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. It’s a challenge that affects a large percentage of new drug candidates—one we’re passionate about helping to solve.

Small Molecule

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.

Drug Development

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.

Drugs

Alta Sciences

JUNE 26, 2025

Showcasing Breakthroughs in Ocular Safety and Translational Models We were especially honored to have Dr. Makori and Dr. Iwabe present a symposium titled Ocular Toxicology Studies of New Drug Modalities: An Approach to Reduce Animal Use. 1] [link] ; This blog was originally published in June 2025. conference locations.

Drug Development

Broad Institute

JULY 18, 2025

Drug Discovery at the Broad Institute By Rose Circeo July 18, 2025 Breadcrumb Home Drug Discovery at the Broad Institute Broad Institute is home to a community of drug development experts who collaborate closely with other Broad scientists to turn discoveries about the biological roots of disease into new medicines.

Drugs

Plenge Gen

JANUARY 7, 2025

My message was that AI-enabled drug discovery was comingsomeday. Fast forward to 2025, and that someday is now. … The post AI Unleashed: Transforming Drug Discovery from Theory to Practice appeared first on Plenge Gen @rplenge. Weve seen an explosion in the availability and capability of AI tools.

Drugs

Fierce BioTech

JULY 18, 2025

These advanced computational methods enable more sophisticated analysis of molecular interactions and better predictions of drug behavior, reducing the time and cost associated with the drug development process. On Demand Start Date Tue, 08/26/2025 - 14:00 End Date/Time Tue, 08/26/2025 - 14:00

Computational Chemistry

Fierce BioTech

JUNE 23, 2025

Leveraging Machine Learning to Accelerate Drug Development Discover how CDMOs are using machine learning to speed up drug development, cut costs, and improve quality. mcottam Mon, 06/23/2025 - 14:54 Discover how CDMOs are using machine learning to speed up drug development, cut costs, and improve quality.

Drug Development

Alta Sciences

JULY 23, 2025

Get in touch with me or one of my colleagues to see how our innovative solutions can speed up your drug development process. ABOUT THE AUTHOR: MARTIN TURCOTTE Martin Turcotte, Senior Director, Flow Cytometry, has been at Altasciences since 2023. Image blog-thumbnail-martin-turcotte-cyto-2025.jpg

International

Alta Sciences

JULY 18, 2025

Highlights From the 2025 American Society for Mass Spectrometry Conference | By Jean-François Larocque and Benjamin Charron aasimakopoulos Tue, 07/22/2025 - 18:05 We were thrilled to represent Altasciences at this year’s American Society for Mass Spectrometry (ASMS) conference in Baltimore. Curious to see this poster in action?

Assay Development

Drug Target Review

JUNE 16, 2025

Unlike traditional pharmacokinetic (PK) studies that rely on plasma measurements alone, MSI, when combined with traditional histology, enables spatial mapping of drug distribution, metabolism and target engagement. Toxicological investigations play a key role in assessing drug safety and, importantly, inform development decisions.

Drugs

FDA Law Blog: Drug Discovery

JANUARY 30, 2025

As a result of reforms enacted by the Food and Drug Omnibus Reform Act of 2022 (FDORA), FDAs authority to approve as well as withdraw an accelerated approval was given new regulatory teeth to ensure that confirmatory trials are conducted expeditiously.

FDA

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. This scarcity disrupts research timelines and limits the ability to replicate results across studies.

Drug Research

PPD

FEBRUARY 12, 2025

Unlocking new levels of value with expanded offerings We are launching more dynamic and integrated service offerings that leverage the very latest automation and integrations to accelerate your unique drug development journey in new and different ways. Contact your business development representative to learn more.

Clinical Supply

The Premier Consulting Blog

APRIL 13, 2025

On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ One great example is the FDAs 505(b)(2) New Drug Application (NDA) pathway. 7] This was a landmark change in philosophy.

Animal Testing

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. Her team sits right at the edge of innovation, where discovery science meets clinical execution. she said.

Therapies

Alta Sciences

JUNE 6, 2025

Case Study: Two Examples of Successful Automation Integration at Altasciences for Pharmacokinetic Studies pmjackson Fri, 06/06/2025 - 09:01 By Martin Rougée, Optimization Scientist, Bioanalytical Operations Automation offers several advantages to any industry. This can result in failed runs and wasted reagents.

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. “My passion for science drew me to DARPin technology, and I was eager to contribute to the development of new DARPin therapies.”

Science

SugarCone Biotech

JUNE 19, 2025

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. The Next Wave: Targeting B7H3 – a drug development tsunami in the making? An awesome space to watch. Stay tuned.

