Keyword: clinicaltrials
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The Pfizer COVID-19 “vaccine” injected into billions of arms was not the same one used in Pfizer’s clinical trials. There was a "bait and switch." The clinical trials tested "Process 1" while the public received "Process 2." And what they never told you is that "Process 2" was only tested on about 252 people, instead of 40,000 people. They also didn't tell you that the vials were contaminated with plasmid DNA. A new study by Kevin McKernan and colleagues found "the presence of billions to hundreds of billions of DNA molecules per dose in these vaccines. Using fluorometry, all vaccines...
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A customized Moderna Inc. vaccine combined with a Merck & Co. cancer drug helped ward off the recurrence of the skin cancer melanoma after surgery in patients in a mid-stage clinical trial, the companies said. The companies said Tuesday the combination of Moderna’s personalized cancer vaccine and Merck’s Keytruda cancer immunotherapy reduced patients’ risk of relapse or death by about 44%, versus Keytruda alone, in the 150-volunteer study. The results, which the companies said were statistically significant but haven’t been reviewed by independent scientists, suggest promise for an emerging but unproven class of vaccines that aim to treat diseases rather...
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The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine on Dec. 11, 2020. A week later, the FDA issued an EUA for Moderna's COVID-19 vaccine. Now, nearly two years later, Pfizer and Moderna will launch clinical trials to track adverse health issues stemming from the COVID-19 vaccines, such as myocarditis – inflammation of the heart muscle. Pfizer is in the infancy of beginning clinical trials to determine if there are any health risks associated with their own vaccine. In a partnership with the Pediatric Heart Network, the trial will focus on...
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There are times when defendants are forced to use strategies that expose others to wrongdoing. The case of Pfizer outing the U.S. government for their knowledge of wrongdoing is a doozy. ... the lawyer representing whistleblower Brook Jackson said Pfizer is arguing the court should dismiss Jackson’s lawsuit alleging fraud in Pfizer’s COVID-19 clinical trials because the U.S. government knew about the wrongdoings but continued to do business with the vaccine maker. A lawsuit filed by whistleblower Brook Jackson alleging Pfizer and two of its contractors manipulated data and committed other acts of fraud during Pfizer’s COVID-19 clinical trials is...
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Antiviral Nasal Spray A single inhaled dose treated or even prevented infection by COVID-19 and its variants. Current antibody treatments block SARS-CoV-2 by binding to one of three binding sites on the spike protein New antiviral binds to all three sites on the spike protein, making it more effective than current therapies Antiviral is also low-cost, easy to manufacture, does not require complicated supply chains with extreme refrigeration and potentially could be self-administered A new protein-based antiviral nasal spray developed by researchers at Northwestern University, University of Washington and Washington University at St. Louis is being advanced toward Phase I...
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A new study shows that a potential treatment for Alzheimer's disease may also improve cognitive function in people with Down syndrome. The drug sargramostim (GM-CSF, which stands for granulocyte-macrophage colony-stimulating factor) is the first to show memory improvement in Alzheimer's patients in a phase II clinical trial. GM-CSF is a normal human protein that is safe and well-tolerated with over 30 years of FDA-approved use for other disorders. A multidisciplinary team studied the safety and tolerability of GM-CSF treatment and its effects on behavior and brain pathology in a mouse model of Down syndrome and in mice undergoing typical aging....
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It takes 10 to 15 years and around US$1 billion to develop one successful drug. Despite these significant investments in time and money, 90 percent of drug candidates in clinical trials fail. Whether because they don't adequately treat the condition they're meant to target or the side effects are too strong, many drug candidates never advance to the approval stage. As a pharmaceutical scientist working in drug development, I have been frustrated by this high failure rate. Over the past 20 years, my lab has been investigating ways to improve this process. We believe that starting from the very early...
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A study describes a new and effective therapy to treat glioblastoma: the concomitant use of ADI-PEG20 together with focal brain radiotherapy. This double treatment completely eliminated the tumor in the animal models used in the study. Currently, glioblastoma is a terminal disease whose average life expectancy is less than two years. The treatments used at present are based on therapies that are more than 30 years old. The results of this study offer a new therapeutic option against glioblastoma: the use of the drug ADI-PEG20, which eliminates systemic arginine, in combination with the application of focal brain radiotherapy. With this,...
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Results from an international, randomized, double-blind, placebo-controlled, phase 3 clinical trial indicate that adding the androgen-receptor inhibitor darolutamide to androgen-deprivation therapy and chemotherapy prolongs the survival of men with metastatic, hormone-sensitive prostate cancer, a disease that is fatal in most cases. Standard treatment for patients with metastatic, hormone-sensitive prostate cancer includes the addition of either the chemotherapy drug docetaxel or an androgen-receptor pathway inhibitor to androgen-deprivation therapy, with the latter two treatments acting to lower the effects of androgen hormones, such as testosterone. Clinical trials that have combined all three treatments have generated conflicting results. To provide clarity, investigators designed...
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An investigational cancer drug that starves tumors of their energy supply also shows evidence of improving whole body metabolism, leading to improved weight control, according to a new study. The drug is being investigated for potential use as a treatment for a number of cancers, including sarcoma, breast and pancreatic cancers. The drug breaks down the amino acid arginine in the blood, which deprives cancer cells of a key source of fuel. The researchers became interested in studying the drug after finding that genes responsible for breaking down arginine are dialed up tremendously when the body is in a fasting...
