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.

Trials 52

Trials Vaccine Virus Pharmacokinetics 52

The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

Licensing 52

Licensing Licensing Therapies Engineering 52

Codon

JANUARY 21, 2024

Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October. But for all of their benefits, human challenge trials have their drawbacks. Jake himself has participated in both Zika and Shigella challenge trials.

Vaccine 109

Vaccine Trials Disease Treatment 109

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

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. The gene therapy demonstrated that it increased Factor IX (“FIX”) plasma levels at 6 months, the original primary endpoint of the Phase 3 trial. Essentially, FDA was now asking for 18 months of data following treatment.

Therapies 119

Therapies FDA FDA Approval Treatment 119

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. MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

NOVEMBER 2, 2020

GWACHEON, KOREA, November 02, 2020 /24-7PressRelease/ — The trial of Shincheonji Church of Jesus Chairman Man Hee Lee continued on October 21st as the court discussed the alleged violation of the Infectious Disease Prevention Act earlier this year. When in court, he has attended using a wheelchair.

Trials 52

Trials Licensing Licensing Virus 52

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

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.

Trials 52

Trials Treatment Virus Disease 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

Codon

SEPTEMBER 29, 2024

The average pass rate of phase I trials went up by 5 percent. At best, the corporations with the best models released weak versions to the public under non-commercial licenses. On the surface, they hadn't deviated much from the early 2020s: a virus infected a cell and released the genetic therapy hidden within.

Engineering 131

Engineering Virus DNA Therapies 131

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).

Hospitals 52

Hospitals Trials Clinical Trials Production 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

The Pharma Data

MARCH 16, 2021

Pascal Soriot, Chief Executive Officer, said: “The long-acting antibody combination has the potential to offer almost immediate protection to those who are not able to be vaccinated, to both prevent infection or treat the disease in patients already infected with the virus. Financial considerations.

Treatment 52

Treatment Virus Trials Government 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

The Pharma Data

SEPTEMBER 6, 2021

Takeda today announced that the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) will purchase 150 million doses of Novavax’ vaccine candidate (TAK-019 in Japan) manufactured in Japan by Takeda subject to licensing and approval. The details of the terms and conditions of the agreement are confidential.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

MARCH 14, 2021

This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines. Furthermore, in clinical trials, even though the number of thrombotic events was small, these were lower in the vaccinated group.

Vaccine 52

Vaccine Virus Licensing Licensing 52

The Pharma Data

MARCH 4, 2021

” Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus and BK virus were reported with Olumiant. Increases of ALT ?5x

Trials 52

Trials Therapies Treatment Clinical Trials 52

The Pharma Data

AUGUST 15, 2021

adults and children against the TBE virus when visiting or living in TBE endemic areas. is developed using a master ‘seed’ virus that is similar to the TBE virus found in nature. In clinical trials, the safety and immunogenicity of TICOVAC were assessed across two age groups (1-15 years of age and >16 years of age).

FDA Approval 52

FDA Approval Vaccine FDA Virus 52

The Pharma Data

DECEMBER 14, 2020

Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie. AbbVie has initiated a Phase I clinical trial of the antibody, and it will conduct the initial clinical program in the U.S. before expanding it into Europe.

Licensing 52

Licensing Licensing Pharmacokinetics Clinical Trials 52

The Pharma Data

OCTOBER 25, 2020

It was another busy week for clinical trial updates and news. Army Medical Research and Development (USAMRDC ) initiated a Phase I clinical trial of its novel vaccine against COVID-19. The trials won’t begin until early 2021 and are expected to finish in May 2021. The trial has already restarted in the UK and elsewhere.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

The Pharma Data

NOVEMBER 22, 2020

MP0420 is subject to an option and license agreement with Novartis AG to develop, manufacture and commercialize Molecular Partners’ anti-COVID-19 DARPin® program. MP0420 is designed to bind the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein at three distinct locations to prevent viral entry into cells.

Trials 40

Trials Clinical Trials Licensing Licensing 40

The Pharma Data

JANUARY 24, 2021

With a presidential inauguration and a federal holiday, it wasn’t an enormously busy week for clinical trial news, but there was a fair amount, nonetheless. It inked a deal with the National Institute of Allergy and Infectious Diseases (NIAID) to launch a Phase I trial. Read on to see. COVID-19-Related. Non-COVID-19-Related.

