Clinical Trials
Moleculin obtains UK MHRA authorisation for Phase Ia trial of Covid-19 drug
Moleculin Biotech has obtained the UK Medicines and Healthcare Products Regulatory Agency (MHRA) authorisation to initiate a Phase Ia clinical trial of its drug, WP1122, in the country to treat Covid-19.
An inhibitor of metabolism/glycosylation, WP1122 is a prodrug of...
Clinical Trials
Symbiosis Pharmaceutical Services Starts Producing Sevuparin for Modus Future Clinical Development in Sepsis/septic shock
Modus Therapeutics Holding AB , a company developing innovative treatments for patients with high unmet medical needs, announces that Symbiosis Pharmaceutical Services Ltd (“Symbiosis”), a specialist contract manufacturing organization (CMO), has started manufacturing sevuparin drug product securing the supply...
Clinical Trials
Brii Bio Initiates Submission of EUA Filing to U.S. FDA for BRII-196/BRII-198, , its Monoclonal Antibody Combination Therapy for Non-Hospitalized COVID-19 Patients
Brii Biosciences Limited a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, announced the filing of an emergency use authorization (EUA) application for its investigational SARS-CoV-2 (virus that causes COVID-19)...
Clinical Trials
Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years
Pfizer Inc. and BioNTech SE announced results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 µg administered 21...
Clinical Trials
Valneva Completes Recruitment of Elderly Participants in Phase 3 Trial of its Inactivated COVID-19 Vaccine
Valneva SE, a specialty vaccine company, announced that it has completed recruitment of the initial cohort of elderly participants in Valneva’s Phase 3 trial, VLA2001-304, of its inactivated COVID-19 vaccine candidate, VLA2001.
300 volunteers aged 56 years and older have...
Clinical Trials
RedHill Biopharma Reports Top-Line Data from Opaganib Phase 2/3 Study in Severe COVID-19 Patients
RedHill Biopharma Ltd. , a specialty biopharmaceutical company, announced preliminary top-line data from the 475-patient global Phase 2/3 study with opaganib (ABC294640) in hospitalized patients with severe COVID-19 pneumonia.
Preliminary top-line data showed that the study did not meet its...
Articles
Why real-world data is helping us overcome the shortcomings of traditional clinical trials
Karen Ooms at Quanticate explains why clinical trial data alone is not enough to truly understand a drug’s effectiveness and argues that real-world data (RWD) is the key to filling the gap.
Randomized clinical trials have long been a...
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