BioPharma Drive: Drug Pricing

DECEMBER 8, 2023

The setbacks for Merck demonstrate the challenge drug developers face in improving on Keytruda, which has brought in at least $18 billion so far this year for its maker.

Trials 291

Trials Drug Development Drugs 291

Drug Patent Watch

DECEMBER 30, 2024

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Types of Drug Applications The PMDA accepts three main types of drug applications: Investigational New Drug (IND) : Required for conducting clinical trials in Japan.

Drug Development 52

Drug Development Clinical Pharmacology Clinical Trials Pharmaceutical Companies 52

FDA Law Blog: Drug Discovery

JANUARY 30, 2025

However, as we note in that post, the design, timing of initiation, and timely conduct of confirmatory trials are also important considerations in FDAs determination of whether accelerated approval is appropriate. This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials.

FDA 105

FDA Trials Disease Drugs 105

Science Daily: Pharmacology News

JUNE 18, 2024

Tests, in mice, of a drug developed by the researchers showed that regulatory T cells can be attracted to specific body parts, boosted in number, and activated to suppress immune response and rebuild tissue. Clinical trials in humans are now planned.

Treatment 338

Treatment Immune Response Disease Clinical Trials 338

PPD

DECEMBER 16, 2024

Our annual look at the state of the drug development industry highlights a dual set of challenges complicating progress. Pressure and requirements to engage diverse patient populations in trials have become more challenging and expensive, requiring tailored strategies that can stretch both resources and budgets.

Drug Development 52

Drug Development Clinical Trials Compliance Trials 52

PPD

MARCH 11, 2025

Developing treatments for individuals living with rare diseases is critical, but orphan drug development is laden with unique obstacles that necessitate innovative, multifaceted approaches. Moreover, in some rare disease trials, it is unethical to design a control group of patients with a placebo.

Drug Development 52

Drug Development Clinical Trials Disease Trials 52

Quanticate

AUGUST 2, 2024

Real-world evidence (RWE) is changing clinical drug development, bridging the gap between controlled clinical trial environments and the complexities of everyday patient experiences.

Drug Development 104

Drug Development Clinical Trials Drugs Trials 104

Quanticate

SEPTEMBER 13, 2024

With the implementation of technology rapidly increasing, stricter regulatory standards, and growing demand for innovative treatments, the trends within the industry continue to evolve, impacting the future of clinical trials both positively and negatively.

Clinical Trials 95

Clinical Trials Trials Drug Development Treatment 95

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.

Drug Development 52

Drug Development Clinical Pharmacology Immune Response Drugs 52

BioPharma Drive: Drug Pricing

FEBRUARY 28, 2025

The brain drug developer is continuing a trial despite a recommendation it be stopped for futility. Elsewhere, Eli Lilly struck a molecular glue deal and Zevra sold a priority review voucher.

Trials 144

Trials Drug Development Drugs 144

BioPharma Drive: Drug Pricing

SEPTEMBER 16, 2024

Worldwide Clinical Trials is at the forefront, partnering with drug development teams to map this new path forward. Applying CAR T-cell therapy in new clinical settings presents unique challenges.

Therapies 130

Therapies Trials Clinical Trials Drug Development 130

PPD

SEPTEMBER 25, 2023

As the clinical trial landscape evolves, drug developers are faced with novel challenges and changes in study recruitment, trial size and structure, and more. The adoption of new innovations, strategies and technologies offers opportunities to address persistent challenges and develop suitable approaches for the future.

Drug Development 104

Drug Development Clinical Trials Drugs Trials 104

BioPharma Drive: Drug Pricing

MARCH 21, 2024

Though the medicine hit its goal in a Phase 3 study in myasthenia gravis, the results fell short of expectations in a boost to rival drug developers like Argenx and AstraZeneca.

Disease 184

Disease Trials Drugs Drug Development 184

Broad Institute

DECEMBER 18, 2023

Brain disorders are difficult to study and many drug candidates have failed in clinical trials, causing pharmaceutical companies to reduce their investments or even exit the field entirely. The key problem is that there appear to be many different underlying mechanisms that lead to depression. Biomarkers could take many forms.

Drug Development 130

Drug Development Clinical Trials Drugs Disease 130

Drug Target Review

APRIL 7, 2025

Advanced strategies and tools are being implemented to establish the safety and efficacy of new therapeutic modalities, with the development of new biomarkers becoming one of the most relevant approaches for enhancing the precision and utility of early-stage studies.

Clinical Development 69

Clinical Development Clinical Trials Clinical Pharmacology Trials 69

DrugBank

OCTOBER 17, 2024

Data science has emerged as an innovative tool in the biopharmaceutical industry, leveraging the power of machine learning and artificial intelligence to drive innovation and efficiency across the entire drug development lifecycle. This was seen in the case of the BRAF V600E mutation test for melanoma patients receiving vemurafenib.

Drug Development 98

Drug Development Metabolic Stability Clinical Trials Drugs 98

FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

Clinical Development 69

Clinical Development Production Clinical Trials Treatment 69

DrugBank

JUNE 6, 2024

In the rapidly evolving landscape of oncology drug development, artificial intelligence (AI) has emerged as a revolutionary force, altering not just the pace but the very methodology of discovery and development. Lantern Pharma's RADR ® platform stands as a pivotal advancement in the fight against cancer.

Drug Development 98

Drug Development Clinical Trials Drugs Therapies 98

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. Overseen by an insourced project manager. Contracts are milestone- or unit-based.

