Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allovir, Alphamab, CSPC, Nrx, Oncolyze, Oncotelic, Oncternal, Samsung, Simcere.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 2seventy, Alnylam, Biomea, Biomérieux, Cantabio, Clear Creek, Eisai, Exelixis, Genevant, ICER, Iconic, Liscure, Lqt, Novartis, Novo, Noxxon, Plus, Rain, Roche, Roivant.
The epic rise and fall of Elizabeth Holmes, founder of Theranos Inc., will preoccupy the world of business for decades to come, but this story has also left a large footprint in the world of clinical diagnostics. David Stein, CEO of Babson Diagnostics Inc., of Austin, Texas, told BioWorld that investors are a bit more wary than usual because of the Theranos saga, forcing test developers to be more rigorous in test development and more transparent with investors about a test.
China’s med-tech products exports declined in 2021 as manufacturing in other countries picked up, while med-tech imports to the country increased. In the first half of 2021, China’s med-tech exports amounted to $47.931 billion, a decrease of 23.1% year-on-year. But imports for the same period amounted to $24.392 billion, an increase of 25.2% year-on-year, according to med-tech data company Guangzhou Joinchain Big Data Technology Co. Ltd.
Once the CDC accepts the recommendation of its Advisory Committee on Immunization Practices (ACIP), the COVID-19 vaccine regimen, at least for the Pfizer Inc.-Biontech SE vaccine, will include a booster dose for everyone 12 and older. ACIP voted 13-1 at a Jan. 5 emergency meeting to recommend the booster dose for 12- to 17-year-olds at least five months after a primary series of the Pfizer vaccine.
Just as the world appeared to be winning the battle against COVID-19, the rules of the game changed. Omicron and concerns about future variants flipped the board. Vaccines and monoclonal antibodies are attracting fresh scrutiny as SARS-CoV-2 evolves. Cases are climbing closer to the highest levels recorded since the pandemic began. Antivirals are aiming to fill treatment gaps, but whether they will or not is about as clear as the virus’ next move.
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