Tag Archives: pharma

The Associated Press reports: The first home test for COVID-19 that doesn’t require a prescription will soon be on U.S. store shelves. The FDA’s action Tuesday allows sales in places like drugstores “where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen Hahn. …

ABC News reports: With the trucks rolling and the first government-authorized coronavirus vaccine making its way to all 50 states, a strong majority of Americans are inclined to get the vaccine but are divided over exactly when, a new ABC News/Ipsos poll released Monday finds. More than eight in 10 Americans say they would receive the vaccine, with 40% saying …

CNN reports: Freight trucks carrying about 184,275 vials of coronavirus vaccine departed a Pfizer plant in Portage, Michigan, on Sunday, a landmark moment in the fight against the deadly virus. The combined 189 boxes of vaccine vials are expected to arrive in all 50 states on Monday, and another 3,900 vials are expected to ship later Sunday to United States …

Reuters reports: Walmart Inc said on Thursday it was entering into agreements with U.S. states to administer COVID-19 vaccine to the public once it was approved for use. The retailer said it was preparing over 5,000 Walmart and Sam’s Club pharmacies with freezers and dry ice to handle storage requirements for the vaccine doses. Walmart is preparing its 5,000 pharmacies …

Via press release from the FDA: AvKARE, Pulaski, TN is voluntarily recalling one lot of Sildenafil 100 mg tablets and one lot of Trazodone 100mg tablets to the consumer level. These products have been recalled due to a product mix-up of the listed two separate products inadvertently packaged together during bottling at a 3rd party facility. Unintentional consumption of sildenafil …

Politico reports: The United States could be heading for a vaccine cliff this spring, with shortages forcing hundreds of millions of Americans to wait for shots amid intense global competition for limited doses. The Trump administration has bought 100 million doses each of vaccines from Pfizer and Moderna, but the U.S. is unlikely to get additional doses anytime soon because …

CNN reports: The US Food and Drug Administration has granted an emergency use authorization for the first non-prescription, over-the-counter Covid-19 test kit for at-home use. The LabCorp Pixel COVID-19 Test Home Collection Kit allows anyone 18 and older to buy the kit and collect nasal swab samples at home, the FDA said in a news release Wednesday. The samples are …

The New York Times reports: The coronavirus vaccine made by Pfizer and BioNTech provides strong protection against Covid-19 within about 10 days of the first dose, according to documents published on Tuesday by the Food and Drug Administration before a meeting of its vaccine advisory group. The finding is one of several significant new results featured in the briefing materials, …

The Arizona Republic reports: The treatment, called KEPTIDE, is a nasal spray that works by stopping the virus from attaching onto and entering cells. Studies done in mice, primate cells, and human lung cells have all been promising so far, the company said, showing 100% effectiveness with no negative side effects. One hitch: The treatment won’t offer long-term protection. Its …

The Associated Press reports: A company has started selling the first blood test to help diagnose Alzheimer’s disease, a leap for the field that could make it much easier for people to learn whether they have dementia. It also raises concern about the accuracy and impact of such life-altering news. Independent experts are leery because key test results have not …

Forbes reports: Moderna will submit its Covid-19 vaccine for emergency use approval in the U.S. Monday after new trial data showed it to be 94% effective at preventing the disease, findings that are consistent with earlier data from the Phase 3 clinical trial. New findings from the Phase 3 clinical trial, which involved over 30,000 participants, showed the vaccine to …

CNBC reports: British pharmaceutical giant AstraZeneca on Monday said an interim analysis of clinical trials showed its coronavirus vaccine has an average efficacy of 70% in protecting against the virus. It comes after a string of encouraging vaccine results in recent weeks, following late-stage trial readouts from Pfizer-BioNTech and Moderna. The AstraZeneca vaccine, developed in collaboration with the University of …

The New York Times reports: The Food and Drug Administration has granted emergency authorization for the experimental antibody treatment given to President Trump shortly after he was diagnosed with Covid-19, giving doctors another option to treat Covid-19 patients as cases across the country continue to rise. The emergency authorization for Regeneron’s drug is limited in scope: It is for people …

CNBC reports: Pfizer and BioNTech will apply Friday for an emergency use authorization from the Food and Drug Administration for their coronavirus vaccine. If Pfizer’s application is approved, the vaccine will likely be limited and rolled out in phases, with health-care workers, the elderly and people with underlying health conditions getting the first inoculations. Essential workers, teachers and people in …

The BBC reports: The Oxford coronavirus vaccine shows a strong immune response in adults in their 60s and 70s, raising hopes that it can protect age groups most at risk from the virus. Researchers say the Lancet phase two findings, based on 560 healthy adult volunteers, are “encouraging”. They are also testing whether the vaccine stops people developing Covid-19 in …

Via press release from the FDA: Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 …

The New York Times reports: The drug maker Pfizer said on Wednesday that its coronavirus vaccine was 95 percent effective and had no serious side effects — the first set of complete results from a late-stage vaccine trial as Covid-19 cases skyrocket around the globe. The data showed that the vaccine prevented mild and severe forms of Covid-19, the company …

The New York Times reports: The drugmaker Moderna announced on Monday that its coronavirus vaccine was 94.5 percent effective, based on an early look at the results from its large, continuing study. Researchers said the results were better than they had dared to imagine. But the vaccine will not be widely available for months, probably not until spring. Moderna is …

Agence France-Presse reports: The vaccine developed by US pharmaceutical giant Pfizer and Germany’s BioNTech, on track to be the first authorized for use in the United States, must be stored at -94 degrees Fahrenheit (-70 degrees Celsius), whereas the flu vaccine can be kept in a normal refrigerator. Pfizer vaccines distributed in the US will come from its largest manufacturing …

The New York Times reports: The Food and Drug Administration has granted emergency authorization of a Covid-19 treatment made by the American pharmaceutical company Eli Lilly that was given to Chris Christie, the former New Jersey governor, when he was infected with the coronavirus. The authorization, announced on Monday, applies only to people newly infected with the virus, and the …