Drug Development 98

Drug Development Clinical Trials Drugs Clinical Research 98

Drug Target Review

MARCH 24, 2025

To understand the significance of this goal, it is important to recognise the current drug development process. This uncertainty contributes to the high failure rate and enormous costs of drug development. Currently, understanding these aspects requires extensive animal testing followed by human trials.

Clinical Trials 59

Clinical Trials Animal Testing Drugs Pharmacokinetics 59

Quanticate

APRIL 29, 2025

Clinical research is evolving as technology advancements enable more sophisticated drug development methods, dramatically increasing the speed, volume, and complexity of clinical trial data generation.

Clinical Trials 59

Clinical Trials Drug Development Trials Compliance 59

Conversations in Drug Development Trends

JANUARY 21, 2025

Rigorous procedures to ensure that drugs are effective and safe. Regulatory bodies such as the FDA oversee clinical trials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws. No matter how small, any lack of efficiency can snowball into costly delays in drug approval.

Clinical Trials 78

Clinical Trials Laboratories Trials Drug Development 78

PPD

JUNE 7, 2023

Food and Drug Administration (FDA) for approval , much work remains for drug developers aiming to advance treatments for pediatric populations. Reflecting Patient Diversity in NASH Trials Data from NASH clinical trials within adult populations may support clinical research into treatment for pediatric populations.

Trials 98

Trials Clinical Trials Clinical Research Disease 98

ProRelix Research

APRIL 5, 2023

Clinical trials form the decisions for regulatory approval of drugs and medical devices and as a result are the most important step of a drug development program.

Trials 98

Trials Clinical Trials Drug Development Research 98

Conversations in Drug Development Trends

MAY 10, 2024

Over the past two decades, industry-sponsored clinical trials have targeted treatments for BPD, yielding some promising outcomes; however, broader psychiatric research often excludes BPD patients, a trend that extends to the emerging field of psychedelic studies.

Clinical Trials 95

Clinical Trials Trials Treatment Drug Development 95

PPD

AUGUST 14, 2024

Clinical trials have significantly increased in complexity over the last 20 years, creating new challenges. One of the top reported challenges facing drug developers today is recruiting, enrolling and retaining the right patients for studies. The increase in complexity isn’t just creating challenges for patients.

Clinical Trials 92

Clinical Trials Trials Clinical Research Research 92

Conversations in Drug Development Trends

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

FDA 96

FDA Trials Clinical Trials Disease 96

Conversations in Drug Development Trends

MARCH 1, 2024

These designs facilitate streamlined trial logistics and centralized governance and create higher-quality data. Master protocols allow a trial to perform multiple tests on diverse patient populations or diseases under a unified design. Do you have various stakeholders invested in the success of your development programs?

Trials 78

Trials Disease Drug Development Clinical Trials 78

PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. Many of these patients’ conditions are disabling.

Trials 69

Trials Clinical Trials Drug Development Therapies 69

BioPharma Drive: Drug Pricing

SEPTEMBER 30, 2024

Clinical services organizations can help pharma with global drug development and clinical trial challenges.

Clinical Trials 130

Clinical Trials Marketing Drug Development Trials 130

Antidote

JULY 8, 2022

This includes the six to seven years that the medicine will go through clinical trial phases, plus a few others that we’ll discuss below.

Pharmacy 98

Pharmacy Drug Development Clinical Trials Research 98

BioPharma Drive: Drug Pricing

JANUARY 27, 2025

Pharmacies play a key role in improving drug development and patient care, offering insights, clinical trial support and personalized patient programs.

Pharmacy 130

Pharmacy Clinical Trials Drug Development Trials 130

Conversations in Drug Development Trends

OCTOBER 26, 2022

Bringing a psychedelic into a clinical trial setting is complex and requires a thorough operational approach to ensure the study’s success. Psychedelic trials need to be done with scientific rigor. Our team published recently in The Journal of Psychedelic Psychiatry exploring how we can bring more rigor to these trials.

Trials 97

Trials Clinical Trials Licensing Licensing 97

Drug Target Review

JULY 18, 2023

Artificial Intelligence (AI) is poised to transform the field of target discovery in drug development, offering immense potential to enhance efficacy, personalised medicine, and accelerate the development of innovative compounds.

Drug Development 98

Drug Development Drugs Clinical Development Pharmaceutical Companies 98

Drug Patent Watch

DECEMBER 9, 2024

This approach has led to the discovery of numerous potential drug candidates. From Lab to Market: The Long Road of Drug Development Once a promising compound is identified, it enters the long and costly process of drug development. Q: How long does a drug patent last?

Drugs 93

Drugs Drug Development Pharmaceuticals Production 93

Conversations in Drug Development Trends

JANUARY 24, 2024

Written By: Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Disease Given that 80% of rare diseases have a genetic etiology, genetic implications should be addressed at the onset of a clinical program to support trial enrollment. One diagnostic example that I discussed in my presentation is autism.

Trials 75

Trials Disease Clinical Trials Clinical Research 75

Drug Target Review

APRIL 30, 2025

It involves a dynamic and often unpredictable process where every stage, from target identification to clinical trials, generates vast amounts of data. Additionally, AI-driven predictive modelling can shorten the preclinical phase by simulating biological responses, leading to more targeted and efficient clinical trials. The result?

Therapies 90

Therapies Drugs Clinical Trials Trials 90