The Pharma Data

JUNE 27, 2025

The GEMZ study is a randomized, double-blind, placebo-controlled, fixed-dose, multi-center clinical trial designed to assess the safety, efficacy, and pharmacokinetics of fenfluramine in children and adults aged 1 to 35 years diagnosed with CDD who experience uncontrolled seizures.

Trials

Drug Target Review

JULY 7, 2025

Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. Food and Drug Administration (FDA). Bailey J, et al. Trends in Non-Human Primate Use for Research and Testing.

Drug Research

Alta Sciences

DECEMBER 31, 2024

Listen to the audiobook or download the PDF below, to learn more about: key factors to consider in drug development (age, biological sex, genetics, DDIs); examples of common DDI involving the cytochrome P450 enzyme system; and drug interactions and guidance for marketed drugs. The Altascientist, Issue 7, pg.

Therapies

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.

Drug Development

DrugBank

JULY 14, 2025

These interactions can alter the pharmacological activity of one or more drugs, potentially leading to diminished therapeutic effects or unexpected toxic reactions. DDI can occur through multiple mechanisms, including alterations in drug absorption, distribution, metabolism, and excretion.

Clinical Development

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. This is based on the traditional model of occupancy-driven pharmacology, where a drug’s therapeutic effects are directly related to the time it occupies its target.

Treatment

New Drug Approvals

AUGUST 7, 2025

After undergoing currently approved targeted therapies, patients with tumors containing ROS1 and neurotrophic tyrosine kinase receptor (NTRK) gene fusions frequently acquire resistance mutations [88,89]. These mutations restrict the ability of drugs to bind to their targets, ultimately resulting in the advancement of tumors.

FDA

Alta Sciences

APRIL 24, 2025

Case Study: How Altasciences Overcame Pharmacological Challenges in a GLP-1 IND-Enabling Study pmjackson Thu, 04/24/2025 - 21:43 For emerging therapies with pronounced pharmacological effects, thoughtful study design is critical to ensuring reliable and interpretable data.

Small Molecule

PPD

APRIL 14, 2025

This expansion is creating opportunities for clinical trials related to a range of new therapy areas and their subpopulations. Were applying that expertise and commitment to every aspect of developing and running successful GLP-1 studies.

Clinical Trials

Alta Sciences

JUNE 26, 2025

MENU logo-altasciences EN - Main navigation Proactive Drug Development Solutions Compare Us Facilities About Us Resource Center Careers News & Events 30th Anniversary Celebration Contact Us Participate in a study Français Home Current: Salt Lake City Salt Lake City Share this page Submitted by pmjackson on Thu, 06/26/2025 - 15:11 Image Downtown (..)

Pharmacokinetics

Alta Sciences

JUNE 26, 2025

MENU logo-altasciences EN - Main navigation Proactive Drug Development Solutions Compare Us Facilities About Us Resource Center Careers News & Events 30th Anniversary Celebration Contact Us Participate in a study Français Home Current: Gretchen Green Gretchen Green Share this page Submitted by pmjackson on Thu, 06/26/2025 - 15:12 Image gretchen-green.jpg (..)

Pharmacokinetics

Alta Sciences

JULY 3, 2025

MENU logo-altasciences EN - Main navigation Proactive Drug Development Solutions Compare Us Facilities About Us Resource Center Careers News & Events 30th Anniversary Celebration Contact Us Participate in a study Français Home Current: Business Leaders Review - The Heart and Strategy Behind Altasciences' Marketing Evolution Business Leaders (..)

Marketing

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

ASPET

JULY 15, 2024

XELOX therapy, which comprises capecitabine and oxaliplatin, is the standard first-line chemotherapeutic regimen for colorectal cancer. Mathematical modeling combining pharmacokinetics (PK) and toxicodynamics (TD) is a promising approach for optimizing dosing strategies and reducing toxicity.

Pharmacokinetics

DrugBank

APRIL 3, 2025

Advances in predictive modeling, high-throughput screening, and omics technologies have provided powerful tools to uncover safety risks early in the drug development pipeline. This increases costs and delays the introduction of potentially life-saving therapies. Preclinical studies form the backbone of early safety assessment.

Drug Development

Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

Drug Development

Drug Target Review

SEPTEMBER 25, 2024

While these approaches often produce encouraging initial results, the development of drug resistance remains a major obstacle for long-term patient survival. Most targeted cancer therapies used today operate by inhibiting targets along well-known oncogenic signalling cascades.

