Drug Discovery World

MAY 18, 2023

A clinical trial of an experimental universal influenza vaccine developed by researchers at the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center (VRC) has begun enrolling volunteers at Duke University in Durham, North Carolina. The trial will enrol up to 50 healthy volunteers aged 18 to 49.

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Pharmaceutical Technology

MAY 19, 2023

OncoResponse has secured a $13m grant from the Cancer Prevention and Research Institute of Texas (CPRIT) and raised an additional $14m in funding from investors for advancing OR502 to investigational new drug (IND) and clinical trials. It is planned to enter clinical studies this year. ”

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Drug Discovery World

JUNE 28, 2023

Lidia Oostvogels, Chief Medical Officer of MinervaX, said: “The smooth completion of enrolment and dose escalation provides an indication of the overall acceptable reactogenicity profile of our novel GBS vaccine and replicates the findings in our two ongoing Phase II trials in pregnant women.

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Pharmaceutical Technology

JUNE 23, 2022

The US Food and Drug Administration (FDA) has granted approval for Merck's (MSD outside the US and Canada) pneumococcal 15-valent conjugate vaccine, Vaxneuvance, for use in children aged six weeks to 17 years.

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Pharmaceutical Technology

FEBRUARY 6, 2023

Led by Feinstein Institutes researcher Haichao Wang, the new study focuses on detecting protein mediators that might contribute to uncontrolled immune responses to lethal infections. Feinstein Institutes president and CEO Kevin Tracey said: “The first step in drug discovery is identifying molecular targets. “Dr

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STAT News

DECEMBER 23, 2022

Food and Drug Administration approved a new treatment for patients with follicular lymphoma, a slow-growing type of blood cancer, said Genentech , its maker and a subsidiary of Roche. In a clinical trial, 60% of patients with follicular lymphoma treated with Lunsumio achieved a complete response.

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XTalks

DECEMBER 29, 2023

Amgen recently reported that the US Food and Drug Administration (FDA) has given priority review status to its drug candidate, tarlatamab, intended for the treatment of small-cell lung cancer (SCLC). New Drugs Approved for Small-Cell Lung Cancer Several drugs have received FDA approval for treating SCLC.

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Pharmaceutical Technology

JUNE 10, 2023

According to GlobalData, Phase I drugs for Pandemic Influenza does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Influenza vaccine 2 LoA Report. Buy the report here.

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Pharmaceutical Technology

JUNE 10, 2023

According to GlobalData, Phase I drugs for Pandemic Influenza does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Influenza vaccine 2 LoA Report. Buy the report here.

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The Pharma Data

DECEMBER 20, 2020

UK drug developer Scancell said it has chosen a COVID-19 vaccine candidate, SN14, from more than a dozen potential products to advance to a clinical trial. . In October, Scancell signed a manufacturing deal for SN14 with Cobra Biologics, a Cognate BioServices subsidiary, ahead of a planned phase 1 trial in 2021.

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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.

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Pharmaceutical Technology

APRIL 28, 2023

Therini Bio will use part of the funds to advance its potential first-in-class investigational antibody, THN391, into clinical trials. THN391 binds the inflammation-driving component of fibrin, known for activating the immune responses in neurodegenerative and ophthalmologic diseases.

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Scienmag

JANUARY 26, 2022

WHAT: In adults who had previously received a full regimen of any of three COVID-19 vaccines granted Emergency Use Authorization (EUA) or approved by the Food and Drug Administration (FDA), an additional booster dose of any of these vaccines was safe and prompted an immune response, according to preliminary clinical trial results reported in The […]. (..)

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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.

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NY Times

MAY 11, 2022

Antibody levels rose in the children who received it, suggesting the vaccine protects against infection. But the data were gathered before the arrival of Omicron.

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Pharmaceutical Technology

JUNE 5, 2023

According to GlobalData, Phase I drugs for Pediatric Diffuse Intrinsic Pontine Glioma does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Kid EDV LoA Report. Buy the report here.

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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.

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Cloudbyz

MARCH 5, 2024

In the intricate dance of drug discovery and development, two protagonists emerge as the cornerstones of modern medicine: biologics and small molecules. Manufacturing Process : Small Molecules: Manufactured through chemical synthesis, small molecule drugs can be consistently reproduced with a high degree of purity and stability.

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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. Research into new cancer drugs remain strong. expressing cancers.

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Drug Discovery World

MARCH 4, 2024

In an early phase clinical trial, a combination of antibody-based medications targeting the immune system generated promising safety data and anti-tumour activity in individuals with advanced cancer. Both medications tested in the trial support immune responses against tumour cells.

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Pharmaceutical Technology

OCTOBER 6, 2022

Ramatroban will be analysed in a placebo-controlled, randomised Phase II/III RAMBAN-1 clinical trial. Additionally, the therapy demonstrated initial evidence for quick dyspnea and hypoxemia relief in Covid-19 pneumonia.