Long-Term Care Facilities 52

Long-Term Care Facilities Trials Virus Clinical Trials 52

The Pharma Data

FEBRUARY 25, 2021

Food and Drug Administration (FDA) accepted for Priority Review the company’s Biologics License Application (BLA) for TicoVac , its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE in individuals 1 year of age and older. About TicoVac (TBE vaccine, whole virus inactivated). If approved in the U.S.,

FDA 52

FDA Vaccine Virus Clinical Trials 52

The Pharma Data

MARCH 26, 2021

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation. About COMET-ICE.

Treatment 52

Treatment FDA Vaccine Trials 52

The Pharma Data

OCTOBER 26, 2020

Hasan Jafri , Chief Medical Officer of Aridis Pharmaceuticals, will be a speaker on a panel entitled “Direct Antivirals and Other Agents Against SARS-CoV2 Virus.” ” Panel: Direct Antivirals and Other Agents Against SARS-CoV2 Virus Date: Wednesday, October 28, 2020 Time: 10:30AM- 11:50AM ET.

Pharmaceuticals 52

Pharmaceuticals Virus Hospitals Clinical Trials 52

The Pharma Data

SEPTEMBER 7, 2021

Bristol Myers Squibb has a global exclusive license to develop, manufacture and commercialize the Rockefeller University’s novel monoclonal antibody (“mAb”) duo treatment that neutralizes the SARS-CoV-2 virus for therapy or prevention of COVID-19. Our Clinical Trials and Research. All of our U.S.

Clinical Trials 52

Clinical Trials Vaccine Virus Trials 52

The Pharma Data

NOVEMBER 17, 2021

2) From the body of evidence in clinical trials and real-world data, the vaccine has been shown to have an acceptable safety profile.(3,4,5,6,7). After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body. 3,4,5,6,7). About AstraZeneca.

Vaccine 52

Vaccine Clinical Trials Virus Licensing 52

The Pharma Data

MARCH 22, 2021

Companion dose-ranging phase II trial showed significant and comparable viral reductions for a range of doses of casirivimab and imdevimab. Casirivimab and imdevimab also met all key secondary endpoints in the phase III REGN-COV 2067 trial, including the ability to reduce symptom duration from 14 to 10 days (median numbers).

Clinical Trials 52

Clinical Trials Virus Trials FDA 52

The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic. Increases of ALT ?5x

Licensing 40

Licensing Licensing Therapies Laboratories 40

The Pharma Data

JANUARY 3, 2021

Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for the company’s lead product candidate, PBGM01, an adeno-associated virus (AAV)-delivery gene therapy that is being studied for the treatment of infantile GM1 gangliosidosis (GM1). Imagine-1 study to commence in 1Q 2021. About PBGM01.

Therapies 52

Therapies FDA Treatment Clinical Trials 52

The Pharma Data

MARCH 29, 2022

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months Evusheld retains neutralising activity against the Omicron BA.2 1-3 Evusheld was generally well-tolerated in the trial. Evusheld was generally well-tolerated in the trials.

Vaccine 52

Vaccine Virus Immune Response Trials 52

The Pharma Data

MARCH 25, 2022

2-4 Evusheld was generally well-tolerated in the trial.(2-4). Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein(10) and were optimised by AstraZeneca with half-life extension and reduction of Fc effector function.

Vaccine 52

Vaccine Virus Immune Response Trials 52

The Pharma Data

JANUARY 31, 2021

Our preclinical work at Gritstone developing our powerful prime-boost vaccine technology utilized simian immunodeficiency virus (SIV) derived antigens as model antigens, which are very similar to HIV-1. This press release features multimedia. View the full release here: [link].

Vaccine 52

Vaccine Science Clinical Trials Licensing 52

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

DECEMBER 30, 2020

31, 2020 /PRNewswire/ — ImmVira Group Company (“the Company”), a biotechnology platform dedicated to the development of oncolytic virus(“OV”) and vector type approaches to create more effective and safer therapies against cancer, announced today the signing of Series C financing.

Virus 40

Virus International Trials Clinical Trials 40

The Pharma Data

APRIL 18, 2022

Novavax licensed and transferred its manufacturing technologies to enable Takeda to develop and manufacture the vaccine at its facility in Hikari. Interim results from the Phase 1/2 study in Japan were positive and consistent with previously reported clinical trial results. TAK-019 Clinical Trial.

Vaccine 52

Vaccine Clinical Trials Trials Virus 52