DrugBank

MARCH 19, 2025

  Precision Medicine – A New Standard in Healthcare Precision medicine is fundamentally changing how we think about disease treatment and prevention. It provides detailed data on drug interactions, molecular targets, pharmacokinetics, and biological pathways, all critical for developing personalized therapies.

Therapies 90

Therapies Clinical Trials Pharmacokinetics Treatment 90

Alta Sciences

SEPTEMBER 13, 2023

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials pmjackson Wed, 09/13/2023 - 17:01 September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions.

Clinical Trials 52

Clinical Trials Treatment Trials Drug Development 52

PPD

JULY 29, 2024

AI also has the potential to incorporate real-world data (RWD) obtained from electronic health records (EHRs), medical claims or other data sources to inform the design and optimization strategy of clinical trials.

Clinical Research 98

Clinical Research Clinical Trials Research Trials 98

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

The Pharma Data

JULY 21, 2021

Islatravir is currently being evaluated across a variety of dosing regimens, for both the treatment of HIV-1 infection in combination with other antiretroviral agents and for the prevention of HIV-1 infection as a monotherapy. Phase 2a Oral Study Results for Investigational Islatravir.

Clinical Trials 52

Clinical Trials Pharmacokinetics Trials International 52

Drug Target Review

OCTOBER 24, 2023

Live Bacterial Products (LBPs) will provide patients with a desirable, credible, safe and effective treatment option. The human microbiome, a complex ecosystem of microorganisms residing within our bodies, has emerged as a promising frontier in the quest for innovative medical treatments.

Treatment 122

Treatment Pharmaceuticals Pharmacokinetics Trials 122

Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

Clinical Trials 52

Clinical Trials Treatment Trials Small Molecule 52

The Pharma Data

NOVEMBER 17, 2020

The study demonstrated favorable proof-of-concept for LYT-100’s tolerability and pharmacokinetic (PK) profile, which will also enable twice-a-day (BID) dosing of LYT-100 in future studies. The therapeutic dose of pirfenidone approved by the US Food and Drug Administration (FDA) for the treatment of IPF is 801 mg three times a day.

Pharmacokinetics 52

Pharmacokinetics Treatment Trials Production 52

Alta Sciences

AUGUST 28, 2023

Altasciences Completes Successful Phase I Trial of Ischemix’ Novel Compound for Treatment of Traumatic Brain Injury (TBI) pmjackson Mon, 08/28/2023 - 14:04 Laval, Québec, August 30, 2023 – Altasciences is pleased to have completed a Phase I trial on Ischemix, Inc.’s Stern, MD, Chief Medical Officer for Ischemix.

Trials 40

Trials Treatment Clinical Pharmacology Pharmacokinetics 40

The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company. “We

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

Advarra

JUNE 20, 2023

Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community. More targeted therapies may change which patients and cancers may benefit, since a given treatment may only impact very specific biomarkers and genetic profiles.

Trials 52

Trials Clinical Trials FDA Approval Therapies 52

The Pharma Data

APRIL 26, 2022

This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age. As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population,” said Patrizia Cavazzoni, M.D.,

FDA Approval 52

FDA Approval FDA Treatment Vaccine 52

Drug Target Review

APRIL 7, 2025

A surrogate endpoint is a marker used in clinical trials as a substitute for a direct clinical outcome. Susceptibility or risk biomarkers can detect the likelihood of a patient developing a disease or medical condition, which is crucial for treatments that are most effective before the onset of symptoms.

Clinical Development 52

Clinical Development Clinical Trials Clinical Pharmacology Trials 52

The Pharma Data

MARCH 9, 2022

Treatment-emergent adverse events were comparable between PAXLOVID (23%) and placebo (24%), most of which were mild in intensity. million treatment courses delivered thus far and 30 million expected by July to help combat this devastating disease. Pfizer Inc.

Treatment 52

Treatment Pharmacokinetics Hospitals Trials 52

DrugBank

MARCH 7, 2024

Inspired by its success, pharmaceutical companies are pursuing the development of drugs with similar therapeutic profiles, aiming to expand treatment options. Supply issues have plagued the availability of their weight loss treatments, creating hurdles for patients seeking these medications.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceuticals Clinical Trials Therapies 98

The Pharma Data

AUGUST 22, 2021

The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium.

Trials 52

Trials Virus Vaccine Pharmacokinetics 52

The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. galactosidase-A product candidate under development for the treatment of Fabry disease. Twenty of twenty-two patients completed the 12-month treatment duration. CARMIEL, Israel and BOSTON , Dec.

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

The Pharma Data

SEPTEMBER 7, 2021

The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by researchers at the University of Minnesota Medical School. The study plans to enroll up to 45 volunteers.

Clinical Trials 52

Clinical Trials Vaccine Trials Medical Schools 52

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 52

Drug Development Treatment FDA Approval Drugs 52

Drug Target Review

JULY 1, 2024

As a non-opioid, SRP-001 also eliminates abuse potential, positioning it as a safer and effective drug candidate for the treatment of acute and neuropathic pain and migraine headache. In Phase I clinical trials, SRP-001 showed no serious adverse events among 56 healthy volunteers, highlighting its safety.

