Broad Institute

NOVEMBER 25, 2024

As a proof of concept, a drug designed to target a newly discovered biological node is showing efficacy in treating rare genetic diseases in the kidney, the eye, and the brain and is now making its way to clinical trials in collaboration with a pharmaceutical partner. You can learn more about how clinical trials work here.

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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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Fierce BioTech

SEPTEMBER 6, 2024

RWE Impact: When Empowered Patients Drive Pharma Outcomes pesurya Fri, 09/06/2024 - 11:33 Thu, 10/03/2024 - 11:00 Resource Type Webinar Leigh Ann Bruhn Arturo LoAIza-Bonilla MD Nico O'Kuinghttons Cathy Zaremba Promotion Start Mon, 09/09/2024 - 11:45 Promotion End Sun, 03/09/2025 - 11:45 Duration 60 Minutes Discover the transformative power of RWE.

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Fierce BioTech

JANUARY 13, 2025

Applying Technology Advancements to Overcome Challenges in Clinical Trials pesurya Mon, 01/13/2025 - 13:14 Tue, 03/11/2025 - 11:00 Resource Type Webinar Marc Lisi Priyanka Sharma Duration 60 Minutes As technology evolves at a rapid pace, it promises solutions to myriad problems, from streamlining workflows to advancing life-saving therapies.

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Fierce BioTech

MARCH 14, 2025

Advancing the Future of Biomarker-Driven Immunotherapy swheeler Fri, 03/14/2025 - 13:43 Mon, 04/21/2025 - 12:00 Resource Type Webinar Eduard Porta-Pardo Can spatial biomarkers revolutionize patient stratification for immune checkpoint inhibitors? On Demand Start Date Mon, 04/21/2025 - 13:00 End Date/Time Mon, 04/21/2025 - 13:00

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National Institute on Drug Abuse: Nora's Blog

MARCH 6, 2025

Advancing reduction of drug use as an endpoint in addiction treatment trials astewart Thu, 03/06/2025 - 09:59 Nora's Blog March 18, 2025 Image Getty Images/ SolStock This blog was also published in the American Society of Addiction Medicine (ASAM) Weekly on March 18, 2025.&

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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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Fierce BioTech

AUGUST 7, 2024

Recent advancements in innovative therapies, particularly antibody-drug conjugates (ADCs) and radioisotope therapies (RIT), have expanded the range of effective cancer treatments. They will highlight how effective imaging can accelerate the success of ADC and RIT clinical trials and facilitate the approval of new drugs.

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Vial

DECEMBER 8, 2023

With technological innovation and scientific research propelling the development of new therapies, anticipation for the future is high. As we look forward to 2024, several groundbreaking therapies are poised to radically change the landscape of ophthalmology, providing hope and improved treatment options for patients with ocular conditions.

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Conversations in Drug Development Trends

MAY 23, 2024

By: Sarah Bly, Regulatory Science and Innovation and Matt Cooper, Executive Director, Therapeutic Strategy Lead, Oncology The European Union (EU) presents a unique set of regulatory challenges and opportunities for clinical trials in oncology. Increased Transparency : Ensures that information on clinical trials is more accessible.

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LifeSciVC

JANUARY 16, 2024

These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline. Additional trials (e.g.,

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Drug Target Review

JANUARY 8, 2024

Contrary to popular belief, ageing is not caused by just random wear and tear of our bodies over time but is instead caused by a discrete set of biological mechanisms that we now better understand and can target with therapies. a clinical-stage private biopharma company developing therapies for neurological and psychiatric diseases.

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PPD

NOVEMBER 30, 2023

These shifts are a prelude to further change and progress in the clinical trial landscape in 2024. Overall, new technological approaches applied in these settings show remarkable potential to make trials more robust, promote more reliable data acquisition and keep trials on-time and on-budget. This year, the U.S.

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The Pharma Data

JULY 15, 2021

Trial will include participants at risk for cognitive and functional decline related to Alzheimer’s disease. TRAILBLAZER-ALZ 3 will evaluate whether treatment with donanemab can slow the clinical progression of Alzheimer’s disease in trial participants. vice president of pain and neurodegeneration, Lilly.

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Codon

SEPTEMBER 29, 2024

2025 While the broader life sciences community had pivoted towards working on traditional mechanistic interpretations of biology, one graduate student still believed there was something to be learned using the models of life so celebrated previously. The 2025 genetic network paper fit that bill exactly.

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Fierce BioTech

JANUARY 16, 2025

pesurya Thu, 01/16/2025 - 14:23 Thu, 02/27/2025 - 14:00 Resource Type Webinar Dr. David Braun Dan Serie, M.S. These biomarkers have the potential to play a crucial role in early intervention and personalized therapy decisions. On Demand Start Date Thu, 02/27/2025 - 15:00 End Date/Time Thu, 02/27/2025 - 15:00

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Agency IQ

JULY 22, 2024

Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024 In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products. As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER.

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Alta Sciences

JANUARY 28, 2025

Immunogenicity Data Delivered Without Delay blussier Tue, 01/28/2025 - 20:11 HTML Preclinical Assays for Immunogenicity Testing in Clinical Trials Whether developing a vaccine, biologic, or gene therapy, immunogenicity testing is required for regulatory approval and is critical for determining the safety and efficacy of your product.

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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. Clinical Trials Are your clinical trials on track? What has the impact of summer been on recruiting efforts and the ability to manage clinical trial participants? Was that only six months ago?

