pharmaphorum

MAY 27, 2022

This is the second in a two-part series examining how pharma can embrace the DEI agenda to create more effective medicines through more representative clinical trials. The same principles are increasingly being applied to clinical trials to improve diversity, mitigate bias, and reinforce inclusion in clinical trials.

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Velocity Clinical Research

AUGUST 18, 2023

Even as a teen in Egypt, Amira Nada was drawn to the idea of clinical research and how it could help people live healthier, richer lives. They weren’t getting the relief they needed, and I wanted to help change that,” Amira adds. She decided to focus on patient recruitment to promote diversity in clinical trial populations.

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XTalks

FEBRUARY 19, 2024

In a recent study published by Weill Cornell Medicine in the Journal of Infectious Diseases , researchers have reported the potential of Moderna’s experimental mRNA vaccine in protecting adults against CMV, which could potentially also stop the transmission of the virus from mothers to their infants during pregnancy.

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pharmaphorum

AUGUST 19, 2021

A common set of standards for randomised clinical trials (RCTs) aims to help researchers develop the drugs and interventions of the future – no matter what they do or where they are based. Many guidelines focus narrowly on clinical trials that are intended to generate data for regulatory submission to support a new drug license.

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Pharmaceutical Technology

APRIL 3, 2023

The company is licensing the first-in-class drug candidate under an existing deal with RayzeBio. Ablaze Pharmaceuticals is set to develop a new GPC3-targeted peptide drug candidate for the treatment of liver cancer in China. The agreement allows Ablaze to clinically develop and commercialise the drug in Greater China.

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Cloudbyz

AUGUST 2, 2022

Premarketing drug studies vs Post- Marketing research Premarketing drug studies consist of phase I-III trials, and are represented by pharmacokinetic and pharmacodynamic studies, dose ranging studies, and Randomized Controlled Trials (RCTs). Approximately only 20 % of the drugs that enter phase I are approved for marketing.

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XTalks

JANUARY 29, 2021

This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. This means that sponsors are having to fork out for these blockbuster products in order to run their trials more often.

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The Pharma Data

MARCH 31, 2023

AstraZeneca has completed an exclusive global license agreement with KYM Biosciences Inc. CMG901 is currently being evaluated in a Phase I trial for the treatment of Claudin 18.2-positive CMG901 is currently being evaluated in a Phase I trial for the treatment of Claudin 18.2-positive million deaths. Source link: [link]

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Pharmaceutical Technology

MARCH 27, 2023

Iovance Bioterapeutics announced it has completed its rolling Biologics License Application (BLA) submission to the U.S. The late-stage biotechnology company also reached an agreement with the FDA regarding the registrational trial design for the Phase 3 trial of lifileucel in combination with pembrolizumab in frontline advanced melanoma.

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Pharmaceutical Technology

DECEMBER 28, 2022

Gilead Sciences and Jounce Therapeutics have amended their current license agreement for first-in-class immunotherapy, GS-1811 (formerly JTX-1811). The initial license agreement was signed in 2020. Now, the company will be solely responsible for all further research, development, and commercialisation of GS-1811 across the world.

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The Pharma Data

OCTOBER 27, 2021

NYSE and TASE: TEVA) and MODAG GmbH today announced a strategic collaboration on the exclusive worldwide licensing and development of MODAG’s lead compound anle138b and a related compound, sery433. NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. About MODAG.

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Pharmaceutical Technology

OCTOBER 31, 2022

The European Medicines Agency (EMA) has validated AbbVie ’s marketing authorization application (MAA) for epcoritamab (DuoBody-CD3xCD20) to treat relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adult patients following two or more lines of systemic therapy.

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Delveinsight

AUGUST 13, 2020

Researchers call out Gilead over the diversity of remdesivir trials. Researchers have challenged the sponsors of COVID-19 clinical trials to run more diverse studies. However, the researchers found data supporting the efficacy and safety of remdesivir, which is an early COVID-19 drug , in minority groups are limited.

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Pharmaceutical Technology

FEBRUARY 17, 2023

Under the multiyear deal, Zephyr AI will license M2Gen’s RWD and will, in return, provide M2Gen will AI and machine learning technologies to enhance its products and services. M2GEN and Zephyr AI will together discover new cancer treatments and expanded use cases for better identifying new targets and enhancing clinical trial design.

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Worldwide Clinical Trials

NOVEMBER 27, 2023

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. In trials, Casgevy was shown to help prevent episodes of debilitating pain, known as vaso-occlusive crises, that often plague patients affected by sickle cell disease.

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XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases.

