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…
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…
Pfizer, BioNTech moving forward on seeking COVID-19 vaccine EUA for youngest children
Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) announced today that data support a three-dose primary series of their COVID-19 vaccine in young children. Topline safety, immunogenicity and vaccine efficacy data from a Phase 2/3 trial in young children evaluating a third 3-µg dose of the vaccine — marketed in the U.S. as Comirnaty — showed a strong…
Pfizer to shell out $11.6B for migraine drugmaker Biohaven
Pfizer (NYSE:PFE) today announced that it has entered into an agreement to acquire Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN), which is best known for Nurtec ODT (rimegepant), a dual-acting migraine therapy. Pfizer will pay $148.50 per share in cash to acquire Biohaven, totaling approximately $11.6 billion. Nurtec generated $462 million in revenue in 2021. Pfizer…
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…
Pfizer’s COVID-19 antiviral disappoints as post-exposure prophylactic
Pfizer (NYSE:PFE) announced that its COVID-19 antiviral Paxlovid failed to reach statistical significance in reducing risk after patients were exposed to the SARS-CoV-2 virus. The primary endpoint of the Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) study was to reduce the risk of confirmed and symptomatic COVID-19 in adults after…
Pfizer and BioNTech file for EUA for COVID-19 vaccine booster in kids 5 to 11
Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application with the FDA for emergency use authorization (EUA) for a 10-µg booster dose of their BNT162b2 COVID-19 vaccine in children aged 5 to 11. The companies included data in the application from a Phase 2/3 study that tested a booster dose in children between…
Pfizer recalls certain lots of blood-pressure drug Accupril
Pfizer (NYSE:PFE) has announced a voluntary recall of five lots of Accupril (Quinapril HCl) tablets owing to elevated levels of the nitrosamine N-nitroso-quinapril. Accupril, an angiotensin-converting enzyme (ACE) inhibitor, is indicated for treating hypertension. FDA has also approved its use as an adjunctive therapy for treating heart failure. N-nitroso-quinapril, which can be frequently found in…
Pfizer appoints new chief financial officer
Pfizer (NYSE: PFE) has named David M. Denton as its new chief financial officer (CFO) and executive vice president. Denton, who now serves as CFO of Lowe’s Companies, will officially take the role on May 2. Before taking on his role at Lowe’s (NYSE:LOW), Denton served as the CFO of CVS Health (NYSE:CVS). Denton oversaw…