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

Drug Target Review

JULY 7, 2025

Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. Federal ruling on USDA primate welfare petition, 2023. Food and Drug Administration (FDA). USDA (2020).

Drug Research

PPD

JANUARY 2, 2025

Its ability to maneuver persistent drug development challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success. This blog explores the value of functional service provider (FSP) models and how they help biotech companies augment their clinical development needs.

Clinical Development

Drug Target Review

APRIL 7, 2025

GPCRs are critical targets for drug development due to their involvement in numerous disease pathologies, with many medications working by either activating or inhibiting these receptors. 2022) Why 90% of clinical drug development fails and how to improve it?, References Sun D, et al. doi:10.1016/j.apsb.2022.02.002.

Fragment Screening

Drug Target Review

JULY 14, 2025

The pharmaceutical industry faces a persistent challenge: despite significant investments in drug development, a substantial proportion of promising candidates fail due to unforeseen toxicity issues. By this point, companies have invested heavily in their assets but have not yet reached human trials.

Drugs

New Drug Approvals

APRIL 2, 2025

This action and the agencys designations to expedite the drugs development and review underscore FDAs commitment to approving safe and effective alternatives to opioids for pain management. Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared to placebo. August 2023).

FDA

Codon

NOVEMBER 3, 2024

As an undergraduate biology student, I spent some time in a TB lab working on antibiotic resistance — a growing concern for drug developers. billion people received this same vaccine between 1980 and 2023, making it the most widely administered vaccination on Earth. Subscribe to Asimov Press.

Vaccine

SugarCone Biotech

JULY 6, 2025

It follows that HER3-targeting therapies have emerged as a class of anti-cancer treatments designed to treat various tumors that have developed resistance to EGFR or HER2-directed therapies or have emerged due to a NRG1 gene fusion. This is an active drug development landscape with a lot of recent news.

Drug Development

BioPharma Drive: Drug Pricing

JUNE 11, 2025

SciePro via Getty Images Dive Brief: The Food and Drug Administration has approved a new oral medication for an uncommon kind of tumor, clearing Nuvation Bio’s Ibtrozi on Wednesday for certain people whose metastatic non-small cell lung cancer has a type of alteration in the gene ROS1. You can unsubscribe at anytime. Sanofi’s $9.1

FDA

The Premier Consulting Blog

DECEMBER 16, 2024

New drug development is a long and expensive process that can be fraught with obstacles, including unexpected delays, poor efficacy results, safety issues, or regulatory challenges. There are many reasons why a drug development program may need to be delayed or suspended altogether, as shown in Table 1 below.

Pharmacokinetics

FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3). Meanwhile, Annex 2, which provides guidance on pragmatic and decentralized clinical trials as well as trials incorporating real-world data, is expected to be finalized by ICH later in 2025.

Clinical Trials

BioPharma Drive: Drug Pricing

JULY 9, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Merck to buy Verona and its lung drug in $10B deal The New Jersey-based pharma has inked one of the biggest deals of the year in pursuit of a promising new way to treat COPD.

Clinical Trials

BioPharma Drive: Drug Pricing

JUNE 26, 2025

Meury, whose appointment is effective immediately, previously ran Anthos Therapeutics, which he sold this year to Novartis for nearly $1 billion, and Karuna Therapeutics, which Bristol Myers Squibb bought for $14 billion in 2023. Prior to those posts, Meury was chief commercial officer at Allergan.

Therapies

Broad Institute

DECEMBER 18, 2023

Brain disorders are difficult to study and many drug candidates have failed in clinical trials, causing pharmaceutical companies to reduce their investments or even exit the field entirely. The key problem is that there appear to be many different underlying mechanisms that lead to depression. Biomarkers could take many forms.

Drug Development

KIF1A

SEPTEMBER 30, 2023

Read the Guide FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies One frustrating aspect of traditional drug development, especially for rare disease communities, is the tempo of regulatory decisions on potential drugs.

Disease

Conversations in Drug Development Trends

AUGUST 10, 2023

With so many exciting developments in the last few years, it’s critical for the psychedelic community to come together to reflect on our progress, share the latest discoveries, and discuss the future of psychedelic research. Check out our full psychedelics offering, and meet the team responsible for planning your clinical trial.

Science

KIF1A

JULY 22, 2023

2023 Scientific findings need to be validated, replicated, and applied to new systems; this is the reason KIF1A.ORG has invested in our Treatment Accelerator Program. In a clinical trial, treatments are assessed by whether they change endpoints selected before the study. ” Chai et al. Endpoints are measurements of a disease.

Small Molecule

Conversations in Drug Development Trends

DECEMBER 5, 2023

Author: Lona Sheeran, SVP, Clinical Operations, Early Phase At this year’s Clinical Trials Nexus, I had the privilege of representing Worldwide Clinical Trials as the sole CRO on a panel discussion: “Reversing the Conversation: What the Clinical Trial Industry Really Wants from its Service Providers.”

Clinical Trials

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.

