The Pharma Data

SEPTEMBER 14, 2020

. AstraZeneca has confirmed that clinical trials assessing its Oxford University partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA). Source link. Source link.

Vaccine 52

Vaccine Trials Immune Response Virus 52

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.

Virus 52

Virus Small Molecule Protein Production Research 52

The Pharma Data

MARCH 8, 2021

The companies today reported findings on one secondary objective from the Phase 2a study, showing a reduction in time (days) to negativity of infectious virus isolation in nasopharyngeal swabs from participants with symptomatic SARS-CoV-2 infection, as determined by isolation in Vero cell line culture. About Molnupiravir.

Trials 69

Trials Virus RNA Research Laboratories 69

Drug Discovery Today

AUGUST 18, 2022

The large European interventional clinical study is investigating protection against Respiratory syncytial virus (RSV) in infants. HARMONIE is an open label trial that will evaluate the use of nirsevimab, a passive immunisation, in a broad population.

Virus 100

Virus Trials Research 100

Chemical Biology and Drug Design

OCTOBER 10, 2023

Abstract Human immunodeficiency virus (HIV) causes acquired immunodeficiency syndrome (AIDS), a lethal disease that is prevalent worldwide. Several agents are in clinical trials, including apricitabine, racivir, elvucitabine, doravirine, dapivirine, and elsulfavirine. Molecular insights of HIV Reverse transcriptase and it's inhibitors.

FDA Approval 100

FDA Approval Clinical Trials FDA Virus 100

The Pharma Data

AUGUST 13, 2020

With most vaccine trials ending in failure, the government is effectively hedging its bets, hoping that at least one of the vaccines it has purchased proves safe and effective. Inactivated whole virus vaccines: 60 million doses Valneva. In theory, there should be enough for everyone in the UK to get five doses.

Vaccine 52

Vaccine Virus Government Clinical Trials 52

SCIENMAG: Medicine & Health

NOVEMBER 6, 2023

The fight against dengue fever has a new weapon: a mosquito infected with the bacteria Wolbachia, which prevents the spread of the virus. These mosquitoes have now been deployed in several trials demonstrating their potential in preventing disease transmission.

Virus 89

Virus Trials Disease 89

The Pharma Data

SEPTEMBER 1, 2020

AstraZeneca has started a Phase 3 trial of its experimental coronavirus vaccines in the US, making it the third company to start late-stage trials of a vaccine. . The trial will see participants receive either two doses of the vaccine or a placebo. Photo by Daniel Paquet from Regina, Canada. Conor Kavanagh. Source link.

Vaccine 52

Vaccine Trials Immune Response Virus 52

The Pharma Data

AUGUST 20, 2020

NHS staff are taking part in a trial to see if dogs can sniff out Covid-19 – even in people who are asymptomatic. If the trial is successful, the dogs could be used at UK airports to screen people arriving from abroad. If the trial is successful, the dogs could be used at UK airports to screen people arriving from abroad.

Trials 52

Trials Nurses Hospitals Virus 52

The Pharma Data

SEPTEMBER 25, 2020

A trial of a new vaccine that appears to train the immune system to fight coronavirus has begun in the UK. Early tests showed the jab, developed by US biotechnology company Novavax, leads to high levels of virus-fighting antibodies being produced. The trial on 10,000 people will now see if the vaccine can prevent people getting ill.

Vaccine 52

Vaccine Trials Immune Response Virus 52

The Pharma Data

AUGUST 28, 2020

Celltrion Group has announced that the Korean Ministry of Food and Drug Safety has approved the company’s Investigational New Drug application for a Phase 1 trial for their coronavirus antiviral antibody treatment candidate.

Trials 52

Trials Treatment Clinical Trials Pharmacokinetics 52

The Pharma Data

AUGUST 27, 2020

Moderna has announced that its coronavirus vaccine candidate has shown promise in generating an immune response in elderly patients in an early-stage clinical trial. . These antibodies were higher than those seen in people who had recovered from the virus. Each patient was given two 100 microgram doses of the vaccine 28 days apart.

Vaccine 90

Vaccine Immune Response Clinical Trials Virus 90

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. In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36

Virus 40

Virus Trials Clinical Trials Production 40

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.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration were based on mRNA, more conventional protein-based vaccines have also shown promise in clinical trials. Although the first vaccines to receive Emergency Use Authorization by the U.S. So the team made polymersomes that were similar in size to SARS-CoV-2 and decorated them with many RBDs.

Vaccine 52

Vaccine Virus Immune Response Clinical Trials 52

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.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

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.

Vaccine 52

Vaccine Trials Virus RNA 52

The Pharma Data

NOVEMBER 13, 2020

A new survey shows one in five cancer patients are far less likely to participate in future clinical trials due to fear of COVID-19 exposure, raising the question of whether enrollment levels that have dropped precipitously since the beginning of the pandemic are likely to recover after the virus is controlled. percent since March 15.

