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Regulatory Guidance for Oligonucleotide Bioanalysis in DrugDevelopment 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.
Amgen’s clinicaldevelopment 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.
Drugdevelopment 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.
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.
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.
By Ned Pagliarulo, Jacob Bell and Julia Himmel • Updated June 17, 2025 Spencer Platt via Getty Images Facing ‘uncertainty on steroids,’ biotech dealmakers tread more cautiously Experts say market turmoil has made it harder for buyers and sellers to agree on price, which can be an especially imposing obstacle to large acquisitions.
We are at the forefront of drugdevelopment in an area of research called cellular rejuvenation, which is an approach that has the potential to address many diseases of ageing by restoring aged and injured cells to a more youthful and resilient state. About the author Jerry McLaughlin CEO, Life Biosciences, Inc.
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. Global Head of R&D. “We
First-in-Human, Drug-Drug Interaction, Food Effect, Bioequivalence, etc.), and often require consistent batches of drug product be administered to groups of research participants within a short timeframe, early phase studies present unique challenges for drugdevelopers not typically experienced in later stages of development.
As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drugdevelopment 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 DrugDevelopment Industry in 2024 1.
The market for each target class likely asymptotes with the number of Pharma or large biotech who can clinicallydevelop and commercialize such assets; thus, there is intense focus on the first handful of assets to market. Figure 2 shows pipelines across modalities for some of the competitive targets today.
Could you give us an overview of IRLAB’s current drugdevelopment pipeline? Top-line data from the Phase IIb study is expected at the beginning of 2025. The third project in clinical phase, IRL757, is in Phase I and is being developed for the treatment of apathy.
At this point of the year, the JPMorgan conference seems like ancient history and you are looking into flights for JPM 2025. Drugdevelopment is a long process, and patients are waiting. We will have to support an evolving clinicaldevelopment plan and to keep manufacturing off the critical path.
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 drugdevelopment landscape with a lot of recent news. regulatory application in NSCLC.
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).
By 2025, Dupixent is expected to generate an additional 11 new regulatory submissions across indications and age groups. These drugdevelopment programs include our acceleration of priority asset amlitelimab, an anti-OX40L antibody that aims to restore immune homeostasis between pro-inflammatory and anti-inflammatory T cells.
For drugs, the rationale should describe data and information, if any, that suggest the potential for differential safety and effectiveness across the clinically relevant population, such as possible differences in PK or PD.
The new DAP guidance goes into more detail about research programs with “several clinical studies” that are subject to DAP requirements. The draft guidance offers some information for how to think about DAPs under “multi-regional clinical studies,” including “globally conducted clinicaldevelopment programs.”
Published June 23, 2025 Delilah Alvarado Staff Reporter post share post print email license A micrograph image of influenza A virus. By Ben Fidler and Gwendolyn Wu • Updated June 19, 2025 Retrieved from Vinay Prasad on May 08, 2025 Biotech is guessing how Vinay Prasad might change the FDA. Influenza A virus" [Micrograph].
The drugdevelopment landscape continues to grow in complexity and cost. Drugdevelopers should consider several approaches when implementing an FSP partnership that is fit-for-purpose and positioned for optimal performance. In the complex field of clinicaldevelopment, timely delivery is essential.
Drugdevelopment is hampered by high costs, long timelines and a low probability of success and complex therapies exacerbate these challenges. By integrating diverse data modalities, including clinical genomics , it can impact target identification, patient stratification and clinical trial design. Lifescienceleader.com.
Drug Target Review had the pleasure of attending the American Association for Cancer Research (AACR) Annual Meeting 2025 , held from 25 to 30 April 2025 in Chicago, Illinois. Early-phase clinical trial results AACR 2025 continued to serve as a key platform for early-phase clinical trial disclosures.
The PPD clinical research business of Thermo Fisher Scientific conducted its third annual Pulse Report a survey of 150 leaders from biotech and pharmaceutical organizations worldwide. Patient recruitment: Drugdevelopers can advance and expand their clinical research by working with an FSP partner to access untapped patient populations.
As 2025 kicks off, the biopharma and biotech industries find themselves at a pivotal juncture, navigating an era of rapid transformation marked by new technological advancements, evolving regulations and shifting industry priorities. However, amid this progress, the complexities of drugdevelopment have never been more apparent.
[link] (accessed March 20, 2025). [13] 2024 [cited 2025 Apr 16]. Opportunities for Microphysiological Systems in Toxicity Testing of New Drug Modalities. Annu Rev Pharmacol Toxicol 65 (2025). 13] Bell CC, Dankers ACA, Lauschke VM, et al. Toxicological Sciences 162 (2018) 655666.
Co-founder and CEO Dr Dan Williams brings over 20 years of experience in biochemistry and drugdevelopment, with a strong background in research and clinical trials. His expertise has positioned SynaptixBio to advance its drug candidates toward clinical trials.
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 Sponsored The golden era of GLP-1 drugs: How will it impact medicine and society? By Ned Pagliarulo • June 4, 2025 Keep up with the story.
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 FDA’s AI tool ‘Elsa’ is here, and the industry has questions The agency has provided only limited details about its AI pilot as it advances an “aggressive timeline” for the tool’s rollout.
Published June 23, 2025 Ned Pagliarulo Lead Editor post share post print email license A sign for the Food and Drug Administration is seen outside of the agency's headquarters on July 20, 2020 in White Oak, Maryland. Track funding rounds here.
Published June 11, 2025 Ben Fidler Senior Editor post share post print email license The FDA on June 11, 2025 approved Nuvation's Ibtrozi for ROS1-positive non-small cell lung cancer. Sanofi’s $9.1 Track the deals that are happening here. Sanofi’s $9.1
Published July 10, 2025 Ben Fidler Senior Editor post share post print email license Soleno Therapeutics on July 10, 2025 announced preliminary sales for its new Prader-Willi Syndrome drug Vykat. By Jonathan Gardner • Updated April 9, 2025 Keep up with the story. Condulis, for instance, predicts Vykat could reach $2.5
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