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KIF1A

AUGUST 28, 2024

2025 Conference Interest Survey : Help shape the future of our community by sharing your interest in the upcoming 2025 conference. We also extend our deepest gratitude to n-Lorem for creating and providing the ASO drug that made this trial possible. She is the 2nd KAND Pioneer blazing the trail with ASO therapy.

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The Pharma Data

JUNE 11, 2023

Boehringer Ingelheim and Zealand Pharma announce phase II trial showed 14.9% The phase II clinical trial evaluating the effect of different doses of the novel glucagon/GLP-1 receptor dual agonist BI 456906 in people living with obesity or overweight without type 2 diabetes (NCT04667377) met its primary endpoint.

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PPD

OCTOBER 12, 2023

Cell and gene therapies (CGTs) are one of the fastest growing areas in human therapeutics. Since chimeric antigen receptor T cell (CAR-T) therapy was first approved in 2017, there has been a marked increase of cell and gene therapy studies resulting in significant changes in the way diseases are treated as well as patient outcomes.

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Drug Target Review

JULY 1, 2024

Overall, SRP-001’s modulation of pain signalling genes and pathways through endocannabinoid enhancement and FAAH inhibition supports its potential as an effective non-opioid pain therapeutic, validating the planned clinical trials. was founded in 2016 to develop safer, non-opioid therapies for acute and chronic pain.

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The Pharma Data

SEPTEMBER 15, 2020

27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame. Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. Protease Inhibitor Program.

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The Pharma Data

JANUARY 19, 2021

TCR 2 is developing novel T-cell therapies for solid tumors and hematological cancers. TC-210 is currently in a Phase I/II trial for mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. million shares of common stock at $14 per share, to raise $75.6

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The Pharma Data

JANUARY 6, 2021

CAMBRIDGE, England & WETHERBY, England–( BUSINESS WIRE )– Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer ® and pre|CISION platforms, is pleased to announce that it has entered into a license agreement with POINT Biopharma Inc. 7, 2021 08:49 UTC.

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Vial

APRIL 18, 2024

Market research indicates significant growth in the ophthalmic clinical trials market, driven by increased disease prevalence, demand for ocular treatments, and rising research funding. Specifically, the global ophthalmic clinical trials market, valued at USD 1.5 from 2023 to 2030.

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The Pharma Data

NOVEMBER 10, 2020

Billion by 2025. The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. billion by 2025, according to Grand View Research 1. . P otential to be a safer and effective alternative to the intravenous immunotherapies currently used for Crohn’s Disease. NEW YORK and LONDON, Nov.

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The Pharma Data

JANUARY 15, 2021

In the DESTINY-Gastric01 trial, patients (n=126) in the Enhertu treatment arm had a 41% reduction in the risk of death versus patients (n=62) treated with chemotherapy (based on a hazard ratio [HR] of 0.59; 95% confidence interval [CI] 0.39-0.88; Regular approval by the U.S. months [95% CI 9.6-14.3] months [95% CI 6.9-10.7] with chemotherapy.

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The Pharma Data

NOVEMBER 2, 2020

The notes will mature on November 1, 2025, unless earlier repurchased, redeemed or converted. Prior to the close of business on the business day immediately preceding August 1, 2025, the notes are convertible at the option of the holders only upon the satisfaction of certain conditions and during certain periods.

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The Pharma Data

JANUARY 12, 2021

“For almost 30 years, Alexion has been committed to transforming the lives of those impacted by rare diseases and devastating conditions, and the company remains focused on advancing its innovative therapies and pipeline to drive value for patients and shareholders once we are part of AstraZeneca.”. Continued Pipeline Progress.

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The Pharma Data

AUGUST 3, 2021

This pipeline has the potential to deliver up to 15 medicines for approval by 2025. A recent trial showed a significantly lower risk with empagliflozin of hospitalization for heart failure or cardiovascular death in adult patients with HFpEF. More than 60 million patients worldwide suffer from this disease, approx.

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The Pharma Data

NOVEMBER 26, 2020

The EGM resolved to approve the Board of Directors’ previous resolution on October 27, 2020 on a directed issue of 29,395,311 new shares and 14,697,655 new warrants of series 2020/2025, both to CASI Pharmaceuticals, Inc. per share during the period from and including 27 November 2020 up to and including 27 November 2025.

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Agency IQ

AUGUST 16, 2024

However, the agency can describe a concomitant therapy in labeling for a product it has authority to regulate if it is essential for the therapeutic effect. While the ability to describe and specify aspects of the therapy is limited, the agency can specify the number and licensure of therapists who would participate in the MDMA treatment.

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The Pharma Data

JANUARY 4, 2021

SENS-401 has demonstrated highly encouraging efficacy in preclinical models and we are excited to progress this small molecule towards clinical trials to address this significant unmet medical need in cancer patients undergoing cisplatin treatment. Further details on the trial design will be communicated in H2 2021. About Sensorion.

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PPD

MAY 7, 2024

The European Union (EU) is on the verge of a significant shift as it prepares to implement new health technology assessment (HTA) regulations in 2025. This harmonization aims to enhance the efficient use of resources, reduce duplication in HTA submissions and address inequities in patient access to innovative therapies.

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The Pharma Data

JUNE 18, 2021

The FDA’s decision is based on evidence from Pfizer’s clinical program in adults, including Phase 1 and 2 trials, and three Phase 3 trials (NCT03760146, NCT03828617, and NCT03835975) describing the safety and evaluating the immunogenicity of the vaccine. 2011;364(21):2016-2025. On September 20, 2018, Pfizer announced the U.S.

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