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Subcutaneous injection of the immunotherapy nivolumab (brand name Opdivo) is noninferior to intravenous delivery and dramatically reduces treatment time in patients with renal cell carcinoma, as seen in the results of a large phase 3 clinical trial reported today. "The burden of treatment felt by cancer patients is tremendous. If nivolumab can be given as a subcutaneous injection instead of an intravenous infusion, their treatment experience will be significantly improved," says Dr. George. "Instead of one hour in an infusion chair, they will get the injection done in five minutes." The clinical trial began in May 2021, randomizing 495 patients...

UCI researchers have found that a simple sugar, N-acetylglucosamine, reduces multiple inflammation and neurodegeneration markers in people who suffer from multiple sclerosis (MS). In addition, they also found this dietary supplement improved neurological function in 30% of patients. A major issue with current therapies in MS is the inability to treat chronic-active neuroinflammation in the brain and the associated failure to repair the loss of myelin that covers and protects axons, the electrical wires of the brain. Over time, this leads to permanent nerve cell damage and slow progressive loss of neurological function in patients. "Our previous studies in mice...

Brief Summary: The CDC and WHO have deemed the COVID-19 virus a global pandemic of unprecedented severity in modern times. In 2019, this novel Coronavirus (COVID-19) emerged from the Asian continent and has now caused upwards of 1million deaths and over 6 million infections globally. Currently, the estimated global economic impact is over 5 Trillion dollars. Understanding the host response to pathogens, specifically the cellular and humoral responses, has played an important role in new non-antibiotic therapies. Bismuth subsalicylate (Pepto-Bismol) has a potential role in the clearance and/or recurrence of enteric viral infections.

ClinicalTrials.gov Identifier: NCT05295290 Recruitment Status : Not yet recruiting First Posted : March 25, 2022 Last Update Posted : October 19, 2022 Sponsor: Pfizer Collaborator: HealthCore-NERI Information provided by (Responsible Party): Pfizer Study Description Brief Summary: The primary aim of this low interventional cohort study is to characterize the potential long-term sequelae associated with myocarditis/pericarditis following vaccination with COMIRNATY, compared with associated myocarditis/pericarditis following COVID-19 in persons <21 years old, with up to 5 years of follow-up. Study Type : Interventional (Clinical Trial) Estimated Enrollment : 300 participants Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Masking Description:...

Fauci on covid boosters: "We don't have time to do a clinical trial" https://twitter.com/urhomie4l/status/1567785327594721281

Patients with a particular kind of cancer and a particular kind of mutation received a new therapy called dostarlimab and had results not seen in a cancer trial before. To be sure, the trial — led by doctors at Memorial Sloan Kettering and backed by drug maker GlaxoSmithKline — has only completed treatment of 12 patients, with a specific cancer in its early stages and with a rare mutation as well. But the results, reported Sunday in the New England Journal of Medicine and the New York Times, were still striking enough to prompt multiple physicians to tell the paper...

Dr. Cadegiani just published a new research paper (“Pfizergate 2.0 - Active actions against competitive anti- COVID drugs? The case of the anti-androgens.”) that shows that there is no rational explanation for the corruption of clinical trial results other than deliberate sabotage by Pfizer to ensure that there are no viable competitors to Pfizer's products. I interviewed him just minutes before he published the paper:

First human trial for intranasal vaccine for AD represents culmination of 20 years of research led at the Brigham Brigham and Women’s Hospital is set to begin a clinical trial that will test the safety and efficacy of a new vaccine delivered nasally intended to prevent and slow the progression of Alzheimer’s disease (AD). The trial represents the culmination of nearly 20 years of research led by Howard L. Weiner, MD, co-director of the Ann Romney Center for Neurologic Diseases at the Brigham. “The launch of the first human trial of a nasal vaccine for Alzheimer’s is a remarkable milestone,”...

[H/T Tatown]Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reportsSNIPA regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director,...

Pfizer Inc said on Monday it has started a large study testing its investigational oral antiviral drug for the prevention of COVID-19 infection among those who have been exposed to the virus. The drugmaker and its rivals, including U.S.-based Merck & Co Inc and Swiss pharmaceutical Roche Holding AG , have been racing to develop an easy-to-administer antiviral pill for COVID-19. The mid-to-late-stage study will test Pfizer's drug, PF-07321332, in up to 2,660 healthy adult participants aged 18 and older who live in the same household as an individual with a confirmed symptomatic COVID-19 infection. In the trial, PF-07321332, designed...

