Staidson Biopharmaceuticals Co. Ltd. is testing a combination of two monoclonal antibodies (MAb), STSA-1002 and STSA-1005, in China for the potential treatment of people with severe-to-critical COVID-19.
It’s a step forward and a step back at Pfizer Inc. Even as Pfizer and its partner Biontech SE finished filing an emergency use authorization application with the U.S. FDA seeking to field an updated booster dose of their omicron COVID vaccine, the regulator has made a request of its own, for more data on the company's oral antiviral, Paxlovid (nirmatrelvir + ritonavir), for treating COVID-19. An Aug. 5, 2022, letter from the FDA stipulates post-EUA requirements for Paxlovid, including that Pfizer conduct a trial in patients with a relapse of COVID symptoms, longhand for a “rebound,” after an initial Paxlovid treatment course.
After nearly four decades as director of the U.S. NIH’s National Institute of Allergy and Infectious Diseases (NIAID), 81-year-old Anthony Fauci will be stepping down in December. He also announced Aug. 22 that he will be handing over the reins as chief of the NIAID Laboratory of Immunoregulation and as chief medical adviser to President Joe Biden.
A study involving more than 1.25 million people in the U.S. has shown there is an increased risk of developing certain neurological and psychiatric conditions for up to two years after COVID-19 infection, and that despite causing less serious disease in the acute phase, the risk with omicron is the same as with the delta variant of SARS-CoV-2.
Staidson Biopharmaceuticals Co. Ltd. is testing a combination of two monoclonal antibodies (MAb), STSA-1002 and STSA-1005, in China for the potential treatment of people with severe-to-critical COVID-19.
A study involving more than 1.25 million people in the U.S. has shown there is an increased risk of developing certain neurological and psychiatric conditions for up to two years after COVID-19 infection, and that despite causing less serious disease in the acute phase, the risk with omicron is the same as with the delta variant of SARS-CoV-2.
Moderna Inc. has received conditional authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency for its bivalent COVID-19 booster vaccine mRNA-1273.214 (Spikevax bivalent original/omicron). The conditional approval, which covers adults aged 18 years and older, marks a new phase in the ongoing global effort to curb the COVID-19 pandemic, as the new vaccine represents the first commercial product to incorporate omicron-specific epitopes. It contains 25 micrograms each of the spike proteins of the omicron BA.1 variant and the original Wuhan strain of SARS-CoV-2.
Sironax Ltd. has raised $200 million in a series B financing round to support the development of its receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitors. The latest financing has brought the capital raised by the Beijing and Shanghai-based company to more than $300 million to date.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avenda, Bodyport, Bot Image, Cerevasc, Imspex Diagnostics, Medalliance, Neuroone.
Following the readout of a phase II trial evaluating its COVID-19 oral antiviral Pentarlandir (SNB-01), Taiwan’s Syneurx International Corp. said it expects to launch a phase III test of the candidate in the next few months.