Small Molecule

DrugBank

MARCH 7, 2024

Moreover, smaller companies like Altimmune are seeking partnerships to propel the development of their experimental drugs. As larger players scout for innovative solutions, partnerships with smaller firms offer a pathway to accelerate drug development and diversify product portfolios.

Pharmaceutical Companies

Alta Sciences

OCTOBER 30, 2023

TOP NONCLINICAL SCIENTIFIC RESOURCES eBook : Safety Assessment for Ophthalmic Products Designing preclinical studies for ocular therapies take a lot of deliberation. The Altascientist : Issue No. Read or listen now. Watch the video. Listen here. Watch it now. The Altascientist : Issue No.

Science

DrugBank

APRIL 24, 2025

Epigenetic drugs, which target the enzymes and processes involved in these modifications, represent a novel approach to precision medicine. These therapies aim to reverse abnormal epigenetic patterns, restore normal gene function, and offer hope for previously uncurable diseases.

DNA

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. MB097, our drug with immune-oncology applications, is a consortium of nine bacterial strains.

Treatment

Conversations in Drug Development Trends

DECEMBER 20, 2023

Single-Arm Trial Design Single-arm trials have also become an increasingly common development strategy to support regulatory approval and allow patients expedited access to novel therapies, particularly in the accelerated access setting.

Clinical Trials

Drug Target Review

JULY 12, 2023

We also leverage existing clinical gene expression data from different subsets of molecularly profiled cancer patients, who differ in a certain aspect of disease or response to a particular therapy. Author Bio: Brett Hall Brett has been Chief Scientific Officer at Immuneering since November 2019.

Biochemical Assays

Alta Sciences

SEPTEMBER 13, 2023

COMMONLY USED PAIN MODELS As pain models continue to expand, there are still many tried and tested ways to achieve the most accurate results possible, such as pain stimulation, pharmacodynamics (PD), and pharmacokinetics (PK) for early phase analgesic trials. At Altasciences , we have extensive experience testing various pain models.

Clinical Trials

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.

Licensing

The Pharma Data

DECEMBER 9, 2020

The first trial will be conducted as a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the intravenous liposomal formulation of ibrexafungerp in healthy subjects. The study will be conducted in South Africa. For more information, visit www.scynexis.com.

Hospitals

The Pharma Data

OCTOBER 25, 2020

Treatment choices are limited, and commonly used off-label therapies are not always effective or may result in prolonged, deep sedation. In addition, this indication offers synergy with the commercial infrastructure being developed to support our first New Drug Application.”. NEW HAVEN, Conn., BioXcel Therapeutics, Inc.

Treatment

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

The Pharma Data

OCTOBER 18, 2020

Several clinical sites are screening patients for the Phase 1 a/b multicenter, open-label, dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the maximum tolerated dose or recommended dose in patients with relapsed or refractory AML. About CG-806.

Clinical Trials

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. ” About Hepion Pharmaceuticals.

Clinical Trials

The Pharma Data

AUGUST 29, 2020

Oral, investigational complement factor B inhibitor LNP023 substantially improved hematological response as add-on therapy to eculizumab. To date, after at least six months of stable LNP023 add-on therapy, and at the investigators’ discretion, seven patients (70%) have discontinued eculizumab and remained on LNP023 as monotherapy.

Treatment

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Importantly, midomafetamine was proposed for use in conjunction with psychotherapy.

FDA

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

The Pharma Data

AUGUST 30, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Dupixent for the treatment of severe atopic dermatitis (in children aged 6 months to 11 years of age). Detailed results from this trial will be presented at a future medical meeting, and data will be submitted to regulatory authorities. In 2016, the U.S.

Trials

The Pharma Data

DECEMBER 5, 2020

” In the trial, the 49 patients evaluated had a median of five prior lines of therapy (range: 2-17) with 100% being triple-refractory and 57% being penta-refractory; all patients were refractory to anti-CD38 therapy. With a median follow up of 2.6 Multiple myeloma is not curable despite treatment advances.

Production

DrugBank

MARCH 19, 2025

Unlike the traditional “ one-size-fits-all ” model, precision medicine leverages individual patient data, genetic profiles, environmental exposures, and lifestyle factors to design therapies tailored to each person’s unique needs. Precision medicine's benefits extend far beyond cancer care.

Clinical Trials

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. By fostering the fluid movement between research and clinical practice, we can better contribute to the development of therapies, which has been the most rewarding aspect of my career.

Clinical Development