The Pharma Data

AUGUST 3, 2021

The drug, which has undergone several clinical trials for human conditions but has not yet received approval to treat humans, inhibited the replication of SARS-CoV-2, the virus that causes COVID-19, in human cell cultures and in a mouse model, leading to much lower viral loads. The research team, including scientists from the U.S. .

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The Pharma Data

JULY 21, 2021

Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, and Pfizer Inc. If successful, this trial could enable the inclusion of a pediatric population in the Phase 3 trial.

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The Pharma Data

MARCH 23, 2022

To treat Ebola virus infections, researchers are taking a close look at a key piece of the virus: polymerase. Polymerase is a viral protein that directs how Ebola virus replicates its genome as it infects new hosts. Drugs that target polymerase could potentially treat Ebola virus infections and save lives.

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The Pharma Data

APRIL 8, 2022

Using a Human Lung Chip that replicates the structures and functions of the lung air sac, or “alveolus,” the research team discovered that applying mechanical forces that mimic breathing motions suppresses influenza virus replication by activating protective innate immune responses. During his Ph.D.

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Codon

AUGUST 26, 2024

When COVID-19 emerged in 2019, by contrast, mRNA vaccines developed by Pfizer and Moderna took just 326 days from the initial sequencing of the virus to gaining approval for emergency use. These drugs would be ideal tools to bridge the wait for a vaccine against a quickly-spreading virus. Unsubscribe any time.

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Advarra

JUNE 13, 2024

Recombinant DNA technologies and genetically modified biological agents are being adapted for a wide scope of therapeutic applications, and their use is becoming increasingly common in clinical trials. For example, a site conducting only protocols involving mRNA may be able to leverage a generic SOP covering any mRNA protocol at that site.

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The Pharma Data

AUGUST 22, 2021

The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium.

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The Pharma Data

NOVEMBER 18, 2020

18, 2020 — Children should be included in clinical trials for a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine at the earliest stages, according to a letter from the president of the American Academy of Pediatrics (AAP), on behalf of more than 67,000 pediatricians and pediatric medical and surgical subspecialists.

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The Pharma Data

APRIL 27, 2023

1 If approved, GSK’s candidate has the potential to be the first vaccine available to help protect older adults from RSV disease. The positive opinion is supported by data from the pivotal AReSVi-006 ( A dult R espiratory S yncytial V irus) phase III vaccine efficacy trial.

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The Pharma Data

SEPTEMBER 2, 2021

RSV is a significant cause of severe respiratory disease in older adults, and it can cause disability and death. There is an important unmet medical need for an effective vaccine that can help protect older adults against this highly-contagious disease,” said Kathrin U. Jansen, Ph.D., Burden of RSV. 2 In the U.S.,

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The Pharma Data

MARCH 3, 2022

Pfizer will publish outcomes from this clinical trial at a future date. Today’s decision is a pivotal next step in our path towards potential regulatory approval for our maternal RSV vaccine candidate and is an important milestone in our efforts to help address the detrimental impact RSV disease has on infants,” said Kathrin U.

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The Pharma Data

JUNE 25, 2021

AstraZeneca today announced results from the STORM CHASER trial assessing the safety and efficacy of AZD7442, a long-acting antibody (LAAB) combination, for the prevention of symptomatic COVID-19 in participants recently exposed to the SARS-CoV-2 virus. The PROVENT trial will give us more clarity in this patient population.

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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.

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The Pharma Data

DECEMBER 8, 2020

8 December 2020 — Results of an interim analysis of the Phase III programme conducted by Oxford University with AZD1222, peer-reviewed and published in The Lancet today, demonstrated that the vaccine is safe and effective at preventing symptomatic COVID-19 and that it protects against severe disease and hospitalisation.

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The Premier Consulting Blog

JUNE 18, 2023

One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases. However, with rare diseases there may be no available treatments that could serve as SoC or active control in a clinical trial and assigning patients to placebo may be unethical.

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The Pharma Data

MARCH 22, 2021

100% efficacy against severe or critical disease and hospitalisation. The AstraZeneca US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation.

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Broad Institute

JANUARY 30, 2024

Bhattacharyya wears many coats today, splitting his time between the Broad and the infectious disease ward at MGH, where a diagnostic method he developed at Broad is now being tested to see if it helps patients quickly receive the best antibiotics for their infections.

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The Pharma Data

DECEMBER 15, 2020

A healthy immune system defends the body against disease and other conditions. Autoimmune disease impacts different parts of the body, weakening functionality. Researchers are aware of more than 80 diseases that occur when the immune system attacks the body’s own organs, tissues and cells. It may be life-threatening.

