The U.S. FDA’s emergency use authorization for two oral antivirals to be used to treat individuals at high risk of progressing to severe disease is just one hurdle cleared, as Pfizer Inc.’s Paxlovid and Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s molnupiravir still have many more laps to run.
China’s NMPA has given thumbs up to Cstone Pharmaceuticals Co. Ltd.’s Cejemly (sugemalimab), an anti-PD-L1 monoclonal antibody. It was approved for use in treatment-naïve metastatic (stage IV) non-small-cell lung cancer (NSCLC) patients in combination with chemotherapy.
Top-line results from Bridgebio Pharma Inc.’s ongoing phase III study of acoramidis are no holiday gift for the company. The clinical trial for treating symptomatic transthyretin amyloid cardiomyopathy missed its primary endpoint. The Palo Alto, Calif.-based company’s stock (NASDAQ:BBIO) plunged on the news as shares closed 72% lower Dec. 27 at $11.38 each.
The FDA went from zero to two oral antivirals to treat COVID-19 in the space of two days, granting emergency use authorizations last week to Pfizer Inc.’s Paxlovid and Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s molnupiravir. Both five-day regimens are authorized for use, within five days of COVID-19 symptom onset, in individuals at high risk of progressing to severe disease, including hospitalization and death.
With Omicron spreading rapidly, U.S. COVID-19 vaccine producers are facing increasing pressure to up their production and to do more to ensure their vaccines are accessible globally.
Little more than a year since FDA approval of its COVID-19 vaccine, Pfizer Inc. has published final phase II/III data on its oral antiviral candidate, Paxlovid (nirmatrelvir + ritonavir), confirming that, for non-hospitalized, high-risk adults with COVID-19, taking the drug within three days of symptom onset reduced all-cause risk of hospitalization or death by 89% vs. placebo.
LONDON – There was a substantial fall in neutralization titers against the Omicron variant of SARS-CoV-2 in the stored sera of people who had received two doses of either Astrazeneca plc’s or Pfizer Inc./Biontech SE’s COVID-19 vaccines, with some samples failing to neutralize the virus at all, according to the latest data from the U.K. Com-Cov study.
Pfizer Inc. is to buy Arena Pharmaceuticals Inc. for $6.7 billion, adding a potential follow-up to inflammatory diseases pill Xeljanz (tofacitinib) to its pipeline plus several other potential medicines targeting gastroenterology, dermatology and cardiology.
There is now more clarity on the Omicron variant of SARS-CoV-2, as serum antibodies produced by three doses of the Pfizer Inc.-Biontech SE COVID-19 vaccine have been shown to neutralize it. The data arrived a day after Glaxosmithkline plc and Vir Biotechnology Inc. said the monoclonal antibody sotrovimab retains activity against key mutations of the Omicron variant, including those found in sotrovimab’s binding site.
