PPD

JULY 29, 2024

In today’s data-driven world, AI has become valuable and indispensable, enabling organizations to extract valuable insights from vast amounts of data, make informed decisions and drive innovation across different sectors — including drug development.

Clinical Research 98

Clinical Research Clinical Trials Research Trials 98

Drug Target Review

SEPTEMBER 19, 2023

The chips can be modelled with primary cells, IPS derived stem cells or patient derived cells and potentiates to unlock molecular mechanisms that drive the disease pathophysiology, holding a greater promise. The first successful chip adaptation to a lung model was first described in 2010 by Donald Ingber, a bioengineer at Wyss institute.

Animal Testing 98

Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

Drug Target Review

MARCH 17, 2025

By adjusting the activity of this receptor, these drugs can influence brain functions associated with mood, cognition and pain, positioning them as potential treatments for conditions like depression, cognitive disorders and neurological diseases. The drug’s pharmacokinetics (PK) and pharmacodynamics (PD) are closely linked.

Treatment 52

Treatment Licensing Licensing Science 52

The Pharma Data

NOVEMBER 5, 2021

With presently no approved treatments, there’s a major unmet need for curatives that can delay progression to order failure, “ said John Tsai, Head of Global Drug Development and Chief Medical Officer at Novartis.

Disease 52

Disease Treatment Pharmacokinetics FDA 52

Drug Target Review

SEPTEMBER 25, 2024

However, this will not be straightforward, given that non-oncogene resistance is driven by complex transcriptional networks, and the key drivers that determine how these mechanisms could be targets for drug development remain elusive. Available from: [link] 8.Boni Journal of Clinical Oncology [Internet]. Available from: [link] 9.Mohanty

Small Molecule 105

Small Molecule Therapies Regulations Treatment 105

Drug Target Review

JULY 12, 2023

These assays provide insights into the molecular mechanisms of disease biology and drug response, enabling the characterisation of gene expression profiles and deviations in diseased cells. Importantly, transcriptomics information shows that certain aspects of a disease change the gene expression profile.

Biochemical Assays 98

Biochemical Assays Treatment Bioinformatics Disease 98

Drug Target Review

OCTOBER 24, 2023

We also believe that drug development teams should routinely consider the potential modifying effect of the gut microbiome on drug potency and factor it into assessments of PK and PD. What advantages does this offer in the field of precision medicine?

Treatment 122

Treatment Pharmaceuticals Pharmacokinetics Trials 122

Alta Sciences

OCTOBER 30, 2023

36: Nonclinical Studies in Cell and Gene Therapy – Key Considerations and Regulatory Guidance With an estimated 6,000 monogenic diseases affecting over 350 million people worldwide, the advantages of cell and gene therapy can be a ray of hope—but development of complex, leading-edge therapies requires careful planning. Read it now.

Science 52

Science Clinical Trials Pharmacokinetics Clinical Pharmacology 52

DrugBank

FEBRUARY 12, 2025

The pharmaceutical industry grapples with the persistent challenge of high attrition rates and escalating costs inherent in drug development. This necessitates exploring alternative strategies to expedite drug discovery and optimize resource allocation.

Cell Based Assays 52

Cell Based Assays Drugs Pharmacokinetics Disease 52

PPD

MAY 11, 2023

The global COVID-19 pandemic increased awareness of the importance of vaccine development — both for drug developers and the public. The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developed vaccines, there was variation among who could receive the shots and when.

Vaccine 52

Vaccine Clinical Trials Long-Term Care Facilities Trials 52

The Pharma Data

DECEMBER 14, 2020

The Phase I trial is a randomized, double-blind, placebo-controlled study that is meant to evaluate the safety, pharmacokinetics and pharmacodynamics of single ascending doses of ABBV-47D11. ” Under the license agreement, the development of ABBV-47D11 will be greatly advanced. In July, HBM announced that it had raised $102.8