Therapies

Alta Sciences

MARCH 4, 2025

Forging a Path Forward for Substance Abuse Potential Studies With the Cross-Company Abuse Liability Council By Beatrice Setnik, PhD pmjackson Tue, 03/04/2025 - 20:10 Many of my colleagues and I are members of the Cross-Company Abuse Liability Council (CCALC), where I have been a co-chair for the past seven years, and a member for 15.

Clinical Trials

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.,

RNA

Alta Sciences

JULY 22, 2025

45 — Discovery Studies: An Agile Approach to Early Data for Quicker Decisions pmjackson Tue, 07/22/2025 - 21:31 The early identification of toxicity , and flexibility to explore parameters and characteristics of drug candidates in vivo via early discovery non-GLP studies , allow for improved drug development strategy and faster go/no-go decisions.

Virus

SugarCone Biotech

JUNE 27, 2025

A post-ASCO update on tumor targets DLL3, B7H3 and Her3 June 2025 Paul D Rennert, SugarCone Biotech LLC Introduction: DLL3, B7H3 and Her3 are compelling tumor antigens to target with cancer therapeutics. As we’ll see, ASCO 2025 was a breakout conference for B7-H3-targeted therapies. That trial is in second-line NSCLC.

Therapies

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.

Laboratories

New Drug Approvals

APRIL 2, 2025

1] [2] It was developed by Vertex Pharmaceuticals , [5] and was approved for medical use in the United States in January 2025. [2] 2] [6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this new class of pain management medicines. [2] Suzetrigine is taken by mouth. [1]

FDA

BioPharma Drive: Drug Pricing

JULY 14, 2025

Published July 14, 2025 Ben Fidler Senior Editor post share post print email license Takeda reported positive results for oveporexton, a drug being developed for narcolepsy Type 1, on July 14, 2025. and elsewhere in its 2025 fiscal year and plans to present detailed results at an upcoming medical meeting.

Drugs

Conversations in Drug Development Trends

NOVEMBER 5, 2024

In preparation for World Orphan Drug Congress Europe, we interviewed Nathan Chadwick, Senior Director, Therapeutic Strategy Lead, Rare Disease, and Derek Ansel, MS, LCGC, Vice President, Therapeutic Strategy Lead, Rare Disease, to hear their insights into the current progress in rare disease research and their hopes for 2025.

Disease

The Pharma Data

JUNE 9, 2025

Food and Drug Administration (FDA) as a monotherapy for children with achondroplasia. Ascendis expects to report final 52-week results in the fourth quarter of 2025 and plans to initiate a Phase 3 trial around the same time. Administered once weekly, TransCon CNP is currently under Priority Review by the U.S.

Trials

Alta Sciences

JUNE 23, 2025

CNS Drug Development Solutions, Simplified. tchichekian Mon, 06/23/2025 - 15:37 Publication CNS-End-to-End-Drug-Development-eBook_0.pdf pdf Tags End-to-End Program Category eBook Weight 1

Drug Development

The Pharma Data

JULY 2, 2025

FDA Grants Accelerated Approval to Regeneron’s Lynozyfic™ (linvoseltamab-gcpt) for Relapsed or Refractory Multiple Myeloma Regeneron Pharmaceuticals has secured a critical milestone in oncology drug development with the U.S. alone, more than 36,000 new diagnoses and approximately 12,000 deaths are anticipated in 2025.

FDA

Drug Target Review

AUGUST 8, 2025

While monoclonal antibodies and antibody-drug conjugates continue to drive therapeutic pipelines, bispecific T-cell engagers (TCEs) are gaining momentum as a versatile and scalable class of immunotherapies. Global News Wire; 2025 Mar 17. Dr Rob Holgate Rob has over 25 years’ experience in Drug Discovery and early-stage Development.

Engineering

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).

Immune Response

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).

Immune Response

New Drug Approvals

AUGUST 7, 2025

5] Repotrectinib was approved for medical use in the United States in November 2023, [5] [6] and in the European Union in January 2025. [3] These mutations restrict the ability of drugs to bind to their targets, ultimately resulting in the advancement of tumors. Retrieved 23 May 2025. 14 January 2025. in DMF (4.0

FDA

The Pharma Data

JUNE 26, 2025

BeOne Medicines Showcases Bold Vision and Expansive Oncology Pipeline at 2025 R&D Day BeOne Medicines Ltd., a global oncology-focused biopharmaceutical company, delivered a comprehensive update to investors today during its highly anticipated Research and Development (R&D) Day.

Research

Drug Target Review

JUNE 5, 2025

Currently, three FDA-approved disease-modifying drug therapies are available: hydroxyurea, crizanlizumab and L-glutamine, though each has limitations that affect patient compliance. Treasure Island (FL): StatPearls Publishing; 2025 Jan-.Available The therapeutic landscape for SCD has evolved significantly in recent years.

Disease

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

RNA