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. Save your seat at IDBS’s upcoming webinar. Source link.

Vaccine 52

Vaccine Virus International Immune Response 52

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

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

Codon

OCTOBER 13, 2024

.” From their first intrepid steps into the fields, GM crops have become a scapegoat for distrust in science and its overextension into formerly “unadulterated” products. Genetic engineering in the medicine cabinet is one thing; allowing it at the dinner table is another. Yields were devastated.

Engineering 104

Engineering Virus Production DNA 104

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 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

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. That product often failed to detect cases involving two iPhones because of restrictions imposed on third-party software by Apple.

Trials 52

Trials Virus Government Production 52

The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. The full set of results will be published once the complete Phase 1/2a trial data are available.

Clinical Trials 52

Clinical Trials Vaccine Trials 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

DrugBank

MARCH 12, 2025

Its individualized neoantigen-specific immunotherapy platform has demonstrated promising results in early clinical trials for melanoma and other cancers. Many genetic disorders result from mutations that impair the production of functional proteins, leading to severe physiological consequences.

Vaccine 97

Vaccine Treatment Clinical Trials Therapies 97

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. Efforts are also underway to enable the product to be stable at routine refrigerator temperature (2-8°C).

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

Drug Target Review

DECEMBER 5, 2024

The large number of ongoing clinical trials of recombinant AAV (rAAV)-based therapies highlights their promise for addressing a wide variety of human genetic disorders. These production challenges should be met with precise and sensitive tools that can prevent roadblocks during vector development for new therapies.

Therapies 52

Therapies Virus DNA Compliance 52

The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

Trials 52

Trials Production Clinical Trials Government 52

The Pharma Data

DECEMBER 21, 2020

Nasdaq:BCRX) today announced that data from part 1 of a clinical trial of its broad-spectrum antiviral, galidesivir, showed that galidesivir was safe and generally well tolerated in patients infected with SARS-CoV-2, the virus that causes COVID-19. The trial was conducted in Brazil under a U.S. RESEARCH TRIANGLE PARK, N.C.,

Clinical Trials 52

Clinical Trials Virus RNA Trials 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

OCTOBER 30, 2020

30, 2020 /PRNewswire/ — The IDMC also recommends continuation of enrollment in the REGN-COV2 outpatient trial. NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified.

Hospitals 52

Hospitals Virus Production Clinical Trials 52

The Pharma Data

JANUARY 11, 2021

-based company has been in business for 10 years, but the COVID-19 vaccine was its first approved product. Using the same technology, it is now developing a seasonal flu vaccine program to cover four seasonal viruses recommended by the World Health Organization, with a phase 1 clinical trial scheduled to begin this year.

Vaccine 52

Vaccine Clinical Trials Virus RNA 52

The Pharma Data

JANUARY 21, 2021

Senhwa’s Silmitasertib is an oral medication, targeting the host protein kinase CK2 (casein kinase 2), where virus mutations are unlikely to affect its anti-viral and anti-inflammatory efficacy. It is thought that Silmitasertib challenges the virus’ ability to replicate quickly and spread to nearby healthy cells.

Trials 40

Trials Treatment Small Molecule Hospitals 40

The Pharma Data

NOVEMBER 22, 2020

As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. Trials are also being run in the U.S.,

Vaccine 52

Vaccine Virus Trials Regulations 52

The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,

Trials 40

Trials Production Clinical Trials Therapies 40

The Pharma Data

NOVEMBER 14, 2020

In addition to the single-dose regimen ENSEMBLE study, Janssen has now initiated the two-dose regimen ENSEMBLE 2 trial. The ENSEMBLE and ENSEMBLE 2 trials will run in parallel. As such, we are investigating multiple doses and dosing regimens to evaluate their long-term efficacy. PHASE 3 ENSEMBLE 2 STUDY.

Clinical Trials 40

Clinical Trials Vaccine Trials Pharmaceutical Companies 40

The Pharma Data

DECEMBER 3, 2020

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

Vaccine 52

Vaccine Immune Response Virus RNA 52

The Pharma Data

NOVEMBER 13, 2020

If not enough children are immunized against polio, the weakened virus can pass between individuals and over time genetically revert to a form that can cause paralysis. If not enough children are immunized against polio, the weakened virus can pass between individuals and over time genetically revert to a form that can cause paralysis.

