Drug Target Review

JULY 1, 2025

The company worked closely with agencies including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) from the outset, aligning its methodology with evolving guidance. Unlearn’s digital twins are now in use in both early and late-stage clinical trials, with adoption continuing to grow.

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The Pharma Data

JUNE 25, 2025

By integrating Regulus’ expertise in microRNA science with its own deep capabilities in clinical development, regulatory affairs, and commercialization, Novartis is well-positioned to accelerate farabursen’s clinical path and potentially bring a first-in-class treatment to ADPKD patients.

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Drug Target Review

JUNE 6, 2025

Image credit: Crystal Eye Media / Shutterstock The role of SPICA and manufacturing capabilities Drug development in the radiopharmaceutical space is particularly resource intensive. Shared goals in cancer drug discovery For all its internal capabilities, RMX does not operate in isolation. This is where the SPICA Center comes in.

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Alta Sciences

FEBRUARY 19, 2025

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.

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PPD

JUNE 20, 2025

The complexity of diagnosing IPF, understanding its root causes, and translating preclinical findings to clinical success make it a challenging disease for drug development. However, recent advancements and strategic approaches in clinical trials offer hope that additional treatments are on the way. Ready to connect?

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The Pharma Data

JUNE 24, 2025

The partnership represents a major financial and strategic milestone for Revolution Medicines, which has built a robust pipeline of targeted therapies aimed at cancers driven by mutations in the RAS family of genes—some of the most prevalent and historically difficult-to-drug oncogenes in human cancer.

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Drug Target Review

JULY 18, 2025

Domain Therapeutics is addressing this challenge by focusing on G protein-coupled receptors (GPCRs) – a well-validated and the largest family of drug targets that remains underexplored in cancer and inflammation. Targeting PAR2 is not simple, and its structural complexity and unique biology have made the receptor difficult to drug.

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The Pharma Data

JUNE 12, 2025

We look forward to further evaluating rilzabrutinib in subsequent phases of its clinical development.” Fast Track and Orphan Drug Designations from FDA The U.S. Clinical Development Looking forward, rilzabrutinib’s further clinical development is underway , with plans to initate a Phase 3 trial later this year.

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PPD

MARCH 11, 2025

Developing treatments for individuals living with rare diseases is critical, but orphan drug development is laden with unique obstacles that necessitate innovative, multifaceted approaches. RWE is transforming rare disease drug development, providing the insights needed to overcome unique challenges.

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Drug Target Review

JUNE 28, 2025

DARPins – designed ankyrin repeat proteins – are small, engineered protein scaffolds with high specificity and affinity, developed as an alternative to traditional antibodies. “My passion for science drew me to DARPin technology, and I was eager to contribute to the development of new DARPin therapies.”

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The Pharma Data

JUNE 18, 2025

Pushkal Garg to Lead Unified Research and Development Organization, Signaling Strategic Expansion into Next Phase of RNAi Therapeutics Innovation Alnylam Pharmaceuticals , a global leader in RNA interference (RNAi) therapeutics, has announced the promotion of Pushkal Garg, M.D., A New Chapter for Alnylam and RNAi Science With Dr.

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Drug Target Review

FEBRUARY 10, 2025

Ive been involved in therapeutics development for over 25 years, working with small, medium, and large biotech companies. My focus has always been on advancing novel medicines from research to clinical development. Over the years, Ive had the privilege of working on more than 25 different products, Bock shared.

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The Pharma Data

JUNE 16, 2025

Teva and Fosun Pharma Forge Strategic Partnership to Develop and Commercialize Innovative Anti-PD1-IL2 Therapy (TEV-56278) in Immuno-Oncology Teva Pharmaceutical Industries Ltd. This collaboration marks a significant step forward in global oncology drug development. and Shanghai Fosun Pharmaceutical (Group) Co.,

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The Pharma Data

JUNE 18, 2025

A Next-Generation Antibody-Drug Conjugate Targeting B7-H3 Ifinatamab deruxtecan is a potential first-in-class antibody-drug conjugate (ADC) specifically engineered to target B7-H3 , a surface protein overexpressed in many solid tumors, including prostate cancer. Source link

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The Pharma Data

JUNE 22, 2025

Broader Clinical Program and Regulatory Pathway Mim8, a next-generation investigational bispecific antibody, is currently being evaluated across multiple studies within Novo Nordisk’s comprehensive FRONTIER clinical development program.

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Drug Target Review

MAY 23, 2025

At the forefront of this development is Dr Liam Tremble, Principal Scientist at Poolbeg Pharma, whose background as an immunologist and cancer researcher gives him a unique perspective on this promising drug. “It takes a family to develop a drug and identify the opportunities and pitfalls.

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PPD

JANUARY 15, 2025

As a result, drug developers make better decisions more quickly (removing 50% of study timeline whitespace) to bring new therapies to market faster. Accelerate customer speed to market With a modern and integrated user experience, AI solutions put the right data and insights into the right hands in real time.

