The Pharma Data

MARCH 15, 2021

Clinical research is a key component of developing. A critical component of our medicinal product development is clinical research. This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. The clinical development process.

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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.

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The Pharma Data

AUGUST 12, 2020

Moderna continues to rise to meet the demands of the pandemic, signing a new deal with the US Government to supply 100 million doses of its messenger RNA (mRNA) vaccine candidate for the prevention of COVID-19. Under the terms of the deal, the US Government will also have the option to reserve a further 400 million doses of the vaccine. “We

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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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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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Cytel

APRIL 24, 2023

In the last 10 years, the Asia-Pacific (APAC) region has become a hotspot for clinical trials: the region contributed almost 50% of new clinical trial activity globally.

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PPD

JUNE 17, 2024

Each model delivers a distinct set of capabilities to the study sponsor: In an FSP arrangement, the contract research organization (CRO) performs a specific function or multiple functions (clinical operations, pharmacovigilance, etc.) across protocols, medicinal products, a portfolio of studies or the entire company.

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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. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics.

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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. in North America) in late 2017.

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The Pharma Data

OCTOBER 28, 2020

We appreciate the confidence of the MHLW in Moderna and mRNA-1273, which we hope will help address the pandemic, especially given the encouraging data we have recently published together with the NIH related to the clinical trial in the elderly and older adult population,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We

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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 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

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4

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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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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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PPD

DECEMBER 14, 2023

In an increasingly competitive clinical trial and post-marketing surveillance sphere, many companies have turned to outsourcing models to rapidly expand their capabilities, more efficiently leverage internal resources and reach a broader population of trial participants and research personnel.

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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 The Phase 2 CRC trial is expected to have a data readout in early 2021. Additional information about CodeBreaK clinical trials can be found at [link].

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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

JANUARY 17, 2021

The trial is comprised of three dose escalation cohorts ranging from 30 ?g g with five patients in each group, and a total of 15 patients will be enrolled in the trial. ” The Company expects to report initial clinical data from the trial in 2021. . 1 and COX-2. the founder, President and CEO of Sirnaomics.

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Conversations in Drug Development Trends

FEBRUARY 22, 2023

Rare Disease Day on February 28th is a chance for rare disease communities to come together as one and join in conversation with stakeholders searching for treatments, raising money to support research, and changing the way healthcare and governments interact with patients. I have participated in many trials and studies.

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The Pharma Data

JANUARY 3, 2021

TLC19 Hydroxychloroquine Liposome Inhalation Suspension was thus incubated, with Phase I clinical trial currently taking place in Taiwan and Australia. TLC is consistently ranked top 5% among all listed companies in Taiwan’s Corporate Governance Evaluations. Cautionary Note on Forward-Looking Statements.

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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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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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The Pharma Data

SEPTEMBER 9, 2020

“We have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted.”. “As About the Phase 2/3 Study. billion doses by the end of 2021.

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The Pharma Data

OCTOBER 30, 2020

30, 2020 /PRNewswire/ — The IDMC also recommends continuation of enrollment in the REGN-COV2 outpatient trial. NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified.

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The Pharma Data

APRIL 26, 2022

Based on these new results, Valneva and Pfizer plan to proceed with inclusion of pediatric participants in their planned Phase 3 trial. The trial will evaluate VLA15 in adults and pediatric subjects 5 years of age and above and is expected to be initiated in the third quarter of 2022, subject to regulatory approval.

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The Pharma Data

OCTOBER 29, 2020

Importantly, the AU/EU model allows biotechs to keep their data and trial management in Australia, and take advantage of the Australian cash rebate of up to 43.5% on clinical trial costs, throughout all study phases, across both regions. “We About Avance Clinical www.avancecro.com.

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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 The Phase 2 CRC trial is expected to have a data readout in 2021. Additional information about CodeBreaK clinical trials can be found at [link].

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The Pharma Data

NOVEMBER 20, 2020

18 years of age and unsolicited safety data from approximately 38,000 trial participants who have been followed for a median of two months following the second dose of the vaccine candidate. In some cases, governments may have regulatory pathways similar to an EUA. Manufacturing and Delivery Capabilities. About the Study.

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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 10, 2020

Pending discussions with the FDA, the oral vaccine will enter Phase I trials as a prime and boost, and will be explored to provide a boost to subcutaneous vaccinations. For more information about ImmunityBio’s COVID-19 vaccine trials, please contact clinicalresearch@hoag.org. link] 1. About ImmunityBio. ImmunityBio, Inc.

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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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The Pharma Data

JULY 21, 2021

The companies are firmly committed to working towards equitable and affordable access for COVID-19 vaccines for all people around the world, actively working with global governments as well as global health partners with the aim to provide 2 billion doses to low and middle income countries in 2021 and 2022 – 1 billion each year.

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The Pharma Data

MAY 6, 2021

Under the MoU framework, NOCs and their local governments are expected to coordinate the administration of vaccinations to eligible Games participants. Doses provided under this MoU would be in addition to doses provided under supply agreements with governments worldwide.

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The Pharma Data

DECEMBER 11, 2020

Government to supply doses in 2020 & 2021. All trial participants will continue to be monitored to assess long-term protection and safety for an additional two years after their second dose. government’s Operation Warp Speed program goal to deliver doses of a vaccine for COVID-19. immediately.

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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The Pharma Data

MAY 7, 2021

Government,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S.

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