The Pharma Data

NOVEMBER 30, 2020

For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn. Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax Forward Looking Statements.

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Conversations in Drug Development Trends

JANUARY 21, 2025

Regulatory bodies such as the FDA oversee clinical trials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws. Continuous feedback loops , like embedding Plan-Do-Check-Act (PDCA) cycles, foster iterative improvements and ensure sustainable outcomes.

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The Pharma Data

JULY 8, 2021

The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials. Information about the population studied has been previously communicated by Biogen and Eisai, including in the companies’ statement of June 23, 2021. Please see the full Prescribing Information.

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Cytel

NOVEMBER 8, 2023

Written by Natalia Muehlemann, Vice President, Clinical Development, and Ari Brettman, Senior Managing Director, Blackstone Life Sciences When working with investors, it’s critical that drug and device developers consider how their clinical trial design aligns with investment priorities. Let’s take a closer look:

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SugarCone Biotech

MARCH 2, 2025

Our skepticism was based on our understanding of the biology of those pathways and informed by observations made by the Antonia lab, several Roche groups and others that TGF- expression is sufficient to prevent T cell activation. The lead program here was bintrafusp alfa, now terminated.

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PPD

OCTOBER 16, 2023

Consent development: Informed consent is the most important step in the tokenization process. Part of the operational model includes selection of the tokenization vendor and determining what technology and data sources are required. If you don’t tokenize today, you may miss an opportunity to do so tomorrow.

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Drug Target Review

JULY 31, 2023

This targeted approach provides readers interested diseases or applications with tailored information and insights that align with their specific interests. By exploring the latest advancements and potential treatment approaches for their areas of interest, readers can deepen their understanding of disease-specific applications.

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Alta Sciences

NOVEMBER 15, 2024

Your Project History Be open to sharing relevant information about your study history and development plans. Be prepared to share necessary information about your study with the CRO,” says Chad. One of the first steps in this process is highlighting key milestones already achieved.

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Conversations in Drug Development Trends

MAY 14, 2024

As the strategists for Worldwide Clinical Trials’ rare disease sponsors, we design customized solutions that make a difference in achieving successful outcomes. Our approach is informed by our combined 30+ years in rare disease clinical development and our time in various stakeholder roles, such as scientists, CRAs, and project managers.

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Alta Sciences

MAY 29, 2024

How to Optimize Your Early-Phase Drug Development Program pmjackson Wed, 05/29/2024 - 20:32 The Challenges With Outsourcing Drug Development In a Biopharma Dive survey, 45% of the over 143 biopharmaceutical executives surveyed cited the inability to adhere to tight deadlines as a common challenge in preclinical and Phase I clinical development.

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Alta Sciences

JULY 22, 2024

Insights in FIH studies provide valuable information on potential dosing, efficacy, and safety, and serve as a good guide for the regulatory requirements needed throughout clinical development. jpg Tags Clinical Trials Weight 1

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The Pharma Data

DECEMBER 10, 2020

executive vice president of research and development. “We We look forward to working closely with the FDA throughout the clinical development process to bring this potential new innovative treatment to patients as quickly as possible.”. For additional information, please visit www.lexpharma.com. Safe Harbor Statement.

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PPD

SEPTEMBER 6, 2023

Examples include: Determining whether to use FSO or FSP models based on geography Combining FSP and FSO models based on therapeutic area, services and clinical trial phase Incorporating FSP resources into FSO studies when specific key roles (e.g.

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Drug Target Review

APRIL 3, 2024

The results from these trials will build the basis for addressing therapy-induced GDF-15-mediated resistance of cancers, a problem that represents a significant challenge across several therapeutic classes, including approaches currently in advanced stages of clinical development.

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The Pharma Data

SEPTEMBER 16, 2020

executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C inhibitor sotorasib (AMG 510). Reese , M.D., On Monday, Sept. PDT , David M.

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The Open Targets Blog

JUNE 26, 2023

This is crucial safety information for drug discovery scientists looking to develop inhibition strategies. This information is now available to browse in the Cancer DepMap widget on target profile pages. Hovering over a data point brings up additional information on the experiment and score.

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H1 Blog

JUNE 7, 2023

Performance data on principal investigators and clinical trial sites provides invaluable insights to pharma companies, helping them leverage successful sites and patient populations to maximize their clinical development feasibility and operations. There is a tendency to want to measure everything.” The Michael J.

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The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections. SHANGHAI , Jan.