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SugarCone Biotech

JUNE 19, 2025

Amgen’s clinical development studies of tarlatamab include the DeLLphi-305 trial in ES-SCLC testing a first-line maintenance regimen following durvalumab plus chemo (Amgen markets the anti-PD-L1 checkpoint inhibitor durvalumab). The tarlatamab results have of course triggered a stampede of development of DLL3-targeted therapies.

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The Pharma Data

JUNE 23, 2025

This study explored the effects of beginning treatment with lower starting doses of MariTide to improve tolerability while maintaining clinical benefit. Both data sets now provide foundational insight into the design and direction of Amgen’s upcoming Phase 3 MARITIME clinical development program. in the placebo group.

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The Pharma Data

JUNE 25, 2025

FDA Orphan Drug Designation for Antibody-Mediated Rejection in Solid Organ Transplantation The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to riliprubart , an investigational immunology therapy developed by Sanofi, for the treatment of antibody-mediated rejection (AMR) in solid organ transplantation.

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thought leadership

FEBRUARY 26, 2025

Rare diseases are defined in the Orphan Drug Act as diseases or conditions that affect less than 200,000 people in the United States. Evaluating and developing treatments for rare diseases remains a key priority for FDA and is incentivized through the Orphan Drug Act.

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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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DrugBank

JUNE 18, 2025

Drug development is a complex and highly regulated process. Before a therapy can be approved for patient use, it must undergo extensive clinical testing and strictly adhere to regulatory guidelines. One of the most significant challenges in drug development is global regulatory variability.

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The Pharma Data

JUNE 11, 2025

This open-label extension aims to provide further insights into the long-term safety and efficacy of the drug while allowing continued access to therapy for trial participants. The study’s primary endpoint focuses on expressive communication, one of the most impaired and distressing symptoms of Angelman syndrome. Source link

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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. It’s equally important to communicate your long-term plans.

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The Pharma Data

JUNE 26, 2025

This unmet need has driven the development of alternative pharmacological options, including topical eye drops like MR-141, which aim to improve near vision through non-surgical means. Details of the VEGA-3 Phase 3 Trial The VEGA-3 study is part of Viatris’ broader clinical development program to evaluate MR-141 for presbyopia.

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The Pharma Data

JUNE 6, 2025

This mechanism allows the drug to modulate the immune system without causing complete immune suppression, making it a promising candidate in autoimmune conditions marked by dysregulated inflammation. In the U.S.,

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The Pharma Data

JUNE 12, 2025

The presentations highlight the ongoing progress and growing promise of the company’s innovative therapeutic platform, featuring its investigational oral CELMoD™ (Cereblon E3 Ligase Modulating Drugs) agents mezigdomide, iberdomide, and golcadomide, alongside its first-in-class, oral BCL6 (B-Cell lymphoma 6) ligand-directed degrader (LDD) BMS-986458.

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The Pharma Data

JUNE 26, 2025

BeOne Medicines’ rise has been fueled by a strategic commitment to innovation at every level of the drug development continuum. Its end-to-end R&D model integrates in-house discovery, development, and manufacturing capabilities—enabling rapid iteration, lower development costs, and sustained pipeline productivity.

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Conversations in Drug Development Trends

JANUARY 21, 2025

Jayaprakash Kotha, MBBS, PhD, ASCP (SH), Vice President, Bioanalytical Laboratory Satish Kumar, MBB, Head of Process Improvement Continuous Innovation is a Cornerstone of Bioanalysis Approximately 80% of drugs that begin the research process fail to reach approval. Rigorous procedures to ensure that drugs are effective and safe.

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Alta Sciences

JULY 7, 2025

ISSUE 44 — The Importance of Cytokine Release Assays to Derisk the Development of Immunomodulatory Drugs pmjackson Mon, 07/07/2025 - 21:31 New immunomodulatory drugs have the potential to cause serious immune-related adverse events, including cytokine release syndrome (CRS).

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The Pharma Data

JUNE 24, 2025

In just three years, nine promising research projects have received funding under the program, setting the stage for innovative breakthroughs in drug discovery. This agreement grants Bayer exclusive global rights to develop, manufacture, and commercialize the MTA-cooperative PRMT5 inhibitor.

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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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Drug Target Review

MARCH 17, 2025

Advancing drug candidates across key therapeutic areas Dr John Donello brings over 25 years of experience in pharmaceutical drug discovery, development and collaborations. “The classic paradigm with todays psychiatry drugs involves patients chronically taking a daily medication,” says Donello.

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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. though the drug’s commercial prospects are unclear.

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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. months (see [link] ).

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Metabolite Tales Blog

DECEMBER 12, 2024

Notably hepatocyte co-culture seems to be relatively commonly used where tailoring of the approach is needed, particularly relevant for more metabolically resistant drugs. This transitions into a far more in-depth investigation from candidate selection onwards with the most frequent cutoff 1-2% of total DRM (drug related material).

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