Eli Lilly and Co. has withdrawn a filing for its COVID-19 antibody cocktail in Europe after health authorities backed rivals – the day after a $1.29 billion purchase of the same medicines from the U.S. government. Indianapolis-based Lilly began filing data from the combination of bamlanivimab and etesevimab in March to enable a fast authorization by the European Medicines Agency.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Autobahn, Biomunex, Cytovant, Defence, Eisbach, Flagship Pioneering, Gb, Medigene, Pharmather, Reithera, Resverlogix, Revive, Roivant, Tessera.
As a counterpoint to the raft of wellness-promoting smartwatches, Purdue University and Physiq Inc. have developed a smartwatch algorithm that flags illness. A year after launching their co-development program, the two organizations reported they have created an algorithm designed for smartwatches that enables detection of early signs of infection. The algorithm is already in use in a number of Physiq’s customers’ applications, Physiq Chief Scientific Officer Stephan Wegerich told BioWorld.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Magstim, Orasure, Perimeter Medical Imagining AI, Transit Scientific, Vuno.
In a move that had been expected, the CDC’s Advisory Committee on Immunization Practices unanimously recommended the Pfizer Inc.-Biontech SE COVID-19 vaccine as safe and beneficial for children ages 5 through 11. The recommendation, coming from a 14-0 vote, is the committee’s way of reassuring the American public that the vaccine is safe, according to committee member Beth Bell, clinical professor in the School of Public Health at the University of Washington in Seattle.
As booster shots become increasingly available and COVID-19 vaccines for young children are introduced into pediatric offices, several potential therapeutics to battle the SARS-CoV-2 virus are lining up for regulatory authorizations.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Bicycle, Endo, Eli Lilly, Galecto, Inovio, Medimmune, Roche, Queensland University of Technology, Theoremrx, Quoin, Valirx, Venatorx, Zealand.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 7 Hills, Aldeyra, Astrazeneca, Aurinia, Axon, Clene, Compass, Equillium, Huyabio, Hyloris, Metacrine, Oncoresponse, Primmune, Rhythm, Uniqure, Vicore.
An ongoing evaluation of heart muscle inflammation risk, a key concern with mRNA COVID-19 vaccines globally, could delay through January 2022 completion of an FDA review of Moderna Inc.'s vaccine in adolescents 12 to 17 years of age. The side effect, called myocarditis, has been a particular concern with regulators, especially for adolescents and young men.