Advarra

JUNE 20, 2023

According to a 10-year oncology research study conducted by the Biotechnology Innovation Organization (BIO), only 5.1% Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54

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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. Multiple ascending dose and food effect study results.

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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 Vaccine Virus Pharmacokinetics 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. To learn more about the study or to review the volunteer qualifications, call 646-774-6243 or visit [link].

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DrugBank

OCTOBER 17, 2024

By harnessing the vast amounts of data generated throughout the development pipeline, pharmaceutical companies can accelerate the discovery of novel therapies, optimize clinical trial design, enhance drug safety monitoring, and deliver personalized medicine, ultimately improving patient outcomes and transforming the future of healthcare.

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Drug Development Metabolic Stability Clinical Trials Drugs 70

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.

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Clinical Trials Treatment Trials Drug Development 52

The ChEMBL-og

APRIL 16, 2024

The data in MOLECULE_DICTIONARY.MAX_PHASE now includes consideration of: EMA approved drugs (max_phase=4 for human drugs), USAN clinical candidate drugs (assigned as max_phase = 1 based on USAN guidance that states “Firms usually apply for a USAN when the investigational therapy is in Phase I or Phase II trials”.

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Clinical Trials FDA Cell Based Assays Compound Screening 108

DrugBank

MARCH 7, 2024

Pharmaceutical researchers, in particular, have a keen interest in understanding the unfolding dynamics of this market. On the other hand, Amgen revealed early-stage trial data on a promising once-a-month, weight loss medication, signaling its entry into this competitive arena.

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Pharmaceutical Companies Clinical Trials Pharmaceuticals Therapies 80

biobide

SEPTEMBER 29, 2023

Nowadays, the development of informatic models and the advances in Artificial Intelligence (AI) allow accurate predictions on complex biological processes such as pharmacokinetics or vast screenings of Drug candidates, based on the prediction of their pharmacological effects.

Animal Testing 106

Animal Testing Drugs Pharmacokinetics Regulations 106

Drug Target Review

JUNE 6, 2023

Difficult-to-treat and rare, complicated cancers remain a perplexing challenge for IO researchers. Research has shown that these immune system proteins have the ability to trigger anti-cancer immune pathways. Some approaches have already reached the clinical trial stage, with others not far behind.

Engineering 98

Engineering Immune Response Biochemical Pharmacology Clinical Trials 98

New Drug Approvals

OCTOBER 14, 2024

Avenciguat can be used in research of chronic kidney disease (CKD) and diabetic kidney disease (DKD). “Safety, tolerability, pharmacodynamics and pharmacokinetics of the soluble guanylyl cyclase activator BI 685509 in patients with diabetic kidney disease: A randomized trial” Diabetes, Obesity and Metabolism.

Pharmacokinetics 57

Pharmacokinetics Disease Trials Clinical Trials 57

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

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 We are proud to support Ischemix in advancing this vital new therapy.”

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Trials Treatment Clinical Pharmacology Pharmacokinetics 40

Drug Target Review

JUNE 12, 2023

Leveraging AI-guided structure-based drug design, Insilico’s research and development team generated an impressive portfolio of over 6,000 molecules and identified three highly promising hit series. 2021 – and a robust pipeline that includes 3 AI-designed drugs (for IPF, COVID-19 and cancer) currently in clinical trials.

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Metabolic Stability Clinical Trials Small Molecule Pharmacokinetics 92

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.

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Clinical Trials Trials Treatment FDA 52

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 Pharmacokinetics Pharmaceuticals Trials 122

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.

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Clinical Trials Trials Pharmacokinetics Clinical Development 40

The Pharma Data

APRIL 11, 2023

Bayer is progressing novel research around its prostate cancer treatment darolutamide. A focus of the presentation will be on the target engagement results and pharmacokinetics from its ongoing monotherapy dose-escalation study to explore a potential optimal dose and schedule to effectively inhibit AhR.

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Research Clinical Trials Small Molecule Trials 40

Vial

MARCH 15, 2024

A contract research organizations (CROs) is a third-party firm contracted by sponsors to deliver specialized services aimed at optimizing their research. This article explores the roles of CROs and highlights strategic partnerships between CROs and external vendors, designed to enhance research outcomes.

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The Pharma Data

OCTOBER 15, 2020

Vertex Pharmaceuticals has decided to give up on its experimental VX-814, a small molecule drug for the rare genetic disease Alpha-1 antitrypsin deficiency (AATD), canning the drug’s development after seeing lackluster results from an early phase 2 trial.

