The Pharma Data

JUNE 22, 2025

Throughout the 26-week study period, the investigational therapy was well-tolerated. Additionally, no participants developed neutralizing antibodies to Mim8—a key concern with biological therapies that could undermine long-term efficacy.

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The Pharma Data

JUNE 22, 2025

The results from the Phase I/II NXTAGE trial, announced during the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress in Washington, D.C., The results from the Phase I/II NXTAGE trial, announced during the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress in Washington, D.C.,

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Drug Target Review

JUNE 11, 2025

Drug development faces significant challenges: long timelines, high costs , complex processes and low probabilities of success (PoS), exacerbated by the shift towards more complex molecules, biologics and cell and gene therapies, hindering patient access to vital treatments.

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The Pharma Data

JUNE 18, 2025

“As our science has advanced, so has the need for tighter alignment across Research and Development to ensure that we continue to scale our impact and transform the lives of patients across a growing number of diseases,” Greenstreet stated. He holds a B.A. A New Chapter for Alnylam and RNAi Science With Dr.

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The Pharma Data

JUNE 6, 2025

Sanofi Highlights Robust Pipeline of Innovations in Rare Blood Disorders at ISTH 2025 Sanofi is poised to take center stage at the 33rd Congress of the International Society on Thrombosis and Haemostasis (ISTH), set to be held in Washington, D.C., and EU, in late 2024 as the first therapy of its kind. from June 21 to 25, 2025.

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The Pharma Data

JUNE 24, 2025

To date, more than 70 joint research projects have been initiated, and over 10 co-authored publications have appeared in top-tier international academic journals. Oncology remains a core priority, reflecting the rising global burden of cancer and the need for more effective, targeted therapies.

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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 6, 2025

Designed to serve a diverse international audience—including patients, healthcare providers, business partners, and investors—the site embodies the company’s twin commitments to scientific rigor and human empathy. “In In September, we celebrate the 50th anniversary of the company I founded in 1975. JCR Pharmaceuticals Co.,

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Drug Target Review

MARCH 17, 2025

However, a deeper understanding of brain function particularly the role of synaptic plasticity is now opening the door to innovative therapies. Donello has led numerous international scientific collaborations, acquisition integrations, and the in-licensing and out-licensing of various drug programmes.

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SugarCone Biotech

JULY 6, 2025

They have interesting patterns of expression in different cancer indications; thus, diverse therapies for attacking these targets have been developed. Each target and each therapeutic modality induces varying degrees of clinical efficacy, as well as causing toxicities. These activities are pro-oncogenic (reviewed here: [link] ).

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New Drug Approvals

MAY 15, 2025

A final lipophilicity adjustment led to the discovery of CDZ173 (leniolisib), a potent PI3K selective inhibitor with suitable properties and efficacy for clinical development as an anti-inflammatory therapeutic. New Drug Therapy Approvals 2023 (PDF). 29 March 2023. Retrieved 20 June 2023. World Health Organization (2016).

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The Pharma Data

JUNE 19, 2025

Grifols’ BT524 Fibrinogen Therapy Shows Promise in Phase 3 Trial Published in The Lancet’s eClinicalMedicine Grifols , a globally recognized healthcare company and a leader in the production of plasma-derived therapies, has marked a significant advancement in the treatment of acquired fibrinogen deficiency (AFD).

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Drug Target Review

MAY 26, 2025

With a particular focus on biologics, cell, and gene therapies, Galbraiths work is centred on equipping drug developers with the tools, insights, and support needed to advance their therapies from concept to clinic. We are driving rapid analytics to support the release of cell and gene therapies and other biologics.

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Drug Target Review

MAY 5, 2025

They wait for the therapies that could significantly improve their quality of life or even save it knowing approval could be years or decades away. And yet, despite this learning, traditional clinical development processes have failed to evolve; they still have high asset failure rates, longer development timelines, and significant costs.

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The Pharma Data

JULY 3, 2025

This support will accelerate the clinical development of the company’s pioneering DUO™ System—a minimally invasive transcatheter device designed to treat severe cases of tricuspid regurgitation. These attributes are expected to make the therapy more accessible in routine clinical practice. CroíValve Awarded €12.5M

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PPD

MARCH 13, 2024

Within cell therapy clinical trials, apheresis collections contribute to the specific constituents of the given therapy. Whether this is via an allogeneic (healthy donors) or autologous (patient) approach, the material collected is then manufactured and returned to patients for infusion therapy.

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FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” It finalized a draft guidance published in 2022.

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The Pharma Data

NOVEMBER 29, 2020

Prior to joining Gannex, Dr. Palmer was Head of Liver Disease Clinical Development at Takeda Pharmaceuticals. She has also held senior leadership positions at Shire Pharmaceuticals and Kadmon Corporation, where she was in charge of the global development of NASH and other liver disease programs. . ” About Ascletis.

