Advarra

NOVEMBER 14, 2024

In an era where clinical trials are increasingly global, it’s more imperative than ever to leverage international expertise. Data and safety monitoring boards (DSMBs), also known as data monitoring committees (DMCs), play a critical role in overseeing a clinical trial’s safety and efficacy. local standards of care).

Clinical Trials

PPD

JULY 18, 2025

Effective communication with regulatory authorities is critical for small biotech companies, as it is often the key to success in clinical trials. When small and emerging companies are able to build strong, trust-based relationships with regulators, they often see benefits like reduced development risk and accelerated timelines.

Regulations

Advarra

JULY 3, 2025

Designed to better manage risk, patient safety, and data integrity in clinical trials, the updated guideline is expected to be adopted by regulatory authorities worldwide. Read on to explore how ICH E6 (R3) may affect your ongoing and future trials—and use the following 10 critical categories of questions to assess your readiness.

Compliance

Conversations in Drug Development Trends

OCTOBER 29, 2024

By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinical research, particularly in rare disease, represents a significant shift in the clinical trial landscape. Why Is There an Increase in Patient-Led Rare Disease Research?

Clinical Research

The Premier Consulting Blog

JANUARY 14, 2025

Oncology Regulatory Affairs and Policy Program Advancing Oncology Decentralized Trials Multiple trial modernization initiatives Evaluate the benefits and challenges of decentralized trials to prioritize streamlined procedures for future trials. Provides the Oncology Dosing Toolkit.

Clinical Trials

New Drug Approvals

APRIL 25, 2025

Members of the PI3K family regulate cellular processes such as cell growth and proliferation, survival, remodelling, and intracellular transport of organelles. [15] 3] Names Inavolisib is the international nonproprietary name. [22] 3] Names Inavolisib is the international nonproprietary name. [22] 3 November 2006. 122.001096.

FDA

PPD

JUNE 17, 2025

In the past decade alone, the time needed to complete a clinical trial has increased by 20–30%, and the cost to bring a new drug to market has risen to an average of about $2.6 This, in turn, allows sponsors to focus on core competencies and strengthen internal capabilities to create a more focused and agile clinical development operation.

Clinical Development

DrugBank

JUNE 18, 2025

Drug development is a complex and highly regulated process. While these regulations protect public health, they also introduce significant challenges for pharmaceutical researchers. The failure rate in clinical trials exceeds 90%, often due to insufficient safety data, efficacy concerns, or regulatory non-compliance.

Drug Development

The Pharma Data

JUNE 9, 2025

“With the acceptance of our application for pimicotinib and the initiation of the priority review, we aim to offer patients in China the first approved systemic therapy for TGCT, addressing a tremendous unmet need in this country,” stated Hong Chow , Head of China and International, Healthcare Business of Merck. Source link

Treatment

Codon

JULY 28, 2025

The first of these components is the therapeutic genetic payload, or cargo, which is designed to correct or regulate the disease-causing mutation, whether that means offering a healthy copy of a mutated gene or delivering precision-editing tools like CRISPR. After internalization, AAV escapes from endosomes and moves to the nucleus.

Immune Response

The Pharma Data

JUNE 27, 2025

Understanding the Medications Involved: Semaglutide’s Growing Role in Global Health Semaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1RA) , a class of drugs that has gained substantial popularity over recent years for its efficacy in blood glucose regulation, weight reduction, and cardiovascular risk management.

Therapies

Codon

JUNE 5, 2025

Gray, in London to discuss the significance of her recovery at the Third International Summit on Human Genome Editing , described Casgevy as “a new beginning for people with sickle cell disease.” Dozens more clinical trials, based upon similar gene-editing technologies, are now underway.

DNA

Drug Target Review

MARCH 17, 2025

Neuropsychiatric disorders, affecting millions worldwide, disrupt the brain’s intricate processes of mood regulation, cognition and behaviour. Hopes for the Phase IIb trial Donello discusses the key outcomes he hopes to see in the Phase IIb VITALIZE study of zelquistinel for major depressive disorder (MDD).

Treatment

The Pharma Data

JUNE 20, 2025

Speaking about the significance of this new approval, Patrick Dunn , Executive Director of the International Pemphigus and Pemphigoid Foundation, said: “People affected by bullous pemphigoid endure unrelenting itch and painful blisters that can damage the skin. of patients receiving Dupixent compared to 6.1% receiving placebo. Dr. George D.

FDA Approval

The Pharma Data

JUNE 13, 2025

This favorable opinion, following a rigorous evaluation by European regulators, is based on a comprehensive package of data demonstrating the medication’s quality, safety, and efficacy. This rigorous trial further strengthens the medication’s credibility and its ability to aid dogs suffering from these chronic skin disorders.

Treatment

FDA Law Blog: Biosimilars

JUNE 4, 2025

In this instance, the Assessment appears to have been developed behind closed doors, and evidently did not undergo an internal or external review thorough enough to capture these errors. Notably, many of the issues regarding drugs are typically considered the practice of medicine, which FDA does not regulate.

