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. IPF, unclassifiable interstitial lung diseases (uILDs), Long COVID respiratory complications and related sequelae) and lymphedema.

Pharmacokinetics 52

Pharmacokinetics Treatment Trials Production 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. A high-risk participant can be even excluded from the study based on the severity of the adverse event.

Clinical Research 98

Clinical Research Clinical Trials Research Trials 98

New Drug Approvals

OCTOBER 14, 2024

Avenciguat can be used in research of chronic kidney disease (CKD) and diabetic kidney disease (DKD). Avenciguat (development name BI 685509 ) is a soluble guanylate cyclase activator developed by Boehringer Ingelheim for kidney disease, [1] [2] and cirrhosis. [3] 25 (8): 2218–2226. doi : 10.1111/dom.15099. PMID 37232058.

Pharmacokinetics 57

Pharmacokinetics Disease Trials Clinical Trials 57

The Pharma Data

DECEMBER 15, 2020

A healthy immune system defends the body against disease and other conditions. Autoimmune disease impacts different parts of the body, weakening functionality. Researchers are aware of more than 80 diseases that occur when the immune system attacks the body’s own organs, tissues and cells. It may be life-threatening.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

LifeSciVC

APRIL 24, 2024

Target validation : Do we believe the target(s) plays a central role in disease biology and that modulation will modify disease? There is nothing more exciting than digging into a new target and trying to develop a thesis on whether modulation may be impactful in disease. Is the functionality of mutations known?

Production 124

Production Small Molecule Regulations Trials 124

The Pharma Data

MARCH 22, 2021

Basel, 22 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the decision to discontinue dosing in the Phase III GENERATION HD1 study of tominersen in manifest Huntington’s disease (HD). About tominersen and the clinical trials. About Huntington’s disease. said Levi Garraway, M.D.,

Disease 52

Disease Clinical Trials Pharmacokinetics Treatment 52

Drug Target Review

DECEMBER 11, 2024

This shift in focus is especially critical in toxicology, where accurate target analysis plays a vital role in identifying toxic effects and ensuring patient safety, particularly as the field transitions from traditional drugs to the promising realm of biotherapeutics, especially for rare diseases.

International 52

International Laboratories Drugs Pharmacokinetics 52

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., Alzheon licensed ALZ-801 from NeuroChem and is developing it for Alzheimer’s disease. Clin Pharmacokinet. 2016 ; Abushakra et al., 2018; 32(9): 849–861. [2]. Hey JA, et al.

Pharmacokinetics 62

Pharmacokinetics Small Molecule Disease Licensing 62

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

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.

Trials 52

Trials Disease Treatment Clinical Trials 52

The Pharma Data

NOVEMBER 26, 2020

(NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx ® plant cell-based protein expression system, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A.,

Disease 52

Disease Treatment Clinical Trials FDA 52

Drug Target Review

SEPTEMBER 19, 2023

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. 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.

Animal Testing 98

Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

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. BOSTON, Jan.

Clinical Trials 52

Clinical Trials Trials Treatment FDA 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

Drug Target Review

OCTOBER 24, 2023

We identified these species as being important for treatment of UC by generating and analysing metagenomics data from a Faecal Microbiota Transplant (FMT) trial that was undertaken at the University of Adelaide. In addition to analysing metagenomics data, we also isolated bacteria from the healthy donor stool banked as part of that trial.

Treatment 122

Treatment Pharmaceuticals Pharmacokinetics Trials 122

The Pharma Data

JANUARY 19, 2021

The Phase 1 clinical trial is planned to be conducted in Canada and targeted to recruit up to 48 and 24 healthy volunteers for the single-ascending dose (SAD) and multiple- ascending dose (MAD) cohorts, respectively. About ALS-4.

Small Molecule 52

Small Molecule Clinical Trials Trials Pharmacokinetics 52

The Pharma Data

DECEMBER 21, 2020

Phase I safety, tolerability, and pharmacokinetic study in healthy volunteers expected to start in coming weeks following acceptance of a request for a Clinical Trial Authorization (CTA) granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA). ALLSCHWIL, Switzerland, Dec.

Clinical Trials 40

Clinical Trials Trials Pharmacokinetics Clinical Development 40

The Pharma Data

JANUARY 19, 2021

a privately-held neuron regeneration therapeutics company, today announced the publication of results of their novel pharmacotherapy: NNI-362 to allosterically stimulate neural regeneration in human cultures and in vivo models of aging and disease. There is a great need for a disease-modifying treatment for the 5.3 CLARKSVILLE, Md.,

Disease 40

Disease Small Molecule Clinical Trials Therapies 40

The Pharma Data

OCTOBER 14, 2021

For all other classes evaluated in the analysis, including the broad range of MS therapies offered by Biogen, the antibody response to vaccination is consistent with the response of patients not being treated with an MS disease-modifying therapy (DMT). Cleveland Clinic, and a paid consultant for Biogen. Source link: [link].

Vaccine 52

Vaccine Therapies Immune Response Disease 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. The primary objective of the trial is to evaluate the safety and tolerability of SAD and MAD of ALS-4 administered orally to healthy subjects. About ALS-4.

