Tag Archives: pharma

Recall: Antidepressant Accidentally Mixed With Viagra

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 …

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US Could Face Vax Shortages Amid Global Competition

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 …

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FDA Approves First OTC At-Home COVID Test Kit

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 …

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FDA: Pfizer Vax Provides Protection After First Dose

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, …

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Nasal Drug May Offer Short-Term COVID Protection

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 …

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Blood Test To Detect Alzheimer’s Goes On Sale To Labs

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 …

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Moderna To Seek FDA Approval For Vaccine Today

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 …

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Trials Show Oxford Vax Is 70% Effective On Average

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 …

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FDA Approves Antibody Treatment Given To Trump

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 …

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TODAY: Pfizer To Seek Vaccine Approval From FDA

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 …

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UK’s Oxford Vaccine Shows Strong Immune Response

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 …

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FDA Approves First At-Home 30-Minute COVID Test

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 …

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Pfizer Says Vax Has No Serious Side Effects, Works In 94% Of Older Adults, Will Seek FDA Approval In Days

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 …

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Moderna Says Its COVID Vaccine Is 94.5% Effective

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 …

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Pfizer Vaccine Faces Storage And Distribution Hurdles

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 …

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FDA Approves Antibody Drug Given To Chris Christie

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 …

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Pfizer Says Their COVID Vaccine Is 90% Effective

STAT News reports: Pfizer and partner BioNTech said Monday that their vaccine against Covid-19 was strongly effective, exceeding expectations with results that are likely to be met with cautious excitement — and relief — in the face of the global pandemic. The vaccine is the first to be tested in the United States to generate late-stage data. The companies said …

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OxyContin Maker Pleads Guilty In $8.3B Settlement

The New York Times reports: Purdue Pharma, the maker of OxyContin, has agreed to plead guilty to criminal charges of defrauding federal health agencies and violating anti-kickback laws, and faces penalties of roughly $8.3 billion, the Justice Department announced on Wednesday. The company’s owners, members of the wealthy Sackler family, will pay $225 million in civil penalties. Still, it is …

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UK Volunteers To Get COVID In Vax “Challenge Trials”

The Guardian reports: More than £30m of UK government money is to fund the world’s first Covid-19 “challenge trials”, in which healthy young volunteers are intentionally infected with the virus to hasten the development of a vaccine. The trials have the potential to yield results more quickly than conventional vaccine field trials in which researchers must wait for participants to …

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CVS To Prep For COVID Vaccine With 15K New Hires

NBC News reports: CVS Health said Monday it plans to immediately hire 15,000 employees to prepare for an expected rise in Covid-19 and flu cases this fall and winter. More than 10,000 of those will be full-time and part-time licensed pharmacy technicians who can help dispense medications and administer Covid-19 tests. The larger workforce could also help CVS prepare for …

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