Vaccine 52

Vaccine Virus Clinical Trials Licensing 52

Fierce BioTech

JULY 17, 2023

Sponsors are faced with a stark learning curve that, without intervention, may lead to high costs, delays, and a failure to bring their drug to patients.

Clinical Trials 52

Clinical Trials Virus Trials Therapies 52

The Pharma Data

DECEMBER 10, 2020

In the study, immunization with the hAd5-COVID-19 vaccine inhibited SARS-CoV-2 virus replication in 100% (10 of 10) of Rhesus macaques, with a drop in viral replication starting on the first day of vaccine administration, and undetectable viral levels as early as three to five days post-challenge in most of the animals.

Vaccine 52

Vaccine Immune Response Virus Clinical Trials 52

The Pharma Data

AUGUST 18, 2020

REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S. and around the world.

Clinical Trials 52

Clinical Trials Virus Trials Treatment 52

The Pharma Data

JANUARY 21, 2021

Cabotegravir is a ViiV product marketed as Cabenuva, and rilpivirine is a Janssen product with a brand name Edurant. The approval was built on the Phase III ATLAS and FLAIR trials. In the trials, Cabenuva was as effective as a daily oral three-drug regimen. Janssen is a Johnson & Johnson company. clinical practices.

FDA Approval 52

FDA Approval Treatment FDA Clinical Trials 52

The Pharma Data

OCTOBER 27, 2021

The scientists are confident of the efficiency of the new product. “The main finding in our study is that the equine hyperimmune globulins antibodies developed against the spike protein of the ancestral SARS-CoV-2 had high neutralizing action against the new variants of the virus, such as the gamma strain. .

Clinical Trials 52

Clinical Trials Virus Production Treatment 52

The Pharma Data

APRIL 15, 2022

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced positive results from a Phase 2/3 clinical trial evaluating the safety, tolerability and immunogenicity of a 10-µg booster (third) dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children 5 through 11 years of age. About the Phase 1/2/3 Trial in Children. Pfizer Inc.

Immune Response 52

Immune Response Vaccine Clinical Trials Virus 52

Advarra

AUGUST 8, 2023

These studies were previously considered to be highly experimental and limited to early phase trials at a handful of highly specialized academic medical centers. As of June 2023, 416 Phase III studies are listed, representing a growing pipeline of gene therapy products preparing to undergo consideration for FDA approval.

Therapies 52

Therapies Research Engineering Clinical Research 52

The Pharma Data

AUGUST 16, 2021

Still, with the continuing threat of the Delta variant and possible emergence of other variants in the future, we must remain vigilant against this highly contagious virus,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. We continuously strive to stay at least one step ahead of the virus.

Vaccine 52

Vaccine FDA Virus Immune Response 52

The Pharma Data

JANUARY 29, 2021

Following review of the application, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on data from a rolling review of trial data from the primary analysis of the Phase III programme led by the University of Oxford.

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

The Pharma Data

JANUARY 29, 2021

Following review of the application, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on data from a rolling review of trial data from the primary analysis of the Phase III programme led by the University of Oxford.

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

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. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

Hospitals 52

Hospitals Production Clinical Trials Virus 52

The Pharma Data

NOVEMBER 9, 2020

Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November. Data from the event-driven trial could support global authorization and approval, including in the U.S. and globally.”. About NVX-CoV2373. and Australia. billion from the U.S. government.

Vaccine 52

Vaccine FDA Clinical Trials Immune Response 52

Alta Sciences

JULY 25, 2024

Discover some of the nonclinical requirements for moving dermal studies into Phase I clinical trials, including formulation considerations, species selection, and ideal candidates for transdermal drug delivery systems (TDDS). Read or listen now. Watch the webinar. Because of this, considering other regulatory pathways is necessary.

Science 52

Science Clinical Trials Clinical Pharmacology FDA 52

The Pharma Data

DECEMBER 16, 2020

The company will work with Medsafe, New Zealand’s regulatory agency, to obtain product approvals as needed. Food and Drug Administration, European Medicines Agency and/or Medicines and Healthcare products Regulatory Authority in the United Kingdom. NVX-CoV2373 is being evaluated in an ongoing Phase 3 trial in the U.K.

Vaccine 52

Vaccine Government Immune Response Clinical Trials 52