Drug Discovery World

SEPTEMBER 14, 2023

Evaluating Immatics’ IMA203 TCR-T therapy, targeting PRAME, in combination with Moderna’s PRAME mRNA-based cancer vaccine. Moderna will lead the clinical development and commercialisation of cancer vaccines and TCER therapeutics resulting from the collaboration.

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FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” It finalized a draft guidance published in 2022.

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Drug Discovery World

OCTOBER 16, 2023

A company within this ecosystem is STORM Therapeutics, a clinical stage biotechnology company creating novel small molecule therapies that inhibit RNA modifying enzymes (RME) for use in oncology and other diseases. billion in funding.

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Conversations in Drug Development Trends

JANUARY 24, 2024

Why Partnering with Genetic Counselors May Benefit Your Clinical Program The American College of Medical Genetics (ACMG) has issued a statement that geneticists should be involved in the development of genetic therapies. Enrolling adequate populations will be required to advance these programs.

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Vial

MARCH 25, 2024

Worldwide Clinical Trials is a mid-size, full-service global contract research organization (CRO) that works with biotech and pharma to advance new medications. With an international presence in nearly 60 countries, Worldwide is supported by over 3,400 team members. Other therapeutic areas include cell and gene therapy.

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PPD

NOVEMBER 14, 2023

In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development. This comes as the demand for qualified clinical research associates (CRAs) is expected to increase by more than 36% in the next decade.

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Drug Target Review

APRIL 9, 2024

Initial works from the lab concentrated on exploring the role of replicative stress in cancer and ageing, for which the group combined cell biology, mouse models and drug development projects. Among other discoveries, the group developed inhibitors of the ATR kinase and showed their potential for cancer therapy.

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The Pharma Data

DECEMBER 15, 2020

The Data Contribution Agreement between Diamyd Medical and C-Path will allow for this unique set of fully anonymized clinical trial data to be integrated into an ever-growing list of committed trial data sets within the TOMI-T1D project. For more information, please visit jdrf.org or follow us on Twitter: @JDRF.

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Drug Discovery World

MARCH 29, 2023

On January 31 2023, an internally circulated version of the European Commission’s overhaul of the EU’s pharma legislation was leaked, and published by Politico 1. However, stakeholders should be aware that the leaked review contains no such analysis.

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Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. Importantly, unlike IQVIA, Vial’s EDC is entirely developed by an internal software engineering team, reducing vendor dependencies.

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The Pharma Data

DECEMBER 13, 2020

CEO of EdiGene, “Translating cutting-edge gene editing technologies into innovative solutions for patients requires deep internal R&D expertise as well as strong external partnerships. Zhang has around 20 years of experience in research and drug development in both industry and academia in the US. He received his B.S.

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The Pharma Data

OCTOBER 18, 2020

DUBLIN–( BUSINESS WIRE )– Inflection Biosciences Ltd , a company developing innovative therapeutics for the treatment of cancer, today announced the appointment of industry veteran Gregory I. Greg possesses a wealth of experience in developing new cancer therapeutics across multiple U.S. Berk, MD, to its Board of Directors.

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PPD

MARCH 13, 2024

This significance and focus are ever more apparent when the starting cellular material is imperative to drug product success. Within cell therapy clinical trials, apheresis collections contribute to the specific constituents of the given therapy.

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LifeSciVC

JANUARY 16, 2024

These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline. recent announcements from Merck and Sanofi for obesity and broader metabolic disease).

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The Pharma Data

OCTOBER 27, 2020

28, 2020 /PRNewswire/ — Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, today announces the formation of a new Scientific Advisory Board (SAB). OSLO, Norway , Oct. Fennel cover the key scientific focus areas of Targovax.

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The Pharma Data

JANUARY 20, 2021

21, 2021 /PRNewswire/ — Dynacure , a clinical-stage company focused on developing and commercializing novel therapies to transform the lives of patients with rare diseases who have limited or no treatment options, announced today the appointment of Jean M. and international companies. Previously, Ms.

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The Pharma Data

JANUARY 27, 2021

A total of 15 patients have been recruited to date in the Phase I dose escalation part of the study, all of whom were late stage and have failed conventional treatments, including several lines of rituximab-containing therapies. ET ) to discuss the results and next steps in clinical development of BI-1206.

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The Pharma Data

JULY 29, 2021

Eisai and Biogen Present Preliminary Assessment of the Clinical Effects of Lecanemab Following 18 Months of Treatment in the Open-Label Extension of the Phase 2 Proof of Concept Study at 2021 Alzheimer’s Association International Conference (AAIC) . Chief Clinical Officer, Neurology Business Group, Eisai.