Licensing 52

Licensing Licensing Pharmacokinetics Clinical Trials 52

The Pharma Data

AUGUST 30, 2021

Dupixent plus TCS reduced overall disease severity by 70% and itch by 49%. A pivotal Phase 3 trial evaluating Dupixent ® (dupilumab) for the treatment of children aged 6 months to 5 years with moderate-to-severe atopic dermatitis, a chronic type 2 inflammatory disease, met its primary and all secondary endpoints. Yancopoulos, M.D.,

Trials 52

Trials Disease Treatment Clinical Trials 52

The Pharma Data

AUGUST 29, 2020

Seven of ten patients discontinued eculizumab and remained on LNP023 as monotherapy, retaining hemoglobin (Hb) levels with no changes in biomarkers of disease activity and with no signs or symptoms of breakthrough hemolysis . Peffault de Latour.

Treatment 52

Treatment Disease Small Molecule Production 52

The Pharma Data

DECEMBER 9, 2020

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days.

Clinical Trials 40

Clinical Trials Trials Pharmaceuticals Pharmacokinetics 40

New Drug Approvals

SEPTEMBER 13, 2024

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 12] Positron emission tomography imaging revealed that brain KORs were almost completely saturated by the drug 2.5 Drug Discovery. nM vs. 24.0

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

The Pharma Data

DECEMBER 5, 2020

57% of evaluable patients (4 of 7 patients) were minimal residual disease (MRD) negative. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. 42% (n=8) had a CR or sCR. and the world, respectively, in 2020.

Production 40

Production Trials Treatment Disease 40

The Pharma Data

OCTOBER 25, 2020

In addition, this indication offers synergy with the commercial infrastructure being developed to support our first New Drug Application.”. This condition may be caused by numerous underlying pathologic processes and disease states. Agitation associated with delirium occurs in the majority of patients with this condition.

Treatment 40

Treatment Trials FDA Hospitals 40

Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

Science 40

Science FDA Trials Clinical Pharmacology 40

Agency IQ

DECEMBER 11, 2023

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time.

FDA 40

FDA Research Clinical Trials Trials 40

New Drug Approvals

JANUARY 9, 2024

The present invention is directed to methods of preparation of compound of formula (I) that is useful for inhibiting Cyclin-dependent kinase 7 (CDK7) and for treating diseases or disorders mediated thereby. Inhibitors of CDK7 are currently being developed for the treatment of cancer. Aug 26;78(4):713- 24, 1994).

Production 62

Production DNA RNA Regulations 62

PPD

APRIL 14, 2025

Last year, an American Heart Association presidential advisory for the first time formally identified the strong connections between cardiovascular disease (CVD), kidney disease, Type 2 diabetes and obesity as reason to define cardiovascular-kidney-metabolic (CKM) syndrome.

Clinical Trials 52

Clinical Trials Trials Clinical Development Disease 52

DrugBank

MARCH 19, 2025

Introduction At DrugBank, we are proud to play a pivotal role in advancing precision medicine, a new healthcare approach that is transforming how diseases are treated and prevented. This shift has already reshaped fields such as oncology, rare genetic disorders, and metabolic diseases, and its influence continues to expand.

Therapies 90

Therapies Clinical Trials Pharmacokinetics Treatment 90

The Pharma Data

NOVEMBER 6, 2020

The Advisory Committee also voted 0 yes, 7 no and 4 uncertain on the question, “Does Study 103 (PRIME) provide supportive evidence of the effectiveness of aducanumab for the treatment of Alzheimer’s disease?”, Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer’s disease.

Disease 40

Disease FDA Clinical Trials Licensing 40

Drug Target Review

OCTOBER 16, 2024

My clinical background as a physician led me to drug development, where I realised I could have an even broader impact on patient well-being. In reality, our deep understanding of disease pathology and patient needs is instrumental in shaping both basic and clinical research into viable treatments.

Clinical Development 52

Clinical Development Drug Development Therapies Disease 52

DrugBank

FEBRUARY 26, 2025

Introduction The rise of antibiotic resistance is a pressing challenge facing modern medicine, threatening to reverse decades of progress in treating infectious diseases. This stagnation has created a perfect storm, threatening the effectiveness of current therapies and limiting the pipeline of new drugs.

