FDA Law Blog: Drug Discovery

FEBRUARY 11, 2025

However, as we suggested in a recent blog post , the statute did not actually provide any limitations on FDAs authority to grant rare pediatric disease designations , only its authority to grant vouchers. In the meantime, the Pink Sheet confirmed that FDA was continuing to review rare pediatric disease designation requests.

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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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SugarCone Biotech

JUNE 19, 2025

Over 70% of new patients are diagnosed with stage IV disease, also called extensive stage disease (ES-SCLC). That is a decent hypothesis to explore and their early clinical data at ASCO 2025 looked interesting. Now to antibody-drug conjugates (ADC) where we saw some early programs with difficult toxicities. Stay tuned.

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Quanticate

SEPTEMBER 13, 2024

In our article, we cover the key trends that have been shaping clinical trials so far in 2024, and those that are predicted to continue into 2025.

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Clinical Trials Trials Drug Development Treatment 95

The Pharma Data

JUNE 26, 2025

Located in Jiangsu Province, China, the Nantong site serves as a critical component of WuXi AppTec’s expansive Contract Research, Development, and Manufacturing Organization (CRDMO) platform. By integrating operational excellence with architectural brilliance, the site has become a blueprint for the future of industrial science campuses.

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Laboratories Science Pharmaceuticals Compliance 40

Drug Target Review

JULY 8, 2025

As Vice President of Oncology Early Development (OED) at AbbVie , she leads the charge on translating bold scientific ideas into real-world impact – and she’s doing it with a focus on some of the most tenacious cancers out there. At that stage, the disease becomes more difficult to treat,” Eleni said.

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H1 Blog

DECEMBER 11, 2024

In this edition, our CEO and co-founder, Ariel Katz, along with Regional VP of Trial Landscape, Ryan Brown, share their top predictions for 2025. Drug Policy There will be significant changes in clinical trials & drug development due to the Inflation Reduction Act.

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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.,

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Perficient: Drug Development

FEBRUARY 28, 2025

The 2025 National Conference on Artificial Intelligence is an unparalleled opportunity to dive deep into the transformative potential of AI across various sectors. With topics ranging from responsible AI to workforce development, this conference explores the vast possibilities of AI.

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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). National Primate Research Centers (NPRCs) Annual Report, 2021. Bailey J, et al.

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Drug Target Review

JANUARY 8, 2024

It is no mystery that as we age our health starts to deteriorate, and we become increasingly susceptible to diseases. Through years of scientific exploration and research, we now know there are several biological changes that make our bodies more susceptible to disease or injury, and we can target those with therapeutic interventions.

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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.

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The Pharma Data

JUNE 6, 2025

Drivers of Market Growth: From Precision Medicine to Cost Optimization The shift toward targeted therapies , rare diseases , and personalized medicine is fundamentally altering pharmaceutical commercialization strategies. CNS Disorders and Autoimmune Diseases : Where nuanced communication and long-term patient management are key.

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BioPharma Drive: Drug Pricing

JUNE 23, 2025

Expanding potential uses Emerging research suggests GLP-1 drugs might effectively treat chronic kidney disease, liver conditions, and certain cardiac diseases. By Jacob Bell • May 6, 2025 Keep up with the story. © 2025 TechTarget, Inc. or its subsidiaries. All rights reserved.

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Alta Sciences

JUNE 26, 2025

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Pharmacokinetics Testimonials Biosimilars Drug Development 40

Alta Sciences

JUNE 26, 2025

All Rights Reserved. Cookie Policy | Privacy Policy Have a question?

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Pharmacokinetics Testimonials Biosimilars Drug Development 40

Drug Target Review

SEPTEMBER 19, 2024

Could you give us an overview of IRLAB’s current drug development pipeline? Based on Nobel Prize-winning research, IRLAB has grown rapidly to become recognised and respected as a world-leader in understanding the complex neuropharmacology of CNS disorders, especially Parkinson’s disease (PD).

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Drug Target Review

JUNE 16, 2025

By complementing traditional analytical methods, it provides a more accurate representation of drug behaviour to support translational and pre-clinical studies. This article explores the principles, applications and future potential of MSI in drug development. Drug Discovery Today 2025, 30 (1), 104275.

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The Pharma Data

JUNE 9, 2025

Executive Commentary on Interim Results Dr. Aimee Shu, Executive Vice President of Endocrine & Rare Disease Medical Sciences and Chief Medical Officer at Ascendis Pharma, expressed optimism about the interim results. cm/year , which reflects a 4.23 cm/year increase from baseline. Source link

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LifeSciVC

JUNE 12, 2025

2025 holds to be a transformative year for us, with the potential for multiple milestones to come to fruition, with the biggest value inflection being the interim clinical data from our lead asset KRRO-110, a potential best in class compound for patients with Alpha-1 antitrypsin deficiency (AATD). Over the last 4.5

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LifeSciVC

JANUARY 16, 2024

recent announcements from Merck and Sanofi for obesity and broader metabolic disease). Whether trial design, execution, or otherwise, drug development even where there is precedent is a challenging road and should not be taken for granted. Join the club. Additional trials (e.g.,

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Alta Sciences

JULY 3, 2025

All Rights Reserved. Cookie Policy | Privacy Policy Have a question?