Drugs

Drug Target Review

MAY 26, 2025

“A big part of my role involves interacting with customers, learning from them on their challenges and providing solutions to expedite their path to clinical trials or commercialisation of their drug,” Galbraith explains. We are driving rapid analytics to support the release of cell and gene therapies and other biologics.

Drug Development

BioPharma Drive: Drug Pricing

JULY 18, 2025

Both decisions were contentious, sparking internal disagreements between FDA reviewers and Peter Marks, then the head of the FDA office that reviews gene therapies. You can unsubscribe at anytime. You can unsubscribe at anytime. Sign up A valid email address is required. Please select at least one newsletter. Registered in England and Wales.

Therapies

FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. Clarification of Roles and Responsibilities The Roles & Responsibilities section was added to provide clearer expectations for all trial stakeholders.

Clinical Trials

Advarra

MARCH 6, 2025

For more than 35 years, Advarra has been committed to protecting the rights and welfare of clinical trial participants while helping to improve healthcare outcomes, advancing medical knowledge, and bringing innovative, life-extending treatments to market that benefit millions of patients worldwide.

Clinical Research

Conversations in Drug Development Trends

JANUARY 6, 2025

In contrast, an adaptive trial design allows for modifications to an ongoing trial and its analyses under a pre-specified framework, which is outlined in the FDAs Adaptive Designs for Clinical Trials for Drugs and Biologics Guidance for Industry, published in 2019.

Trials

Advarra

MAY 14, 2025

With a decade of experience as regulatory counsel in the FDAs Center for Drug Evaluation and Research Office of Scientific Investigations, her experience will help Advarras clients and internal teams navigate the ever-shifting regulatory landscape for human subjects research. Sponsors often ask, How will the FDA view this?

FDA

FDA Law Blog: Biosimilars

MAY 15, 2025

Dr. Makary noted that he doesnt believe that the traditional playbook works for everythingparticularly in the case of life-threatening diseases where randomized controlled trials are neither feasible nor humane. He also specifically mentioned rare diseases here , in addition to his example of late-stage illnesses.

FDA

Advarra

JANUARY 13, 2023

New privacy regulations seem to form every few months, especially with individual U.S. states adopting their own privacy regulations (e.g., This blog explores what it takes for an EAC/CEC to adequately support worldwide clinical trials. The Nigerian Data Protection Regulation (NDPR). The Global Reach of EACs and CECs.

Clinical Trials

Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

Trials

PPD

AUGUST 5, 2024

Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success. Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success.

Clinical Trials

The Pharma Data

OCTOBER 15, 2020

Moderna is working with international regulators to accelerate approval of the company’s coronavirus disease 2019 (COVID-19) vaccine candidate, mRNA-1273, which is currently leading the global COVID-19 vaccine race alongside vaccine candidates from AstraZeneca, Pfizer and Johnson & Johnson. In the U.S.,

Vaccine

Conversations in Drug Development Trends

APRIL 3, 2024

Are you aware of the challenges you must address for a successful radiopharmaceutical trial? Enhancing Patient Participation in Radiopharmaceutical Trials Patient recruitment is a critical yet challenging part of radiopharmaceutical trials.

Trials

PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). In addition, the constant evolution of EMA and Clinical Trials Coordination Group (CTCG) guidelines requires constant attention.

Clinical Trials

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. Maintaining open lines of communication helps address issues as they arise, allowing for real-time clarification and adjustments.

Clinical Research

Agency IQ

MAY 28, 2024

regulator lays out proposal for international device and diagnostics recognition The British medical device regulator just issued its promised framework on international recognition. law as the Medical Devices Regulation 2002 (UK MDR 2002). law as the Medical Devices Regulation 2002 (UK MDR 2002).

International

The Pharma Data

SEPTEMBER 14, 2020

. AstraZeneca has confirmed that clinical trials assessing its Oxford University partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA). Source link.

Vaccine

The Pharma Data

SEPTEMBER 14, 2020

After sparking a wave of concern through industry and mainstream media with the news it had halted international studies investigating its COVID-19 vaccine on 6 September, AstraZeneca has now announced that clinical trial operations conducted alongside its partners at the University of Oxford are now back in full swing.

Vaccine

DrugBank

APRIL 25, 2024

Overcoming internal resistance to change is also part of the journey, requiring clear demonstration of AI's benefits and involving your team in the transition. This tech can speed up everything from drug design to clinical trials by processing complex datasets more efficiently. In the U.S.,

Clinical Trials

Alta Sciences

AUGUST 21, 2024

Internships at Altasciences: Q&A With Our Summer Interns nbartlett Thu, 08/22/2024 - 04:44 Internships at Altasciences are more than just a stepping stone—they’re a gateway to real-world-experience and professional growth, giving the next generation opportunities to help shape progress in the drug development industry. The work environment.

International

PPD

JULY 16, 2024

Staying current with PV-relevant regulations and regulatory guidance can be challenging and often requires an FSP PV RI team that spans multiple countries and languages. This includes everything from clarifications sought from individual regulatory authorities to Q&A documents, other professional publications and conference presentations.

Compliance

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. Challenges and opportunities of the new EU HTA regulation The implementation of centralized HTA presents both opportunities and challenges for pharmaceutical companies.

Regulations