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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The Pharma Data

OCTOBER 21, 2020

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme. For further information please visit www.gsk.com/about-us.

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The Pharma Data

MARCH 7, 2022

The topline data further characterize the long-term safety profile of fezolinetant and will inform future regulatory filings. 1 About Fezolinetant Fezolinetant is an investigational, oral nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause.

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The Pharma Data

MAY 2, 2021

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. About Sandoz.

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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 Premier Consulting Blog

AUGUST 21, 2024

As clinical development of an investigational product proceeds, Sponsors often conduct global clinical trials which require preparation of content to support dossiers in multiple geographies, meeting the regulatory requirements of each region. Drug substance content in Module 3.2.S

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The Pharma Data

DECEMBER 13, 2020

Our highly experienced teams in Singapore and the US span antibody discovery, pharmacology, production and clinical development. Together we aim to accelerate the journey of new drugs from concept to clinical care. For more information, visit tempus.com. [1] Detection of NRG1 Gene Fusions in Solid Tumors.

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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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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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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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Advarra

OCTOBER 15, 2024

Risks to CtQs factors should be proactively managed and risk language/monitoring adjusted according to new and changing information during the clinical trial. Sponsors should ensure a diverse multidisciplinary team of stakeholders supports the design of the study and the clinical development plan.

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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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Agency IQ

APRIL 8, 2024

For a fee, manufacturers can also consult with expert panels on clinical development plans and clinical investigation proposals (MDR Article 106(11)). In such cases, EMA will inform them whether this will be possible.” There is still no publicly available information on the status of the second phase of the pilot.

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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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PPD

SEPTEMBER 16, 2024

Machine learning is a subset of AI that identifies patterns in large datasets, leveraging identifiable conditions or attributes that are needed to inform sample selection for trials and other prospective data. It identifies cases in instances where diagnosis codes and other information available in each database are too non-specific to do so.

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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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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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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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The Premier Consulting Blog

NOVEMBER 20, 2023

Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. billion each year.

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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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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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Conversations in Drug Development Trends

AUGUST 15, 2023

Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. Our consultative approach ensures success by integrating research methodology, regulatory affairs strategy, and clinical operations. You can expect transparency.

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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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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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The Pharma Data

JANUARY 5, 2021

COVID-19 have caused delays to submission and processing of the regulatory application to initiate clinical development in China. For further information, please contact: Renate Birkeli , Investor Relations Phone: +47 922 61 624 Email: renate.birkeli@targovax.com. OSLO, Norway , Jan.

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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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PPD

NOVEMBER 21, 2023

To keep a pulse on this rapidly changing industry, the PPD clinical research business of Thermo Fisher Scientific surveyed 150 leaders in the biopharma and biotech industries for the second consecutive year. Differences in size, resources and agility have led the two groups to take different approaches to clinical development.

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Drug Target Review

AUGUST 28, 2024

Delivered as an autologous cell therapy, these macrophages have been engineered to increase their anti-inflammatory and anti-fibrotic properties, with the aim of delivering more potent and durable clinical effect to patients with end-stage liver disease. Reference 1 Brennan P et al., J Hep, 2024 (EASL ILC 2024 Abstract #LBP-007).

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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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Drug Target Review

MAY 7, 2024

For instance, AI algorithms could facilitate patient-trial matching, encompassing medical records, genetic information, demographics, and personal preferences. His expertise lies in oncology, encompassing the pre-clinical and clinical development of innovative therapeutics from concept to late-stage clinical trials.

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The Pharma Data

DECEMBER 28, 2020

Her international experience in leading clinical development and in building development organizations will significantly strengthen our clinical capacity. This is crucial in the phase we are in now, with two products on the way to Phase II and another product in clinical Phase I. SOURCE Alligator Bioscience.

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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. Here’s how we do it.

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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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Vial

APRIL 10, 2024

The strong commitment to innovation allows IQVIA to provide advanced analytics, technology solutions, and industry-specific expertise in the health information technologies and clinical research domains. IQVIA has a vast collection of healthcare information, including over 1.2 increase on a reported basis and an 4.8%

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Drug Target Review

MAY 1, 2024

The advent of monoclonal antibodies paired with improvements in each ADC design component has led to the approval of 11 ADCs with more than 180 ADCs currently in clinical development. Notably, novel linker-payload technologies applied to the same target have provided significant improvements over previous generation ADCs.

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The Pharma Data

MARCH 28, 2022

For background slides and webcast information, please refer to the following link. The information will be available beginning Tuesday, March 29 at 1 p.m. The Immunology pipeline consists of 7 potential new medicines in Phase 1 clinical development, 5 in Phase 2 clinical development, and 1 in Phase 3 clinical 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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