COVID-19

The oncology biopharma Veru (Nasdaq: VERU) has announced that the FDA has moved the date for its Pulmonary-Allergy Drugs Advisory Committee to discuss the potential emergency use authorization (EUA) of sabizabulin for hospitalized COVID-19 patients. The meeting is now slated for November 9, 2022. It was originally scheduled for October 6, 2022. VERU shares skidded…

AstraZeneca (LON:AZN) has announced that its long-acting antibody combination Evusheld (tixagevimab and cilgavimab) has received marketing authorization in the European Union.  Formerly known as AZD7442, Evusheld is indicated for treating individuals 12 and older infected with SARS-CoV-2 who are at risk for severe COVID-19. The indication is limited to those weighing at least 40 kg…

Hyderabad, India–based Zenara Pharma has launched a generic version of Pfizer’s (NYSE:PFE) COVID-19 antiviral Paxlovid (nirmatrelvir and ritonavir). Zenara Pharma is naming the generic version of the pill “Paxzen.” The antiviral is indicated for mild to moderate symptoms of COVID-19. India’s Central Drugs Standard Control Organisation (CDSCO) cleared the way for authorization of the drug…

Pfizer (NYSE: PFE) and its partner BioNTech (Nasdaq:BNTX) could potentially win authorization to market a 30-µg booster dose of their omicron BA.4/BA.5 bivalent-adapted COVID-19 vaccine after the Committee for Medicinal Products for Human Use (CHMP) backed the vaccine for individuals 12 and older. The European Commission will likely make a final decision on the updated…

EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended authorizing bivalent COVID-19 vaccines from Pfizer/BioNTech and Moderna. The boosters target the omicron BA.1 sublineage. Assuming the European Commission follows CHMP’s recommendations, the European vaccine campaign will use bivalent vaccines targeting the original version of the omicron variant. U.S. regulators, by contrast, have backed…

Pfizer’s (NYSE:PFE) CEO Dr. Albert Bourla acknowledged in a statement that he has COVID-19.  Bourla, who is 60, has received four doses of the Pfizer-BioNTech Comirnaty vaccine. He also has begun taking a course of the company’s antiviral Paxlovid.  The Pfizer CEO notes that symptoms to date have been very mild.   Pfizer’s revenue has soared during the…

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq: BNTX) have filed paperwork with the European Medicines Agency (EMA) requesting permission to use the Comirnaty COVID-19 vaccine in children aged 6 months to 5 years old. As in the U.S., the companies are attempting to win authorization for a 3-µg dose vaccine administered as a three-dose series.…

FDA has revised the Emergency Use Authorization (EUA) for Pfizer’s (NYSE:PFE) Paxlovid (nirmatrelvir and ritonavir) to allow state-licensed pharmacists to prescribe the drug to some patients with a high risk of COVID-19. While the move allows pharmacists to prescribe Paxlovid, it has limits. It instructs the professionals to refer patients to a physician if there is insufficient…

FDA advisors are slated to meet to discuss the prospect of updating the first generation of COVID-19 vaccines for use as boosters this fall and winter. But it remains unclear whether updating the COVID-19 vaccines will be necessary. Both Pfizer (NYSE:PFE) and Moderna (Nasdaq:MRNA) have updated vaccines in the works. Pfizer and Moderna have both said…

Some 18 months after adults became eligible for COVID-19 vaccines, children between 6 months and 5 years old can now be vaccinated in the U.S. FDA authorized the shots for young children on June 17, while CDC did so a day later. “The United States is now the first country in the world to offer safe…