Quanticate

JULY 14, 2025

Learn how causal inference methods improve real-world observational trials by reducing bias, enhancing validity, and informing decisions.

Trials

Quanticate

JUNE 13, 2025

By organising and analysing this information, researchers can extract actionable insights that improve patient outcomes, data accuracy, drug efficacy and speed up trials. Clinical research generates vast amounts of diverse data from laboratory tests, patients, medical equipment, and outside sources.

Clinical Trials

DrugBank

OCTOBER 30, 2024

From advancing drug discovery, managing clinical trials, or developing new healthcare solutions, reliable and flexible access to quality data is essential for success. From early-stage drug discovery to complex clinical trials, Snowflake scales alongside your work to meet your growing demands. 

Production

Drug Target Review

JULY 3, 2025

It is becoming increasingly evident that generative artificial intelligence (GenAI) is a resourceful tool for helping pharmaceutical companies reduce manual tasks required by clinical trials. Because LLMs are trained on extensive, internet-scale datasets, they can learn to identify contexts linking words and language. Molecular innovation.

Drug Development

The Pharma Data

JUNE 23, 2025

Phase 2 Study: Transformative Weight Loss and Glycemic Control The Phase 2 trial focused on evaluating the efficacy and safety of MariTide in individuals with obesity, both with and without Type 2 diabetes (T2D). This schedule reflects the learnings from the Phase 1 PK-LDI trial and aims to maximize tolerability while sustaining efficacy.

Trials

Broad Institute

JULY 29, 2025

Related groups OASIS Consortium Carpenter-Singh Lab Health and Environment Sciences Institute (HESI) Related news A marriage of microscopy and machine learning Roughly a third of drug candidates fail in the first phase of clinical trials, often due to unanticipated toxic effects that weren’t apparent in animal tests.

Animal Testing

Drug Patent Watch

DECEMBER 9, 2024

Robust Clinical Trial Design : Clinical trials for biosimilars should be designed to demonstrate equivalence or non-inferiority to the reference product. This involves the use of statistical techniques such as equivalence and non-inferiority testing, as well as adaptive design approaches to reduce sample size and trial duration.

Biosimilars

Drug Target Review

JULY 29, 2025

Effective financial management is a cornerstone in the success of clinical trials, which are integral to the advancement of drug discovery. As the pharmaceutical and biotech industries continue to evolve, clinical trials become more complex, and the importance of robust financial oversight has never been clearer.

Clinical Trials

Drug Patent Watch

DECEMBER 12, 2024

Branded drugs, developed through extensive research and clinical trials, often enjoy patent protection for a limited period. Drugs that require extensive clinical trials for generic approval or fall under special regulatory pathways may have a lower risk of generic entry.

Licensing

Drug Target Review

JUNE 11, 2025

Clinical genomics, powered by NGS, enables more precise target validation, improved patient stratification and optimised trial design, ultimately aiming to increase PoS. This approach overcomes the limitations of traditional methods that analyse only single modalities of information. Highlighting data integration.

Drugs

Drug Target Review

JULY 8, 2025

ABBV-969 is currently in a Phase I clinical trial ( NCT06318273 ), with early data reinforcing its potential to reach tumour cells that would otherwise escape detection through single-target strategies. These insights are directly informing both trial design and candidate selection in AbbVie’s preclinical and clinical pipelines. “Key

Therapies

Drug Target Review

JUNE 6, 2025

This dual role enables him to bridge research and clinical practice, ensuring scientific innovation is directly informed by patient care. “As Protocol development can be a complex and meticulous process,” he explains, “as it’s crucial to ensure that trial candidates meet the necessary inclusion criteria.”

Therapies

PPD

DECEMBER 16, 2024

Cost and complexity go hand-in-hand The rising costs and growing complexity in clinical trials are deeply linked, with patient recruitment, extended timelines and meeting regulatory demands emerging as some of the key drivers. Nearly half (49%) of clinical trial sponsors surveyed identified rising costs as their foremost concern in 2024.

Drug Development

Alta Sciences

JULY 31, 2025

Altasciences shares this forward-thinking approach, and we’re excited to work together to support pharmaceutical and biotech companies in making faster, more informed decisions.” Our mission has always been to make drug screening more human-relevant and predictive,” said Karolina Valente, CEO of VoxCell BioInnovation.

Drug Development

The Pharma Data

JUNE 22, 2025

The results from the Phase I/II NXTAGE trial, announced during the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress in Washington, D.C., The trial is evaluating NXT007 in people with hemophilia A without factor VIII inhibitors who have not previously been treated with Hemlibra.

Clinical Trials

BioPharma Drive: Drug Pricing

JULY 8, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. Though it may not be used across a broader patient population, results from Arvinas and Pfizer’s trial of vepdegestrant offer some validation for degraders’ potential.

Targeted Protein Degradation

PPD

FEBRUARY 10, 2025

Todays clinical trials rely on technologically sophisticated systems that require complex integrations to capture and process all manner of data across multiple sites, often spread throughout multiple countries or jurisdictions. Electronic medical records (EMRs), for example, exemplify the evolving role of technology in clinical trials.

Clinical Trials

PPD

MARCH 11, 2025

Breaking through research barriers Challenge #1: Small groups of patients Rare diseases impact a small number of individuals, making it difficult to recruit enough participants for clinical trials. Moreover, in some rare disease trials, it is unethical to design a control group of patients with a placebo.

