The Pharma Data

DECEMBER 29, 2020

29, 2020 /PRNewswire/ — Phase 3 program in hospitalized patients to continue based on passing futility analysis on ability to reduce incidence of death or mechanical ventilation. As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes.

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The Pharma Data

SEPTEMBER 14, 2020

A new antibody treatment is to be trialled on Covid-19 patients in UK hospitals. It forms part of the UK Recovery Trial, which found that a cheap steroid called dexamethasone could save lives. We need to know, and the way to know is to do the trials that will tell us whether that hope turns into reality.”.

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The Pharma Data

OCTOBER 23, 2020

A solidarity clinical trial “is one of the largest international randomized trials for Covid-19 treatments, enrolling almost 12,000 patients in 500 hospital sites in over 30 countries”, according to the World Health Organization (WHO), which launched the trail with a number of partners.

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The Pharma Data

JANUARY 25, 2021

Regeneron’s monoclonal antibody cocktail reduced medical visits for COVID-19 patients who had not been hospitalized by almost 50 percent, according to interim clinical trial results reported by researchers at the company. And safety outcomes were similar in the REGN-COV2 dose groups and the placebo group.

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Drug Discovery World

APRIL 20, 2023

There is a clear opportunity to repurpose some of these candidates for preventative/ prophylactic treatment for post-Covid-19 cognitive impairment. These may provide an opportunity for treatment for post-Covid-19 cognitive impairment. New therapeutics of course depend on an understanding of biological mechanisms.

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The Pharma Data

NOVEMBER 12, 2020

12 November 2020 — The CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. No new safety signal for Calquence was observed in the trials. No new safety signal for Calquence was observed in the trials.

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The Pharma Data

DECEMBER 17, 2020

(NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. “The investigational cocktail is now available to indicated high-risk U.S.

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The Pharma Data

JANUARY 3, 2021

Anecdotal feedback from Foralumab-treated patients was positive and suggests that the treatment was well-tolerated. This trial is the first to evaluate nasally administered Foralumab to improve the immune system’s fight against coronaviruses. NEW YORK and LONDON, Jan.

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NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

hospitals are stretched to the limit trying to help people battling serious cases of COVID-19. Yet the quest to save more lives from COVID-19 isn’t even close to being finished, and researchers continue to work intensively to develop new and better treatments. Credit: NIH Right now, many U.S.

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Drug Discovery World

APRIL 14, 2023

Pettit Nassi and Perlmutter will be honoured during the AACR Annual Meeting 2023 Opening Ceremony on Sunday April 16 at 8am ET. Wherry’s award lecture will be held on Monday April 17 at 3:30pm ET. Simon’s award lecture will be held on Sunday April 16 at 3pm ET.

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The Pharma Data

APRIL 8, 2022

Now, new research from the Wyss Institute at Harvard University has revealed that this constant pattern of stretching and relaxing does even more – it generates immune responses against invading viruses. a Wyss Technology Development Fellow at the Institute. ” The results are published today in Nature Communications. .

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The Pharma Data

OCTOBER 26, 2020

FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). Only a fraction of intravenous antibody treatments will make their way to the lungs of COVID-19 patients, which is where the infection is primarily located.

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Agency IQ

DECEMBER 1, 2023

That guidance, first issued in May 2020 , was released at a time when there were no FDA-approved drugs to treat Covid-19, and the standard-of-care for treatment relied on clinical management of symptoms and supportive care (e.g., Lastly, the revised guidance briefly discussed trials meant to assess drugs intended for prevention of Covid-19.

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The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. TARRYTOWN, N.Y. , 28, 2020 /PRNewswire/ — . Regeneron has shared these results with the U.S. Regeneron has shared these results with the U.S.

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The Pharma Data

NOVEMBER 18, 2020

. “Based upon our anti-Globo H targeted approaches in cancers of high unmet needs, OBI Pharma is proud to have presentations on the progress of our trial presented at ESMO-Asia 2020 for our novel therapeutic cancer vaccine, OBI-833.” Title: A phase I cohort expansion trial of OBI-833 in non-small cell lung cancer patients.

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The Pharma Data

JUNE 17, 2022

In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety profile similar to placebo in young children ages 6 months through 4 years in Phase 2/3 clinical trial Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S.

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NIH Director's Blog: Drug Development

FEBRUARY 1, 2022

Though more study is needed, the researchers say the decoy therapy could potentially be delivered directly to the lungs through an inhaler and used alone or in combination with other COVID-19 treatments. The researchers had been intrigued by an earlier clinical trial testing the ACE2 decoy strategy [2]. Nat Chem Biol. 2022 Jan 19. [2]

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The Pharma Data

OCTOBER 16, 2020

COVID-19 Antibody Treatment Study Paused. Immune Responses Long-Lasting After Serious COVID-19. NIH Launches Trial of Antibody Drugs Against COVID-19. Second COVID-19 Vaccine Trial Paused for Unexplained Illness. THURSDAY, Oct. 12 in JAMA Pediatrics. Read Full Article. WEDNESDAY, Oct. Read Full Article.

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Broad Institute

OCTOBER 4, 2023

Cancer immunotherapy drugs called PD-1 inhibitors are widely used to stimulate the immune system to fight cancer, but many patients either don’t respond or develop resistance to them. A new small-molecule drug candidate being tested in an early-stage clinical trial aims to improve patient responses to immunotherapy.

