Drug Target Review

JANUARY 8, 2024

It is no mystery that as we age our health starts to deteriorate, and we become increasingly susceptible to diseases. Through years of scientific exploration and research, we now know there are several biological changes that make our bodies more susceptible to disease or injury, and we can target those with therapeutic interventions.

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Drug Target Review

AUGUST 6, 2024

A number of areas represent significant opportunities for Antibody Drug Conjugates (ADCs) beyond oncology, leveraging their ability to deliver therapeutic agents specifically to diseased cells or tissues while minimising off-target effects. Oncology also offers high returns and the opportunity to address severe, life-threatening conditions.

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Drug Patent Watch

DECEMBER 9, 2024

High-Throughput Screening: Modern Technology Meets Natural Products Advanced technologies now allow researchers to rapidly test thousands of natural compounds against specific disease targets. This approach has led to the discovery of numerous potential drug candidates. What is a Drug Patent?

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H1 Blog

DECEMBER 4, 2023

As the pharmaceutical and biotech industries continue to push for faster drug development, the importance of equity and diversity in clinical trial recruitment cannot be overlooked. Data is a powerful tool in identifying and reaching vulnerable populations for clinical trials.

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Conversations in Drug Development Trends

MAY 14, 2024

By: Amy Raymond, Derek Ansel, Nathan Chadwick, & Juliane Mills When choosing a CRO for a rare disease study, what truly sets them apart is their methodology: the CRO’s mindset, their approach to each unique study, and their agility in navigating the inherent complexities of rare disease research. Common goals empower change.

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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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Vial

JUNE 24, 2024

Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery. As clinical trials grow in complexity, the volume of data being gathered and utilized for these studies is expanding.

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Drug Target Review

SEPTEMBER 19, 2023

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. The chips can be modelled with primary cells, IPS derived stem cells or patient derived cells and potentiates to unlock molecular mechanisms that drive the disease pathophysiology, holding a greater promise.

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Advarra

AUGUST 16, 2022

A rare, or orphan, disease by definition affects a small percentage of the population — fewer than 200,000 people in the U.S. But the numbers add up, and taken together, rare diseases impact an estimated 30 million Americans. Since then, the FDA has significantly changed its approach to rare and orphan diseases.

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The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. galactosidase-A product candidate under development for the treatment of Fabry disease. CARMIEL, Israel and BOSTON , Dec. 30, 2020 /PRNewswire/ — Protalix BioTherapeutics, Inc. Male patients improved from -6.36

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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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Conversations in Drug Development Trends

MAY 23, 2024

By: Sarah Bly, Regulatory Science and Innovation and Matt Cooper, Executive Director, Therapeutic Strategy Lead, Oncology The European Union (EU) presents a unique set of regulatory challenges and opportunities for clinical trials in oncology. Increased Transparency : Ensures that information on clinical trials is more accessible.

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The Pharma Data

SEPTEMBER 3, 2020

Johnson & Johnson Announces that Janssen’s COVID-19 Investigational Vaccine Candidate Prevents Severe Clinical Disease in Pre-clinical Studies. Johnson & Johnson Announces that Janssen’s COVID-19 Investigational Vaccine Candidate Prevents Severe Clinical Disease in Pre-clinical Studies. Source link.

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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

APRIL 3, 2021

Johnson & Johnson (the Company) has begun vaccinating adolescent participants in the ongoing Phase 2a clinical trial for its COVID-19 vaccine candidate, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. Department of Health and Human Services (HHS). Source link:[link].

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DrugBank

JUNE 27, 2024

Add to that, these drugs have already passed safety tests, meaning they could potentially move through early-phase trials faster if doses are compatible for new uses. These include matching molecular signatures, virtual screening, and analyzing large datasets from health records and clinical trials.

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The Pharma Data

JANUARY 5, 2021

RAD011 is a pivotal-trial ready synthetic cannabidiol oral solution with potential utilization in multiple endocrine and metabolic orphan diseases. Acquisition and associated PWS trial costs to be funded from existing operations. Disease Highlights. Davis, executive chairman of Benuvia.

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Drug Target Review

DECEMBER 11, 2024

This shift in focus is especially critical in toxicology, where accurate target analysis plays a vital role in identifying toxic effects and ensuring patient safety, particularly as the field transitions from traditional drugs to the promising realm of biotherapeutics, especially for rare diseases.