Small Molecule 40

Small Molecule Clinical Trials Trials Treatment 40

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. Islatravir Safety Analysis Through Week 96 from a Phase 2 Trial in Treatment Naïve Adults with HIV-1 Infection.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Trials Treatment 52

The Pharma Data

NOVEMBER 18, 2020

This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels. SEFA’ stands for Structurally Engineered Fatty Acid, i.e. chemically engineered fatty acids, to generate compounds with differentiated physiochemical properties.

Trials 40

Trials Engineering Pharmacokinetics Therapies 40

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

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

Alta Sciences

OCTOBER 30, 2023

Discover the considerations and assessments necessary for performing preclinical research for ophthalmic therapies in this new eBook, that covers everything you need to know, from species selection and routes of administration, to preparing for first-in-human trials. Read it now. The Altascientist : Issue No. Read or listen now. Watch it now.

Science 52

Science Clinical Trials Pharmacokinetics Clinical Pharmacology 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. What are the preclinical characteristics of ISM6331, including its efficacy, safety profile, and drug metabolism and pharmacokinetics (DMPK) properties?

Metabolic Stability 92

Metabolic Stability Clinical Trials Small Molecule Therapies 92

The Pharma Data

MARCH 5, 2021

The publication includes safety and efficacy data for 323 relapsed or refractory patients (including 170 with CLL/SLL, 61 with MCL, 26 with Waldenström’s macroglobulinemia and 66 with other B-cell lymphomas) that were enrolled to the BRUIN Phase 1/2 trial as of September 27, 2020. About the BRUIN Phase 1/2 Trial.

Clinical Trials 52

Clinical Trials Pharmacokinetics Trials Therapies 52

New Drug Approvals

APRIL 18, 2025

4] A medication used to reduce the amount of steroid replacement required in patients with a genetic disease that causes, amongst other symptoms, a steroid deficiency. 2] In the first trial, 122 adults received crinecerfont twice daily and 60 received placebo twice daily for 24 weeks. [2] . : 321839-75-2 Molecular Weight 519.50

FDA 62

FDA FDA Approval Drugs Trials 62

Alta Sciences

AUGUST 12, 2024

Altasciences has over 25 years of experience in metabolic diseases and supports every stage of the development process, from the initial discovery phase and preclinical studies to clinical trials and beyond. We support data management both at our clinics and at external sites.

Drug Development 40

Drug Development Clinical Trials Pharmacokinetics Drugs 40

PPD

MAY 11, 2023

To effectively implement vaccine clinical trials for special populations, it is critical for vaccine developers to partner with a contract research organization (CRO) that has demonstrated experience recruiting and retaining pediatric and elderly study participants — and managing the nuances these patients and their caregivers require.

Vaccine 52

Vaccine Clinical Trials Long-Term Care Facilities Trials 52

The Pharma Data

NOVEMBER 22, 2020

. “In collaboration with our partner, Novartis, our team continues to move at extraordinary speed from idea to bench to clinical trials, driven by a common desire to help patients against this devastating disease and help bring the world back closer to normalcy.” About Molecular Partners’ anti-COVID-19 program.

Trials 40

Trials Clinical Trials Licensing Licensing 40

The Pharma Data

APRIL 8, 2021

OCREVUS data show its consistent benefit on slowing disease progression in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). Data for ENSPRYNG in neuromyelitis optica spectrum disorder (NMOSD) reinforce safety and efficacy, including in patients with concomitant autoimmune diseases (CAIDs). Following U.S.

Clinical Trials 52

Clinical Trials Trials Disease Therapies 52

The Pharma Data

JANUARY 17, 2021

Spero has previously reported data from a Phase 1 double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial of SPR206 suggesting that SPR206 is well-tolerated at doses that are likely to be within a therapeutic range for targeting MDR Gram-negative bacterial infections. ” About SPR206.

Clinical Trials 52

Clinical Trials Clinical Development Pharmacokinetics Pharmaceutical Companies 52

Drug Target Review

JULY 1, 2024

As a non-NSAID, it reduces adverse effects associated with these pain relief drugs, including kidney injury, GI gastritis/ulceration and blood pressure elevation, which can affect patients with cardiovascular disease and the elderly. We set out to improve health by developing a novel non-opioid that avoids potential abuse.

Treatment 59

Treatment Clinical Trials Therapies Molecular Biology 59

PPD

OCTOBER 12, 2023

Since chimeric antigen receptor T cell (CAR-T) therapy was first approved in 2017, there has been a marked increase of cell and gene therapy studies resulting in significant changes in the way diseases are treated as well as patient outcomes. However, key differences between PCR assays and immunotherapeutic assays must be considered.

Laboratories 52

Laboratories Clinical Trials Protein Expression Pharmacokinetics 52

The Pharma Data

JULY 29, 2021

In the second, Lilly shared data showing that treatment with donanemab drives a rapid reduction of a biomarker reflecting Alzheimer’s disease pathology, plasma P-tau217, which was detected within 12 weeks. Visit LillyMemoryTrials.com for additional information on enrolling in Alzheimer’s disease trials.

Disease 52

Disease Treatment Pharmacokinetics Trials 52

The Pharma Data

DECEMBER 14, 2020

AbbVie has initiated a Phase I clinical trial of the antibody, and it will conduct the initial clinical program in the U.S. 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.

Licensing 52

Licensing Licensing Pharmacokinetics Clinical Trials 52