Drug Development

Alta Sciences

JUNE 6, 2025

Optimizing Tube Labeling for Improved Efficiency The tube labeling process starts with the generation of an Excel file generated from our Laboratory Information Management System (LIMS), which contains a list of unique IDs and sample information. This file is then imported into an MS App interface to create the user request.

Pharmacokinetics

Broad Institute

NOVEMBER 25, 2024

The L2C Accelerator’s vision was informed by the lessons learned from the work of many investigators, including our research on one rare genetic disease that de-orphaned many others and was enabled by scalable resources at Broad. You can learn more about how clinical trials work here.

Clinical Trials

The Pharma Data

JUNE 15, 2025

EVEREST is the first-ever trial to demonstrate the superiority of Dupixent over Xolair on both nasal polyp endpoints and related symptoms in patients with co-existing asthma, while retaining a generally similar safety profile. This is crucial information for guiding both patients and physicians in their treatment decisions.”

Treatment

The Pharma Data

JUNE 25, 2025

Clarification of Clinical Study Evidence : The updated clinical studies section outlines the role of amyloid PET imaging in monitoring treatment response, particularly referencing its use in trials assessing the efficacy of amyloid-targeting therapies.

FDA

Drug Target Review

JULY 28, 2025

Improved scientist–data interaction: “Once we have all these datasets, have run these algorithms and have some outcomes and outputs, how can a scientist really engage with that information and use it to make a decision on what to do next?” ” she enquires.

Drugs

New Drug Approvals

JULY 9, 2025

1] Side effects The US FDA prescribing information for sunvozertinib includes warnings and precautions for interstitial lung disease/pneumonitis, gastrointestinal adverse reactions, dermatologic adverse reactions, ocular toxicity, and embryo-fetal toxicity. [1] 1] History Sunvozertinib is being developed by Dizal Pharmaceutical. [5]

FDA

The Pharma Data

JUNE 27, 2025

This data includes results from two pivotal studies: Part C of the ongoing DEVOTE clinical trial and the final eight-year data from the NURTURE study. The findings were unveiled during the annual SMA Research & Clinical Care Meeting, hosted by Cure SMA in Anaheim, California. Source link

Treatment

Alta Sciences

NOVEMBER 15, 2024

Whether you’re at the discovery phase or gearing up for a clinical trial , your first conversation with a CRO is an excellent opportunity to assess the cultural fit and collaborative potential. Your Project History Be open to sharing relevant information about your study history and development plans.

Drug Development

The Pharma Data

JUNE 16, 2025

Importantly, these data show that Breyanzi covers the broadest patient population of any CD19-directed CAR T-cell therapy for B-cell malignancies while retaining a consistent and favorable safety profile — both in clinical trials and in the real-world setting.”

Therapies

The Pharma Data

JUNE 18, 2025

Safety Profile: Consistent with Prior Studies The adverse event profile observed in the TEMPLE study for atogepant aligned with what has been reported in previous clinical trials, suggesting consistency and predictability in its safety outcomes.

Clinical Trials

Drug Target Review

JULY 7, 2025

Their unique suitability has made them valuable for evaluating pharmacokinetics, toxicology and safety in drug candidates before human clinical trials. 7 If successful, the findings from this pilot will inform expanded regulatory guidance and potentially lead to a broader adoption of animal-free approaches across drug categories.

Drug Research

PPD

JULY 29, 2025

Biopharma and biotech industries are facing remarkable challenges as the cost of developing new drugs has surged dramatically and clinical trial timelines have extended significantly. For example, over the past decade, the average time required to complete a clinical trial has increased by approximately 20-30%. billion (versus $1-1.5

Clinical Trials

PPD

JULY 8, 2025

In clinical trials, generative AI accelerates trial designs through protocol optimization and enrollment forecasting, leading to faster and more effective studies. One major concern is its tendency to hallucinate, confidently producing factually incorrect information. This maintains regulatory compliance and patient safety.

Clinical Research

BioPharma Drive: Drug Pricing

JULY 14, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. No serious treatment-related side effects were reported, and more than 95% of study participants who completed the trials enrolled in a long-term extension study.

Drugs

LifeSciVC

JULY 8, 2025

Dynamic Subordination Principle: Let the Best Information Lead Based on the leadership framework of Mike Hayes, former SEAL Team TWO Commander Mike Hayes introduced the concept of dynamic subordination as a response to the limits of rigid hierarchy. It’s no longer just about accessing lower-cost manufacturing or early-phase trial speed.

Hospitals

The Pharma Data

JUNE 9, 2025

Jude Children’s Research Hospital and lead investigator of the CLEVER (MK-1654-004) and SMART (MK-1654-007) clinical trials, emphasized the significance of this development. Key results from the CLEVER trial include: A 60.5% Octavio Ramilo, Chair of the Department of Infectious Diseases at St.

FDA Approval

Conversations in Drug Development Trends

JANUARY 21, 2025

Regulatory bodies such as the FDA oversee clinical trials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws. Any delays or missteps in bioanalysis during a Phase I trial can derail the trajectory of a promising drug.

Clinical Trials

The Pharma Data

JULY 2, 2025

The approval, granted on the basis of promising results from the ongoing Phase 1/2 LINKER-MM1 trial, targets a subset of patients who have exhausted at least four prior treatment regimens, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

FDA

The Pharma Data

JUNE 15, 2025

This cautious and responsible step will enable the company to gather additional data, make appropriate and fully-informed decisions, and collaborate closely with regulators to enable eventual resumption under a more robust safety framework. The FDA agrees with this cautious approach.

Immune Response