Pharmaceutical Technology

JUNE 10, 2023

Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Production 100

Production Vaccination Vaccine Immune Response 100

Pharmaceutical Technology

JUNE 10, 2023

Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Production 100

Production Vaccination Vaccine Immune Response 100

The Pharma Data

NOVEMBER 30, 2020

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.

Clinical Development 52

Clinical Development Vaccination Vaccine Development 52

pharmaphorum

NOVEMBER 20, 2022

One standout success we have all benefitted from is vaccine development, with notable vaccines from Pfizer/BioNTech, AstraZeneca, and Moderna. New hurdles from COVID-19 vaccine development. Trials testing SARS-CoV-2 vaccines saw high enrollment, which reduced the time between each clinical trial phase.

Vaccination 97

Vaccination Vaccine Development Clinical Development 97

Pharmaceutical Technology

JUNE 5, 2023

Kid EDV is under clinical development by ImmunityBio and currently in Phase I for Pediatric Diffuse Intrinsic Pontine Glioma. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Immune Response 130

Immune Response Clinical Trials Clinical Trials Development 130

Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

Drug Discovery World

FEBRUARY 28, 2024

Lu Rahman selects some of the year’s interesting and noteworthy advances in cancer research drug discovery and development. As always, a year within cancer drug discovery and development brings with it significant breakthroughs, and 2023 has been no exception. Figures from the Amercian Cancer Society 1 state that “a little over 1.9

Development 64

Development Research Drugs Antibody 64

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.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

XTalks

MARCH 13, 2023

The US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) held a recent town hall where three experts from the regulator provided guidance on how to design and conduct gene therapy clinical trials for rare diseases. All except for Adstiladrin were cleared for rare disease indications.

Gene Therapy 52

Gene Therapy Clinical Trials Clinical Trials Gene 52

VirTrial

OCTOBER 25, 2023

Members of the science and medicine team have additionally worked on hundreds of other vaccine trials involving hundreds of thousands more volunteers. While vaccine development has come a long way, there is much to accomplish in the future. Today, smallpox is the only human disease to have been eradicated.

Vaccination 52

Vaccination Vaccine Development Clinical Trials 52

Pharmaceutical Technology

FEBRUARY 26, 2023

Cellular Immunotherapy for Non-Small Cell Lung Cancer is under clinical development by Iovance Biotherapeutics and currently in Phase II for Non-Small Cell Lung Cancer. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Immune Response 100

Immune Response Production Clinical Trials Clinical Trials 100

Drug Discovery World

NOVEMBER 8, 2022

Merck has exercised its option to jointly develop and commercialise personalised cancer vaccine (PCV) mRNA-4157/V940 pursuant to the terms of its existing collaboration and license agreement with Moderna. . The post Merck and Moderna to jointly develop personalised cancer vaccine appeared first on Drug Discovery World (DDW).

Vaccination 52

Vaccination Vaccine Development Immune Response 52

Worldwide Clinical Trials

JUNE 15, 2022

At the end of May, we hosted a webinar titled “ Changing Times, Changing Therapies: Keeping Up with Advancements in Cell and Gene Therapies ” to provide a quick update on the latest advancements and ongoing in development of these advanced therapeutics. Clinical holds are becoming more common, especially in gene therapy programs.

Gene Therapy 130

Gene Therapy Gene Clinical Trials Clinical Trials 130

XTalks

JULY 31, 2024

Alopecia areata can be triggered by genetics, immune system dysfunction and environmental factors. Leqselvi works by selectively inhibiting the Janus kinases (JAK) JAK1 and JAK2, pathways that play a key role in this misguided immune response.

Immune Response 105

Immune Response Dermatology Clinical Trials Clinical Trials 105

Drug Discovery World

JULY 26, 2023

A Cancer Research UK-funded clinical trial has shown, for the first time, that a new class of antibody could benefit cancer patients whose existing treatments have stopped working. The drug, MOv18 IgE, was developed by researchers at King’s College London.

Antibody 52

Antibody Drugs Clinical Trials Clinical Trials 52

Drug Discovery World

MARCH 30, 2023

Likang Life Sciences has been granted implied approval by China’s National Medical Products Administration (NMPA) for the clinical trial of its innovative personalised neoantigen-targeted vaccine LK101 Injection for advanced solid tumours.

Regulation 52

Regulation Vaccination Vaccine Trials 52

Camargo

JULY 27, 2021

How and When to Incorporate PK Design into Your Gene Therapy Development Plan. While most gene therapy clinical studies are ongoing, a number of products are in advanced clinical development, and several are approved by FDA. PK Planning for Gene Therapy Development Programs. Exposure-Response Considerations.

Gene Therapy 238

Gene Therapy Gene Gene Editing Genetics 238

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. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

APRIL 12, 2021

The adenosine pathway has emerged as an attractive target for immuno-oncology R&D because it is thought to reduce the activity of misfunctioning regulatory T-cells that inhibit the immune response against cancers. Exscientia will lead the clinical development of the A2A drug, with Evotec retaining co-ownership rights.

Trials 125

Trials Clinical Trials Clinical Trials Immune Response 125

XTalks

SEPTEMBER 21, 2023

The trial’s primary objective is to assess the safety of VIR-1388 and its capacity to stimulate a specific immune response against HIV in study participants. More HIV Vaccine Trials Are on the Way Several other HIV vaccine clinical trials are presently underway nationwide.