Therapies 52

Therapies Pharmaceutical Companies Pharmacokinetics Treatment 52

Alta Sciences

JULY 31, 2024

Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025. Similarly, more than 90% of people in the United States with sickle cell disease are Black, with an estimated three to nine percent being Hispanic or Latino.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Treatment 52

The Pharma Data

DECEMBER 28, 2020

NASH, which is a severe form of non-alcoholic fatty liver disease affects approximately 17 million people in the U.S. The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. and is a leading cause of liver transplantation.

Clinical Trials 40

Clinical Trials Trials Pharmaceuticals Treatment 40

FDA Law Blog: Drug Discovery

JULY 9, 2024

DAP Content In developing DAPs, the Draft Guidance recommends that sponsors consider whether certain demographic groups may have a different response to a medical product regarding either effectiveness or safety. The enrollment goals should be informed by the estimated prevalence or incidence of the disease or condition in the U.S.

FDA 59

FDA Clinical Trials Disease Trials 59

Agency IQ

SEPTEMBER 22, 2023

Since that time, the FDA’s use of single pivotal trials has become more common , especially due to FDA’s expanded reviews of products intended to treat, cure or prevent rare diseases or life-threatening conditions for which there is an unmet clinical need.

FDA 40

FDA Science Trials Clinical Trials 40

Agency IQ

JULY 28, 2023

The assessment should include recommendations “on further enhancements” for hiring and retention of staff in FDA’s human drug review program. The Centers for Disease Control and Prevention (CDC) explains that the first wave began with increased prescription of opioids in the 1990s. Read the full AgencyIQ analysis here.

FDA 40

FDA Pharmacokinetics Clinical Pharmacology Government 40

Agency IQ

FEBRUARY 12, 2024

Another guidance will focus on pharmacokinetics in pregnancy, likely replacing a 2004 guidance document that the FDA never finalized, while a guidance the creation of a “REMS Logic Model” framework is meant to “link program design with assessment” – something called for in the most recent PDUFA VII commitment letter.

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

DECEMBER 11, 2023

Diagnostic and therapeutic advances in oncology have moved many cancer types into the categories of curable or treatable diseases. That’s why, according to FDA’s Oncology Center of Excellence, the determination of an appropriate endpoint in oncology is based on the specific disease and is highly dependent upon numerous factors.

FDA 40

FDA Science Clinical Trials Trials 40

Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

FDA 40

FDA Science Biosimilars Clinical Trials 40

Agency IQ

FEBRUARY 2, 2024

The revisions flesh out considerations for use of biomarkers at all stages of product development and add new content on rare cancers and platform trial designs. after ischemic heart disease and stroke. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996. were from cancer.

Clinical Trials 40

Clinical Trials Trials Treatment Disease 40

Agency IQ

FEBRUARY 23, 2024

Overdue EMA reflection paper on drug dosing in obesity introduces more questions than answers Although the prevalence of overweight and obesity in Europe exceeds 50%, the EMA does not currently offer guidance to sponsors on investigating the effects of obesity during drug development.

Drugs 40

Drugs Clinical Trials Pharmacokinetics Drug Development 40

Alta Sciences

SEPTEMBER 27, 2024

Featuring two scenarios that explore the complexities of bioanalysis for immunomodulators, The Altascientist offers practical considerations for ensuring accurate bioanalysis, as well as pharmacokinetic, pharmacodynamic , and safety data in clinical trials.

Clinical Trials 52

Clinical Trials Trials Pharmacokinetics Small Molecule 52

Agency IQ

OCTOBER 20, 2023

BY KARI OAKES, CHELSEY MCINTYRE, PHARMD | OCT 16, 2023 9:28 PM CDT Background: Diabetic foot infections Diabetes mellitus, a disease that occurs when blood glucose levels are too high , is highly prevalent. The Centers for Disease Control and Prevention’s National Diabetes Statistics Report estimates that over 11% of the U.S.

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FDA Treatment Trials Therapies 40