The COVID-19 pandemic has had a profound impact on the best-selling pharmaceuticals, leading to shifts in the list with Pfizer and BioNTech’s Comirnaty surpassing AbbVie’s Humira for the No. 1 spot in 2021. That momentum continued in 2022, with Pfizer and BioNTech jointly raking in $59.1 billion in revenue from the sales of the COVID-19…
Emory and Pfizer partner to develop new COVID-19 treatments
Emory University has partnered with Pfizer (NYSE:PFE) to create new drugs and therapies aimed at stopping serious disease from COVID-19. The Emory and Pfizer collaboration will take place in Emory University’s Schinazi Laboratory, led by scientist Raymond Schinazi, with the goal of producing novel antiviral compounds to combat COVID, according to The Atlanta Journal-Constitution. Although…
Pfizer seeks full FDA approval for COVID-19 antiviral Paxlovid
Pfizer Inc. (NYSE:PFE) has filed a new drug application (NDA) with the FDA for approval of Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for individuals facing a high-risk for progression to severe illness from COVID-19. Paxlovid consists of the SARS-CoV-2 main protease inhibitor nirmatrelvir (PF-07321332) and the HIV-1 protease inhibitor and CYP3A inhibitor ritonavir. Because…
Pfizer gears up for Paxlovid new drug application submission to FDA
The most popular COVID-19 antiviral is Paxlovid (nirmatrelvir [PF-07321332] and ritonavir). The manufacturer of the drug, Pfizer Inc. (NYSE: PFE), anticipates selling about $22 billion worth of Paxlovid this year. Complicating matters, however, is the failure of the drug to meet its primary endpoint of self-reported, sustained alleviation of all COVID-19 symptoms for four consecutive days in the…
FDA and Pfizer differ in interpreting Paxlovid treatment recommendations
Pfizer CEO Dr. Albert Bourla recently said that patients who relapse after completing a course of the COVID-19 antiviral Paxlovid (nirmatrelvir and ritonavir) could continue taking the drug. “Paxlovid does what it has to do: it reduces the viral load,” Bourla told Bloomberg. “Then your body is supposed to do the job.” “While the…
Pfizer’s Paxlovid wins positive opinion from CHMP
The Committee for Medicinal Products for Human Use (CHMP) has recommended that Pfizer’s (NYSE:PFE) COVID-19 pill be granted conditional marketing authorization. Specifically, CHMP recommended that the antiviral, comprising PF-07321332 and ritonavir, be used in adults not requiring supplemental oxygen who face an elevated risk of severe COVID-19. If the European Commission signs off on the…
COVID-19 oral antiviral molnupiravir wins FDA nod
Merck (NYSE: MRK) and its partner Ridgeback Biotherapeutics have won emergency use authorization from FDA for the investigational oral antiviral molnupiravir (MK-4482, EIDD-2801). In late November, an FDA advisory panel narrowly voted in favor of authorizing molnupiravir. FDA recently also granted emergency use authorization to Pfizer’s (NYSE:PFE) oral SARS-CoV-2 antiviral Paxlovid (nirmatrelvir and ritonavir). FDA’s authorization of…
Pfizer’s COVID-19 antiviral pill could be poised for European regulatory authorization
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided advice about using Pfizer’s COVID-19 antiviral Paxlovid. CHMP has concluded that Paxlovid (nirmatrelvir/ritonavir) could be used for adults with COVID-19 who don’t need supplemental oxygen and face an elevated risk of developing severe disease. CHMP also stressed the…