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Drug Target Review

FEBRUARY 1, 2024

What challenges has the industry faced in developing and commercialising treatments for neurological diseases, including rare diseases? There are a lot of drug development challenges that are, in some cases, unique to neuroscience, including neurological diseases, psychiatric disorders, and rare diseases affecting the nervous system.

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The Pharma Data

JULY 8, 2021

ADUHELM should be initiated in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia. 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).

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DrugBank

OCTOBER 4, 2024

Emerging Markets Emerging markets, particularly in Asia and Latin America, have become increasingly attractive destinations for pharmaceutical M&A activity. The growing middle class and government initiatives to improve access to medicines have created an ecosystem for pharmaceutical companies seeking growth opportunities.

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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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Advarra

AUGUST 8, 2024

We also summarize the key information pharmaceutical companies and contract research organizations (CROs) need to know to prepare for compliance. High Risk AI-powered Systems: Key Requirements The AI Act will likely consider many AI-based systems used in clinical trials today as “high risk.” a synthetic control arm)?

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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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DrugBank

APRIL 12, 2024

Harnessing AI in Drug Discovery: A Snapshot AI’s penetration into healthcare and pharmaceuticals, particularly through machine learning algorithms and generative models, is profound. Regulatory bodies are yet to catch up with the rapid pace of AI, leading to a regulatory gray area that complicates the path from discovery to delivery.

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NIH Director's Blog: Drug Development

APRIL 7, 2015

Credit: NIH Alzheimer’s disease research is among the many areas of biomedical science that Senator Barbara Mikulski has championed during her nearly 40 years on Capitol Hill. Although the oral drug proved safe in human clinical trials, its performance was not impressive against cancer. population continues to age.

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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

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

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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The Pharma Data

JANUARY 19, 2021

The Phase 1 clinical trial is planned to be conducted in Canada and targeted to recruit up to 48 and 24 healthy volunteers for the single-ascending dose (SAD) and multiple- ascending dose (MAD) cohorts, respectively. About ALS-4. About Aptorum Group.

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Drug Target Review

JULY 6, 2023

TPD is a rapidly evolving therapeutic modality to degrade a disease-causing proteins, thereby eliminating their function specifically. Programme : the leader programme ASP3082 entered the clinical trial phase last year, and multiple forum programmes are currently under investigation in the light research phase.

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H1 Blog

DECEMBER 11, 2024

In this edition, our CEO and co-founder, Ariel Katz, along with Regional VP of Trial Landscape, Ryan Brown, share their top predictions for 2025. Drug Policy There will be significant changes in clinical trials & drug development due to the Inflation Reduction Act.

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The Pharma Data

OCTOBER 27, 2020

The objective of the Phase 3 clinical trial is to evaluate safety and effectiveness of 18 F-APN-1607 to differentiate patients with Mild Cognitive Impairment (MCI) and different stages of Alzheimer’s disease (AD) from healthy subjects. The proposed trial will enroll approximately 230 subjects with all receiving 18 F-APN-1607.

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DrugBank

JANUARY 15, 2025

Introduction Orphan drugs, specifically developed to treat rare diseases, represent a unique and challenging pharmaceutical industry segment. However, their significance in addressing the unmet medical needs of patients with rare diseases must be considered. Estimates show the median price of developing an orphan drug to be $2.6

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Drug Target Review

JULY 18, 2023

Where AI can help us is to interrogate that biological question and make sure that we are identifying and drugging disease modifying targets in the right way.” With support from pharmaceutical companies, ultimately, the answer to this question should be yes. This means that we are not doing something right.

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The Pharma Data

NOVEMBER 29, 2020

(HKEX:1672) and fully dedicated to the R&D and commercialization of new drugs in the field of NASH, announced today that Melissa Palmer , MD, an internationally renowned Hepatologist, will join the Company as Chief Medical Officer, effective December 1, 2020. The clinical trial application of ASC09F has been approved.

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The Open Targets Blog

OCTOBER 24, 2023

OMass Therapeutics is using a new technology platform to develop treatments for rare immunological and genetic diseases with high unmet patient needs. We primarily work on immune system diseases, integrating data and analyses from OTG on a large scale. However, the API presented two challenges.

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