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The Pharma Data

NOVEMBER 5, 2021

s Medicines and Healthcare Products Regulatory Agency Authorizes Molnupiravir for the Treatment of Mild-to-Moderate COVID-19 in Grown-ups With a Positive SARS-CoV-2 Diagnostic Test and Who Have at Least One Threat Factor for Developing Severe Illness. Li, administrative vice chairman and chairman, Merck Research Laboratories. “

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Scienmag

DECEMBER 18, 2020

18, 2020 – Invirsa, a Columbus-based pharmaceutical company, today announced execution of a license agreement with the Abigail Wexner Research Institute (AWRI) at Nationwide Children’s Hospital as Invirsa seeks to broaden its treatment platform to address […].

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Delveinsight

AUGUST 17, 2021

The efficacy and safety results were produced from a broad research study, multicenter, open-label, randomized phase 3 trial data from the Keynote-581 trial of the first-line therapy indicated to the patients that resulted in an extension of their survival.

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Pharmaceutical Technology

AUGUST 4, 2022

The research and development (R&D) of various present and new ‘off-the-shelf’ cell therapies against targets in B-cell lymphomas, multiple myeloma and other hematologic indications are included in this alliance. This would help them co-develop further allogeneic CAR-T product candidates for current and new hematologic targets.

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The Pharma Data

DECEMBER 20, 2020

Allecra, subject to the satisfaction of terms and conditions as set forth in the Exclusive Licensing Agreement, is to receive an upfront cash payment and is eligible to receive additional development and commercial milestone payments with an overall deal value of $78 million, in addition to royalties.

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Pharmaceutical Technology

MARCH 1, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company conducts research to focus on the discovery and development of novel medicines that address serious diseases in areas of significant unmet medical need.

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pharmaphorum

SEPTEMBER 29, 2020

Cell therapy research has been built on collaborations amongst scientists and entrepreneurs, providing early proof of concept for modalities thought to be too difficult to commercialise but with a strong potential for patient benefit”.

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Velocity Clinical Research

AUGUST 8, 2024

Before that, he’d spent 36 years in primary care, treating patients skewed toward the age group most at risk of Alzheimer’s, and it was this experience that, in part, encouraged him to cross over into clinical research. “It The importance of clinical trials That hope is a motivator for many clinical trial participants.

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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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Pharmaceutical Technology

JANUARY 5, 2023

Under the multi-year strategic partnership, Prevail will detect and advance capsids, which are clinically translatable, along with its cargo to develop the transformative genetic medicines by using Capsida’s novel adeno-associated virus (AAV) engineering platform.

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Pharmaceutical Technology

JANUARY 2, 2023

The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next. Its primary focus is on cancer, cardiovascular, immunology and fibrotic therapeutic projects.

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The Pharma Data

SEPTEMBER 8, 2020

Fourteen newly licensed medicines have been accepted for use on NHS Scotland by the Scottish Medicines Consortium (SMC), bringing a raft of new treatment options for conditions including epilepsy, depression and cancer.

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pharmaphorum

MARCH 24, 2021

The UK drugs regulator is now asking that all applications for new medicines or indications detail the efforts made to involve patients in the drug development process. . In future, the hope is that it may encourage a higher level of patient involvement in its final assessment of whether clinical trials are approved or drugs are licensed.

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The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration and the European Medicines Agency. NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicinehas published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. Jansen, Ph.D.,

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The Pharma Data

AUGUST 19, 2021

today announced that the company’s Marketing Authorization Application (MAA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated and is now under evaluation with the European Medicines Agency (EMA). For further information, please see [link].

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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.

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The Pharma Data

MAY 7, 2021

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. This includes the most recent analyses from the pivotal Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose. “We are pleased to work with U.S.

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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.

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The Pharma Data

AUGUST 17, 2020

In addition, Dragonfly has an ongoing Phase 1/2 clinical trial for patients with advanced solid tumors, which began in July 2020. Bristol Myers Squibb intends to advance the research and development of DF6002 in oncology and hematology. “As About Bristol Myers Squibb.

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The Pharma Data

NOVEMBER 30, 2020

The lead candidate, HTL0022562, has advanced through preclinical development demonstrating promising and differentiated properties for further investigation in human trials. Biohaven acquires exclusive global rights to a portfolio of novel, small-molecule CGRP antagonists. TOKYO and CAMBRIDGE, England , Dec.

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The Pharma Data

MARCH 30, 2021

Targeted radioligand therapy is a type of precision medicine combining two key elements: a targeting compound, or ligand, and a radioactive isotope, causing DNA damage that inhibits tumor growth and replication. We believe this technology has the potential to transform many patients’ lives.”.

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