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The Pharma Data

DECEMBER 8, 2020

Since partnering with Eli Lilly to produce the first monoclonal antibody therapy approved for mild-to-moderate COVID-19 patients, antibody discovery company AbCellera is going big on the Nasdaq. Tackle the toughest problems in drug development.” The promise to partners is to “move quickly. Reduce cost. Silverback Therapeutics

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The Pharma Data

NOVEMBER 3, 2020

According to the FDA, the purpose of Fast Track designation is to get important new drugs to patients earlier by facilitating the development, and expediting the review, of drugs to treat serious conditions and fill an unmet medical need. Commenting on the announcement, Daniel Gruskin, M.D., About LogicBio Therapeutics.

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NIH Director's Blog: Drug Development

JUNE 14, 2016

Several years ago, the Food and Drug Administration (FDA) recommended that drug developers take special care to show that potential drugs to treat diabetes don’t adversely affect the cardiovascular system [1]. In fact, the evidence suggests that such drugs might even offer some protection against heart disease.

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PPD

SEPTEMBER 6, 2023

Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster.

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Agency IQ

APRIL 12, 2024

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. How does “potency” apply to cell and gene therapy (CGT) products?

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LifeSciVC

AUGUST 21, 2024

Drug development is a long process, and patients are waiting. As the CEO of Lifordi Immunotherapeutics, an ADC company developing treatments for autoimmune and inflammatory diseases, there are three components to manufacture, multiple international CDMOs to manage, and complex supply chains to navigate.

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Drug Discovery World

OCTOBER 10, 2022

Will an expansion in the use of effective digital biomarkers help improve the productivity of drug development in neuroscience? Increasingly, digital biomarkers are becoming more effectively used in the discovery and development of drugs that act in the central nervous system.

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The Pharma Data

JANUARY 13, 2021

This is our sixth global approval for an internally-developed product, and our first approval for tislelizumab in a lung cancer indication, an area where we believe tislelizumab can have a large impact for patients.”. General Manager of China and President of BeiGene. Chief Medical Officer, Immuno-Oncology at BeiGene.

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The Pharma Data

OCTOBER 19, 2020

. “Innovation in cancer treatment is realized through collaboration, and the physicians and researchers at Emory’s Winship Cancer Institute have consistently shown their commitment to developing novel cancer therapies using this collaborative approach,” said Chadi Nabhan , M.D., Ramalingam , M.D.,

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The Pharma Data

NOVEMBER 29, 2020

Antiviral therapies are used to help control disease, but they are limited by toxicity and the emergence of viral resistance. Participants receive either pre-emptive or prophylactic antiviral therapy post-transplant and are followed for a 12-month observation period.

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Drug Discovery World

MAY 23, 2024

Reece Armstrong speaks to Samuel Deutsch , Chief Scientific Officer of Nutcracker Therapeutics about the RNA landscape and how it can benefit the development of immunotherapies. RA: What role does RNA play in the development of effective immunotherapies? NTX-471 is one of our early-stage preclinical candidates.

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Drug Discovery World

APRIL 10, 2024

Some of the current optimism may be related to the nearly two decades of experience we now have with certain incretin hormone therapies based on glucagon-like peptide receptor agonists (GLP-1 RA), which modulate appetite, satiation and food intake and have revolutionised treatment for type 2 diabetes.

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Drug Discovery World

JANUARY 17, 2024

With oncology accounting for a third of pharma’s product pipeline, significant challenges include fierce competition, high research and development costs over, 10-15 years for clinical development, and pressures to rapidly meet the demand for new treatments 2-4.

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Conversations in Drug Development Trends

JULY 8, 2024

With radiopharmaceuticals emerging as a diagnostic and therapeutic (theranostics) procedure, many are in the clinical development pipeline and are expected to play a crucial role in the future of healthcare. Tissue Sensitivity : The sensitivity of target tissues and nearby organs to radiation therapy can vary considerably.

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The Pharma Data

AUGUST 29, 2020

Oral, investigational complement factor B inhibitor LNP023 substantially improved hematological response as add-on therapy to eculizumab. To date, after at least six months of stable LNP023 add-on therapy, and at the investigators’ discretion, seven patients (70%) have discontinued eculizumab and remained on LNP023 as monotherapy.

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Drug Discovery World

AUGUST 2, 2023

For instance, protein palmitoylation involves the covalent attachment of fatty acyl chains, typically a palmitate to internal cysteine residues of a protein via labile thioester linkages. Ezurpimtrostat (GNS561) was identified from a large library of small molecules as a lead compound for drug development.

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The Pharma Data

OCTOBER 26, 2020

V590 — a SARS-CoV-2 vaccine candidate in development in collaboration with the International AIDS Vaccine Initiative (IAVI) that uses a recombinant vesicular stomatitis virus (rVSV) platform, the same platform used for Merck’s approved Ebola Zaire virus vaccine, will enter Phase 1 development shortly.

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The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

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PPD

JUNE 17, 2024

When outsourcing some or all key functions to an FSP provider, a drug developer gains access to a wider pool of talent, including specialized functional, scientific and technical experts. This approach enables unbroken continuity of support and resources across clinical trial operations.

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