H1 Blog

DECEMBER 18, 2023

How will AI impact clinical trials? Every year, we take a look at annual predictions to help life sciences, pharmaceutical, and healthcare companies understand larger industry trends and dynamics to prepare for the new year. Will FDA legislation improve diversity? What platforms will key opinion leaders adopt?

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PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). In addition, the constant evolution of EMA and Clinical Trials Coordination Group (CTCG) guidelines requires constant attention.

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DS in Pharmatics

SEPTEMBER 25, 2023

A robust Quality Management System (QMS) is an important aspect of a Pharmaceutical company as it demonstrates a company’s Senior Management commitment to Quality. QMS instills the mindset that assures that the company will have qualified and trained individuals who focus on “Quality” throughout the lifecycle of the product.

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DrugBank

AUGUST 9, 2024

Moreover, the probability of success for a drug candidate entering clinical trials is only around 10%, highlighting the substantial risks involved. Blockbuster drugs – those with annual sales exceeding $1 billion, can generate large revenue streams for pharmaceutical companies and deliver significant returns for investors.

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PPD

NOVEMBER 11, 2024

As companies undertake these steps, they increasingly rely on supply partners like Thermo Fisher who can address challenges in real time, helping maintain the highest levels of quality throughout the process without losing time or momentum.

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Advarra

JUNE 9, 2022

Optimizing clinical trial access for potential patients is a critical goal for researchers and sponsors. Decentralized clinical trials (DCTs) can meet that need, but they come with some challenges. Designing a DCT comes with certain challenges of course, particularly when proposing to utilize outside groups or locations for the trial.

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The Pharma Data

SEPTEMBER 15, 2020

Biopharma and pharmaceutical companies developing treatments and vaccines have long faced operational challenges that cost time and money while draining resources from the important work of changing lives. Working closely with researchers, Avantor quickly developed a solution that incorporated customized kits for the clinical trial.

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The Pharma Data

FEBRUARY 25, 2021

Takeda Provides Updates on Phase 1/2 Clinical Trials of Novavax’ and Moderna’s COVID-19 Vaccine Candidates in Japan. – Phase 1/2 immunogenicity and safety trials designed to include 200 healthy Japanese adults followed for 12 months after second vaccination. TAK-919 clinical trial. TAK-019 clinical trial.

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The Pharma Data

OCTOBER 20, 2020

Led by scientists at Imperial College London, people in this challenge trial will be guaranteed treatment if they become ill. The United States says human challenge trials might be too risky or unnecessary. Challenge trials have a long history, going back to Edward Jenner’s development of a smallpox vaccine in 1796.

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The Pharma Data

JANUARY 12, 2021

a leader in precision medicine and artificial intelligence (AI)-enabled patient-centric oncology clinical trial enrollment, announced today it has launched its SYNERGY-AI Oncology Clinical Trial Command Center (OCTCC) with the mission to disrupt and accelerate the clinical trial enrollment process.

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Drug Channels

FEBRUARY 7, 2024

Tomorrow, we’ll be treated to a Senate show trial featuring pharmaceutical company executives. In reality, nearly all drug spending growth occurred due to growth in the number of people treated, prescriptions dispensed, and other nonprice factors. healthcare expenditures.

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DrugBank

MARCH 7, 2024

Inspired by its success, pharmaceutical companies are pursuing the development of drugs with similar therapeutic profiles, aiming to expand treatment options. Key Players and Challenges For pharmaceutical giants like Novo Nordisk and Eli Lilly, 2024 presents both opportunities and challenges.

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H1 Blog

SEPTEMBER 14, 2023

As pharmaceutical companies turn to CROs (Clinical Research Organizations) for trial design and technology, there are new opportunities emerging with healthcare data intelligence that can help ensure a bright future for the industry and to make trials more effective, efficient and accessible. million data points.”

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BioPharma Drive: Drug Pricing

AUGUST 17, 2023

The German pharmaceutical company is launching three Phase 3 trials of an obesity drug called survodutide, which like Wegovy targets the GLP-1 receptor

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DrugBank

OCTOBER 17, 2024

By harnessing the vast amounts of data generated throughout the development pipeline, pharmaceutical companies can accelerate the discovery of novel therapies, optimize clinical trial design, enhance drug safety monitoring, and deliver personalized medicine, ultimately improving patient outcomes and transforming the future of healthcare.

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Advarra

APRIL 4, 2024

One crucial aspect of this process involves establishing data safety monitoring boards (DSMBs) (also known as data monitoring committees [DMCs]) to oversee clinical trials. Traditionally, pharmaceutical sponsors have formed a new DSMB for each individual trial.

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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. This philosophy is encapsulated in our belief: “If you’ve seen one trial for a rare indication, you’ve seen one trial.”

