The U.S. Food and Drug Administration approved AbbVie’s Skyrizi (risankizumab-rzaa) for the treatment of adults with active psoriatic arthritis (PsA), a systemic inflammatory disease that affects the skin and joints and impacts 30 percent of patients with psoriasis.
Pfizer released data from several studies showing that nirmatrelvir, the active main protease inhibitor of the company’s antiviral combination therapy Paxlovid (nirmatrelvir/ritonavir), is effective against the Omicron variant of SARS-CoV-2. Additionally, a study conducted by 23andMe and published in Nature Genetics identified a genetic risk factor tied to the loss of smell from COVID-19.
The United States on December 22 authorized Pfizer Inc.’s antiviral Covid-19 pill for people ages 12 and older at risk of severe illness, the first oral and at-home treatment as well as a new tool against the fast-spreading Omicron variant.
The U.S. Food and Drug Administration on December 8 authorized the use of AstraZeneca’s antibody cocktail to prevent Covid-19 infections in individuals with weak immune systems or a history of severe side effects from coronavirus vaccines.
A panel of expert advisers to the U.S. Food and Drug Administration on November 30 narrowly voted to recommend the regulatory agency authorize Merck & Co.’s antiviral pill to treat Covid-19.
Pfizer Inc. now expects to manufacture 80 million treatment courses of the company’s experimental COVID-19 antiviral drug, up from a previous forecast of 50 million, Chief Executive Officer Albert Bourla said in a CNBC interview on November 29.
Eli Lilly said on Nov. 2 that the U.S. government bought 614,000 additional doses of the company’s Covid-19 antibody therapy for $1.29 billion.
Mike Hidock, Director of Quality and Compliance Services at IQVIA, analyzes key considerations for preparing quality management systems (QMS) for fast tracked COVID-19 treatment approvals.
Monoclonal antibodies are playing a key therapeutic role in the treatment of some Covid-19 patients, but new research suggests that nanobodies derived from llamas could provide an alternative to monoclonal antibodies through a more effective delivery method—inhalation.