Alta Sciences

JULY 3, 2025

Altasciences At CPHI Americas 2025 pmjackson Thu, 07/03/2025 - 13:41 In the ever-changing drug development world, staying agile is essential to enabling more informed decisions, faster. This blog was originally published in July 2025. Image Thumbnail_Blog_Lisa-v2.jpg Tags Manufacturing and Analytical Services Weight 14

Small Molecule

Covalent Modifiers

FEBRUARY 25, 2025

Gill Journal of Medicinal Chemistry 2025 DOI: 10.1021/acs.jmedchem.4c02313 Seamon, Matthew Holderfield, Xing Wei, Yongxian Zhuang, Yu Chi Yang, Jingjing Jiang, Yue Huang, Ruiping Zhao, Yun Ling, Zhican Wang, Michael Flagella, Zhengping Wang, Mallika Singh, John E. Knox, Robert Nichols, David Wildes, Jacqueline A. Smith, Elena S.

Clinical Trials

Covalent Modifiers

JULY 25, 2025

Research Square Preprint, 23 July 2025, [link] Orelabrutinib is a highly selective, irreversible inhibitor of Bruton’s tyrosine kinase (BTK). A multicentre, double-blind, randomised, placebo-controlled, phase Ib/IIa trial (NCT04305197) was conducted. A total of 55 patients completed the trial.

Treatment

Covalent Modifiers

MAY 18, 2025

Nafizul Haque Kazi, Nikolas Klink, Kai Gallant, Gian-Marvin Kipka & Malte Gersch Nat Struct Mol Biol , 2025 [link] The mitochondrial deubiquitinase ubiquitin-specific protease (USP) 30 negatively regulates PINK1parkin-driven mitophagy.

Engineering

Advarra

DECEMBER 17, 2024

As we look to 2025, Advarra thought leaders have compiled predictions and perspectives on key topics shaping the industry. For example, AI tools can pull data from protocols and automatically update clinical trial management systems (CTMS), reducing manual entry errors and increasing workflow speed.

Clinical Research

FDA Law Blog: Biosimilars

APRIL 13, 2025

By Sarah Wicks & Dara Katcher Levy FDAs Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter of 2025 to Taiho Oncology (Taiho) for a healthcare provider branded website for its drug LYTGOBI (futibatinib). As a single-arm trial (i.e., The problem?

Drugs

Drugs.com

MAY 5, 2025

MONDAY, May 5, 2025 Testing positive for leukemia actually saved the life of 51-year-old Jan Leahy, a business process owner from Wimbledon, England.Leahy benefitted from a clinical trial evaluating a new bone marrow test that can detect a p.

Clinical Trials

The Pharma Data

JUNE 18, 2025

Many of these companies have used the grant as a springboard for clinical trials, regulatory approvals, and successful funding rounds. Merck has deliberately structured the program to not only recognize scientific excellence but to serve as a meaningful catalyst for translational development.

Therapies

Drugs.com

MAY 5, 2025

MONDAY, May 5, 2025 An experimental drug might help people with uncontrolled high blood pressure, according to early clinical trial results.People taking lorundrostat experienced twice the decline in their systolic blood pressure than people t.

Clinical Trials

The Pharma Data

JUNE 9, 2025

Cardiovascular Insights from the XYLO Trial One of the most notable late-breaking presentations was the Phase 4 XYLO study, which examined the cardiovascular benefits of switching patients from high-sodium, twice-nightly oxybate therapy to the same dosage of low-sodium Xywav over a six-week period. According to Dr. Richard J.

FDA Approval

Broad Institute

JULY 29, 2025

Collaboration aims to reduce animal use in drug safety testing By Leah Eisenstadt July 29, 2025 Breadcrumb Home Collaboration aims to reduce animal use in drug safety testing OASIS consortium is evaluating omics tools in cells, including Cell Painting and transcriptomics, to predict liver toxicity of potential new medicines and agrochemicals.

Animal Testing

Drugs.com

JUNE 6, 2025

FRIDAY, June 6, 2025 — Immunotherapy combined with chemo can give people a fighting chance against stomach and esophageal cancers, a new clinical trial says.People treated with durvalumab and chemotherapy were much more likely to go into remission.

Clinical Trials

The Pharma Data

JUNE 11, 2025

argenx Unveils Positive Phase 2 Results for Efgartigimod in Myositis and Sjogren’s Disease at EULAR 2025 argenx SE a global immunology company dedicated to advancing treatments for severe autoimmune diseases, presented encouraging new clinical data at the 2025 European Congress of Rheumatology (EULAR), held June 11–14 in Barcelona, Spain.

Disease

Fierce BioTech

JUNE 24, 2025

Accelerate Clinical Trials with Methylation-Based ctDNA Detection Download now to learn from biopharma industry leaders about how methylation-based ctDNA detection for precise MRD and response monitoring can accelerate your clinical trials.

Clinical Trials

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.

Drug Development

The Pharma Data

JUNE 12, 2025

Evidence of Clinical Benefit from CELMoD Agents in Multiple Myeloma The data presented at EHA 2025 further illuminate the potential for CELMoD agents to make a measurable improvement in the lives of patients battling multiple myeloma — a plasma cell malignancy that often relapses after standard treatments and is challenging to control.

Targeted Protein Degradation

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. Only in this way can AI reach its full potential in accelerating drug discovery and improving trial success rates. Highlighting data integration.

Drugs

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

Drugs.com

MAY 5, 2025

MONDAY, May 5, 2025 — An experimental drug might help people with uncontrolled high blood pressure, according to early clinical trial results. People taking lorundrostat experienced twice the decline in their systolic blood pressure than.

