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 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 (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 (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…

FDA has authorized a second booster dose of COVID-19 vaccine for individuals who are immunocompromised or 50 and over. The expanded emergency use authorization applies to the vaccines from Pfizer (NYSE: Pfizer) and Moderna (Nasdaq: MRNA). Individuals interested in obtaining a second booster dose must wait at least four months after receiving the first booster dose.…

Pfizer (NYSE: PFE) announced that it would redirect all profits from its Russian subsidiary to relief efforts in Ukraine.  Concluding that pausing shipments of medicines to Russia would be counter to its principles, Pfizer had already decided to offer humanitarian efforts to Ukraine.  Pfizer also announced that it would refrain from launching new clinical trials…

Pfizer (NYSE:PFE) has completed its $6.7 billion acquisition of Arena Pharmaceuticals, a developer of immuno-inflammatory drugs. The acquisition of San Diego-based Arena will bolster Pfizer’s pipeline of therapeutic candidates in gastroenterology, dermatology and cardiology. Among Arena Pharmaceuticals’ assets is etrasimod, an oral, selective sphingosine 1-phosphate (S1P) receptor modulator with the potential to treat ulcerative colitis…

President Biden said in his State of the Union address that the U.S. aims to ramp up the use of Pfizer‘s (NYSE:PFE) Plaxovid. The treatment has been in short supply since it won emergency use authorization late last year. Last year, when Merck & Co. (NYSE: MRK) and Pfizer were close to winning regulatory authorization for…

Israel could be one of the first countries to begin administering a fourth dose of COVID-19 vaccine to individuals over 18 after a positive advisory committee decision. Before the decision becomes binding, the director of Israel’s Ministry of Health, Nitzan Horowitz, must sign off on the recommendation. If implemented, Israeli adults would be eligible for…

Pfizer (NYSE:PFE) revealed that its COVID-19 drug Paxlovid retained in vitro efficacy against the omicron SARS-CoV-2 variant. The company said that the research indicates that the drug can potentially maintain plasma concentrates “many-fold” times higher than the level needed to prevent replication of the highly transmissible variant. “These data suggest that our oral COVID-19 therapy…