Trial of Second-Generation Zika Vaccine Candidate
March 26, 2024
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8 min read
Drug Development
Stoke Therapeutics Announces Landmark New Data That Support the Potential for STK-001 to be the First Disease-Modifying Medicine for the Treatment of Patients with Dravet Syndrome
March 25, 2024
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15 min read
Drug Development
Brain Trust Bio Receives Approval for Patient Trials Targeting ALS and Other CNS Diseases with Continuous Intrathecal Drug Delivery Method
March 25, 2024
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2 min read
Business
Andelyn Biosciences and Grace Science, LLC Partner to Tech Transfer Phase I/II/III Manufacturing of a Suspension Process Adeno-Associated Virus (AAV) Gene Therapy for NGLY1 Deficiency
March 25, 2024
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3 min read
Drug Development
Rhythm Pharmaceuticals Announces First Patient Dosed in Phase 1 Trial Evaluating RM-718, a Weekly MC4R-specific Agonist
March 25, 2024
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8 min read
Drug Development
Astria Therapeutics Announces Positive Initial Proof-of-Concept Results from the ALPHA-STAR Phase 1b/2 Trial of STAR-0215 for HAE
March 25, 2024
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12 min read
Drug Development
Blue Lake Biotechnology Reports Positive Interim Clinical Data in Children for Its RSV Vaccine Candidate
March 21, 2024
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4 min read
Drug Development
Public Health Vaccines Announces Initiation of First Clinical Trial Evaluating Its Marburg Virus Vaccine
March 21, 2024
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2 min read
Drug Development
Theratechnologies Initiates Increased Dose Level in Phase 1 Clinical Trial of Sudocetaxel Zendusortide in Advanced Ovarian Cancer
March 21, 2024
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7 min read
Drug Development
Celularity Submits Request to U.S. FDA for Orphan Drug Designation for PDA-002 Asset Treating Facioscapulohumeral Muscular Dystrophy
March 20, 2024
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5 min read
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