Drug Target Review

APRIL 7, 2025

Advanced strategies and tools are being implemented to establish the safety and efficacy of new therapeutic modalities, with the development of new biomarkers becoming one of the most relevant approaches for enhancing the precision and utility of early-stage studies.

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FDA Law Blog: Drug Discovery

JANUARY 30, 2025

However, as we note in that post, the design, timing of initiation, and timely conduct of confirmatory trials are also important considerations in FDAs determination of whether accelerated approval is appropriate. This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials.

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Drug Patent Watch

DECEMBER 12, 2024

This approach not only helps maintain market exclusivity but also ensures a steady revenue stream for pharmaceutical companies. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.

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Drug Target Review

JUNE 9, 2025

A personal journey to Alltrna Michelle Werner’s career has spanned over 20 years in the pharmaceutical industry, where she developed her expertise in oncology drug development at leading companies such as Bristol Myers Squibb, AstraZeneca, and Novartis.

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The Pharma Data

JUNE 24, 2025

The strategic funding arrangement is designed to support the continued advancement and global commercialization of Revolution Medicines’ RAS(ON) inhibitor portfolio, including its lead candidate daraxonrasib, as the company scales its operations independently across the international oncology market.

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Drug Target Review

JUNE 11, 2025

Drug development is plagued by complex challenges, but multimodal AI is unlocking new opportunities. By integrating diverse data sources – from genomics to clinical insights – this approach is accelerating drug discovery, improving patient stratification and boosting success rates. Highlighting data integration.

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The Pharma Data

JUNE 27, 2025

The trial met both its primary and key secondary endpoints, signaling a potential breakthrough in a condition with few, if any, effective treatment options. It is marketed under the brand name Fintepla® and has shown considerable success in significantly reducing seizure frequency while improving quality of life in these populations.

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Drug Patent Watch

DECEMBER 9, 2024

This approach has led to the discovery of numerous potential drug candidates. From Lab to Market: The Long Road of Drug Development Once a promising compound is identified, it enters the long and costly process of drug development. Q: How long does a drug patent last?

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Drug Target Review

APRIL 30, 2025

It involves a dynamic and often unpredictable process where every stage, from target identification to clinical trials, generates vast amounts of data. Additionally, AI-driven predictive modelling can shorten the preclinical phase by simulating biological responses, leading to more targeted and efficient clinical trials. The result?

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The Pharma Data

JUNE 9, 2025

Food and Drug Administration (FDA) as a monotherapy for children with achondroplasia. TransCon hGH , marketed as SKYTROFA® for pediatric growth hormone deficiency, is a once-weekly prodrug of somatropin (human growth hormone). It provides sustained release of unmodified somatropin, supporting normal growth and development in children.

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Alta Sciences

JUNE 6, 2025

For a contract research organization (CRO), it can play an integral role in increasing the quality and speed of drug development while reducing costs, repetitive manual tasks, and human error. This can result in failed runs and wasted reagents.

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PPD

FEBRUARY 10, 2025

Sponsors find that an FSP solution is often the best choice to help advance their drug development projects, whether they need to fill small gaps in services or support large-scale programs with dedicated teams across functions. EMRs give clinical operations teams direct, remote access to an array of patient health information.

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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.

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Alta Sciences

MARCH 4, 2025

Over time, this group of professionals evolved and grew, having regular stakeholder interactions with the FDA and Controlled Substances staff to discuss requirements for drug developers. I have spent the better part of my career working to make drugs safer. Tags Clinical Trials Weight 16

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Drug Target Review

NOVEMBER 25, 2024

I went on to complete my MBA and PhD at The Institute of Cancer Research (ICR) in drug development. The PI3K pathway is a master switch of cancer, but first-generation inhibitors are associated with numerous side effects and poor long-term safety, which led to their withdrawal from the market.

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Alta Sciences

NOVEMBER 15, 2024

4 Essential Topics to Cover in Your First CRO Meeting pmjackson Fri, 11/15/2024 - 19:22 Starting a partnership with a contract research organization (CRO) is a sometimes intimidating—yet exciting—first step in your drug development journey. Let the CRO know any key outcomes from each.

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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.

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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. Food and Drug Administration (FDA). Bailey J, et al. Trends in Non-Human Primate Use for Research and Testing.