Trials 52

Trials Clinical Trials Virus Research 52

The Pharma Data

SEPTEMBER 17, 2020

The illness of one of the participants in the Oxford-AstraZeneca COVID-19 vaccine trial may not have been caused by the treatment itself, according to newly revealed information. . The trials testing the vaccine have resumed in Britain, Brazil and South Africa after they were initially paused on 6 September. Photo by Retha Ferguson.

Vaccine 52

Vaccine Trials Virus Treatment 52

The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19.

Clinical Trials 52

Clinical Trials Trials Packaging Therapies 52

The Pharma Data

SEPTEMBER 23, 2020

The halting of AstraZeneca’s COVID-19 vaccine trial around the world was cause for much initial concern over the eventual safety and efficacy of the therapy. Trials have resumed in the UK, Brazil and South Africa, but US trials remain on hold. Matt Fellows. Source link.

Vaccine 52

Vaccine Trials Science Regulations 52

The Pharma Data

NOVEMBER 10, 2020

Johnson & Johnson (J&J) announced that it has restarted all clinical trials in Europe evaluating its COVID-19 vaccine, Ad26.COV2.S, The clinical trials resuming in Europe this week are phase 2 studies in Germany, the Netherlands and Spain, as well as a phase 1/2 study in Belgium, the company said. . Source link.

Vaccine 40

Vaccine Trials Clinical Trials Virus 40

SCIENMAG: Medicine & Health

JUNE 21, 2023

In an earlier clinical trial, in which the Bochum researchers were also involved, patients with chronic hepatitis E virus (HEV) infection were treated with the drug sofosbuvir, which was actually developed for the treatment of hepatitis C. […] Which viral variants circulate in the blood?

Therapies 72

Therapies Clinical Trials Virus Trials 72

The Pharma Data

JANUARY 6, 2021

A Novel Ebola Virus VP40 Matrix Protein-Based Screening for Identification of Novel Candidate Medical Countermeasures.’ The published study results showed that OYA1 was “highly effective” in reducing the spread of Ebola Virus infection in laboratory tests with the live Ebola virus carried out by NIAID.

Virus 40

Virus Clinical Trials Government Laboratories 40

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?)

Clinical Trials 52

Clinical Trials Trials Small Molecule Treatment 52

The Pharma Data

AUGUST 13, 2020

A trial of the English coronavirus app is getting under way. The software will tell users to self-isolate for a fortnight if the app detects they have been close to someone else diagnosed with the virus. It will be limited to residents in the Isle of Wight, the London Borough of Newham and NHS volunteer responders to begin with.

Trials 52

Trials Virus Government Production 52

The Pharma Data

JUNE 25, 2021

The outcome confirms that only one single case was attributable to the original SARS-CoV-2 virus. “In addition, the variant-rich environment underlines the importance of developing next-generation vaccines as new virus variants continue to emerge.” More than half of the cases (57%) were caused by Variants of Concern.

Vaccine 52

Vaccine Trials Immune Response Virus 52

The Pharma Data

NOVEMBER 27, 2020

UK firm develops solution for identifying whether patients are actually infectious from a virus or not. Iceni Diagnostics has revealed it is developing a new technology that can disclose if patients are actually infectious with a live virus or not. Read on to for the full insight.

Vaccine 52

Vaccine Virus International Immune Response 52

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.

Clinical Trials 52

Clinical Trials Trials Treatment Hospitals 52

The Pharma Data

SEPTEMBER 12, 2020

Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.

Vaccine 52

Vaccine Trials Clinical Trials Small Molecule 52

The Pharma Data

MARCH 18, 2021

Medicago received approval from Canadian and US regulatory authorities to proceed with enrolment of healthy adults in the Phase 3 portion of the trial based on positive interim Phase 2 results. “We The Phase 2 portion of the trial is approaching completion and results are expected to be made publicly available in April 2021.

Vaccine 52

Vaccine Trials Clinical Trials FDA 52

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.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

APRIL 3, 2021

Johnson & Johnson (the Company) has begun vaccinating adolescent participants in the ongoing Phase 2a clinical trial for its COVID-19 vaccine candidate, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “The

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

OCTOBER 16, 2020

As pharma companies search for solutions to avoid cancelling or delaying clinical trials, virtualizing trials are fast becoming commonplace during the Covid-19 pandemic. With many nationwide and regional lockdowns coming into force, virtual clinical trials are proving to be an effective way to monitor patients remotely.

Clinical Trials 52

Clinical Trials Trials Pharma Companies Clinical Research 52

The Pharma Data

JANUARY 13, 2021

13, 2021 — A single-shot COVID-19 vaccine from Johnson & Johnson has shown very strong results in early clinical trials, potentially providing a significant boost to U.S. The vaccine produced an immune response of all 805 clinical trial participants within two months of inoculation, according to results published Jan.

Vaccine 40

Vaccine Trials Clinical Trials Immune Response 40

The Pharma Data

NOVEMBER 5, 2020

Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

The gene therapy demonstrated that it increased Factor IX (“FIX”) plasma levels at 6 months, the original primary endpoint of the Phase 3 trial. Again, this was despite the fact that subjects in the trial had demonstrated durable FIX activity to this point, with a mean of 41.5%

Therapies 119

Therapies FDA FDA Approval Treatment 119