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PPD

MARCH 26, 2024

A large majority of drug developers utilize FSP or hybrid FSP/FSO models, half are “heavy users” Heavy users: Those that use FSP or hybrid FSP/FSO models for most of their clinical development outsourcing. Heavy users leverage these models for nearly three-quarters of their outsourcing.

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The Pharma Data

JULY 23, 2021

Nasdaq: BIIB) today announced it will share multiple oral and poster presentations from its Alzheimer’s disease clinical development portfolio at the Alzheimer’s Association International Conference (AAIC), which will be held in Denver, Colorado and online July 26-30, 2021. Biogen Inc.

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Conversations in Drug Development Trends

MAY 1, 2024

This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinical trials. Ultimately, our goal is to bring safe and effective new therapies to patients. Japan, and China. and the U.S.

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LifeSciVC

APRIL 2, 2024

And the experience of those around you, including Board members and internal investors. We are confident that there is room for improvement over existing cystic fibrosis (CF) therapies because we have not yet achieved fully normalized function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein.

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The Pharma Data

JANUARY 27, 2021

HK), announced today that China Center for Drug Evaluation (CDE) has granted Breakthrough Therapy designation to Batoclimab (HBM 9161), a fully human anti-FcRn monoclonal antibody (mAb), for the treatment of adult patients with Myasthenia Gravis (MG). CAMBRIDGE, Mass. ROTTERDAM, Netherlands and SUZHOU, China , Jan. ” he added.

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Drug Target Review

OCTOBER 1, 2024

Indeed, I’m afraid to say I experienced some biases regarding my lack of experience when I joined my first company, especially from non-medical colleagues who saw me as an internal competitor. That paper, of which I was in the authorship, remains a current point of reference for that therapy usage.

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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. recent announcements from Merck and Sanofi for obesity and broader metabolic disease).

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Conversations in Drug Development Trends

JANUARY 24, 2024

Why Partnering with Genetic Counselors May Benefit Your Clinical Program The American College of Medical Genetics (ACMG) has issued a statement that geneticists should be involved in the development of genetic therapies. Enrolling adequate populations will be required to advance these programs.

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The Pharma Data

MARCH 9, 2021

New data from 10 studies will be presented by Eli Lilly and Company (NYSE: LLY) at the upcoming virtual International Conference on Alzheimer’s & Parkinson Diseases 2021 (AD/PD 2021), March 9-14, 2021. vice president of Alzheimer’s disease development unit, Eli Lilly and Company.

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The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Lonza announced today their agreement in support of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD). NEW YORK , Jan.

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PPD

SEPTEMBER 6, 2023

Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster.

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Conversations in Drug Development Trends

JULY 8, 2024

With radiopharmaceuticals emerging as a diagnostic and therapeutic (theranostics) procedure, many are in the clinical development pipeline and are expected to play a crucial role in the future of healthcare. Tissue Sensitivity : The sensitivity of target tissues and nearby organs to radiation therapy can vary considerably.

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The Pharma Data

NOVEMBER 25, 2020

26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. BioInvent International AB (publ).

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PPD

JUNE 17, 2024

When outsourcing some or all key functions to an FSP provider, a drug developer gains access to a wider pool of talent, including specialized functional, scientific and technical experts. 2) An established FSO arrangement is to be replaced, and the developer needs to transition to FSP without disrupting momentum.

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Drug Target Review

APRIL 9, 2024

Among other discoveries, the group developed inhibitors of the ATR kinase and showed their potential for cancer therapy. These compounds were later licensed to the pharmaceutical industry for clinical development.

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LifeSciVC

APRIL 24, 2024

There is a continuum of evidence for a given target – at one end are novel targets with some evidence of importance in disease, and at the other end are “de-risked” targets where the biology is precedented with an approved product or late-stage clinical asset(s). with gene editing or gene therapy, enzyme replacement therapy), agonism (e.g.,

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Advarra

OCTOBER 15, 2024

The International Council for Harmonisation (ICH) good clinical practice (GCP) guidelines are critical in ensuring the safety and rights of clinical trial participants. Sponsors should ensure a diverse multidisciplinary team of stakeholders supports the design of the study and the clinical development plan.

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PPD

OCTOBER 2, 2024

To support these functions, PPD™ Functional Service Partnership (FSP) Clinical Operations solutions harness the full range of innovative technologies, applying extensive skill and expertise to empower our customers to bring therapies to market quickly and within budget.

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The Pharma Data

SEPTEMBER 6, 2021

Currently, no treatment is approved for the therapy of RCC, and the medical need for new effective treatments is high. The selective mechanism of action of eliapixant appears to be translating into improved tolerability in clinical trials. These results will guide us to advance our clinical development strategy of eliapixant.”.

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