Vaccination 59

Vaccination Vaccine Trials Clinical Trials 59

pharmaphorum

DECEMBER 11, 2020

Sanofi and GlaxoSmithKline have said their COVID-19 vaccine has hit a snag in clinical development, prompting analysts to note this could delay delivery of potentially more than a billion shots globally by up to nine months. This demonstrated rapid viral clearance in a challenge study in non-human primates.

Immune Response 60

Immune Response Trials Vaccination Vaccine 60

pharmaphorum

SEPTEMBER 1, 2020

AstraZeneca has expanded development of COVID-19 vaccine AZD1222 into the US, beginning a phase 3 clinical trial across all adult age groups. The UK pharma said that the trial will recruit up to 30,000 adults aged 18 years or over to assess the safety, efficacy and immune response.

Vaccination 58

Vaccination Vaccine Trials Immune Response 58

The Pharma Data

JANUARY 12, 2021

“The emphasis in the development of cancer immunotherapies has been placed so far mainly on drugs that stimulate the adaptive immune system to attack malignant cells, in particular T lymphocytes. It is being developed for the treatment of solid tumors. Co-Founder and Chief Executive Officer at Biond.

Immune Response 52

Immune Response Clinical Trials Clinical Trials Development 52

The Pharma Data

DECEMBER 3, 2020

Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinical development for both adjuvanted vaccines.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

The Pharma Data

OCTOBER 14, 2020

a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, announced today that the U.S. APX005M is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response. SAN CARLOS, Calif. , About APX005M. About Apexigen.

Immune Response 40

Immune Response Drugs Antibody Clinical Trials 40

pharmaphorum

FEBRUARY 25, 2021

Pandion ’s lead candidate PT101 has completed a phase 1a clinical trial backing its safety and tolerability, and is due to start a phase 1a/2b study in ulcerative colitis and a phase 2 trial in systemic lupus erythematosus before the end of the year.

Clinical Trials 66

Clinical Trials Clinical Trials Immune Response Trials 66

The Pharma Data

SEPTEMBER 2, 2020

Sanofi and GSK have begun a Phase I/II clinical trial testing their adjuvanted COVID-19 vaccine in healthy adults. The vaccine candidate, developed in partnership by the firms, is based on the recombinant protein-based technology used in Sanofi’s seasonal influenza vaccines and GSK’s pandemic adjuvant technology.

Vaccination 52

Vaccination Vaccine Trials Immune Response 52

pharmaphorum

JANUARY 25, 2021

Merck & Co is to axe development of two COVID-19 vaccine candidates, focusing on development of two therapies instead following disappointing results in early trials. US-based Merck & Co said the decision followed findings from phase 1 clinical studies of the vaccines codenamed V590 and V591.

Vaccination 52

Vaccination Vaccine Immune Response Clinical Trials 52

pharmaphorum

DECEMBER 15, 2020

million (around $56 million) in a Series B funding round to take its novel group B streptococcus (GBS) vaccine into mid-stage clinical trials. Proceeds will advance the clinical development of MinervaX’s novel GBS vaccine through phase 2 clinical trials, as well as manufacturing and regulatory preparation for phase 3.

Bacteria 52

Bacteria Vaccination Vaccine Immune Response 52

The Pharma Data

JANUARY 3, 2021

. Weber is a renowned melanoma specialist and leading immunotherapy translational and clinical scientist. Both will help NexImmune advance current early-stage clinical trials and will guide Company’s translational efforts to develop new immunotherapy products. GAITHERSBURG, Md.,

Immune Response 40

Immune Response Clinical Trials Clinical Trials Development 40

The Pharma Data

DECEMBER 13, 2020

SYNB1891 is an investigational drug for the intra-tumoral treatment of solid tumors and lymphoma, composed of an engineered Synthetic Biotic designed to activate the STING pathway in the tumor microenvironment in order to upregulate the patient’s immune response. SYNB1891 is being evaluated in a Phase 1 clinical trial.

Immune Response 40

Immune Response Engineer Containment Clinical Trials 40

The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM adjuvant. “The

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Pfizer

JULY 26, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level.

Vaccination 111

Vaccination Vaccine Protein Immune Response 111

The Pharma Data

JANUARY 3, 2021

Furthermore, nasal anti-CD3 dampens cytotoxic CD8 T cell responses that are known to cause lung damage in COVID-19 patients.”. Dr Thais Moreira, the lead scientist and coordinator of the clinical trial, stated: “We are delighted to receive positive feedback from patients treated in the clinical trial. .

Life Science 40

Life Science Clinical Trials Clinical Trials Antibody 40

The Pharma Data

NOVEMBER 10, 2020

We’re excited to be collaborating with Tiziana to support the development of a novel, oral therapy that could provide Crohn’s patients with another option in their repertoire of treatments to combat this devastating disease.”. In addition to Milciclib, the Company is also developing Foralumab for liver diseases.

Life Science 40

Life Science Clinical Trials Clinical Trials Trials 40

The Pharma Data

NOVEMBER 1, 2020

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. The clinical data from this trial is expected to available by the end of this year. In a humanized mouse model (NOD/SCID IL2?c-/-),

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Life Science 52

The Pharma Data

MAY 15, 2023

The acquisition complements Gilead’s existing clinical development priorities by adding additional pipeline assets for well-validated targets in oncology and inflammation. Both programs have the potential to address multiple indications, offering broad development opportunities alone and in combination with Gilead’s portfolio.

DNA 40

DNA Immune Response Medicine Development 40