Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dexcom, Gleamer, Intrivo, J&J Vision, Valencia Technologies.
New drug and device regulations going into effect in Canada are serving as a reminder of the extended life of the COVID-19 pandemic. After two years of interim orders regulating the importation and sale of drugs and devices for COVID-19 clinical trials and the conduct of those trials, Canada is issuing long-term regulations that will incorporate most of the provisions of the temporary orders.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 9 Meters, Accure, Affinivax, Akeso, Astellas, Blue Willow, BMS, Dragonfly, Gemini, Medigen, Oculis, Prokarium, Promis, Shenzhen Chipscreen.
Researchers from Massachusetts General Hospital have identified peripheral neuropathy in more than half of a group of long COVID patients, suggesting that it may be a mechanism that contributes to multiple, seemingly disparate, long COVID symptoms.
Visby Medical Inc. reeled in more than $100 million in a series E round led by Ping An Voyager Partners. The funds will be used to scale production capacity of Visby’s instrument-free, single-use real-time polymerase chain reaction (RT-PCR) platform from tens to hundreds of thousands of tests per month.
Two years ago, BioWorld reported on 30 therapeutics and vaccines in development for COVID-19, about 3,000 people had died from the disease, and societal lockdowns began. Today, therapeutics and vaccines have ballooned to 1,048, deaths are at 6 million, and the world remains on edge due to highly transmissible variants and breakthrough infections. One thing remains the same: Scientists still do not know where the SARS-CoV-2 virus originated.
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