Clinical Trials

Conversations in Drug Development Trends

JANUARY 24, 2024

Written By: Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Disease Given that 80% of rare diseases have a genetic etiology, genetic implications should be addressed at the onset of a clinical program to support trial enrollment. One diagnostic example that I discussed in my presentation is autism.

Trials

Alta Sciences

NOVEMBER 9, 2023

Streamlining Clinical Trial Start-up for Accelerated Drug Development mecabana Thu, 11/09/2023 - 16:54 Publication StreamliningClinicalTrialStart-up-ReducedTimelines.pdf Category Case Study Weight 5

Clinical Trials

Drug Target Review

JULY 4, 2023

2 However, when dosed at the MTD, ADCs display improved efficacy over small molecules in oncology trials. 3D rendering of Antibody Drug Conjugate Molecules. However, a more detailed look into the clinical data suggests that there is room for further dose optimisation, and this is exemplified by the small molecule drug Sotorasib.

Small Molecule

PPD

NOVEMBER 30, 2023

As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drug development shaped the pharma and biotech industries. These shifts are a prelude to further change and progress in the clinical trial landscape in 2024. Five Predictions for the Drug Development Industry in 2024 1.

Clinical Trials

Cytel

OCTOBER 27, 2023

Speakers discussed investigator, regulatory (FDA), industry, and patient perspectives during the special symposium “Challenging the Status Quo of Early Phase Clinical Trial Design: Project Optimus.” Since its launch in 2021, Project Optimus has been reforming the dose optimization and dose selection paradigm in oncology drug development.

Clinical Trials

Labcorp Drug Development

FEBRUARY 3, 2023

Welcome to the February 2023 Labcorp Drug Development Decentralized Clinical Trial (DCT) blog. With Rare Disease Day coming soon on February 28, we are going to focus on how patients, sites and investigators can benefit by improving the design and execution of rare disease trials. What is Rare Disease Day?

Trials

Alta Sciences

AUGUST 29, 2024

Engaging at the outset with a fully integrated and experienced drug development partner can ensure safety, with timely data sharing at every step of the drug development plan, and facilitate agile, flexible decision-making and planning. billion USD in 2023 to $166.53 billion USD by 2028.

Drug Development

Conversations in Drug Development Trends

NOVEMBER 10, 2023

At this year’s annual Pain Therapeutics Summit , which took place in San Diego, CA, October 19 to 20th, I heard brilliant presentations on novel pain medication development, targeted discoveries, pain classifications, the NIH HEAL Initiative , trial designs, biomarkers, and others.

Clinical Trials

FDA Law Blog: Drug Discovery

MAY 4, 2023

Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories.

Clinical Trials

Alta Sciences

AUGUST 29, 2023

Embarking on a Career in Drug Development nbartlett Tue, 08/29/2023 - 14:38 Getting to the Heart of Science with Amber malloy Amber Malloy, Altasciences At the heart of science are stories—stories of courage, challenges, successes, lessons, and people. They remind us of the immense benefits of drug development.

Drug Development

KIF1A

APRIL 24, 2023

KIF1A.ORG has a lot to share this month including the 2023 KAND Family & Scientific Engagement Conference registration and hotel room links! Community Highlights 2023 KAND Family & Scientific Engagement Conference!! New information from Dr. Chung about the KOALA study and potential future ASO trial! Let’s get started!

Packaging

Conversations in Drug Development Trends

OCTOBER 24, 2023

While this is a small number of people in each rare disease patient community, the significant and continued growth of rare disease drug development is unsurprising given that there are over 10,000 rare diseases , with more being discovered every year.

Clinical Trials

Drug Patent Watch

DECEMBER 12, 2024

The pharmaceutical industry relies heavily on Contract Development and Manufacturing Organizations (CDMOs) to outsource various stages of drug development and manufacturing. With the increasing complexity of drug development and the need for efficient, cost-effective solutions, selecting the right CDMO is crucial.

Drug Development

LifeSciVC

JANUARY 16, 2024

By Aimee Raleigh, Principal at Atlas Venture, as part of the From The Trenches feature of LifeSciVC Just in time for new years’ reflections and resolutions, this year’s JPM felt like a refreshing burst of enthusiasm for a sector that has seen its challenges in 2022 and 2023 but also some green shoots. Additional trials (e.g.,

Small Molecule

Alta Sciences

MAY 30, 2023

Altasciences' Proactive Drug Development Solution: Biologics aasimakopoulos Tue, 05/30/2023 - 17:10 Tags Bioanalysis Clinical Trials Preclinical Research Regulatory Affairs Outsourcing Drug Development URL [link] Category eBook

Drug Development

FDA Law Blog: Drug Discovery

JANUARY 2, 2023

Comprehend the structure of FDA and the roles of the three major agency centers: CDER, CBER and CDHR, master the basics of the application and approval processes for drugs and biologics, gain a practical working knowledge of clinical trial process for pharmaceutical products and much more! Clinical trials for drugs and biologics.

FDA

Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

Drug Development

Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. between 2023 and 2032. Understanding the Numbers: How Many Clinical Trials Utilize CROs?

Clinical Trials