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.

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The Pharma Data

OCTOBER 28, 2020

Over the past nine years, Moderna has invested in creating and developing a novel platform for designing and manufacturing a new class of mRNA-based vaccines. A summary of the company’s work to date on COVID-19 can be found here. mRNA-1273 currently is not approved for use by any regulatory body.

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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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PPD

JUNE 17, 2024

For example, a sponsor may engage with the existing CRO for a new FSP clinical data management solution and launch the engagement with a dedicated implementation phase that enables setup of database standards, communication tools and ways of working before moving into the study delivery phase.

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The Pharma Data

SEPTEMBER 2, 2020

Roger Connor, President of GSK Vaccines, added: “Moving this vaccine candidate into clinical development is an important moment in the progress towards addressing the global pandemic we are all facing. “Our dedicated teams and partner continue to work around the clock as we aim to deliver the first results in early December.”.

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The Pharma Data

AUGUST 18, 2020

government. That roughly translates into $4 per dose, though the entire grant also covers funding for clinical development. government for $1.95 came in at $1.525 billion, not including about $1 billion in development funds. AstraZeneca, in collaboration with the University of Oxford, previously signed a $1.2

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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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Cytel

APRIL 24, 2023

This is driven by its large patient population, lower risk of competing trials, government support, pragmatic regulatory processes, lower cost of conducting trials, and strategic importance of Asian markets.

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The Pharma Data

AUGUST 7, 2020

As the pharma industry stands firm in its commitment to advance the sector to fight Covid-19, news has emerged from the European Commission who intend to streamline the development of therapies using genetically modified organisms to treat Covid-19. Dr. Francis S.

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The Pharma Data

MARCH 1, 2022

A key element of this partnership involves Lifebit’s CloudOS platform – a powerful, secure and cutting-edge platform used by a growing number of research organizations and governments globally, such as Genomics England and The Hong Kong Genome Project.

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The Pharma Data

OCTOBER 25, 2020

SQI is accelerating the clinical development of its direct-to-consumer COVID-19 HOME Antibody Test, its COVID-19 RALI-dx Severity Triage Test and its COVID-19 RALI- fast Severity Triage Point-of-Care (POC) Test. FDA that Emergency Use Authorization (EUA) submission is acceptable for all three COVID diagnostic tests.

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Molecule Blog

MARCH 17, 2023

Clinical development kicks off when the company files an IND with the FDA , progressing through Phase I for safety, Phase II for early signs of efficacy, and Phase III for determining full approval. Funding typically comes from a mix of government agencies, venture capitalists (VCs), and pharmaceutical companies.

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PPD

DECEMBER 14, 2023

In this blog, we’ll explore the benefits associated with employing global resources across time zones for FSP engagements and how PPD ® FSP solutions utilize different regions to drive more efficient clinical development operations.

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PPD

DECEMBER 5, 2023

Clients benefit greatly from strategic partnerships with FSP providers that have the expertise, adaptability and precise operational requirements that deliver clinical development programs on time in non-footprint countries.

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The Pharma Data

DECEMBER 23, 2020

The Company has Now Resumed the Clinical Development of its Proposed Anti-Nausea Pharmaceutical Grade Version of Tauri-Gum. With this funding now complete, the Company is excited about its prospects for 2021 – as it pertains to its pharmaceutical development efforts. . Government Vendor (CAGE CODE # 8QXV4).

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The Pharma Data

APRIL 4, 2022

Roche stands together with society, governments, healthcare providers and all those working towards the common goal of overcoming the COVID-19 pandemic. The extensive Actemra/RoActemra RA intravenous (IV) clinical development programme included five phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries.

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The Pharma Data

MARCH 15, 2021

To ensure these studies are conducted to the highest standards of protection for individuals who participate in the studies, AbbVie strictly follows important rules governing clinical research. Within each of our therapeutic areas, we have various products in development. The clinical development process.

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The Pharma Data

SEPTEMBER 16, 2020

Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C ?inhibitor Our business may be impacted by government investigations, litigation and product liability claims. Amgen, along with members of?Amgen’s

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Advarra

NOVEMBER 29, 2022

However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines. Many companies are unable to develop these niche therapies because of the associated costs and limited financial return.