Treatment 59

Treatment Clinical Trials Therapies Molecular Biology 59

The Pharma Data

AUGUST 30, 2021

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. Global Head of Research and Development at Sanofi. Yancopoulos, M.D.,

Trials 52

Trials Disease Treatment Clinical Trials 52

The Pharma Data

MARCH 26, 2021

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation. About COMET-ICE.

Treatment 52

Treatment FDA Vaccine Trials 52

Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

Clinical Trials 40

Clinical Trials Treatment Trials Small Molecule 40

New Drug Approvals

OCTOBER 12, 2024

Years later, a subgroup analysis of the trial data indicated a potential positive effect in participants who carried two copies of ApoE4 ( Abushakra et al., ALZ-801 is an advanced and markedly improved candidate for the treatment of alzheimer’s disease. Clin Pharmacokinet. 2016 ; Abushakra et al., 2018; 32(9): 849–861. [2].

Pharmacokinetics 62

Pharmacokinetics Small Molecule Disease Licensing 62

The Pharma Data

MARCH 8, 2021

Islatravir is an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) currently being evaluated across a variety of doses, formulations and frequencies for both the treatment of HIV-1 infection in combination with other antiretroviral agents and for the prevention of HIV-1 infection as a single agent.

Trials 52

Trials Clinical Trials Pharmacokinetics Research Laboratories 52

The Premier Consulting Blog

MAY 31, 2023

While the type, number, and design of these studies vary based on product-specific characteristics, IND-enabling packages submitted to the FDA generally include key information about the pharmacology, pharmacokinetics, and toxicology of the product. All these studies need to be performed under GLP.

Packaging 52

Packaging Pharmacokinetics Small Molecule Clinical Trials 52

Drug Target Review

DECEMBER 11, 2024

For these studies, a comprehensive approach to drug metabolism and pharmacokinetics (DMPK), along with immunogenicity is essential, drawing on expertise from multiple disciplines. Such an approach ensures reliable preclinical toxicology data and supports the transition of innovative therapies from the lab to clinical trials.

International 52

International Laboratories Drugs Pharmacokinetics 52

The Pharma Data

NOVEMBER 17, 2021

The blessing of VUMERITY provides a new oral treatment option with low gastrointestinal termination rates that may help cases to start and cleave to treatment,” said Simon Faissner,M.D., In EVOLVE-MS-2, the rate of overall treatment termination was lower in actors treated with VUMERITY compared to those treated with TECFIDERA (1.6

Treatment 52

Treatment Marketing Clinical Trials Biosimilars 52

The Pharma Data

DECEMBER 28, 2020

The AMBITION trial is the first placebo-controlled study of CRV431 in NASH patients with evidence of moderate-to-severe fibrosis. The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. To date, there are no approved drugs to treat NASH.

Clinical Trials 40

Clinical Trials Trials Pharmaceuticals Treatment 40

The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. 4] , [5] , [6].

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

DECEMBER 20, 2020

Pending Health Canada’s approval, the Phase 1 trial is designed to test the safety, tolerability and pharmacokinetics of ALS-4 in healthy volunteers. ALS-4 is an orally administered drug and thereby aligning with global healthcare policy to actively promote the switch from an IV to oral based antimicrobial treatment 1,2,3.

Small Molecule 40

Small Molecule Clinical Trials Trials Treatment 40

The Pharma Data

NOVEMBER 26, 2020

Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company’s Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients with Fabry disease. About Pegunigalsidase Alfa.

Disease 52

Disease Treatment Clinical Trials FDA 52

Drug Target Review

JUNE 12, 2023

With 13 preclinical candidates and three AI-designed drugs currently undergoing clinical trials, Insilico is spearheading a revolution in cancer treatment and beyond. Can you provide a summary of the key findings and implications of the preclinical studies on ISM6331 for the treatment of advanced solid tumours?

Metabolic Stability 92

Metabolic Stability Clinical Trials Small Molecule Pharmacokinetics 92

Drug Target Review

SEPTEMBER 25, 2024

4 Another related and well described non-oncogene resistance mechanism is the histological transformation of EGFR-mutated non-small cell lung cancer (NSCLC) to small-cell lung cancer upon treatment with an EGFR inhibitor. Notably, TT125-802 stabilised disease and prevented further outgrowth of tumours resistant to standard-of-care treatment.

Small Molecule 105

Small Molecule Therapies Regulations Treatment 105

The Pharma Data

JULY 12, 2021

These data include results from a late-breaking presentation from a Phase 2a study evaluating the safety and pharmacokinetics (PK) of once-monthly (QM) oral islatravir for pre-exposure prophylaxis (PrEP) through 24 weeks. An overview of the islatravir treatment and prevention development program is available here. Abstract 2361.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Trials Treatment 52

The Pharma Data

JANUARY 26, 2021

While the preliminary nature of Phase 2 results from COVID-19 neutralizing monoclonal antibodies may have limited acceptance of treatment, these Phase 3 data further strengthen the available evidence,” said Daniel Skovronsky, M.D., INDIANAPOLIS, Jan. Across 1,035 patients, there were 11 events (2.1 have reached record highs.

Hospitals 52

Hospitals Treatment Trials Long-Term Care Facilities 52

The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset. STOCKHOLM , Jan.

Trials 40

Trials Clinical Trials Pharmacokinetics Small Molecule 40