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The Pharma Data

NOVEMBER 1, 2020

Trial facilitated with coll a boration of Harvard Medical School and one of the world’s top Neurologist, Dr. Howard Weiner. This clinical trial will be coordinated by the team at the INTRIALS, a leading, full-service Latin America Clinical Research Organization (CRO), based in Sao Paulo City, Brazil.

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Broad Institute

AUGUST 7, 2023

Now, a team of MIT, Massachusetts General Hospital (MGH), Broad Institute of MIT and Harvard, and Harvard Medical School (HMS) researchers has discovered how STING activates those two pathways. Food and Drug Administration has not approved any STING agonist thus far, although multiple clinical trials are currently underway.

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The Pharma Data

FEBRUARY 23, 2022

* Final analysis of the global VAT02 booster trial confirms universal ability to boost neutralizing antibodies 18- to 30-fold across vaccine platforms (mRNA, adenovirus). * About VAT08 and VAT02 The Phase 3 trial, VAT08 is evaluating a 10µg antigen formulation of the SARS-CoV-2 adjuvanted recombinant protein-based vaccine?for

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The Pharma Data

NOVEMBER 10, 2020

The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. We believe the scientific rationale for oral treatment with Foralumab is logical to facilitate topical action at the inflamed sites in the gastrointestinal tract. NEW YORK and LONDON, Nov. NEW YORK and LONDON, Nov. and Europe. Dr. Howard L.

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The Pharma Data

JANUARY 11, 2021

In clinical trials, it could detect COVID-19 with 90%+ accuracy in about two minutes. . By the end of January, Johnson & Johnson is expected to deliver preliminary trial results for its one-dose COVID-19 vaccine candidate. . I-SPY COVID-19 is assessing multiple drugs for critical COVID-19 hospitalized or ICU patients.

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The Pharma Data

DECEMBER 23, 2020

Joseph Kim , President and CEO of INOVIO, said, “We are very pleased to share peer-reviewed Phase 1 clinical data for INO-4800 published in The Lancet’s EClinicalMedicine , and are grateful for the support of all participants and investigator staff involved in the clinical trial.” mg and 2.0 mg and 2.0 The 1.0

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The Pharma Data

FEBRUARY 18, 2022

“For clinicians treating patients with this serious, chronic disease, results from the True North extension study provide an understanding of long-term therapeutic outcomes and help to identify an appropriate treatment approach for their patients with ulcerative colitis,” said Silvio Danese, M.D., About Ulcerative Colitis.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2). i,ii,iii,iv.

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The Pharma Data

SEPTEMBER 17, 2020

The Elecsys Anti-SARS-CoV-2 serology test can be used to quantitatively measure antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and can play an important part in characterising a vaccine-induced immune response. said Thomas Schinecker, CEO Roche Diagnostics.

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The Pharma Data

NOVEMBER 19, 2020

The study data came from a prospective study of participants at Rutgers and affiliated hospitals during the early phase of the pandemic. The study evaluated 546 healthcare works with direct patient exposure at two hospitals in New Jersey and 283 non-healthcare workers that did not have direct patient contact. Source link.

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The Pharma Data

DECEMBER 18, 2020

. “ With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen M. Hahn , M.D. It is mandatory for ModernaTX, Inc.

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Drug Discovery World

AUGUST 2, 2023

PPT1 inhibitors for the treatment of patients with cancer Contemplating the potential of PPT1 inhibition in cancer led to the development of small molecules with high PPT1 affinity and limited toxicity for clinical drug development. Inhibiting PD-L1 palmitoylation enhances T-cell immune responses against tumours.

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Codon

JULY 14, 2024

The transfusion of platelets thus seems like an obvious treatment to stem bleeding. However, the subsequent death of another patient thrust Denys into a contentious trial. Despite the high costs, researchers in Kyoto generated enough cultured platelets in 2022 to transfuse a 55-year-old woman for an initial human trial.

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The Pharma Data

NOVEMBER 29, 2020

HB-101, a non-replicating arenavirus vaccine, is being investigated in a double-blind Phase 2 clinical trial (NCT03629080) to assess safety, immunogenicity and efficacy in individuals receiving a kidney transplant from a living donor. Safety and tolerability were evaluated in 69 participants who were enrolled in the trial by the cut-off date.

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Drug Discovery World

MARCH 13, 2023

GenSight Biologics has revealed pooled safety data from five clinical studies of lenadogene nolparvovec (Lumevoq), the largest cohort of ND4-LHON (Leber hereditary optic neuropathy) patients studied after gene therapy treatment. The results also highlight a comparable safety profile for unilaterally and bilaterally treated patients. “The

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Drug Discovery World

FEBRUARY 6, 2023

It’s a rapid growth area for clinical trials in the next few years as we seek to understand the underlying biology behind many of the targets and diseases we study. For example, we noticed in a report that signal of the treatment effect in the data was not aligned with what would be expected.

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The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021. We look forward to sharing initial results by year-end. ”. “

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The Pharma Data

APRIL 16, 2021

Approval based on Phase 3 CheckMate -9ER trial results showing Opdivo in combination with Cabometyx significantly improved overall survival and doubled median progression-free survival and objective response rates compared to sunitinib. professor of medicine and urology department head, Jena University Hospital.

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