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The Pharma Data

JANUARY 13, 2021

.” MindMed Chief Development Officer Rob Barrow said, “Psychedelic therapies offer a once in a lifetime opportunity to revolutionize the delivery of mental healthcare.

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The Pharma Data

JANUARY 27, 2021

The two-hour event will cover various topics, including an overview of the Company’s board and executive leadership, its commitment to environment, social and governance (ESG) matters, and progress updates on the Company’s critical care programs, manufacturing and distribution approach, and commercial readiness plans. About MultiStem ®.

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The Pharma Data

JANUARY 3, 2021

TLC is consistently ranked top 5% among all listed companies in Taiwan’s Corporate Governance Evaluations. TLC has a diverse, wholly owned portfolio of therapeutics targeting areas of unmet medical need in pain management, ophthalmology, oncology, and infectious diseases. Cautionary Note on Forward-Looking Statements.

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The Pharma Data

NOVEMBER 2, 2020

In the body, FGF21 helps govern metabolism, calorie-burning and food intake. vice president, clinical development, Principia Biopharma, South San Francisco; Donna Ryan, M.D., Researchers found that a single injection spurred “metabolic improvements” in overweight and obese adults that lasted up to two months.

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The Pharma Data

SEPTEMBER 20, 2020

Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C ?inhibitor Our business may be impacted by government investigations, litigation and product liability claims. Amgen, along with members of?Amgen’s

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The Pharma Data

JULY 27, 2021

As part of the collaboration, working together with AbbVie, Calico pursues discovery-stage research and development utilizing state-of-the-art technology and advanced computing capabilities. AbbVie provides scientific and clinical development support and will lend its expertise to future commercialization activities.

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The Pharma Data

JANUARY 17, 2021

Members of the senior management team have a combined experience in the biopharmaceutical industry, spanning clinical development, regulatory, financial and business management in both the USA and China. The company is supported by funding from institutional investors, corporate partnerships and government grants.

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The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM adjuvant.

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The Pharma Data

JUNE 1, 2022

Under her leadership, Pfizer advanced into clinical development or approval bacterial vaccine programs directed at the prevention of diseases due to Streptococcus pneumoniae, Group B Streptococcus, Neisseria meningitidis, Staphylococcus aureus, and Clostridium difficile.

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The Pharma Data

APRIL 26, 2022

About VLA15 VLA15 is the only Lyme disease vaccine candidate currently in clinical development. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.

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Precision for Medicine

JUNE 26, 2023

Precision applies a transformational approach to clinical research that integrates clinical trial design and execution with deep scientific knowledge, laboratory expertise, data sciences and advanced manufacturing solutions. This convergence is driving faster clinical development and approval.

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The Pharma Data

SEPTEMBER 9, 2020

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. For more than 170 years, we have worked to make a difference for all who rely on us.

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FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

These standards would be developed outside the Federal government, leveraging the expertise of the private sector. In short, Voluntary Consensus Standards (VCS) are intended to be exactly what the name conveys – standards that are adopted by consensus and are not mandatory (not legal or regulatory requirements).

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The Pharma Data

OCTOBER 30, 2020

These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron’s business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron’s and its collaborators’ ability to continue (..)

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The Pharma Data

AUGUST 29, 2020

3,4 LNP023 is currently in clinical development for PNH and a number of renal conditions with complement system involvement where significant unmet needs exist, including IgA nephropathy, complement 3 glomerulopathy (C3G), atypical hemolytic uremic syndrome and membranous nephropathy.

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The Pharma Data

JANUARY 13, 2021

Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need.

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The Pharma Data

OCTOBER 29, 2020

Clinical Development Strategy – we provide expert guidance on study design, favorable venues, local and global landscape to improve study outcomes. About Avance Clinical www.avancecro.com. . The Government R&D grant means up to 43.5% rebate on clinical trial spend 2.

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The Pharma Data

DECEMBER 10, 2020

Should a product be commercialized successfully, the companies have agreed to a 60-40 percent split of net profits, with the larger share going to the company that developed the product. The agreement also details the structure of shared governance of the joint collaboration. link] 1. About ImmunityBio. ImmunityBio, Inc.

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