In a strategic initiative to streamline operations, Pfizer said it would close facilities in Durham and Morrisville, North Carolina. The company aims to cut at least $3.5 billion in costs. The company now employs more than 80,000 people worldwide, with roughly 4,000 based in North Carolina. The closures will not affect Pfizer’s two largest facilities…
CHMP backs updated Pfizer/BioNTech and Moderna COVID-19 boosters
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 and BioNTech seek EMA authorization for COVID-19 vaccination in young children
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.…
Young children in U.S. now eligible for COVID-19 vaccination
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…
Pfizer to spend $120M to make COVID-19 oral treatment in U.S.
Pfizer (NYSE: PFE) announced today that it will invest $120 million into its Kalamazoo, Michigan facility to support U.S.-based production of its COVID-19 antiviral Paxlovid (nirmatrelvir/ritonavir). The investment is expected to create more than 250 additional, high-skilled jobs at the Kalamazoo site. The money will expand the production of active pharmaceutical ingredient (API) and registered…
FDA denies EUA for COVID-19 indication of SSRI fluvoxamine
The infectious disease physician-scientist Dr. David R Boulware filed for the emergency use authorization (EUA) of fluvoxamine, an established selective serotonin reuptake inhibitor (SSRI) whose brand name is Luvox. The FDA has rejected the application, explaining the COVID-19 treatment benefit of the drug was “not persuasive” in the TOGETHER study that was the basis of the…
Pfizer ticks up on Street-beating Q1, lessens full-year guidance
Pfizer (NYSE:PFE) shares rose today on first-quarter financial results that came in ahead of the consensus forecast. The New York-based pharmaceutical company posted profits of $7.9 billion, or $1.37 per share, on sales of $25.7 billion for the three months ended April 3, 2022, for a 61.2% bottom-line gain on sales growth of 76.8%. Adjusted…
The Biden administration vows to increase COVID-19 antiviral supplies
White House officials have a plan to ramp up the availability of Pfizer’s COVID-19 antiviral Paxlovid, according to a report from Bloomberg. White House Covid-19 Response Coordinator Dr. Ashish Jha said that the administration would announce more details about the plans to make Paxlovid more widely available in the coming week. The administration plans to launch…
Johnson & Johnson rises on mixed bag Q1, increased 2022 guidance
Johnson & Johnson (NYSE:JNJ) shares ticked up today on first-quarter results that were mixed compared to the consensus forecast. The New Brunswick, New Jersey-based company posted profits of $5.1 billion, or $1.93 per share, on sales of $23.4 billion in the first quarter for a 16.9% bottom-line slide on sales growth of nearly 5%. Get the…
NIH starts evaluating second COVID-19 booster shots in adults
The NIH recently announced that it has started enrolling adults for a Phase 2 clinical trial evaluating various additional COVID-19 booster shots. NIH’s National Institute of Allergy and Infectious Diseases (NIAID) is sponsoring the COVID-19 Variant Immunologic Landscape (COVAIL) trial. “We are looking beyond the Omicron variant to determine the best strategy to protect against…