Disease 52

Disease Small Molecule Pharmacokinetics Licensing 52

The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. CARMIEL, Israel and BOSTON , Dec. Galactosidase-A enzyme.

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Clinical Trials Disease Treatment Trials 52

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.

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Clinical Trials Pharmacokinetics Trials Therapies 52

Alta Sciences

OCTOBER 15, 2024

Jason started his career as a research assistant carrying out operational phases of drug metabolism and pharmacokinetic studies. As my experience in preclinical research grew, so did my curiosity in the overall drug development process; I wanted to expand into clinical research. What Was your dream job as a child?

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Pharmacokinetics Clinical Trials Drug Development Science 52

Alta Sciences

AUGUST 12, 2024

Metabolic Drug Development: A to Z Solutions blussier Mon, 08/12/2024 - 18:07 HTML In the complex and dynamic field of metabolic drug development, partnering with an accomplished contract research organization is essential. We support data management both at our clinics and at external sites.

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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

PPD

OCTOBER 12, 2023

There are over 2,000 CGTs currently being evaluated in clinical trials, with more than 200 in Phase III and 10-20 per year estimated to come to market by 2025. Emerging areas of pharmaceutical research not only bring novel opportunities but also new regulatory guidance.

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Laboratories Protein Expression Clinical Trials Pharmacokinetics 52

The Pharma Data

APRIL 11, 2021

The data were presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, held virtually April 10-15, 2021. Retevmo was approved based on the Phase 1/2 LIBRETTO-001 trial’s endpoints of ORR and DoR. chief medical officer, oncology at Lilly. Retevmo (marketed as Retsevmo ® outside the U.S.)

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Research Therapies Treatment Trials 52

The Pharma Data

MARCH 9, 2022

There is a significant unmet need for outpatient treatments that can be taken by children and adolescents to help prevent progression to severe illness, including hospitalization or death,” said Mikael Dolsten, Chief Scientific Officer and President, Worldwide Research, Development and Medical, Pfizer.

Treatment 52

Treatment Pharmacokinetics Hospitals Trials 52

The Pharma Data

MARCH 23, 2021

This Phase 1 trial is being conducted in the United States. Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer. “We The structure of PF-07321332, together with the pre-clinical data, will be shared in a COVID-19 session of the Spring American Chemical Society meeting on April 6.

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Virus Vaccine Hospitals Pharmacokinetics 52

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. For more on FDORA’s other provisions, see HPM’s complete summary here ). FDORA § 3209(a)(1).

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Animal Testing Biosimilars Cell Based Assays FDA 64

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. Preclinical research suggests that this antibody against the target can potentially address the existing pandemic, as well as escape mutants. . before expanding it into Europe.

Licensing 52

Licensing Licensing Pharmacokinetics Clinical Trials 52

The Pharma Data

APRIL 26, 2022

director of the FDA’s Center for Drug Evaluation and Research. Given the similar course of COVID-19 disease in adults and pediatric patients, today’s approval of Veklury in certain pediatric patients is supported by efficacy results from phase 3 clinical trials in adults. The only approved dosage form is Veklury for injection.

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FDA Approval FDA Treatment Vaccine 52

Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation.

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The Pharma Data

OCTOBER 19, 2020

Intellia has received approval to launch their Phase I trial of NTLA-2001 in hereditary ATTR. Becky is now in Boston, enrolled in a clinical trial with monthly injections hoping to reverse her mutated proteins. who was part of the research duo that first developed CRISPR into a genome editing tool.

Therapies 52

Therapies Pharmacokinetics Trials Clinical Trials 52

Drug Target Review

SEPTEMBER 25, 2024

8 Preliminary data from the trial have shown good safety and tolerability for TT125-802, with confirmed preliminary target engagement in surrogate tissues such as hair follicles and peripheral blood mononuclear cells. Cancer research [Internet]. Cancer Research [Internet]. 2024 Mar 22 [cited 2024 Jul 8];84(6_Supplement):5891–1.

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Small Molecule Therapies Regulations Treatment 105

The Pharma Data

DECEMBER 15, 2020

Researchers are aware of more than 80 diseases that occur when the immune system attacks the body’s own organs, tissues and cells. The researchers regulated the abnormal immunological memory processes found in these patients. However, if the immune system malfunctions, it can attack healthy cells, tissues and organs.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

PerkinElmer

JUNE 3, 2022

Researchers are now studying the potential of protease inhibitors for the treatment of SARS-CoV-2. 2 PF-07321332, which is now being tested in clinical trials, 3 is a nitrile-containing derivative of PF-00835231.

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Fragment Screening Clinical Trials Vaccine Pharmacokinetics 52