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Drug Discovery World

MARCH 26, 2024

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to half-life extended monoclonal antibody (mAb) Pemgarda (pemivibart, or VYD222) for the pre-exposure prophylaxis (prevention) of Covid-19.

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Pharmaceutical Technology

AUGUST 18, 2022

The company sought expanded provisional approval for the booster shots based on findings from its Phase II clinical trial carried out in Australia, another Phase II trial in South Africa and the COV-BOOST trial sponsored by the UK.

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Pharmaceutical Technology

NOVEMBER 20, 2022

The latest development was based on findings from a Phase II clinical trial of the vaccine in South Africa as well as from the Phase III Prevent-19 trial in the US and Mexico. Healthy adult subjects were inoculated with a booster dose of the vaccine nearly six to 11 months following their initial two-dose regimen in the trials.

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Pharmaceutical Technology

JULY 12, 2022

Health Canada has accepted to review Arcutis Biotherapeutics’ New Drug Submission (NDS) for roflumilast cream 0.3% (ARQ-151) to treat plaque psoriasis in adult and adolescent patients. A validated target in dermatology, PDE4 is an enzyme that induces overactive immune responses.

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Drug Discovery World

AUGUST 2, 2022

Biotechnology company Calidi Biotherapeutics has announced that a Phase I US clinical trial will use the company’s licensed oncolytic virotherapy platform NeuroNova to deliver an oncolytic adenovirus selectively to tumor sites in patients with recurrent high-grade glioma. . Recurrent glioma patients have poor prognosis with a median?

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Drug Discovery World

FEBRUARY 19, 2024

Replicate Bioscience has shared positive results from the Phase I trial of RBI-4000, its srRNA-based rabies vaccine. In this clinical trial, evaluating safety and immunogenicity of RBI-4000 , participants received one or two doses of srRNA vaccine at low doses (0.1mcg, 1mcg or 10mcg).

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XTalks

NOVEMBER 22, 2022

Provention Bio’s Tzield (teplizumab) has won US Food and Drug Administration (FDA) approval to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years of age and older who have stage 2 type 1 diabetes. In clinical trials, the treatment delayed stage 3 disease onset for about two years compared with the placebo.

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The Pharma Data

APRIL 15, 2022

Food and Drug Administration in the coming days with additional submissions to other regulatory agencies worldwide to follow. About the Phase 1/2/3 Trial in Children. Additional children have been enrolled in all age groups following study amendments and the trial currently includes more than 10,000 children. Pfizer Inc.

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Pharmaceutical Technology

JUNE 29, 2022

It merges a glycoprotein E antigen and an adjuvant system, AS01B, to induce a VZV-specific immune response that can aid in overcoming VZV immunity decline as people age. A non-live, recombinant subunit adjuvanted vaccine, Shingrix is administered intramuscularly in two doses.

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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. According to GlobalData, Phase II drugs for Non-Small Cell Lung Cancer have a 39% phase transition success rate (PTSR) indication benchmark for progressing into Phase III.

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Drug Discovery World

AUGUST 3, 2023

The clinical evidence for the authorisation is based on data from a study of 765 adults who had received primary vaccination with two doses of the Comirnaty Covid-19 vaccine and who were given a booster dose of either Bimervax or Comirnaty. The clinical trial has been authorised by the Spanish Agency for Medicines and Health Products (AEMPS).

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Drug Discovery World

AUGUST 16, 2022

Known as a bivalent vaccine, Spikevax was approved following data that show it triggers a strong immune response against both Omicron (BA.1) The booster dose was also found to generate a good immune response against the Omicron sub-variants BA.4 1) and the original 2020 strain 1. . Official comments . References .

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pharmaphorum

APRIL 8, 2022

Jazz Pharma has bolstered its pipeline of cancer drugs through a $1.3 The Dublin-based pharma is paying $15 million upfront for global rights to Werewolf’s WTX-613, a prodrug of the cytokine interferon alfa-2b, which is still back n preclinical development and due to start its first clinical trials next year.

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XTalks

NOVEMBER 30, 2023

New FDA-Approved Treatments For HIV HIV treatment involves the administration of combined antiretroviral therapy (ART) to effectively suppress the viral load, maintain or enhance immune function and reduce the risk of opportunistic infections and cancers commonly associated with HIV. percent in the placebo group.

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pharmaphorum

JUNE 30, 2021

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. .

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Drug Discovery World

MAY 9, 2023

Jantzen Sperry , PhD, Director of Scientific Operations at Certis Oncology looks at how the adoption of orthotopic PDX models can elevate the impact of cancer research and improve translation in oncology drug development. Fewer than 5% of oncology drugs that enter clinical trials in the US receive US FDA approval.

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