Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insightec, Lumos Diagnostics, Mim Software.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt, Betternight, Clario, Cytek Biosciences, Exact Sciences, Heartflow, Innovia, Molex, Nanostring Technologies, Peerbridge Health, Phillips-Medize, Sleep Data Services.
A few hours after the U.S. CDC Advisory Committee on Immunization Practices’ Nov. 2 recommendation to allow children ages 5 through 11 to be administered Pfizer Inc. and Biontech SE’s COVID-19 vaccine, Comirnaty (tozinameran), the agency’s director, Rochelle Walensky, endorsed the recommendation. The recommendation came as the World Health Organization (WHO) expanded the COVID-19 vaccines it recommends in the fight against the pandemic by endorsing Bharat Biotech International Ltd.’s Covaxin.
Although the BioWorld Biopharmaceutical Index has recovered slightly within the last month, it is showing only a small gain since the start of the year. Up by 2.82%, it is somewhat in line with the Nasdaq Biotechnology Index gain of 4.83%, but significantly beneath the broader markets. The Dow Jones Industrial Average, for example, was up by 17.03% at the end of October.
Eli Lilly and Co. has withdrawn a filing for its COVID-19 antibody cocktail in Europe after health authorities backed rivals – the day after a $1.29 billion purchase of the same medicines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.