Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allogene, Apic, Chiesi, Oasmia, Organicell, Pharvaris.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alterity Therapeutics, Atriva Therapeutics, China Biologic Products, Claritas, CMAX, Cybin, Enzychem, Excellthera, Hemoshear, Horizon, Marinomed, Moderna, Nasus, RDIF, Valneva, Willow.
HONG KONG – Laboring under the burden of a new wave of COVID-19 infections that have raised its case total to 15.3 million, second only to the U.S., India is ramping up its vaccination efforts by opening up COVID-19 vaccine availability to citizens 18 years or older from May 1, according to the Ministry of Health and Family Welfare. However, ensuring a steady vaccine supply for the world's second most populous country, with nearly 1.4 billion people, might prove to be an issue. So far, India has administered just over 124 million COVID-19 vaccine doses.
In biotech and biopharma’s third-largest ever up-front development and commercialization deal, Crispr Therapeutics AG will receive an initial $900 million in an amended deal with Vertex Pharmaceuticals Inc. to lead the development, manufacturing and commercialization of gene editing therapy CTX-001 for sickle cell disease and transfusion-dependent beta-thalassemia.
OS Therapies LLC, the developer of a listeria-based cancer vaccine to prevent metastasis and increase overall survival in young people with osteosarcoma, has closed on a $6 million series A financing led by Noble Capital Markets and Tichenor Ventures. The funds will help the company advance its lead candidate, OST-HER2, into a phase IIb trial this year with hopes of a potential FDA filing by in 2022.
Location, location, location. Not only is that the mantra for real estate, it often is seen as an answer to diversifying clinical trials. But having a trial site in or near an underserved community is no guarantee of a diverse study population, as health care disparities can be a more pervasive issue than location. That was one of the lessons learned from the development of Celltrans Inc.’s donislecel at the University of Illinois-Chicago.
DUBLIN – In keeping with the record-breaking year for biotech fundraising across the globe, the Swiss biotech sector also scaled new heights in 2020, with aggregate investment of CHF3.4 billion (US$3.7 billion), according to the newly published Swiss Biotech Report 2021. It represents almost a threefold increase on the CHF1.2 billion total it logged in 2019.
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