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PPD

JULY 18, 2025

Effective communication with regulatory authorities is critical for small biotech companies, as it is often the key to success in clinical trials. When small and emerging companies are able to build strong, trust-based relationships with regulators, they often see benefits like reduced development risk and accelerated timelines.

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The Pharma Data

JUNE 13, 2025

Startups that become participants in this new acceleration program will be able to reside at SakuLab™-Tsukuba, collaborate alongside their peers, and tap into the expertise and guidance offered by Astellas’ team of drug-development experts.

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Conversations in Drug Development Trends

OCTOBER 14, 2024

With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world. One of the biggest hurdles in developing new therapies is recruiting diverse patients for clinical trials.

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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.

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PPD

JUNE 17, 2025

Biopharmaceutical and biotech drug developers have faced increasing challenges in recent years. In the past decade alone, the time needed to complete a clinical trial has increased by 20–30%, and the cost to bring a new drug to market has risen to an average of about $2.6

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Alta Sciences

DECEMBER 31, 2024

Listen to the audiobook or download the PDF below, to learn more about: key factors to consider in drug development (age, biological sex, genetics, DDIs); examples of common DDI involving the cytochrome P450 enzyme system; and drug interactions and guidance for marketed drugs. The Altascientist, Issue 7, pg.

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DrugBank

JUNE 18, 2025

Drug development is a complex and highly regulated process. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global counterparts, set rigorous standards to ensure that drugs are safe, effective, and high-quality. Regulatory agencies, such as the U.S.

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BioPharma Drive: Drug Pricing

JULY 14, 2025

Stock via Getty Images A new kind of sleeplessness medicine developed by Takeda met its goals in late-stage testing, positioning the company to capitalize on what Wall Street analysts believe could be a multibillion-dollar market opportunity. 10, 2024 Psychiatry drugs finally have pharma’s attention. Can they keep it?

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Conversations in Drug Development Trends

JULY 3, 2025

The CRO Perspective From a Contract Research Organization (CRO) specializing in the design and execution of studies for innovative therapies, the REMS requirements have significantly complicated the design and execution of CAR T clinical trials.

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Conversations in Drug Development Trends

NOVEMBER 12, 2024

Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. While clinical supply is essential to any successful trial, autologous cell therapy trials occupy the far end of the spectrum regarding risk tolerance.

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Drug Patent Watch

JANUARY 9, 2025

Navigating the complex landscape of drug development and manufacturing can be a daunting task. Enter the Contract Development and Manufacturing Organization (CDMO) a lifeline for many startups looking to bring their innovative therapies to market. Your timeline will significantly impact your CDMO requirements.

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DrugBank

JULY 14, 2025

Drug-drug interactions (DDI) are a significant concern in clinical trials, where the safe and effective administration of drugs to patients is crucial. These interactions can alter the pharmacological activity of one or more drugs, potentially leading to diminished therapeutic effects or unexpected toxic reactions.

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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.

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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. Sanofi’s $9.1 Sanofi’s $9.1

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LifeSciVC

JUNE 12, 2025

It was a time where “platforms” were in vogue, talent jumped shipped often, people working from home during COVID and all the while working towards developing a clinical candidate. These are exciting times for us at Korro, and the field in general!

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Conversations in Drug Development Trends

NOVEMBER 5, 2024

The focus on getting PRIME/ODD designations for gene therapies and personalized medicines is allowing sponsors and CROs to speed up the traditionally long process of getting these drugs to market, often in indications where no therapeutic intervention exists. There’s now a focus on expediting drug development, which is quite exciting.

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Drug Target Review

MAY 26, 2025

With a particular focus on biologics, cell, and gene therapies, Galbraiths work is centred on equipping drug developers with the tools, insights, and support needed to advance their therapies from concept to clinic. Harnessing emerging technologies The rapid pace of technological innovation is reshaping the landscape of drug discovery.

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BioPharma Drive: Drug Pricing

JUNE 26, 2025

Vor is paying RemeGene $45 million upfront along with $80 million in warrants to purchase common stock in exchange for the drug, called telitacicept. Data from that trial is expected in 2027. “I You can unsubscribe at anytime. Telitacicept is in Phase 3 testing for generalized myasthenia gravis in the U.S.,

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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. The need for difficult decisions The latest estimates on the median cost of bringing a new drug to market is now $2.3

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