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The Pharma Data

SEPTEMBER 23, 2020

September 23, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. NEW BRUNSWICK, N.J., In the U.S.,

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Perficient: Drug Development

SEPTEMBER 10, 2024

Powering Patient-Centric Clinical Trials with AI and Data Explore how Life Sciences Cloud leverages AI to power comprehensive, customized, next-generation clinical trials for pharmaceutical companies. Gain insights into AI-driven solutions for optimizing clinical trials and enhancing customer experiences.

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DrugBank

NOVEMBER 4, 2024

  Pharmaceutical companies are, therefore, exploring innovative approaches. Gepotidacin has shown promising results in clinical trials for uncomplicated urinary tract infections and gonorrhea, demonstrating its potential to address the growing threat of MDR Gram-negative infections. 

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The Pharma Data

JANUARY 20, 2021

21, 2021 /PRNewswire/ — Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX: CALTX) (NASDAQ: CALT) today announced that all 360 patients have been enrolled for the global Phase 3 clinical trial NefIgArd, which investigates the effect of Nefecon® versus placebo in patients with primary IgA nephropathy (IgAN).

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The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. The full set of results will be published once the complete Phase 1/2a trial data are available.

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Vial

FEBRUARY 15, 2024

Clinical trials play a crucial role in advancing medical breakthroughs, but effective management is essential to unlock their full potential. Pharmaceutical companies often face challenges in conducting clinical trials due to the need for substantial knowledge, time, and resources. over the forecast period (2022-2030).

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Conversations in Drug Development Trends

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.

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The Pharma Data

NOVEMBER 14, 2020

November 15, 2020 — The Phase 3 ENSEMBLE study of the single-dose regimen of JNJ-78436735, the investigational vaccine candidate for the prevention of COVID-19 being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, continues to enroll and vaccinate study participants. PHASE 3 ENSEMBLE 2 STUDY.

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ACTO

NOVEMBER 25, 2024

It was basically the first computer to learn new skills by trial and error, using a type of neural network that simulates human thought processes. Predictive analytics: Through ML, pharmaceutical companies can forecast drug demand and optimize supply chain logistics—essential for maintaining market competitiveness.

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The Pharma Data

NOVEMBER 5, 2020

There was a handful of positive clinical trial news reported today. The Janssen Pharmaceutical Companies of Johnson & Johnson announced two Phase III trials, DISCOVER-1 and 2 demonstrated Tremfya (guselkumab) improved fatigue in adults with active psoriatic arthritis (PsA). Here’s a look. Janssen’s Tremfya.

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The Pharma Data

SEPTEMBER 23, 2020

First participants dosed in Phase 3 trial (ENSEMBLE) evaluating safety and efficacy of Janssen’s COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S. We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol.” NEW BRUNSWICK, N.J.

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Fierce BioTech

MARCH 4, 2024

With approximately 90% of candidates entering clinical trials failing to achieve regulatory approval, understanding the reasons behind these failures is crucial for companies aiming to future-proof their product candidates. On Demand Start Date Tue, 04/09/2024 - 11:00

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Predictive Oncology

FEBRUARY 7, 2023

“We’re providing that richness of tumor diversity and the population diversity that normally the companies will not be able to see until they are in a clinical trial and [the drug is] challenged against a multitude of different patients.”

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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. This philosophy is encapsulated in our belief: “If you’ve seen one trial for a rare indication, you’ve seen one trial.”

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H1 Blog

JULY 30, 2024

Increasing diversity in clinical trials not only makes the findings more relevant to various patient groups, but also enhances knowledge about the disease or medical product being studied. Hence, pharmaceutical companies need to start making preparations to ensure compliance with the new requirements.

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The Pharma Data

DECEMBER 27, 2020

In these unprecedented times, we are especially grateful for the dedication of our research site staff and trial participants, whose commitment to EXCELLENCE facilitated the advancement of our lead program,” said George Yeh, President of TLC. “We SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec.

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The Pharma Data

JANUARY 25, 2021

agree to place handheld Ceribell Rapid Response EEG systems in hospitals in connection with its Phase 3 RSE clinical trial. –( BUSINESS WIRE )– Marinus Pharmaceuticals, Inc. About the RAISE Trial. About Marinus Pharmaceuticals. Marinus Pharmaceuticals, Inc. Marinus and Ceribell, Inc. RADNOR, Pa.–(

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The Pharma Data

JANUARY 17, 2021

The results provide an opportunity for the company to pursue a pivotal Phase 2/3 clinical trial in patients with primary biliary cholangitis (PBC), based on interactions with the FDA. The trial consisted of a single ascending dose (SAD) part and a multiple ascending dose (MAD) part with dosing up to 1600mg/day. About Calliditas.

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The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

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DrugBank

AUGUST 15, 2024

To effectively navigate this ecosystem and expedite the development of new therapies, collaboration between the pharmaceutical industry and academia is proving increasingly vital. This includes funding large-scale clinical trials and establishing robust manufacturing/distribution networks.

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