Clinical Trials

New Drug Approvals

JULY 9, 2025

2] [4] Sunvozertinib was approved for medical use in the United States in July 2025. [1] 5] In China, it was conditionally approved in 2023 for the treatment of NSCLC and full approval is contingent on results of phase 3 clinical trials. [6] 2] [4] Sunvozertinib was approved for medical use in the United States in July 2025. [1]

FDA

Quanticate

JULY 16, 2025

This article is based on the final, Step 4 version of the ICH E6(R3) Good Clinical Practice guidance, officially adopted on 6 January 2025 by the International Council for Harmonisation. For full details, see the official PDF: ICH E6(R3) Step 4 Final Guidance (06 Jan 2025)

Clinical Trials

The Pharma Data

JUNE 9, 2025

The Week 26 data from the COACH Trial now show that TransCon hGH may further enhance these benefits. COACH Trial Overview The COACH Trial is a prospective, Phase 2, open-label, proof-of-concept study designed to evaluate the efficacy, safety, and tolerability of the combination therapy. mg/kg/week) during the trial.

Trials

Broad Institute

APRIL 5, 2025

David Liu receives Breakthrough Prize in Life Sciences By Corie Lok April 5, 2025 Breadcrumb Home David Liu receives Breakthrough Prize in Life Sciences Liu is honored for the development of base editing and prime editing, two gene editing technologies transforming medicine.

Science

The Pharma Data

JUNE 6, 2025

has announced encouraging interim findings from the pivotal Phase 3 VISIONARY trial evaluating sibeprenlimab in adults with Immunoglobulin A nephropathy (IgAN), a rare and progressive autoimmune kidney disorder. We are grateful to the patients who have contributed to advancing the science through their participation in this landmark trial.”

Trials

Drug Target Review

JULY 21, 2025

This heterogeneity also affects the ability to produce consistent results in clinical trials, as study groups sharing the same symptoms and disease progressions are hard to find. These gaps in knowledge can lead to a trial-and-error approach to clinical trials, which can result in high failure rates. Pandit R, Chen L, Götz J.

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

PPD

FEBRUARY 12, 2025

Reach out to us The post Enhancing Your Experience: What to Expect From Us in 2025 appeared first on PPD. Upgrading our technology stack Weve prioritized targeted improvements and new systems and tools that drive innovation, enhance efficiency, and improve site and patient relationships.

Clinical Supply

The Pharma Data

JUNE 22, 2025

In the trial, participants were directly switched to Mim8 without a washout period. Strong Safety Profile Reinforces Mim8’s Potential Mim8’s safety profile was a central focus of the FRONTIER5 trial. Throughout the 26-week study period, the investigational therapy was well-tolerated.

Pharmacokinetics

Drug Target Review

JUNE 28, 2025

DARPin therapeutics were a prominent theme at AACR 2025 , with Molecular Partners presenting a trio of preclinical programmes spanning radiopharmaceuticals and immune cell engagers. ” With an IND filing and first-in-human trials expected in 2025, MP0712 is moving steadily towards clinical evaluation.

Science

The Pharma Data

JUNE 25, 2025

In March 2025 , Regulus announced the successful completion of its Phase 1b multiple-ascending dose clinical trial for farabursen. Eastern Time on June 25, 2025. The development of farabursen is expected to move into Phase 2 clinical trials in the second half of 2025, pending regulatory clearance.

RNA

Advarra

MAY 21, 2025

The release of ICH E6(R3) in January 2025 marks the most significant evolution in Good Clinical Practice (GCP) guidelines in over a decade. Many pharma companies are unsure how to begin aligning with the new expectations, especially around trial design and quality systems. What needs to change?

Pharma Companies

SugarCone Biotech

JUNE 19, 2025

Two large and randomized clinical trials, IMpower-133 and CASPIAN, showing statistically significant improvements in outcomes when chemotherapy was combined with atezolizumab or durvalumab, respectively, in the first-line treatment of ES-SCLC. This Phase 3 trial compared tarlatamab with chemotherapy as second-line treatment.

Therapies

New Drug Approvals

APRIL 11, 2025

2] Fitusiran was approved for medical use in the United States in March 2025. [2] 2] History The efficacy and safety of fitusiran were assessed in two multicenter, randomized clinical trials which enrolled a total of 177 adult and pediatric male participants with either hemophilia A or hemophilia B. [2] 26 March 2025.

Clinical Trials

The Pharma Data

JUNE 12, 2025

Foundation, explained during the EULAR 2025 presentation: “IgG4-related disease is a progressive, immune-mediated condition with a significant unmet patient need. Safety Profile Consistent with Previous Studies : The safety profile of rilzabrutinib was well-understood from previous trials, with no new safety signals.

Disease

Codon

FEBRUARY 13, 2025

Traditionally, scientists discover enzymes in nature and adapt them through trial and error. 2025) For a second round of filtering, the team introduced a new method called PLACER (Protein- Ligand Atomistic Conformational Ensemble Resolver), which predicts how atoms should arrange themselves based on physical and chemical principles.

Small Molecule

BioPharma Drive: Drug Pricing

JULY 8, 2025

Published July 8, 2025 Gwendolyn Wu Senior reporter post share post print email license Proteasomes are cellular machines for breaking down proteins. Dupixent, which blocks IL-4, alone brought in more than $4 billion in sales for Sanofi in the first quarter of 2025. But hurdles remain.

Targeted Protein Degradation

The Pharma Data

JUNE 11, 2025

The findings were presented as part of a late-breaking abstract session (#LB0001) at the European Alliance of Associations for Rheumatology (EULAR) Congress 2025 , held June 11–14 in Barcelona, Spain. No new safety signals emerged, and the treatment continued to be well tolerated. of patients achieving an ACR20 response versus 39.4%

Trials