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Abstract A key driver in biopharmaceutical investment decisions is the probability of success of a drug development program. We estimate the probabilities of success (PoSs) of clinical trials for vaccines and other anti-infective therapeutics using 43,414 unique triplets of clinical trial, drug, and disease between January 1, 2000, and January 7, 2020, yielding 2,544 vaccine programs and 6,829 nonvaccine programs targeting infectious diseases. The overall estimated PoS for an industry-sponsored vaccine program is 39.6%, and 16.3% for an industry-sponsored anti-infective therapeutic....We plot the number of development programs known to start in each month from January 2000 through December 2019 in...
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The probability of success (POS) of a clinical trial is critical for clinical researchers and biopharma investors to evaluate when making scientific and economic decisions. Prudent resource allocation relies on the accurate and timely assessment of risk. Without up-to-date estimates of the POS, however, investors may misjudge the risk and value of drug development, leading to lost opportunities for both investors and patients....The trials range from January 1, 2000, to October 31, 2015, the latter being the date that we received the data set... Of these, 34.7% (141,086) are industry sponsored and 65.3% (264,952) are non-industry sponsored. ...Table 1 contains...
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The Food and Drug Administration has provided its first batch of ‘confidential’ documents, in accordance with a FOIA lawsuit by the Public Health and Medical Professionals for Transparency. The redacted documents were the basis of the FDA’s Emergency Use Authorization of the Pfizer-BioNTech “vaccine*,” and subsequent federal vaccine mandates. As reported earlier, the FDA does not intend to fully release the clinical trials information used to justify its authorization of the Pfizer-BioNTech ‘vaccine’ for 55 years. The non-partisan advocacy group’s sole mission is pressing for transparency in public health decision-making, such as the vaccine authorization process. “The FDA has proposed...
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SPARTANBURG, S.C. (WSPA) – A new clinical trial that’s aimed at testing the effectiveness of three common drugs is now open to all COVID-19 positive South Carolinians. Researchers at the Medical University of South Carolina (MUSC) are now conducting clinical trials to not only help with the fight against COVID-19, but to settle a few heavily contested questions surrounding the drug Ivermectin. This is all a part of a nationwide effort called ACTIV-6, which is aimed at discovering new COVID-19 treatments with already existing drugs. The trial is led by the Duke Clinical Research Institute in North Carolina and covers...
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A drug used to treat rheumatoid arthritis has been found to improve survival of hospitalized Covid-19 patients. The discovery comes from a study of over 1,500 Covid-19 patients in 12 countries and is being hailed as a significant breakthrough for treatment options for people who are severely ill with Covid-19. Early on in the pandemic in February 2020, baricitinib was identified as a promising drug to treat Covid-19 by a company using artificial intelligence (AI) and machine learning to identify potential treatments for diseases. The drug, normally used to treat rheumatoid arthritis, was thought to have possible antivirus properties, but...
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The developer of ivermectin is performing late-stage trials on a drug that could actually prevent COVID-19. Merck & Co partnered with Ridgeback Biotherapeutics to develop molnupiravir. Enrollment for late-stage trials for their drug have already started.... The drug, which can be taken via a pill, is now entering late stage trials in the United States as Merck plans to eventually seek FDA approval. Over 1,300 volunteers aged 18 or older will be recruited for the study and live in a house with someone who has a symptomatic case of the COVID-19. Merck also plans to use the drug in some...
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...Researchers design clinical trials to answer specific research questions related to a medical product. These trials follow a specific study plan, called a protocol, that is developed by the researcher or manufacturer. ...Phase 1 Study Participants: 20 to 100 healthy volunteers or people with the disease/condition. Length of Study: Several months Purpose: Safety and dosageApproximately 70% of drugs move to the next phasePhase 2 Study Participants: Up to several hundred people with the disease/condition. Length of Study: Several months to 2 years Purpose: Efficacy and side effectsApproximately 33% of drugs move to the next phasePhase 3 Study Participants: 300 to...
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In a recorded phone call between a vaccine victim and a representative of Moderna, the rep admitted that everyone that subjects themselves to the vaccine is a participant in the trial.He also admits long-term protective efficacy against Covid-19.The woman on the phone call is suffering from Guillain-Barré syndrome after her first dose and recorded the conversation with this Moderna representaive. https://vidmax.com/video/205736-moderna-rep-admits-during-phone-call-that-everyone-getting-vaccinated-is-part-of-phase-3-of-trails
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The clinical trial results on the use of anti-parasitic drug Ivermectin as a treatment for coronavirus disease (COVID-19) could be expected by January 2022 or by first quarter of 2022, a top official of the Department of Science and Technology-Philippine Council for Health Research and Development (DOST-PCHRD) said Monday, May 3. DOST-PCHRD Executive Director Dr. Jaime C. Montoya said preparations were underway to ensure the smooth conduct of the clinical trial, which will likely be conducted by end of May or first week of June. "The clinical trial may be completed before the end of year, but of course, the...
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The Philippine College of Physicians (PCP) maintained that people should wait for the results of the clinical trials of the anti-parasitic drug Ivermectin before it can be used for the treatment of coronavirus disease (COVID-19) in the country. PCP Vice President Dr. Maricar Limpin warned that taking the drug despite the lack of evidence to support claims that it is supposedly effective against COVID-19 will only give people false security. “Our position in that is we still have to wait for the results of the clinical trials because that will be our evidence on whether we can give it for...
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