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The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

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Codon

SEPTEMBER 29, 2024

The earliest ones relied on simple linear regression and attempted to correlate genetic variations with observable traits or disease risks — such as drug metabolization rates or cancer susceptibility. The average pass rate of phase I trials went up by 5 percent. 2024 Statistical models of organisms have existed for decades.

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The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. EMERYVILLE, Calif. and CHENGDU, China , Feb.

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The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has granted Fast Track designation to VTX-801, Vivet’s clinical-stage gene therapy for the treatment of Wilson Disease – a rare, genetic disorder that reduces the ability of the liver and other tissues to regulate copper levels, causing severe hepatic damage, neurological symptoms, and potentially death.

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The Pharma Data

MARCH 3, 2021

(Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today provided an update on the VIR-7831 (GSK4182136) arm of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial.

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The Pharma Data

DECEMBER 3, 2020

New Tau Protein is Abnormal in Very Early Alzheimer’s Disease. Investigators with the University of Gothenburg identified new forms of tau protein that become abnormal in the very early stages of Alzheimer’s disease, even before the development of cognitive problems. Kidney Disease Leading Risk Factor for COVID-related Hospitalization.

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The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. About the Phase 1/2 clinical trial. Expected to enroll 415 participants; interim results expected in Q3 2021.

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The Pharma Data

JUNE 7, 2023

This authorisation for Arexvy means eligible adults can be vaccinated against RSV disease for the first time, reinforcing GSK’s long history of vaccine innovation. 1 Those with underlying medical conditions, such as diabetes and chronic heart and lung disease, drive the majority of RSV hospitalisations. Find out more at gsk.com.

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The Pharma Data

JUNE 25, 2021

In the unprecedented context of at least 13 variants circulating within the study population subset assessed at this interim analysis, CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. 37, first identified in Peru (21%) and B.1.621,

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The Pharma Data

OCTOBER 12, 2021

Trial met primary endpoint. The trial met the primary endpoint, with a cure of 600 mg of AZD7442 given by intramuscular (IM) injection reducing the threat of developing severe COVID-19 or death (from any cause) by 50 compared to placebo in rehabilitants who had been characteristic for seven days or lower.

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The Pharma Data

JANUARY 17, 2021

The treatment could be administered in primary care centers to people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease and complementing the vaccine in the early phase after vaccination. BARCELONA, Spain , Jan. 18, 2021 /PRNewswire/ — Grifols (MCE: GRF, MCE: GRF.P,

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The Pharma Data

DECEMBER 23, 2020

But three clinical trials testing full doses of these drugs in COVID-19 patients have now paused recruitment of critically ill patients because the medications could end up doing more harm than good. The three trials are being conducted on four continents. WEDNESDAY, Dec.

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Drug Target Review

OCTOBER 26, 2023

1 Adeno-associated virus (AAV) vectors are the leading platform for in vivo gene delivery for the treatment of various human diseases. It has been well established that exposure to wild-type AAV results in priming of the immune system against the virus. Adeno-associated virus vector as a platform for gene therapy delivery.

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The Pharma Data

APRIL 3, 2021

The CoVIg-19 Plasma Alliance today announced that the Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints. About the ITAC Trial.

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The Pharma Data

APRIL 26, 2022

NYSE: PFE) today reported positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15. Based on these new results, Valneva and Pfizer plan to proceed with inclusion of pediatric participants in their planned Phase 3 trial. Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc.

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The Pharma Data

DECEMBER 5, 2020

.–(BUSINESS WIRE) December 5, 2020 — Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, today announced new clinical data from its Phase 2 trial evaluating SY-1425, its first-in-class selective retinoic acid receptor alpha (RAR?)

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Codon

MARCH 20, 2023

Genetic association analysis of 77,539 genomes reveals rare disease etiologies. How to build a virus-proof cell. Synchron to Begin Patient Enrollment for the COMMAND Trial of Brain-Computer Interface at Gates Vascular Institute. Biointerface mineralization generates ultraresistant gut microbes as oral biotherapeutics.

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The Pharma Data

DECEMBER 23, 2020

Eligible patients enrolled in the trial receive treatment with AIM’s flagship pipeline drug Ampligen. The Ampligen EAP protocol is authorized to enroll up to 100 active trial participants, 20 of whom may be Long Haulers. Centers for Disease Control and Prevention’s criteria for chronic fatigue syndrome. See: PLOS ONE ).

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The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e., futility analysis).

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