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The FDA has found deficiencies in the biologics license application (BLA) data submitted for Provention Bio’s teplizumab, a monoclonal antibody being reviewed for delaying or preventing type 1 diabetes, and the agency’s evaluation of it is likely to be delayed as a result, the company said. Read More
For each patient group, approximately two-thirds of participants will be female, as most severe allergic reactions to vaccines have occurred in women. Read More
Eli Lilly’s and Incyte’s Janus kinase (JAK) inhibitor Olumiant (baricitinib) proved unable to significantly reduce progression to noninvasive ventilation for COVID-19 patients in a phase 3 trial, though the drug still managed to significantly reduce the risk of death. Read More
The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) has begun a phase 2 study to evaluate the risk of allergic reactions to the Moderna and Pfizer/BioNTech COVID-19 vaccines in patients who are severely allergic or have a mast-cell disorder. Read More
Johnson & Johnson subsidiary Janssen has agreed to pay up to $780 million for the global rights to Cidara Therapeutics’ Cloudbreak antiviral conjugate (AVC) candidates being developed for preventing and treating seasonal and pandemic influenza. Read More
The University of Oxford said it has paused a trial evaluating its COVID-19 vaccine co-developed with AstraZeneca in children and teenagers while it awaits additional information on the risk of blood clots from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Read More
The U.S. Army this week began phase 1 testing of a COVID-19 vaccine it developed, which is aimed at protecting against many coronavirus variants. Read More
The study is currently enrolling individuals in the UK and Spain, with enrollment occurring soon in the U.S., Canada and the Netherlands, followed by Brazil and Argentina. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) issued a warning letter to Foshan Biours Biosciences, an over-the-counter (OTC) drugmaker in Guangdong, China, following a records-based inspection that revealed inadequate testing and cleaning validation for the company’s biomedical patch. Read More
Bristol Myers Squibb’s blockbuster cancer drug Opdivo (nivolumab) significantly extended the disease-free survival of esophageal/gastroesophageal junction (GEJ) cancer patients with residual pathologic disease when given as an adjuvant treatment, according to phase 3 trial findings. Read More
Pfizer and BioNTech have accrued the data necessary to submit a biologics license application (BLA) for their COVID-19 vaccine and are seeking full approval as soon as this month, following a recent analysis from their phase 3 trial showing the vaccine held 91.3 percent efficacy up to six months after the second dose. Read More