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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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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Laboratories Protein Expression Clinical Trials Pharmacokinetics 52

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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The Pharma Data

MARCH 23, 2023

In this landmark Phase 3 trial, patients with uncontrolled COPD achieved clinical outcomes with Dupixent at a magnitude never before seen with a biologic. Detailed efficacy and safety results from this trial will be presented in a future scientific forum. AEs leading to deaths were balanced between the two arms (1.7% placebo, 1.5%

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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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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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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

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 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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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

JULY 7, 2023

building off the EMA’s Strategy through 2025. Just as a quick reminder: Real-world Data (RWD) is data generated by the health care system outside clinical trials. Regulators at EMA have outlined their intent to “enable” RWE and “establish its value for regulatory decision-making” by 2025.

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Regulations Research Production Government 40

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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Therapies Disease Trials Production 52

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.

Research 52

Research Treatment Clinical Trials Production 52

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.

Treatment 52

Treatment Trials Disease Therapies 52

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.

Clinical Trials 52

Clinical Trials Small Molecule Therapies Treatment 52

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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Trials Clinical Trials Therapies Treatment 52

Agency IQ

FEBRUARY 2, 2024

EPA March 1 FDA Budget FDA’s budget authority will expire as of midnight on March 1 POLITICO March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinical trials of products intended to treat the disease expires.

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Agency IQ

DECEMBER 1, 2023

If all changes are accepted, the date of application is set to be January 1, 2025. The changes to the EMA’s Fee Regulation (Regulation (EC) No 297/95) could be adopted during this month’s planned plenary meeting. The European Parliament is set to vote during the plenary meeting on December 12.

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Drug Target Review

MAY 31, 2024

At CTx, Rachel’s contributions to pioneering work drugging novel epigenetic targets led to a first-in-class asset in the clinic targeting ER+ breast cancer, including patients refractory to endocrine therapy. As a woman in STEM, what unique perspectives or strengths do you believe you bring to your work?

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Organic Chemistry Computational Chemistry Small Molecule Disease 45

Agency IQ

MARCH 29, 2024

Title Type Deadline Guideline on clinical investigation of medicinal products in the treatment of depression [EMA] Scientific guideline 3/31/2024 Concept paper on the establishment of a Guideline on the development and manufacture of human medicinal products specifically designed for phage therapy [EMA] Concept paper 3/31/2024 Pharmeuropa 36.1

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The Pharma Data

JUNE 18, 2021

The ADVANCE study included patients with past intolerance or inadequate response to conventional therapy (non-bio-IR) and/or biologic therapy (bio-IR). The MOTIVATE trial evaluated only bio-IR patients. The MOTIVATE study evaluated patients who had responded inadequately or were intolerant to biologic therapy.

Disease 40

Disease Therapies Treatment Clinical Trials 40

The Pharma Data

JUNE 18, 2021

“In our global clinical trial program to-date, risankizumab has shown clinically meaningful rates of endoscopic response and clinical remission among patients living with moderate to severe Crohn’s disease,” said Michael Severino, M.D., 1 Both patients continued in the trial. vice chairman and president, AbbVie.

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Agency IQ

JULY 8, 2024

Device regulators have dropped important guidance recently , publishing guidance on alternative trial designs for orphan devices and updating how to carry out benefit-risk assessments on the use of toxic phthalates in medical devices. elections over, AgencyIQ is also anticipating the new European Parliament to start work again soon.

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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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Agency IQ

OCTOBER 27, 2023

11/9/2023: Enters into force 11/9/2025: Date of application To contact the authors of this resource, please email Sierra Milam ( smilam@agencyiq.com ). To contact the editor of this resource, please email Chelsey McIntyre ( cmcintyre@agencyiq.com ).

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Agency IQ

JULY 8, 2024

Date What’s Happening Explanation Source June 29 GGP Report FDA expected to finalize report on Good Guidance Practices AgencyIQ June 30 User Fee Payments Industry required to confirm NDA prescription drug products in Orange Book for purposes of PDUFA payments in FY 2025 FDA July 1 Anniversary Anniversary of the signing of the Public Health Service (..)

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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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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.

Treatment 59

Treatment Clinical Trials Therapies Molecular Biology 59

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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Clinical Trials Trials Treatment Clinical Research 52

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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Clinical Trials Trials Science FDA 52

Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

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FDA Science Biosimilars Clinical Trials 40

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.

Regulations 52

Regulations Pharmaceutical Companies International Pharmaceuticals 52

Agency IQ

MAY 3, 2024

Two consultations on clinical trial considerations, one on advanced therapies and the other addressing non-inferiority and equivalence comparisons, are closing at the end of May. The pharma reform package remains in E.U. leaders’ eyesight as the Parliament winds down ahead of its June elections.

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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] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] hours following a single dose of 10 mg, which supported the 4 mg to 25 mg dosages that aticaprant is being explored at in clinical trials. [13]

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Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Agency IQ

JUNE 21, 2024

BY ALEXANDER GAFFNEY, MS, RAC | JUN 20, 2024 10:53 AM CDT Peter Marks on the START Pilot Program: Goals and future PDUFA plans The Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot was formally unveiled in September 2023.

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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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