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FDA Law Blog: Drug Discovery

MARCH 7, 2024

Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development. FDA notes that the distinctions between responsibilities for these groups and DMCs should be clearly defined, particularly with respect to access to unblinded information.

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The Premier Consulting Blog

JULY 31, 2024

A key difference is that the Sponsor of a 505(b)(1) NDA owns or has right of reference to the safety and effectiveness information versus the Sponsor of a 505(b)(2) NDA leverages information from other drug approval packages and/or published information they do not own or have right of reference to.

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Alta Sciences

FEBRUARY 8, 2024

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects. View the Driving Simulation Fact Sheet for more information.

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Conversations in Drug Development Trends

AUGUST 23, 2023

Canary Advisors recommends including patient advisory boards, which a sponsor, CRO, or patient advocacy organization can create in the early stages of clinical development. Kahn explains these in-depth: “Before you have a clinical trial design finalized or sometimes before indication selection, you want to meet with patients,” he says.

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FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. Other Questions. The Agency recommended that sponsors follow the requirements under 21 CFR 211.84(d)(2)

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The Pharma Data

JUNE 2, 2023

“The presentation of longer-term follow-up data from our pivotal studies and real-world evidence reinforce the potential of cell therapy across different blood cancers, lines of treatment and settings,” said Frank Neumann, MD, PhD, Senior Vice President, Global Head of Clinical Development, Kite. “We

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DrugBank

JUNE 6, 2024

In the rapidly evolving landscape of oncology drug development, artificial intelligence (AI) has emerged as a revolutionary force, altering not just the pace but the very methodology of discovery and development.

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The Pharma Data

DECEMBER 27, 2020

The mitazalimab drug candidate has previously reported positive clinical data from two Phase I studies, one performed by Alligator, one performed by Janssen Biotech Inc., The information was submitted for publication, through the agency of the contact person set out above, at 11:00 a.m. The Company is headquartered in Lund, Sweden.

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Drug Target Review

JUNE 6, 2023

Clinical development of IL-18 therapies has been curtailed, however, by the protein’s lack of efficacy. Our deep interest in the interplay between immune cells, cytokines, and the tumour microenvironment has informed our clinical research to date as well as our IO pipeline program.

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The Pharma Data

JANUARY 4, 2021

For further information please contact: For Investors: About Polyphor Polyphor is a research-driven clinical-stage, Swiss biopharmaceutical company committed to discovering and developing first-in-class molecules in oncology and antimicrobial resistance leveraging the company’s leading macrocyclic peptide technology platform.

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PPD

JULY 18, 2023

Drug developers that tap an FSP model should ensure they select a partner that provides access to a deep bench of clinical development experts and services, as well as dedicated problem-solving for their issues. Regular review and management of KPIs and budget. Escalations and risk mitigation. Performance management.

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The Pharma Data

MARCH 29, 2022

Boehringer Ingelheim and Veeva Systems (NYSE: VEEV) today announce Boehringer Ingelheim’s selection of Veeva Development Cloud to drive end-to-end processes and seamless information sharing enterprise wide for greater speed in the delivery of innovative therapies.

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The Pharma Data

JANUARY 10, 2021

Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. More information at www.morphosys.com or www.morphosys-us.com.

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The Pharma Data

OCTOBER 25, 2020

We are advancing the clinical development of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations. For more information about the COVE study, click here. About Moderna.

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Fierce BioTech

SEPTEMBER 10, 2024

Further, women’s health issues tend to be deprioritized in clinical development, medical treatment, and online health information. Yet health economic inequalities including higher out-of-pocket costs and the “pink tax” for non-Rx products persist throughout their lives.

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Drug Target Review

JULY 18, 2024

However, what has really helped the sensitivity is using a tumour-informed approach where mutations found when sequencing the patient’s own tumour are part of the design. How is leveraging liquid biopsy leading to innovative trial designs in oncology and ultimately our ability to develop new drugs in the adjuvant setting?

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The Premier Consulting Blog

JULY 9, 2023

These ICH guidance documents apply at different stages of development and address specific concerns regarding certain types of impurities or degradants. What sets this guidance apart from ICH Q3A and ICH Q3B is that it applies to all stages of clinical development, not just to approval.

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Conversations in Drug Development Trends

FEBRUARY 21, 2024

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study.

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The Pharma Data

JANUARY 4, 2021

Rothenberg did not provide any information as to what his next role may be – whether he will take over the helm of a pharma company or assume a role on one or more boards of directors. “Aida is an extremely accomplished physician-scientist as well as an inspirational leader.

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