A new monoclonal antibody treatment has been found to protect chronically ill adults from developing COVID-19. The Phase 3 trial results suggest the novel antibody cocktail, delivered by intramuscular injection, could offer up to 12 months protection.

Some 93% of 90 coronavirus serious patients treated in several Greek hospitals with a new drug developed by a team at Tel Aviv’s Sourasky Medical Center as part of the Phase II trial of the treatment were discharged in five days or fewer. The Phase II trial confirmed the results of Phase I, which was conducted in Israel last winter and saw 29 out of 30 patients in moderate to serious condition recover within days. “The main goal of this study was to verify that the drug is safe,” Prof. Nadir Arber said. “To this day we have not registered...

Israel’s “precision medicine” for COVID-19, which tackles the immune overreaction that causes deterioration from the disease, will start a second round of clinical trials in Greece next week. The testing comes with interest in coronavirus drugs sky-high, amid spiraling cases in several countries where widespread vaccine protection isn’t expected anytime soon, including India, where there are more than 300,000 new cases per day, and Nepal, where hospitals are struggling. The inhaled drug EXO-CD24 was given to 30 patients in moderate condition or worse, and all of them recovered, 29 of them within three to five days. In February Tel Aviv’s...

CureVac's experimental COVID-19 vaccine failed in a pivotal clinical study, the biotech said Wednesday. It's the first late-stage study to flop, with CureVac's vaccine showing 47% effectiveness. The German biotech saw its stock price drop by more than 50% in post-market trading.

INOVIO's Pan-SARS-CoV-2 vaccine candidate INO-4802 is not matched to a single variant, unlike other variant vaccines in development; INO-4802 could potentially offer broader immune responsesPhase 1/2 clinical trials with INO-4802 are planned this yearINOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, today announced that its next-generation Pan-COVID-19 vaccine candidate, INO-4802, induced potent neutralizing antibodies and T cell responses against the original Wuhan strain as well as against B.1.1.7 (UK variant), B.1.351 (South African variant) and P.1. (Brazilian variant) in preclinical models. These...

While the focus has been largely on vaccines, you might have also heard Pfizer is trialing a pill to treat COVID-19. It almost sounds too good to be true. Indeed, the results are very preliminary — but it’s a promising approach. Where most antiviral agents we’ve tried to treat COVID-19 target the inflammatory and immune response resulting from infection, Pfizer’s pill directly targets SARS-CoV-2 — the virus itself. Mounting our defense against the virus Much of the illness associated with COVID-19 is due to the intense inflammatory and immune response that can occur with an infection. The most successful treatments...

As the first clinical trials in young children start, here’s what scientists want to know. Parents are clamouring to enrol their kids in the first COVID-19 vaccine trials in young children. “Somebody told me they called and called and called until they were allowed to participate,” says Kawsar Talaat, an infectious-disease physician and vaccine scientist at the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland. She is part of a trial that began testing the Pfizer–BioNTech vaccine in children under 12 in late March. As such trials get under way — Moderna began a similar study of its...

The New England Journal of Medicine (NEJM) published findings of the Phase 2b clinical trial conducted in South Africa. NEJM is recognized as the world’s leading medical journal. Shabir Madhi, Professor of Vaccinology, co-author of the study, and the Director of the Vaccines & Infectious Diseases Analytics Research Unit (Wits VIDA), led the Novavax Covid-19 vaccine trial in South Africa. The published data provide additional detail of an initial analysis conducted in January, while more robust data from a complete analysis of the study was subsequently shared in March 2021. Publication of initial primary analysis highlights cross-protection by the Novavax...

As the COVID-19 pandemic continues, the pace of vaccine development has surpassed anyone’s wildest expectations. Unfortunately, drug development for treatments has not kept the same pace. Indeed, there are still very few effective treatments for COVID-19. Now, a collaboration between four research institutes has identified the antimalarial drug amodiaquine as a potent inhibitor of SARS-CoV-2 infection in human lung cells and in living preclinical models. This breakthrough helped secure the inclusion of amodiaquine in a COVID-19 clinical trial that is currently underway in 13 different countries in Africa where this drug is inexpensive and widely available.The research is published in...

Drugmaker Pfizer is currently testing a single pill cure for COVID-19, and if all goes well, the drug could be available this year. The drug, called PF-07321332, is currently in a Phase One clinical trial with healthy adults. According to the Telegraph, the protease inhibitor may be available as soon as this year. The pill was unveiled at the American Chemical Society Spring 2021 meeting in early April. The drug works by targeting the main protease of SARS-CoV-2, the virus that causes COVID-19. By inhibiting the protease, the drug prevents the virus from reproducing itself within the body. CDC changes...