Search Results for: covid-19
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Moderna Initiates Phase 3 Portion of Pivotal Trial for mRNA Respiratory Syncytial Virus Vaccine Candidate February 22, 2022
Moderna, Inc. recently announced the Data and Safety Monitoring Board (DSMB) for the RSV program has endorsed the start of...Veru Announces the Presentation of Updated Data From Phase 1b/2 Sabizabulin Study in Men With Metastatic Castration Resistant Prostate Cancer February 17, 2022
Veru Inc. recently announced that updated clinical data from the positive Phase 1b/2 study of sabizabulin in 80 men with...Revive Therapeutics Receives FDA Orphan Drug Designation February 16, 2022
Revive Therapeutics Ltd. recently announced the US FDA has granted Orphan Drug Designation (ODD) for Bucillamine for the prevention of...Pardes Biosciences Presents Interim Clinical Data From Ongoing PBI-0451 Phase 1 Trial February 14, 2022
Pardes Biosciences, Inc. recently announced interim clinical data from its ongoing PBI-0451 Phase 1 trial in healthy adult volunteers has...Cidara Therapeutics Announces FDA Acceptance of its Investigational New Drug Application for CD388 for Universal Prevention & Treatment of Influenza February 14, 2022
Cidara Therapeutics, Inc. recently announced the US FDA has accepted its Investigational New Drug (IND) application for its lead flu...IsoPlexis’ Immune Monitoring Helps Identify Early Factors of Long COVID in Cell Publication February 10, 2022
IsoPlexis Corporation recently announced the publication of a study in Cell, led by the Institute for Systems Biology and Seattle...CureVac Doses First Participant in Phase 1 Study With Multivalent Influenza Vaccine Candidate Based on Second-Generation mRNA Backbone Developed in Collaboration With GSK February 10, 2022
CureVac N.V. recently announced it has dosed the first participant in a Phase 1 study of its seasonal influenza second-generation...Xanadu Bio Obtains Licenses & Options to Novel Platform Technologies From Yale University to Develop Intranasal SARS CoV-2 mRNA Vaccine Booster February 8, 2022
Xanadu Bio recently announced a broad exclusive license agreement from Yale University for a next-generation polymeric nanoparticle delivery platform known as PACE. Additionally, the company has executed….
Ocuphire Completes Enrollment in MIRA-3 Pivotal Phase 3 Clinical Trial February 8, 2022
Ocuphire Pharma, Inc. recently announced it has completed enrollment in MIRA-3, the second Phase 3 FDA registration trial evaluating the safety and efficacy of Nyxol eye drops to reverse pharmacologically….
CDMO INNOVATION - How a Global CDMO Puts Innovation at the Forefront of its Business Strategy February 7, 2022
Kai Vogt, Senior Vice President Corporate Development/Legal/Corporate Compliance/IT, Vetter, explains how a global CDMO puts innovation at the forefront of its business strategy.
Valneva & Pfizer Report Further Positive Phase 2 Data for Lyme Disease Vaccine Candidate February 7, 2022
Valneva SE and Pfizer Inc. recently reported further positive Phase 2 data for their Lyme disease vaccine candidate, VLA15. Based on these new results….
Pardes Biosciences Announces FDA Clearance of IND Application for Oral Antiviral Drug Candidate for the Treatment & Prevention of SARS-CoV-2 Infections February 3, 2022
Pardes Biosciences, Inc. recently announced its Investigational New Drug (IND) application for PBI-0451 has been cleared by the US FDA....Arch Scientists Publish Data on the Mechanism of Action & Efficacy of Lead Drug Candidate LSALT Peptide in the Prevention of Acute Kidney Injury February 3, 2022
Arch Biopartners Inc. recently announced a scientific team led by Dr. Daniel Muruve at the University of Calgary, and their...Veru Enters Clinical Trial Collaboration & Supply Agreement With Eli Lilly & Company February 1, 2022
Veru Inc. recently announced it has entered into a clinical trial collaboration and supply agreement with Eli Lilly and Company. The objective of the collaboration is to evaluate the efficacy and safety of….
Celsion Corporation Advances Proof of Concept to Non-human Primate Challenge Study Against SARS-CoV-2 With In-Process Vaccine Candidate January 31, 2022
Celsion Corporation recently announced it has engaged BIOQUAL, Inc., a preclinical testing contract research organization, to conduct a non-human primate (NHP) challenge study with Celsion’s DNA-based approach for….
Yamo Pharmaceuticals Announces Enrollment of First Patient in Phase 2 Study of L1-79 in Autism Spectrum Disorder January 27, 2022
Yamo Pharmaceuticals recently announced the first patient has been treated in a Phase 2 study of L1-79 in adolescents and...PDS Biotech Announces Preclinical Data for PDS0202 Universal Influenza Vaccine January 27, 2022
PDS Biotechnology Corporation recently announced preclinical data for its universal flu vaccine, which was shown to be effective against….
BetterLife Receives FDA Response On Its Pre-IND Application For Major Depressive Disorder (MDD) Treatment With BETR-001 January 20, 2022
BetterLife Pharma Inc. recently announced it has received a written response from the US FDA to its pre-investigational new drug...BetterLife Obtains Positive In Vivo Oral Bioavailability, Food Effect & Pharmacokinetics Data for BETR-001 January 18, 2022
BetterLife Pharma Inc. recently announced it has obtained positive results from an in vivo oral bioavailability and food-effect pharmacokinetic (PK)...SPECIAL FEATURE - Analytical Testing Trends in 2022 January 17, 2022
Contributor Cindy H. Dubin reports on the innovative technologies and techniques that several leading outsourcing providers currently offer for both small and large molecules.