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Marketing Pharmacokinetics Testimonials Biosimilars 40

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. Five Predictions for the Drug Development Industry in 2024 1. Stakeholders across the drug development sphere will unlock the transformative potential of AI.

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The Pharma Data

JUNE 24, 2025

Regeneron Unveils Groundbreaking $200 Million Donation Matching Program to Expand Patient Access to Vision-Saving Treatments Regeneron Pharmaceuticals , a leader in biotechnology and a longtime advocate for equitable healthcare access, has announced a bold new philanthropic initiative designed to support patients facing debilitating eye diseases.

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LifeSciVC

AUGUST 21, 2024

At this point of the year, the JPMorgan conference seems like ancient history and you are looking into flights for JPM 2025. Drug development is a long process, and patients are waiting. An adverse event or serious adverse event (SAE) that turns out NOT to be related to the drug may take a while to sort out.

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BioPharma Drive: Drug Pricing

JUNE 26, 2025

Published June 26, 2025 Gwendolyn Wu Senior reporter post share post print email license B cells, like those pictured above, malfunction in autoimmune disease. Vor Biopharma licensed a drug in June 2025 that targets proteins essential to B cell survival. Now, Vor is reestablishing itself as an autoimmune disease company.

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Vial

APRIL 18, 2024

Yet, hereditary and age-related retinal diseases present challenges, often leading to progressive vision loss and potential blindness. Market research indicates significant growth in the ophthalmic clinical trials market, driven by increased disease prevalence, demand for ocular treatments, and rising research funding.

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Conversations in Drug Development Trends

MAY 23, 2024

The Critical EU-CTR Transition Deadline The three-year transition period for clinical trials authorized under the CTD that are expected to continue beyond the critical deadline of 30 January 2025 are required to transition to the new EU-CTR via a transition application through the CTIS.

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Agency IQ

JULY 7, 2023

This study was developed to help establish a workable framework for using real-world evidence (RWE) for regulatory cases within the E.U., building off the EMA’s Strategy through 2025. Regulators at EMA have outlined their intent to “enable” RWE and “establish its value for regulatory decision-making” by 2025.

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Perficient: Drug Development

SEPTEMBER 8, 2023

link] Center for Disease Control and Prevention (CDC). Healthcare Workers Plan To Leave Their Positions By 2025. References: AARP. Promoting Health for Older Adults. link] Gartner. What’s New in Artificial Intelligence from the 2022 Gartner Hype Cycle. link] Forbes. New Survey Shows That Up To 47% Of U.S.

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The Pharma Data

DECEMBER 2, 2020

million aggregate principal amount of 7.25% convertible senior notes due 2025 (the “notes”) in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). The notes will mature on December 1, 2025, unless earlier repurchased, redeemed or converted.

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The Pharma Data

DECEMBER 2, 2020

The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Forward Looking Statements.

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SugarCone Biotech

JULY 6, 2025

A post-ASCO update on tumor targets DLL3, B7H3 and HER3 July 2025 Paul D Rennert, SugarCone Biotech LLC Introduction: DLL3, B7H3 and HER3 are compelling tumor antigens to target with cancer therapeutics. This is an active drug development landscape with a lot of recent news. regulatory application in NSCLC.

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Agency IQ

JULY 22, 2024

Facing headwinds, FDA moves ahead on diagnostics policy implementation but faces Congressional, legal, and judicial questions In April 2024, the FDA issued a final rule to update its regulatory approach to certain test products known as Laboratory Developed Tests (LDTs). AgencyIQ provides a status update for regulated industry.

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Agency IQ

FEBRUARY 2, 2024

BY LAURA DIANGELO, MPH | JAN 30, 2024 10:25 AM CST Diagnostic regulation: A quick overview Diagnostics products are those intended to identify, signal or detect a specific health condition, infection or disease, or monitor a person’s health or health status. The diagnostics landscape in the U.S.: In-house tests (similar to LDTs in the U.S.,

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New Drug Approvals

SEPTEMBER 13, 2024

2] [3] [4] A regulatory application for approval of the medication is expected to be submitted by 2025. [2] 4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] Drug Discovery. nM vs. 24.0 nM vs. 24.0

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Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

BioPharma Drive: Drug Pricing

JUNE 26, 2025

Published June 26, 2025 Ned Pagliarulo Lead Editor post share post print email license An Incyte researcher works in a laboratory. On June 26, 2025, the company announced the replacement of longtime CEO Hervé Hoppenot with Bill Meury. Last year, Jakafi brought in nearly $2.8 billion in sales. Track funding rounds here.

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